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Sample records for hiv prevention trials

  1. The obligation to provide antiretroviral treatment in HIV prevention trials.

    PubMed

    Lo, Bernard; Padian, Nancy; Barnes, Mark

    2007-06-19

    Providing antiretroviral therapy (ART) to participants who seroconvert during HIV prevention trials in developing countries is an ethical expectation. Promising treatment to the few seroconverters widens disparities within a resource-poor country and would be unjust. Such an assurance should be done in a way that also improves access to ART for others in the country. US funds for ART in poor countries from the PEPFAR should be available to all countries that host HIV prevention and clinical trials. PMID:17545698

  2. Creating an African HIV Clinical Research and Prevention Trials Network: HIV Prevalence, Incidence and Transmission

    PubMed Central

    Kamali, Anatoli; Price, Matt A.; Lakhi, Shabir; Karita, Etienne; Inambao, Mubiana; Sanders, Eduard J.; Anzala, Omu; Latka, Mary H.; Bekker, Linda-Gail; Kaleebu, Pontiano; Asiki, Gershim; Ssetaala, Ali; Ruzagira, Eugene; Allen, Susan; Farmer, Paul; Hunter, Eric; Mutua, Gaudensia; Makkan, Heeran; Tichacek, Amanda; Brill, Ilene K.; Fast, Pat; Stevens, Gwynn; Chetty, Paramesh; Amornkul, Pauli N.; Gilmour, Jill

    2015-01-01

    HIV epidemiology informs prevention trial design and program planning. Nine clinical research centers (CRC) in sub-Saharan Africa conducted HIV observational epidemiology studies in populations at risk for HIV infection as part of an HIV prevention and vaccine trial network. Annual HIV incidence ranged from below 2% to above 10% and varied by CRC and risk group, with rates above 5% observed in Zambian men in an HIV-discordant relationship, Ugandan men from Lake Victoria fishing communities, men who have sex with men, and several cohorts of women. HIV incidence tended to fall after the first three months in the study and over calendar time. Among suspected transmission pairs, 28% of HIV infections were not from the reported partner. Volunteers with high incidence were successfully identified and enrolled into large scale cohort studies. Over a quarter of new cases in couples acquired infection from persons other than the suspected transmitting partner. PMID:25602351

  3. Civil society perspectives on negative biomedical HIV prevention trial results and implications for future trials.

    PubMed

    Essack, Zaynab; Koen, Jennifer; Slack, Catherine; Lindegger, Graham; Newman, Peter A

    2012-01-01

    Community engagement is crucial to ongoing development and testing of sorely needed new biomedical HIV prevention technologies. Yet, negative trial results raise significant challenges for community engagement in HIV prevention trials, including the early termination of the Cellulose Sulfate microbicide trial and two Phase IIb HIV vaccine trials (STEP and Phambili). The present study aimed to explore the perspectives and experiences of civil society organization (CSO) representatives regarding negative HIV prevention trial results and perceived implications for future trials. We conducted in-depth interviews with 14 respondents from a broad range of South African and international CSOs, and analyzed data using thematic analysis. CSO representatives reported disappointment in response to negative trial results, but acknowledged such outcomes as inherent to clinical research. Respondents indicated that in theory negative trial results seem likely to impact on willingness to participate in future trials, but that in practice people in South Africa have continued to volunteer. Negative trial results were described as having contributed to improving ethical standards, and to a re-evaluation of the scientific agenda. Such negative results were identified as potentially impacting on funding for trials and engagement activities. Our findings indicate that trial closures may be used constructively to support opportunities for reflection and renewed vigilance in strategies for stakeholder engagement, communicating trial outcomes, and building research literacy among communities; however, these strategies require sustained resources for community engagement and capacity-building.

  4. HIV-1 transmission linkage in an HIV-1 prevention clinical trial

    SciTech Connect

    Leitner, Thomas; Campbell, Mary S; Mullins, James I; Hughes, James P; Wong, Kim G; Raugi, Dana N; Scrensen, Stefanie

    2009-01-01

    HIV-1 sequencing has been used extensively in epidemiologic and forensic studies to investigate patterns of HIV-1 transmission. However, the criteria for establishing genetic linkage between HIV-1 strains in HIV-1 prevention trials have not been formalized. The Partners in Prevention HSV/HIV Transmission Study (ClinicaITrials.gov NCT00194519) enrolled 3408 HIV-1 serodiscordant heterosexual African couples to determine the efficacy of genital herpes suppression with acyclovir in reducing HIV-1 transmission. The trial analysis required laboratory confirmation of HIV-1 linkage between enrolled partners in couples in which seroconversion occurred. Here we describe the process and results from HIV-1 sequencing studies used to perform transmission linkage determination in this clinical trial. Consensus Sanger sequencing of env (C2-V3-C3) and gag (p17-p24) genes was performed on plasma HIV-1 RNA from both partners within 3 months of seroconversion; env single molecule or pyrosequencing was also performed in some cases. For linkage, we required monophyletic clustering between HIV-1 sequences in the transmitting and seroconverting partners, and developed a Bayesian algorithm using genetic distances to evaluate the posterior probability of linkage of participants sequences. Adjudicators classified transmissions as linked, unlinked, or indeterminate. Among 151 seroconversion events, we found 108 (71.5%) linked, 40 (26.5%) unlinked, and 3 (2.0%) to have indeterminate transmissions. Nine (8.3%) were linked by consensus gag sequencing only and 8 (7.4%) required deep sequencing of env. In this first use of HIV-1 sequencing to establish endpoints in a large clinical trial, more than one-fourth of transmissions were unlinked to the enrolled partner, illustrating the relevance of these methods in the design of future HIV-1 prevention trials in serodiscordant couples. A hierarchy of sequencing techniques, analysis methods, and expert adjudication contributed to the linkage

  5. Adherence and the Lie in a HIV Prevention Clinical Trial

    PubMed Central

    Stadler, Jonathan; Scorgie, Fiona; van der Straten, Ariane; Saethre, Eirik

    2016-01-01

    The lie has been presented as a performance that protects identities against moral judgment in the context of power imbalances. We explore this assertion from the perspective of a pre-exposure prophylaxis trial to prevent HIV for African women in South Africa, in which context biological evidence of widespread lying about product adherence was produced, resulting in a moral discourse that opposed altruistic and selfish motivations. In this article, we seek to understand the meaning of the lie from the perspective of women trial participants. Seeing the trial as representing a hopeful future, and perfect adherence as sustaining their investment in this, participants recited scripted accounts of adherence and performed the role of the perfect adherer, while identifying other participants as dishonest. Given that clinical trials create moral orders and adherence is key to this, we argue that women embraced the apparatus of the clinical trial to assert their moral subjectivities. PMID:26575611

  6. Analyzing Direct Effects in Randomized Trials with Secondary Interventions: An Application to HIV Prevention Trials.

    PubMed

    Rosenblum, Michael; Jewell, Nicholas P; van der Laan, Mark; Shiboski, Steve; van der Straten, Ariane; Padian, Nancy

    2009-04-01

    The Methods for Improving Reproductive Health in Africa (MIRA) trial is a recently completed randomized trial that investigated the effect of diaphragm and lubricant gel use in reducing HIV infection among susceptible women. 5,045 women were randomly assigned to either the active treatment arm or not. Additionally, all subjects in both arms received intensive condom counselling and provision, the "gold standard" HIV prevention barrier method. There was much lower reported condom use in the intervention arm than in the control arm, making it difficult to answer important public health questions based solely on the intention-to-treat analysis. We adapt an analysis technique from causal inference to estimate the "direct effects" of assignment to the diaphragm arm, adjusting for condom use in an appropriate sense. Issues raised in the MIRA trial apply to other trials of HIV prevention methods, some of which are currently being conducted or designed. PMID:20827388

  7. Analyzing Direct Effects in Randomized Trials with Secondary Interventions: An Application to HIV Prevention Trials

    PubMed Central

    Rosenblum, Michael; Jewell, Nicholas P.; van der Laan, Mark; Shiboski, Steve; van der Straten, Ariane; Padian, Nancy

    2010-01-01

    Summary The Methods for Improving Reproductive Health in Africa (MIRA) trial is a recently completed randomized trial that investigated the effect of diaphragm and lubricant gel use in reducing HIV infection among susceptible women. 5,045 women were randomly assigned to either the active treatment arm or not. Additionally, all subjects in both arms received intensive condom counselling and provision, the “gold standard” HIV prevention barrier method. There was much lower reported condom use in the intervention arm than in the control arm, making it difficult to answer important public health questions based solely on the intention-to-treat analysis. We adapt an analysis technique from causal inference to estimate the “direct effects” of assignment to the diaphragm arm, adjusting for condom use in an appropriate sense. Issues raised in the MIRA trial apply to other trials of HIV prevention methods, some of which are currently being conducted or designed. PMID:20827388

  8. Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

    PubMed

    Dawson, Liza; Zwerski, Sheryl

    2015-06-01

    This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. PMID:25230397

  9. Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

    PubMed

    Dawson, Liza; Zwerski, Sheryl

    2015-06-01

    This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions.

  10. Regional Differences in Prevalence of HIV-1 Discordance in Africa and Enrollment of HIV-1 Discordant Couples into an HIV-1 Prevention Trial

    PubMed Central

    Lingappa, Jairam R.; Lambdin, Barrot; Bukusi, Elizabeth Ann; Ngure, Kenneth; Kavuma, Linda; Inambao, Mubiana; Kanweka, William; Allen, Susan; Kiarie, James N.; Makhema, Joseph; Were, Edwin; Manongi, Rachel; Coetzee, David; de Bruyn, Guy; Delany-Moretlwe, Sinead; Magaret, Amalia; Mugo, Nelly; Mujugira, Andrew; Ndase, Patrick; Celum, Connie

    2008-01-01

    Background Most HIV-1 transmission in Africa occurs among HIV-1-discordant couples (one partner HIV-1 infected and one uninfected) who are unaware of their discordant HIV-1 serostatus. Given the high HIV-1 incidence among HIV-1 discordant couples and to assess efficacy of interventions for reducing HIV-1 transmission, HIV-1 discordant couples represent a critical target population for HIV-1 prevention interventions and prevention trials. Substantial regional differences exist in HIV-1 prevalence in Africa, but regional differences in HIV-1 discordance among African couples, has not previously been reported. Methodology/Principal Findings The Partners in Prevention HSV-2/HIV-1 Transmission Trial (“Partners HSV-2 Study”), the first large HIV-1 prevention trial in Africa involving HIV-1 discordant couples, completed enrollment in May 2007. Partners HSV-2 Study recruitment data from 12 sites from East and Southern Africa were used to assess HIV-1 discordance among couples accessing couples HIV-1 counseling and testing, and to correlate with enrollment of HIV-1 discordant couples. HIV-1 discordance at Partners HSV-2 Study sites ranged from 8–31% of couples tested from the community. Across all study sites and, among all couples with one HIV-1 infected partner, almost half (49%) of couples were HIV-1 discordant. Site-specific monthly enrollment of HIV-1 discordant couples into the clinical trial was not directly associated with prevalence of HIV-1 discordance, but was modestly correlated with national HIV-1 counseling and testing rates and access to palliative care/basic health care (r = 0.74, p = 0.09). Conclusions/Significance HIV-1 discordant couples are a critical target for HIV-1 prevention in Africa. In addition to community prevalence of HIV-1 discordance, national infrastructure for HIV-1 testing and healthcare delivery and effective community outreach strategies impact recruitment of HIV-1 discordant couples into HIV-1 prevention trials. PMID

  11. Mind the gap: An empirical study of post-trial access in HIV biomedical prevention trials.

    PubMed

    Haire, Bridget; Jordens, Christopher

    2015-08-01

    The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account. PMID:26193849

  12. Local Knowledge and Experiences of Vaccination: Implications for HIV-Preventive Vaccine Trials in South Africa

    ERIC Educational Resources Information Center

    Lindegger, Graham; Quayle, Michael; Ndlovu, Moses

    2007-01-01

    This study forms part of the preparation of communities for HIV-preventive vaccine trials in South Africa. On the basis of the assumption that attitudes to any HIV vaccine or vaccine trials will partly be influenced by experiences of vaccination in general, this study aimed to investigate knowledge of, attitudes to, and experiences of vaccination…

  13. HIV Treatment as Prevention: Considerations in the Design, Conduct, and Analysis of Cluster Randomized Controlled Trials of Combination HIV Prevention

    PubMed Central

    Boily, Marie-Claude; Mâsse, Benoît; Alsallaq, Ramzi; Padian, Nancy S.; Eaton, Jeffrey W.; Vesga, Juan F.; Hallett, Timothy B.

    2012-01-01

    The rigorous evaluation of the impact of combination HIV prevention packages at the population level will be critical for the future of HIV prevention. In this review, we discuss important considerations for the design and interpretation of cluster randomized controlled trials (C-RCTs) of combination prevention interventions. We focus on three large C-RCTs that will start soon and are designed to test the hypothesis that combination prevention packages, including expanded access to antiretroviral therapy, can substantially reduce HIV incidence. Using a general framework to integrate mathematical modelling analysis into the design, conduct, and analysis of C-RCTs will complement traditional statistical analyses and strengthen the evaluation of the interventions. Importantly, even with combination interventions, it may be challenging to substantially reduce HIV incidence over the 2- to 3-y duration of a C-RCT, unless interventions are scaled up rapidly and key populations are reached. Thus, we propose the innovative use of mathematical modelling to conduct interim analyses, when interim HIV incidence data are not available, to allow the ongoing trials to be modified or adapted to reduce the likelihood of inconclusive outcomes. The preplanned, interactive use of mathematical models during C-RCTs will also provide a valuable opportunity to validate and refine model projections. PMID:22807657

  14. HIV treatment as prevention: considerations in the design, conduct, and analysis of cluster randomized controlled trials of combination HIV prevention.

    PubMed

    Boily, Marie-Claude; Mâsse, Benoît; Alsallaq, Ramzi; Padian, Nancy S; Eaton, Jeffrey W; Vesga, Juan F; Hallett, Timothy B

    2012-01-01

    The rigorous evaluation of the impact of combination HIV prevention packages at the population level will be critical for the future of HIV prevention. In this review, we discuss important considerations for the design and interpretation of cluster randomized controlled trials (C-RCTs) of combination prevention interventions. We focus on three large C-RCTs that will start soon and are designed to test the hypothesis that combination prevention packages, including expanded access to antiretroviral therapy, can substantially reduce HIV incidence. Using a general framework to integrate mathematical modelling analysis into the design, conduct, and analysis of C-RCTs will complement traditional statistical analyses and strengthen the evaluation of the interventions. Importantly, even with combination interventions, it may be challenging to substantially reduce HIV incidence over the 2- to 3-y duration of a C-RCT, unless interventions are scaled up rapidly and key populations are reached. Thus, we propose the innovative use of mathematical modelling to conduct interim analyses, when interim HIV incidence data are not available, to allow the ongoing trials to be modified or adapted to reduce the likelihood of inconclusive outcomes. The preplanned, interactive use of mathematical models during C-RCTs will also provide a valuable opportunity to validate and refine model projections. PMID:22807657

  15. Evaluation of an Intervention among Adolescents to Reduce Preventive Misconception in HIV Vaccine Clinical Trials

    PubMed Central

    Lally, Michelle; Goldsworthy, Richard; Sarr, Moussa; Kahn, Jessica; Brown, Larry; Peralta, Ligia; Zimet, Greg

    2014-01-01

    Purpose Placebo and randomization are important concepts that must be understood before youth can safely participate in HIV vaccine studies or other biomedical trials for HIV prevention. These concepts are central to the phenomenon of preventive misconception which may be associated with an increase in risk behavior among study participants related to mistaken beliefs. Persuasive messaging, traditionally used in the field of marketing, could enhance educational efforts associated with randomized clinical trials. Methods Two educational brochures were designed to increase knowledge about HIV vaccine clinical trials via 1 and 2-sided persuasive messaging. Through the Adolescent Medicine Trials Network, 120 youth were enrolled, administered a mock HIV vaccine trial consent, and then randomized to receive either no supplemental information or one of the two brochures. Results The 2-sided brochure group in which common clinical trial misconceptions were acknowledgedand then refuted had significantly higher scores on knowledge of randomization and interpretation of side effects than the consent-only control group, and willingness to participate in an HIV vaccine trial was not decreased with the use of this brochure. Conclusion Two sided persuasive messaging improves understanding of the concepts of randomization and placebo among youth who would consider participating in an HIV vaccine trial. Further evaluation of this approach should be considered for at-risk youth participating in an actual trial of a biomedical intervention for HIV prevention. PMID:24613097

  16. Advancing community stakeholder engagement in biomedical HIV prevention trials: principles, practices and evidence.

    PubMed

    Newman, Peter A; Rubincam, Clara

    2014-12-01

    Community stakeholder engagement is foundational to fair and ethically conducted biomedical HIV prevention trials. Concerns regarding the ethical engagement of community stakeholders in HIV vaccine trials and early terminations of several international pre-exposure prophylaxis trials have fueled the development of international guidelines, such as UNAIDS' good participatory practice (GPP). GPP aims to ensure that stakeholders are effectively involved in all phases of biomedical HIV prevention trials. We provide an overview of the six guiding principles in the GPP and critically examine them in relation to existing social and behavioral science research. In particular, we highlight the challenges involved in operationalizing these principles on the ground in various global contexts, with a focus on low-income country settings. Increasing integration of social science in biomedical HIV prevention trials will provide evidence to advance a science of community stakeholder engagement to support ethical and effective practices informed by local realities and sociocultural differences.

  17. Taking culture seriously in biomedical HIV prevention trials: a meta-synthesis of qualitative studies.

    PubMed

    Rubincam, Clara; Lacombe-Duncan, Ashley; Newman, Peter A

    2016-01-01

    A substantial gap exists between widespread acknowledgement of the importance of incorporating cultural sensitivity in biomedical HIV prevention trials and empirical evidence to guide the operationalization of cultural sensitivity in these trials. We conducted a systematic literature search and qualitative meta-synthesis to explore how culture is conceptualized and operationalized in global biomedical HIV prevention trials. Across 29 studies, the majority (n = 17) were conducted in resource-limited settings. We identified four overarching themes: (1) semantic cultural sensitivity - challenges in communicating scientific terminology into local vernaculars; (2) instrumental cultural sensitivity - understanding historical experiences to guide tailoring of trial activities; (3) budgetary, logistical, and personnel implications of operationalizing cultural sensitivity; and (4) culture as an asset. Future investigations should address how sociocultural considerations are operationalized across the spectrum of trial preparedness, implementation, and dissemination in particular sociocultural contexts, including intervention studies and evaluations of the effectiveness of methods used to operationalize culturally sensitive practices. PMID:26560332

  18. Provision of HIV treatment in HIV preventive vaccine trials: a developing country perspective.

    PubMed

    Slack, C; Stobie, M; Milford, C; Lindegger, G; Wassenaar, D; Strode, A; Ijsselmuiden, C

    2005-03-01

    HIV treatment for participants who become infected during HIV vaccine trials has been the focus of ethical controversy. The obligations of sponsors to ensure that participants have access to antiretrovirals have been a particular focus of this debate. This paper presents three arguments that have been made in this regard, and some of their limitations, in anticipation of HIV vaccine trials in South Africa. The first argument is that HIV risk behaviour increases in such trials, and HIV infection can be viewed as a research-related injury, justifying sponsor provision of treatment on grounds of compensation for harm. We conclude that risk-behaviour studies to date do not show general increases in risk behaviour that could constitute the basis for a general obligation. Participation may well adversely impact on risk behaviour for some individuals, and conceivably this could be demonstrated. This argument may, therefore, have merit at the individual level; however, it seems a weak platform from which to argue that sponsors should treat all HIV infections acquired during trials. The second argument is that treatment should be provided based on distributive justice. We conclude that traditional concepts of "distributive justice" in research appear limited in justifying obligations of sponsors to ensure access to antiretrovirals. Further, using research initiatives to reduce global health care inequities is controversial, and even proponents may disagree about the fairest use of finite resources. The third argument is that sponsors should ensure antiretroviral access on grounds of beneficence; namely, the maxim that if one can do something beneficial without sacrificing anything of comparable significance, it ought to be done. Thus, sponsors should provide more interventions than those minimally required to conduct the research. However, beneficence may demand levels of altruism that exceeds what is reasonable. While the latter arguments may provide stronger

  19. HIV/AIDS Clinical Trials Fact Sheet

    MedlinePlus

    HIV Prevention HIV/AIDS Clinical Trials (Last updated 9/15/2015; last reviewed 9/15/2015) Key Points HIV/AIDS clinical trials are ... and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help researchers ...

  20. The utility of a composite biological endpoint in HIV/STI prevention trials.

    PubMed

    Hartwell, Tyler D; Pequegnat, Willo; Moore, Janet L; Parker, Corette B; Strader, Lisa C; Green, Annette M; Quinn, Thomas C; Wasserheit, Judith N; Klausner, Jeffrey D

    2013-11-01

    A human immunodeficiency virus (HIV) as a biological endpoint in HIV prevention trials may not be feasible, so investigators have used surrogate biological outcomes. In a multisite trial, the epidemiology of STIs may be different across sites and preclude using one STI as the outcome. This study explored using a composite STI outcome to address that problem. The combined biological endpoint was the incidence of any of six new STIs (chlamydia, gonorrhea, trichomonas (women only), syphilis, herpes simplex virus type 2 infection and HIV) during a 24-month follow up period. We investigated how a composite STI outcome would perform compared to single and dual STI outcomes under various conditions. We simulated outcomes for four populations that represented a wide range of sex and age distributions, and STI prevalences. The simulations demonstrated that a combined biologic outcome was superior to single and dual STI outcomes in assessing intervention effects in 82 % of the cases. A composite biological outcome was effective in detecting intervention effects and might allow more investigations to incorporate multiple biological outcomes in the assessment of behavioral intervention trials for HIV prevention.

  1. Framing the social in biomedical HIV prevention trials: a 20-year retrospective.

    PubMed

    MacQueen, Kathleen M

    2011-09-27

    Biomedical research is critical to identifying effective and safe interventions, such as vaccines, microbicides, male circumcision and antiretrovirals, for prevention. Funding for clinical prevention trials is highly competitive and the benchmarks of success ultimately reduce to quickly enrolling a select group of people at risk, keeping them enrolled, and inducing them to be compliant with trial requirements - all at the lowest cost possible. Juxtaposed with this reality is the fact that HIV is situated with poverty, exploitation, assaults on human dignity, and human rights abuses. The result is a complex web of ethical challenges that are socially constructed along lines of wealth and power. While social science research methods are commonly employed to examine such topics, they have played a marginal role in biomedical HIV prevention research. Why? To answer this question, a core set of persistent interlocking social, behavioural and ethical challenges to biomedical HIV prevention research are described. A critique is offered on how the social has been framed relative to the behavioural, ethical and biomedical components. Examples of how this framing has devalued social knowledge are provided, including the conflation of qualitative research with anecdotal reporting, a bias toward brevity and accuracy over external validity, and difficulties in distinguishing between a moral understanding of social norms and achieving a moral outcome when confronted with ethical challenges in research. Lastly, opportunities are identified for enhancing the success of biomedical HIV prevention research through development of a coherent programme of social science research. Recommendations are offered for reframing the social as a valid domain of scientific inquiry in this highly applied and interdisciplinary context.

  2. Venue-Based Recruitment of Women at Elevated Risk for HIV: An HIV Prevention Trials Network Study

    PubMed Central

    Golin, Carol; El-Sadr, Wafaa; Hughes, James P.; Wang, Jing; Roman Isler, Malika; Mannheimer, Sharon; Kuo, Irene; Lucas, Jonathan; DiNenno, Elizabeth; Justman, Jessica; Frew, Paula M.; Emel, Lynda; Rompalo, Anne; Polk, Sarah; Adimora, Adaora A.; Rodriquez, Lorenna; Soto-Torres, Lydia; Hodder, Sally

    2014-01-01

    Abstract Background: The challenge of identifying and recruiting U.S. women at elevated risk for HIV acquisition impedes prevention studies and services. HIV Prevention Trials Network (HPTN) 064 was a U.S. multisite, longitudinal cohort study designed to estimate HIV incidence among women living in communities with prevalent HIV and poverty. Venue-based sampling (VBS) methodologies and participant and venue characteristics are described. Methods: Eligible women were recruited from 10 U.S. communities with prevalent HIV and poverty using VBS. Participant eligibility criteria included age 18–44 years, residing in a designated census tract/zip code, and self-report of at least one high-risk personal and/or male sexual partner characteristic associated with HIV acquisition (e.g., incarceration history). Ethnography was conducted to finalize recruitment areas and venues. Results: Eight thousand twenty-nine women were screened and 2,099 women were enrolled (88% black, median age 29 years) over 14 months. The majority of participants were recruited from outdoor venues (58%), retail spaces (18%), and social service organizations (13%). The proportion of women recruited per venue category varied by site. Most participants (73%) had both individual and partner characteristics that qualified them for the study; 14% were eligible based on partner risk only. Conclusion: VBS is a feasible and effective approach to rapidly recruit a population of women at enhanced risk for HIV in the United States. Such a recruitment approach is needed in order to engage women most at risk and requires strong community engagement. PMID:24742266

  3. The impact of the 2013 WHO antiretroviral therapy guidelines on the feasibility of HIV population prevention trials

    PubMed Central

    Ross, Eric L.; Tanser, Frank; Pei, Pamela P.; Newell, Marie-Louise; Losina, Elena; Thiebaut, Rodolphe; Weinstein, Milton C.; Freedberg, Kenneth A.; Anglaret, Xavier; Scott, Callie A.; Dabis, Francois; Walensky, Rochelle P.

    2014-01-01

    Introduction Several cluster-randomized HIV prevention trials aim to demonstrate the population-level preventive impact of antiretroviral therapy (ART). 2013 World Health Organization guidelines raising the ART initiation threshold to CD4<500/µL could attenuate these trials’ effect size by increasing ART usage in control clusters. Methods We used a computational model to simulate strategies from a hypothetical cluster-randomized HIV prevention trial. The primary model outcome was the relative reduction in 24-month HIV incidence between control (ART offered with CD4 below threshold) and intervention (ART offered to all) strategies. We assessed this incidence reduction using the revised (CD4<500/µL) and prior (CD4<350/µL) control ART initiation thresholds. Additionally, we evaluated changes to trial characteristics that could bolster the incidence reduction. Results With a control ART initiation threshold of CD4<350/µL, 24-month HIV incidence under control and intervention strategies was 2.46/100PY and 1.96/100PY, a 21% reduction. Raising the threshold to CD4<500/µL decreased the incidence reduction by more than one-third, to 12%. Using this higher threshold, moving to a 36-month horizon (vs. 24-month), yearly control-strategy HIV screening (vs. biannual), and 2-monthly intervention-strategy screening (vs. biannual), resulted in a 31% incidence reduction, similar to effect size projections for ongoing trials. Alternate assumptions regarding cross-cluster contamination had the greatest influence on the incidence reduction. Conclusions Implementing the 2013 WHO HIV treatment threshold could substantially diminish the incidence reduction in HIV population prevention trials. Alternative HIV testing frequencies and trial horizons can bolster this incidence reduction, but could be logistically and ethically challenging. The feasibility of HIV population prevention trials should be reassessed as implementation of treatment guidelines evolves. PMID:25350957

  4. Exploring Barriers and Facilitators to Participation of Male-To-Female Transgender Persons in Preventive HIV Vaccine Clinical Trials

    PubMed Central

    Yoon, Ro; Mooney, Jessica; Broder, Gail; Bolton, Marcus; Votto, Teress; Davis-Vogel, Annet

    2013-01-01

    Observed seroincidence and prevalence rates in male to female (MTF) transgender individuals highlight the need for effective targeted HIV prevention strategies for this community. In order to develop an effective vaccine that can be used by transgender women, researchers must understand and address existing structural issues that present barriers to this group’s participation in HIV vaccine clinical trials. Overcoming barriers to participation is important for ensuring HIV vaccine acceptability and efficacy for the MTF transgender community. To explore barriers and facilitators to MTF transgender participation in preventive HIV vaccine clinical trials, the HIV Vaccine Trials Network (HVTN) conducted focus groups among transgender women in four urban areas (Atlanta, Boston, Philadelphia and San Francisco). Barriers and facilitators to engagement of transgender women in preventive HIV vaccine clinical trials led to the following recommendations: (1) transgender cultural competency training; (2) creating trans-friendly environments; (3) true partnerships with local trans-friendly organizations and health care providers; (4) protocols that focus on transgender specific issues; and (5) data collection and tracking of transgender individuals. These results have implications for the conduct of HIV vaccine trials, as well as engagement of transgender women in research programs in general. PMID:23446435

  5. Exploring barriers and facilitators to participation of male-to-female transgender persons in preventive HIV vaccine clinical trials.

    PubMed

    Andrasik, Michele Peake; Yoon, Ro; Mooney, Jessica; Broder, Gail; Bolton, Marcus; Votto, Teress; Davis-Vogel, Annet

    2014-06-01

    Observed seroincidence and prevalence rates in male-to-female (MTF) transgender individuals highlight the need for effective targeted HIV prevention strategies for this community. In order to develop an effective vaccine that can be used by transgender women, researchers must understand and address existing structural issues that present barriers to this group's participation in HIV vaccine clinical trials. Overcoming barriers to participation is important for ensuring HIV vaccine acceptability and efficacy for the MTF transgender community. To explore barriers and facilitators to MTF transgender participation in preventive HIV vaccine clinical trials, the HIV Vaccine Trials Network conducted focus groups among transgender women in four urban areas (Atlanta, Boston, Philadelphia, and San Francisco). Barriers and facilitators to engagement of transgender women in preventive HIV vaccine clinical trials led to the following recommendations: (a) transgender cultural competency training, (b) creating trans-friendly environments, (c) true partnerships with local trans-friendly organizations and health care providers, (d) protocols that focus on transgender specific issues, and (e) data collection and tracking of transgender individuals. These results have implications for the conduct of HIV vaccine trials, as well as engagement of transgender women in research programs in general.

  6. Rapid Antiretroviral Therapy Initiation for Women in an HIV-1 Prevention Clinical Trial Experiencing Primary HIV-1 Infection during Pregnancy or Breastfeeding.

    PubMed

    Morrison, Susan; John-Stewart, Grace; Egessa, John J; Mubezi, Sezi; Kusemererwa, Sylvia; Bii, Dennis K; Bulya, Nulu; Mugume, Francis; Campbell, James D; Wangisi, Jonathan; Bukusi, Elizabeth A; Celum, Connie; Baeten, Jared M

    2015-01-01

    During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART), despite having CD4 counts exceeding national criteria for ART initiation; breastfeeding women initiated ART or replacement feeding. Rapid ART initiation during primary HIV-1 infection during pregnancy and breastfeeding is feasible in this setting.

  7. Community perceptions of repeat HIV-testing: experiences of the ANRS 12249 Treatment as Prevention trial in rural South Africa.

    PubMed

    Orne-Gliemann, Joanna; Zuma, Thembelihle; Chikovore, Jeremiah; Gillespie, Natasha; Grant, Merridy; Iwuji, Collins; Larmarange, Joseph; McGrath, Nuala; Lert, France; Imrie, John

    2016-01-01

    In the context of the ANRS 12249 Treatment as Prevention (TasP) trial, we investigated perceptions of regular and repeat HIV-testing in rural KwaZulu-Natal (South Africa), an area of very high HIV prevalence and incidence. We conducted two qualitative studies, before (2010) and during the early implementation stages of the trial (2013-2014), to appreciate the evolution in community perceptions of repeat HIV-testing over this period of rapid changes in HIV-testing and treatment approaches. Repeated focus group discussions were organized with young adults, older adults and mixed groups. Repeat and regular HIV-testing was overall well perceived before, and well received during, trial implementation. Yet community members were not able to articulate reasons why people might want to test regularly or repeatedly, apart from individual sexual risk-taking. Repeat home-based HIV-testing was considered as feasible and convenient, and described as more acceptable than clinic-based HIV-testing, mostly because of privacy and confidentiality. However, socially regulated discourses around appropriate sexual behaviour and perceptions of stigma and prejudice regarding HIV and sexual risk-taking were consistently reported. This study suggests several avenues to improve HIV-testing acceptability, including implementing diverse and personalised approaches to HIV-testing and care, and providing opportunities for antiretroviral therapy initiation and care at home. PMID:27421048

  8. Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention

    PubMed Central

    Palanee-Phillips, Thesla; Schwartz, Katie; Brown, Elizabeth R.; Govender, Vaneshree; Mgodi, Nyaradzo; Kiweewa, Flavia Matovu; Nair, Gonasagrie; Mhlanga, Felix; Siva, Samantha; Bekker, Linda-Gail; Jeenarain, Nitesha; Gaffoor, Zakir; Martinson, Francis; Makanani, Bonus; Naidoo, Sarita; Pather, Arendevi; Phillip, Jessica; Husnik, Marla J.; van der Straten, Ariane; Soto-Torres, Lydia; Baeten, Jared

    2015-01-01

    Introduction Women in sub-Saharan Africa are a priority population for evaluation of new biomedical HIV-1 prevention strategies. Antiretroviral pre-exposure prophylaxis is a promising prevention approach; however, clinical trials among young women using daily or coitally-dependent products have found low adherence. Antiretroviral-containing vaginal microbicide rings, which release medication over a month or longer, may reduce these adherence challenges. Methods ASPIRE (A Study to Prevent Infection with a Ring for Extended Use) is a phase III, randomized, double-blind, placebo-controlled trial testing the safety and effectiveness of a vaginal ring containing the non-nucleoside reverse transcriptase inhibitor dapivirine for prevention of HIV-1 infection. We describe the baseline characteristics of African women enrolled in the ASPIRE trial. Results Between August 2012 and June 2014, 5516 women were screened and 2629 HIV-1 seronegative women between 18–45 years of age were enrolled from 15 research sites in Malawi, South Africa, Uganda, and Zimbabwe. The median age was 26 years (IQR 22–31) and the majority (59%) were unmarried. Nearly 100% of participants reported having a primary sex partner in the prior three months but 43% did not know the HIV-1 status of their primary partner; 17% reported additional concurrent partners. Nearly two-thirds (64%) reported having disclosed to primary partners about planned vaginal ring use in the trial. Sexually transmitted infections were prevalent: 12% had Chlamydia trachomatis, 7% Trichomonas vaginalis, 4% Neisseria gonorrhoeae, and 1% syphilis. Conclusions African HIV-1 seronegative women at risk of HIV -1 infection were successfully enrolled into a phase III trial of dapivirine vaginal ring for HIV-1 prevention. PMID:26061040

  9. Effectiveness of Cellulose Sulfate Vaginal Gel for the Prevention of HIV Infection: Results of a Phase III Trial in Nigeria

    PubMed Central

    Halpern, Vera; Ogunsola, Folasade; Obunge, Orikomaba; Wang, Chin-Hua; Onyejepu, Nneka; Oduyebo, Oyinola; Taylor, Doug; McNeil, Linda; Mehta, Neha; Umo-Otong, John; Otusanya, Sakiru; Crucitti, Tania; Abdellati, Said

    2008-01-01

    Background This trial evaluated the safety and effectiveness of 6% cellulose sulfate vaginal gel in preventing male-to-female vaginal transmission of HIV, gonorrhea and chlamydial infection. Methods This Phase III, double-blind, randomized, placebo-controlled trial was conducted between November 2004 and March 2007 in Lagos and Port Harcourt, Nigeria. We enrolled 1644 HIV-antibody negative women at high risk of HIV acquisition. Study participants were randomized 1∶1 to cellulose sulfate or placebo and asked to use gel plus a condom for each act of vaginal intercourse over one year of follow-up. The participants were evaluated monthly for HIV, gonorrhea and chlamydial infection, and for adverse events. Results The trial was stopped prematurely after the data safety monitoring board of a parallel trial concluded that cellulose sulfate might be increasing the risk of HIV. In contrast, we observed fewer infections in the active arm (10) than on placebo (13), a difference that was nonetheless not statistically significant (HR = 0.8, 95% CI 0.3–1.8; p = 0.56). Rates of gonorrhea and chlamydial infection were lower in the CS group but the difference was likewise not statistically significant (HR = 0.8, 95% CI 0.5–1.1; p = 0.19 for the combined STI outcome). Rates of adverse events were similar across study arms. No serious adverse events related to cellulose sulfate use were reported. Conclusions Cellulose sulfate gel appeared to be safe in the evaluated study population but we found insufficient evidence that it prevented male-to-female vaginal transmission of HIV, gonorrhea or chlamydial infection. The early closure of the trial compromised the ability to draw definitive conclusions about the effectiveness of cellulose sulfate against HIV. Trial Registration ClinicalTrials.gov NCT00120770 PMID:19023429

  10. Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial

    PubMed Central

    Padian, Nancy S; van der Straten, Ariane; Ramjee, Gita; Chipato, Tsungai; de Bruyn, Guy; Blanchard, Kelly; Shiboski, Stephen; Montgomery, Elizabeth T; Fancher, Heidi; Cheng, Helen; Rosenblum, Michael; van der Laan, Mark; Jewell, Nicholas; McIntyre, James

    2008-01-01

    Summary Background Female-controlled methods of HIV prevention are urgently needed. We assessed the effect of provision of latex diaphragm, lubricant gel, and condoms (intervention), compared with condoms alone (control) on HIV seroincidence in women in South Africa and Zimbabwe. Methods We did an open-label, randomised controlled trial in HIV-negative, sexually active women recruited from clinics and community-based organisations, who were followed up quarterly for 12–24 months (median 21 months). All participants received an HIV prevention package consisting of pre-test and post-test counselling about HIV and sexually transmitted infections, testing, treatment of curable sexually transmitted infections, and intensive risk-reduction counselling. The primary outcome was incident HIV infection. This study is registered with ClinicalTrials.gov, number NCT00121459. Findings Overall HIV incidence was 4.0% per 100 woman-years: 4.1% in the intervention group (n=2472) and 3.9% in the control group (n=2476), corresponding to a relative hazard of 1.05 (95% CI 0.84–1.32, intention-to-treat analysis). The proportion of women using condoms was significantly lower in the intervention than in the control group (54% vs 85% of visits, p<0.0001). The proportions of participants who reported adverse events (60% [1523] vs 61% [1529]) and serious adverse events (5% [130] vs 4% [101]) were similar between the two groups. Interpretation We observed no added protective benefit against HIV infection when the diaphragm and lubricant gel were provided in addition to condoms and a comprehensive HIV prevention package. Our observation that lower condom use in women provided with diaphragms did not result in increased infection merits further research. Although the intervention seemed safe, our findings do not support addition of the diaphragm to current HIV prevention strategies. PMID:17631387

  11. HIV Prevention

    MedlinePlus

    ... to treat HIV infection (called antiretroviral therapy, or ART) the right way, every day and his or ... way, every day, the medicine to treat HIV (ART) reduces the amount of HIV (called “viral ...

  12. Community-based trials of sexually transmitted disease treatment: repercussions for epidemiology and HIV prevention.

    PubMed Central

    Hudson, C. P.

    2001-01-01

    This paper reviews the scientific basis for trials exploring the relation between sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV) infection in Mwanza in the United Republic of Tanzania and Rakai and Masaka in the Republic of Uganda. The importance of a study's location and explanations for the divergent results of these trials are discussed. The modest effect on STDs seen in the trial of syndromic management in Mwanza, in contrast to the 38% reduction in the incidence of HIV, casts doubt on the underlying hypothesis that treating STDs alone slows the transmission of HIV-1. According to the Piot-Fransen model, the trial in Rakai, which offered treatment of STDs to all subjects irrespective of symptoms ("mass" treatment), should have been more effective both in reducing the prevalence of STDs and the incidence of HIV. However, the Rakai trial was stopped because there was no difference in the incidence of HIV between the intervention and control arms. If Mwanza is seen as the trial that needs explaining, another paradigm becomes relevant. In rural East Africa, where all trials have been conducted, networks of concurrent sexual partnerships are a source of infection with both STDs and HIV. Because of their shorter latency periods, STDs may prompt attendance at a clinic before the early signs of HIV-1 infection appear. Part of the management of STDs is to recommend abstinence or the consistent use of condoms until treatment is completed. This recommendation may cover the earliest period of viraemia during primary HIV-1 infection. This paradigm appears to explain the results from Mwanza and Rakai, emphasizing behavioural aspects of syndromic management. PMID:11217667

  13. Preventing HIV with Medicine

    MedlinePlus

    ... information in Spanish ( en español ) Preventing HIV with medicine Get medicine right after you are exposed to ... to top More information on Preventing HIV with medicine Explore other publications and websites National HIV and ...

  14. Secondary HIV prevention.

    PubMed

    Temoshok, L R; Frerichs, R R

    1998-06-01

    Primary HIV prevention, preventing HIV exposure among uninfected persons, has been the focus of much attention. However, secondary HIV prevention, preventing HIV transmission from infected people to their uninfected contacts, has not received as much interest or attention from HIV researchers, clinicians, and policymakers. The concept of secondary HIV prevention, as distinguished from primary prevention, is clarified, and the current and future strategies to further secondary HIV prevention efforts are explored. Secondary prevention strategies can be incorporated into comprehensive programs and result in shifts in attitudes and behaviors. This could reduce the size of the epidemic, while also benefiting the individual and his or her close relationships.

  15. HIV prevention in favour of the choice-disabled in southern Africa: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    aged 15 to 29 years are gender violence and protective knowledge, attitudes, subjective norms, intention to change, agency, discussion of prevention and practices related to HIV and gender violence. Trial registration Trial registration number: ISRCTN28557578 PMID:23987126

  16. ACCESS TO TREATMENT IN HIV PREVENTION TRIALS: PERSPECTIVES FROM A SOUTH AFRICAN COMMUNITY

    PubMed Central

    BARSDORF, NICOLA; MAMAN, SUZANNE; KASS, NANCY; SLACK, CATHERINE

    2009-01-01

    Access to treatment, in HIV vaccine trials (HVTs), remains ethically controversial. In most prevention trials, including in South Africa, participants who seroconvert are referred to publicly funded programmes for treatment. This strategy is problematic when there is inadequate and uneven access to public sector antiretroviral therapy (ART) and support resources. The responsibilities, if any, of researchers, sponsors and public health authorities involved in HVTs has been hotly debated among academics, scholars, representatives of international organizations and sponsors. However, there is little published on community perceptions. Recent guidance asserts that communities should make inputs into treatment and care decisions. This qualitative study explored a South African community’s perceptions of who should provide what to HVT participants as well as how and why this should be done. Twenty-nine adults working at or attending five primary health care clinics in two rural areas in KwaZulu-Natal participated in in-depth interviews. Respondents expressed that researchers should ‘help participants to access’ treatment and care ‘because they are in a position to do so’ and ‘are in a relationship with’ trial participants. Respondents suggested that researchers could help by ‘facilitating referral’ until such time that participants can access care and treatment on their own. We highlight a series of implications for researchers in HVTs, including their need to be aware of prospective participants’ considerable trust in and respect for researchers, the responsibility that this places on them, and the need for clear communication with communities so as not to erode community trust. PMID:19793135

  17. Unity in Diversity: Results of a Randomized Clinical Culturally Tailored Pilot HIV Prevention Intervention Trial in Baltimore, Maryland, for African American Men Who Have Sex with Men

    ERIC Educational Resources Information Center

    Tobin, Karin; Kuramoto, Satoko J.; German, Danielle; Fields, Errol; Spikes, Pilgrim S.; Patterson, Jocelyn; Latkin, Carl

    2013-01-01

    Unity in Diversity was a randomized controlled trial of a culturally tailored HIV prevention intervention for African American men who have sex with men. The intervention condition was six group-based sessions and one individual session. The control condition was a single-session HIV prevention review. Participants were aged 18 years or older,…

  18. An Online Randomized Controlled Trial Evaluating HIV Prevention Digital Media Interventions for Men Who Have Sex with Men

    PubMed Central

    Hirshfield, Sabina; Chiasson, Mary Ann; Joseph, Heather; Scheinmann, Roberta; Johnson, Wayne D.; Remien, Robert H.; Shaw, Francine Shuchat; Emmons, Reed; Yu, Gary; Margolis, Andrew D.

    2012-01-01

    Background As HIV infection continues unabated, there is a need for effective interventions targeting at-risk men who have sex with men (MSM). Engaging MSM online where they meet sexual partners is critical for HIV prevention efforts. Methods A randomized controlled trial (RCT) conducted online among U.S. MSM recruited from several gay sexual networking websites assessed the impact of 2 HIV prevention videos and an HIV prevention webpage compared to a control condition for the study outcomes HIV testing, serostatus disclosure, and unprotected anal intercourse (UAI) at 60-day follow-up. Video conditions were pooled due to reduced power from low retention (53%, n = 1,631). No participant incentives were provided. Principal Findings Follow-up was completed by 1,631 (53%) of 3,092 eligible men. In the 60 days after the intervention, men in the pooled video condition were significantly more likely than men in the control to report full serostatus disclosure (‘asked and told’) with their last sexual partner (OR 1.32, 95% CI 1.01–1.74). Comparing baseline to follow-up, HIV-negative men in the pooled video (OR 0.70, 95% CI 0.54–0.91) and webpage condition (OR 0.43, 95% CI 0.25–0.72) significantly reduced UAI at follow-up. HIV-positive men in the pooled video condition significantly reduced UAI (OR 0.38, 95% CI 0.20–0.67) and serodiscordant UAI (OR 0.53, 95% CI 0.28–0.96) at follow-up. Conclusions/Significance Findings from this online RCT of MSM recruited from sexual networking websites suggest that a low cost, brief digital media intervention designed to engage critical thinking can increase HIV disclosure to sexual partners and decrease sexual risk. Effective, brief HIV prevention interventions featuring digital media that are made widely available may serve as a complementary part of an overall behavioral and biomedical strategy for reducing sexual risk by addressing the specific needs and circumstances of the target population, and by changing

  19. Ethical Issues to Consider in the Design of HIV Prevention Trials Involving Transgender People.

    PubMed

    Singh, Jerome Amir

    2016-08-15

    Although transgender women have been included in HIV prevention pre-exposure prophylaxis studies, no pre-exposure prophylaxis study has focused exclusively on transgender persons. Drawing on the cardinal principles of ethics espoused in the Belmont Report, this work highlights, among other issues, that (1) the principle of Justice requires the HIV prevention field to focus exclusively on transgender persons, (2) the disclosure of potential study-related risks to study participants demonstrates Respect for Persons, and (3) devising risk mitigation plans, optimizing a proposed study's standard of care, and the provision of ancillary care satisfy the principle of Beneficence. PMID:27429192

  20. Ethical Issues to Consider in the Design of HIV Prevention Trials Involving Transgender People

    PubMed Central

    2016-01-01

    Abstract: Although transgender women have been included in HIV prevention pre-exposure prophylaxis studies, no pre-exposure prophylaxis study has focused exclusively on transgender persons. Drawing on the cardinal principles of ethics espoused in the Belmont Report, this work highlights, among other issues, that (1) the principle of Justice requires the HIV prevention field to focus exclusively on transgender persons, (2) the disclosure of potential study-related risks to study participants demonstrates Respect for Persons, and (3) devising risk mitigation plans, optimizing a proposed study's standard of care, and the provision of ancillary care satisfy the principle of Beneficence. PMID:27429192

  1. Male Partner Influence on Women's HIV Prevention Trial Participation and Use of Pre-exposure Prophylaxis: the Importance of "Understanding".

    PubMed

    Montgomery, Elizabeth T; van der Straten, Ariane; Stadler, Jonathan; Hartmann, Miriam; Magazi, Busisiwe; Mathebula, Florence; Laborde, Nicole; Soto-Torres, Lydia

    2015-05-01

    There is widespread evidence that male partners influence women's ability and willingness to join HIV prevention trials and to use female-controlled prevention strategies such as microbicide gels. VOICE-C was an ancillary study to the Microbicide Trials Network's VOICE trial at the Johannesburg site that explored social and structural factors influencing women's use of study tablets and vaginal gel. Qualitative data were analyzed from 102 randomly-selected VOICE participants interviewed through in-depth interviews (IDI, n = 41); ethnographic interviews (n = 21) or focus group discussions (FGD, n = 40) and 22 male partners interviewed in 14 IDI and 2 FGD. Male partners' "understanding" pervaded as a central explanation for how male partners directly and indirectly influenced their female partners' trial participation and product use, irrespective of assignment to the gel or tablet study groups. The meaning behind "understanding" in this context was described by both men and women in two important and complementary ways: (1) "comprehension" of the study purpose including biological properties or effects of the products, and (2) "support/agreeability" for female partners being study participants or using products. During analysis a third dimension of "understanding" emerged as men's acceptance of larger shifts in gender roles and relationship power, and the potential implications of women's increased access to biomedical knowledge, services and prevention methods. Despite displays of some female agency to negotiate and use HIV prevention methods, male partners still have a critical influence on women's ability and willingness to do so. Efforts to increase their understanding of research goals, study design and products' mechanisms of action could ameliorate distrust, empower men to serve as product advocates, adherence buddies, and foster greater adherence support for women in situations where it is needed. Strategies to address gender norms and the broader

  2. Results of the NIMH Collaborative HIV/STD Prevention Trial of a Community Popular Opinion Leader Intervention

    PubMed Central

    2010-01-01

    Objective To determine whether community populations in Community Popular Opinion Leader (C-POL) intervention venues showed greater reductions in sexual risk practices and lower HIV/STD incidence than those in comparison venues. Methods A 5-country group-randomized trial, conducted from 2002 to 2007, enrolled cohorts from 20 to 40 venues in each country. Venues, matched within country on sexual risk and other factors, were randomly assigned within matched pairs to the C-POL community intervention or an AIDS education comparison. All participants had access to condoms and were assessed with repeated in-depth sexual behavior interviews, STD/HIV testing and treatment, and HIV/STD risk reduction counseling. Sexual behavior change and HIV/STD incidence were measured over two years. Results Both intervention and comparison conditions showed declines of approximately 33% in risk behavior prevalence and had comparable disease incidence within and across countries, target populations, and types of venues. Conclusions The community-level intervention did not produce greater behavioral risk and disease incidence reduction than the comparison condition, perhaps due to the intensive prevention services received by all participants during the assessment. Repeated, detailed self-review of risk behavior practices coupled with HIV/STD testing, treatment, HIV risk reduction counseling, and condom access can themselves substantially change behavior and disease acquisition. PMID:20354444

  3. Social-cognitive theory mediators of behavior change in the National Institute of Mental Health Multisite HIV Prevention Trial.

    PubMed

    2001-09-01

    The National Institute of Mental Health Multisite HIV Prevention Trial was a trial of an intervention to reduce sexual HIV risk behaviors among 3,706 low-income at-risk men and women at 7 U.S. research sites. The intervention, based on social-cognitive theory and designed to influence behavior change by improving expected outcomes of condom use and increasing knowledge, skills, and self-efficacy to execute safer sex behaviors, was effective relative to a control condition in reducing sexual risk behavior. At 3 months after completion of the intervention, measures of these potential mediators were higher in the intervention than in the control condition. Although the effect of the intervention on sexual risk behavior was significantly reduced when the variables were controlled statistically, supporting the hypothesis of their mediation of the intervention effect, most of the effect remained unexplained, indicating the influence of unmeasured factors on outcome.

  4. An interdisciplinary framework for measuring and supporting adherence in HIV prevention trials of ARV-based vaginal rings

    PubMed Central

    MacQueen, Kathleen M; Tolley, Elizabeth E; Owen, Derek H; Amico, K Rivet; Morrow, Kathleen M; Moench, Thomas; Friend, David R; Friedland, Barbara

    2014-01-01

    Introduction Product adherence and its measurement have emerged as a critical challenge in the evaluation of new HIV prevention technologies. Long-acting ARV-based vaginal rings may simplify use instructions and require less user behaviour, thereby facilitating adherence. One ARV-based ring is in efficacy trials and others, including multipurpose rings, are in the pipeline. Participant motivations, counselling support and measurement challenges during ring trials must still be addressed. In previous HIV prevention trials, this has been done largely using descriptive and post-hoc methods that are highly variable and minimally evaluated. We outline an interdisciplinary framework for systematically investigating promising strategies to support product uptake and adherence, and to measure adherence in the context of randomized, blinded clinical trials. Discussion The interdisciplinary framework highlights the dual use of adherence measurement (i.e. to provide feedback during trial implementation and to inform interpretation of trial findings) and underscores the complex pathways that connect measurement, adherence support and enacted adherence behaviour. Three inter-related approaches are highlighted: 1) adherence support – sequential efforts to define motivators of study product adherence and to develop, test, refine and evaluate adherence support messages; 2) self-reported psychometric measures – creation of valid and generalizable measures based in easily administered scales that capture vaginal ring use with improved predictive ability at screening, baseline and follow-up that better engage participants in reporting adherence; and 3) more objective measurement of adherence – real-time adherence monitoring and cumulative measurement to correlate adherence with overall product effectiveness through innovative designs, models and prototypes using electronic and biometric technologies to detect ring insertion and/or removal or expulsion. Coordinating research

  5. Venues for Meeting Sex Partners and Partner HIV Risk Characteristics: HIV Prevention Trials Network (HPTN064) Women's HIV Seroincidence Study (ISIS)

    PubMed Central

    Golin, C.; Wang, J.; Hughes, J.; Justman, J.; Haley, D.; Kuo, I.; Adimora, A.; Chege, W.; Hodder, S.

    2016-01-01

    Identifying venues where women meet sexual partners, particular partners who increase women's risk of acquiring HIV, could inform prevention efforts. We categorized venues where women enrolled in HPTN 064 reported meeting their last three sex partners as: (1) Formal, (2) Public, (3) Private, and (4) Virtual spaces. We used multinomial logistic regression to assess the association between these venues and women's individual characteristics and reports of their partners' HIV risk characteristics. The 2099 women reported meeting 3991 partners, 51 % at Public, 30 % Private, 17 % Formal and 3 % at Virtual venues. Women meeting partners at Formal venues reported more education and condom use than women meeting partners at other venues. Fewer partners met through Formal venues had “high” risk characteristics for HIV than through other venues and hence may pose less risk of HIV transmission. HIV prevention interventions can help women choose partners with fewer risk characteristics across all venue types. PMID:25863466

  6. Venues for Meeting Sex Partners and Partner HIV Risk Characteristics: HIV Prevention Trials Network (HPTN064) Women's HIV Seroincidence Study (ISIS).

    PubMed

    Roman Isler, M; Golin, C; Wang, J; Hughes, J; Justman, J; Haley, D; Kuo, I; Adimora, A; Chege, W; Hodder, S

    2016-06-01

    Identifying venues where women meet sexual partners, particular partners who increase women's risk of acquiring HIV, could inform prevention efforts. We categorized venues where women enrolled in HPTN 064 reported meeting their last three sex partners as: (1) Formal, (2) Public, (3) Private, and (4) Virtual spaces. We used multinomial logistic regression to assess the association between these venues and women's individual characteristics and reports of their partners' HIV risk characteristics. The 2099 women reported meeting 3991 partners, 51 % at Public, 30 % Private, 17 % Formal and 3 % at Virtual venues. Women meeting partners at Formal venues reported more education and condom use than women meeting partners at other venues. Fewer partners met through Formal venues had "high" risk characteristics for HIV than through other venues and hence may pose less risk of HIV transmission. HIV prevention interventions can help women choose partners with fewer risk characteristics across all venue types.

  7. The future of HIV prevention.

    PubMed

    Padian, Nancy S; Isbell, Michael T; Russell, Elizabeth S; Essex, M

    2012-08-01

    In the decades since the emergence of HIV, numerous approaches to prevent transmission have been tested with varying degrees of success. Because a highly effective vaccine will not be available within the next decade, it is increasingly clear that preventing new HIV infections will require successful implementation of promising behavioral and biomedical interventions in combination. These prevention packages must be sufficiently flexible to include a variety of evidence-based interventions that serve each dynamic population they target, particularly those who are most vulnerable. To optimize the impact of combination intervention packages, well-designed implementation science studies are vital. Efficacy in a clinical trial does not necessarily translate to effectiveness at the population-level, and prioritized research studies should investigate programmatic implementation and operations scale-up and new methods to monitor and evaluate these processes both for organization and cost-effectiveness. With an estimated 2.7 million people becoming newly infected with HIV in 2010, the prevention of HIV remains an urgent global health priority. Since the emergence of HIV/AIDS more than 30 years ago, the evidence base for HIV prevention has expanded and evolved. Here we explore the status of evidence-based HIV prevention, describing both the continuing challenges and the emerging opportunities to reduce HIV incidence. PMID:22772385

  8. Effect of rAd5-Vector HIV-1 Preventive Vaccines on HIV-1 Acquisition: A Participant-Level Meta-Analysis of Randomized Trials

    PubMed Central

    Huang, Yunda; Follmann, Dean; Nason, Martha; Zhang, Lily; Huang, Ying; Mehrotra, Devan V.; Moodie, Zoe; Metch, Barbara; Janes, Holly; Keefer, Michael C.; Churchyard, Gavin; Robb, Merlin L.; Fast, Patricia E.; Duerr, Ann; McElrath, M. Juliana; Corey, Lawrence; Mascola, John R.; Graham, Barney S.; Sobieszczyk, Magdalena E.; Kublin, James G.; Robertson, Michael; Hammer, Scott M.; Gray, Glenda E.; Buchbinder, Susan P.; Gilbert, Peter B.

    2015-01-01

    Background Three phase 2b, double-blind, placebo-controlled, randomized efficacy trials have tested recombinant Adenovirus serotype-5 (rAd5)-vector preventive HIV-1 vaccines: MRKAd5 HIV-1 gag/pol/nef in Step and Phambili, and DNA/rAd5 HIV-1 env/gag/pol in HVTN505. Due to efficacy futility observed at the first interim analysis in Step and HVTN505, participants of all three studies were unblinded to their vaccination assignments during the study but continued follow–up. Rigorous meta-analysis can provide crucial information to advise the future utility of rAd5-vector vaccines. Methods We included participant-level data from all three efficacy trials, and three Phase 1–2 trials evaluating the HVTN505 vaccine regimen. We predefined two co-primary analysis cohorts for assessing the vaccine effect on HIV-1 acquisition. The modified-intention-to-treat (MITT) cohort included all randomly assigned participants HIV-1 uninfected at study entry, who received at least the first vaccine/placebo, and the Ad5 cohort included MITT participants who received at least one dose of rAd5-HIV vaccine or rAd5-placebo. Multivariable Cox regression models were used to estimate hazard ratios (HRs) of HIV-1 infection (vaccine vs. placebo) and evaluate HR variation across vaccine regimens, time since vaccination, and subgroups using interaction tests. Findings Results are similar for the MITT and Ad5 cohorts; we summarize MITT cohort results. Pooled across the efficacy trials, over all follow-up time 403 (n = 224 vaccine; n = 179 placebo) of 6266 MITT participants acquired HIV-1, with a non-significantly higher incidence in vaccine recipients (HR 1.21, 95% CI 0.99–1.48, P = 0.06). The HRs significantly differed by vaccine regimen (interaction P = 0.03; MRKAd5 HR 1.41, 95% CI 1.11–1.78, P = 0.005 vs. DNA/rAd5 HR 0.88, 95% CI 0.61–1.26, P = 0.48). Results were similar when including the Phase 1–2 trials. Exploratory analyses based on the efficacy trials supported that the MRKAd5

  9. Effect of preventive treatment for tuberculosis in adults infected with HIV: systematic review of randomised placebo controlled trials

    PubMed Central

    Wilkinson, David; Squire, S B; Garner, Paul

    1998-01-01

    Objective: To determine whether preventive treatment for tuberculosis in adults infected with HIV reduces the frequency of tuberculosis and overall mortality. Design: Systematic review and data synthesis of randomised placebo controlled trials. Main outcome measures: Active tuberculosis, mortality, and adverse drug reaction requiring cessation of the study regimen. Outcomes stratified by status of purified protein derivative skin test. Results: Four trials comprising 4055 adults from Haiti, Kenya, the United States, and Uganda were included. All compared isoniazid (6-12 months) with placebo, and one trial also compared multidrug treatment for 3 months with placebo. Mean follow up was 15-33 months. Overall, frequency of tuberculosis (relative risk 0.57, 95% confidence interval 0.41 to 0.79) was reduced in those receiving preventive treatment compared with placebo: mortality was not significantly reduced (0.93, 0.83 to 1.05). In subjects positive for purified protein derivative receiving preventive treatment, the risk of tuberculosis was reduced substantially (0.32, 0.19 to 0.51) and the risk of death was reduced moderately (0.73, 0.57 to 0.95) compared with those taking placebo. In adults negative for purified protein derivative receiving preventive treatment, the risk of tuberculosis (0.82, 0.50 to 1.36) and the risk of death (1.02, 0.89 to 1.17) were not reduced significantly. Adverse drug reactions were more frequent, but not significantly so, in patients receiving drug compared with placebo (1.45, 0.98 to 2.14). Conclusions: Preventive treatment given for 3-12 months protects against tuberculosis in adults infected with HIV, at least in the short to medium term. Protection is greatest in subjects positive for purified protein derivative, in whom death is also less frequent. Long term benefits remain to be shown. Key messages One third of the world’s population is infected with Mycobacterium tuberculosis People infected with HIV are at much increased risk of

  10. Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study

    PubMed Central

    Newman, Peter A.; Rubincam, Clara; Slack, Catherine; Essack, Zaynab; Chakrapani, Venkatesan; Chuang, Deng-Min; Tepjan, Suchon; Shunmugam, Murali; Roungprakhon, Surachet; Logie, Carmen; Koen, Jennifer; Lindegger, Graham

    2015-01-01

    Objectives Broad international guidelines and studies in the context of individual clinical trials highlight the centrality of community stakeholder engagement in conducting ethically rigorous HIV prevention trials. We explored and identified challenges and facilitators for community stakeholder engagement in biomedical HIV prevention trials in diverse global settings. Our aim was to assess and deepen the empirical foundation for priorities included in the GPP guidelines and to highlight challenges in implementation that may merit further attention in subsequent GPP iterations. Methods From 2008–2012 we conducted an embedded, multiple case study centered in Thailand, India, South Africa and Canada. We conducted in-depth interviews and focus groups with respondents from different trial-related subsystems: civil society organization representatives, community advocates, service providers, clinical trialists/researchers, former trial participants, and key HIV risk populations. Interviews/focus groups were recorded, and coded using thematic content analysis. After intra-case analyses, we conducted cross-case analysis to contrast and synthesize themes and sub-themes across cases. Lastly, we applied the case study findings to explore and assess UNAIDS/AVAC GPP guidelines and the GPP Blueprint for Stakeholder Engagement. Results Across settings, we identified three cross-cutting themes as essential to community stakeholder engagement: trial literacy, including lexicon challenges and misconceptions that imperil sound communication; mistrust due to historical exploitation; and participatory processes: engaging early; considering the breadth of “community”; and, developing appropriate stakeholder roles. Site-specific challenges arose in resource-limited settings and settings where trials were halted. Conclusions This multiple case study revealed common themes underlying community stakeholder engagement across four country settings that largely mirror GPP goals and the

  11. Assessing adherence in the CAPRISA 004 tenofovir gel HIV prevention trial: results of a nested case-control study.

    PubMed

    MacQueen, Kathleen M; Weaver, Mark A; van Loggerenberg, Francois; Succop, Stacey; Majola, Nelisle; Taylor, Doug; Karim, Quarraisha Abdool; Karim, Salim Abdool

    2014-05-01

    Adherence undeniably impacts product effectiveness in microbicide trials, but the connection has proven challenging to quantify using routinely collected behavioral data. We explored this relationship using a nested case-control study in the CAPRISA 004 Tenofovir (TFV) gel HIV prevention trial. Detailed 3-month recall data on sex events, condom and gel use were collected from 72 incident cases and 205 uninfected controls. We then assessed how the relationship between self-reported adherence and HIV acquisition differed between the TFV and placebo gel groups, an interaction effect that should exist if effectiveness increases with adherence. The CAPRISA 004 trial determined that randomization to TFV gel was associated with a significant reduction in risk of HIV acquisition. In our nested case-control study, however, we did not observe a meaningful decrease in the relative odds of infection-TFV versus placebo-as self-reported adherence increased. To the contrary, exploratory sub-group analysis of the case-control data identified greater evidence for a protective effect of TFV gel among participants reporting less than 80 % adherence to the protocol-defined regimen (odds ratio (OR) 0.30; 95 % CI 0.11-0.78) than among those reporting ≥ 80 % adherence (Odds Ratio 0.81; 95 % CI 0.34-1.92). The small number of cases may have inhibited our ability to detect the hypothesized interaction between adherence and effectiveness. Nonetheless, our results re-emphasize the challenges faced by investigators when adherence may be miss-measured, miss-reported, or confounded with the risk of HIV. PMID:24647763

  12. HPTN 071 (PopART): A Cluster-Randomized Trial of the Population Impact of an HIV Combination Prevention Intervention Including Universal Testing and Treatment: Mathematical Model

    PubMed Central

    Cori, Anne; Ayles, Helen; Beyers, Nulda; Schaap, Ab; Floyd, Sian; Sabapathy, Kalpana; Eaton, Jeffrey W.; Hauck, Katharina; Smith, Peter; Griffith, Sam; Moore, Ayana; Donnell, Deborah; Vermund, Sten H.; Fidler, Sarah; Hayes, Richard; Fraser, Christophe

    2014-01-01

    Background The HPTN 052 trial confirmed that antiretroviral therapy (ART) can nearly eliminate HIV transmission from successfully treated HIV-infected individuals within couples. Here, we present the mathematical modeling used to inform the design and monitoring of a new trial aiming to test whether widespread provision of ART is feasible and can substantially reduce population-level HIV incidence. Methods and Findings The HPTN 071 (PopART) trial is a three-arm cluster-randomized trial of 21 large population clusters in Zambia and South Africa, starting in 2013. A combination prevention package including home-based voluntary testing and counseling, and ART for HIV positive individuals, will be delivered in arms A and B, with ART offered universally in arm A and according to national guidelines in arm B. Arm C will be the control arm. The primary endpoint is the cumulative three-year HIV incidence. We developed a mathematical model of heterosexual HIV transmission, informed by recent data on HIV-1 natural history. We focused on realistically modeling the intervention package. Parameters were calibrated to data previously collected in these communities and national surveillance data. We predict that, if targets are reached, HIV incidence over three years will drop by >60% in arm A and >25% in arm B, relative to arm C. The considerable uncertainty in the predicted reduction in incidence justifies the need for a trial. The main drivers of this uncertainty are possible community-level behavioral changes associated with the intervention, uptake of testing and treatment, as well as ART retention and adherence. Conclusions The HPTN 071 (PopART) trial intervention could reduce HIV population-level incidence by >60% over three years. This intervention could serve as a paradigm for national or supra-national implementation. Our analysis highlights the role mathematical modeling can play in trial development and monitoring, and more widely in evaluating the impact of treatment

  13. MSM in HIV-prevention trials are sexual partners with each other: An ancillary study to the EXPLORE intervention.

    PubMed

    Mimiaga, Matthew J; Safren, Steven A; Benet, Dana Jones; Manseau, Marc W; DeSousa, Nancy; Mayer, Kenneth H

    2006-01-01

    The EXPLORE study evaluated a behavioral intervention to prevent HIV seroconversion among men who have sex with men (MSM). The present ancillary study enrolled 345 EXPLORE participants at one study site (Boston) and assessed high-risk sexual behavior with other EXPLORE participants. It also assessed sexual intentions across other EXPLORE participants, HIV-negative individuals, and unknown HIV serostatus partners. Thirty-one percent reported having sex with another EXPLORE participant: 27% unprotected receptive oral sex with ejaculation (UO), 30% unprotected insertive anal sex (UIA), and 34% reported unprotected receptive anal sex (URA). Significant relationships between intentions to engage in UO, UIA, and URA, and type of partner emerged with intentions to engage in UO, UIA, and URA higher in HIV-negative partners, other EXPLORE participants, and unknown-HIV serostatus partners. Future HIV-prevention studies recruiting MSM at increased sexual risk of HIV infection should address participants potentially becoming sexual partners with each other. PMID:16331532

  14. Acceptability of Potential Rectal Microbicide Delivery Systems for HIV Prevention: A Randomized Crossover Trial

    PubMed Central

    Gorbach, Pamina M.; Weiss, Robert E.; Hess, Kristen; Murphy, Ryan; Saunders, Terry; Brown, Joelle; Anton, Peter A.; Cranston, Ross D.

    2012-01-01

    We assessed the acceptability of three of over-the-counter products representative of potential rectal microbicide (RM) delivery systems. From 2009 to 2010, 117 HIV-uninfected males (79 %) and females (21 %) who engage in receptive anal intercourse participated in a 6-week randomized crossover acceptability trial. Participants received each of three products (enema, lubricant-filled applicator, suppository) every 2 weeks in a randomized sequence. CASI and T-ACASI scales assessed product acceptability via Likert responses. Factor analysis was used to identify underlying factors measured by each scale. Random effects models were fit to examine age and gender effects on product acceptability. Three underlying factors were identified: Satisfaction with Product Use, Sexual Pleasure, and Ease of Product Use. For acceptability, the applicator ranked highest; however, differences between product acceptability scores were greatest among females and younger participants. These findings indicate that RM delivery systems impact their acceptability and should be considered early in RM development to enhance potential use. PMID:23114512

  15. A model for community representation and participation in HIV prevention trials among women who engage in transactional sex in Africa.

    PubMed

    Shagi, Charles; Vallely, Andrew; Kasindi, Stella; Chiduo, Betty; Desmond, Nicola; Soteli, Selephina; Kavit, Natujwa; Vallely, Lisa; Lees, Shelley; Hayes, Richard; Ross, David

    2008-10-01

    Actively engaging communities in effective partnerships for the design and implementation of HIV prevention research is vital to the successful conduct of ethically robust, locally-appropriate clinical trials in developing countries. This is especially true in vulnerable at-risk sub-populations, where definitions of "community", "participation" and "representation" can be difficult to apply. This study was conducted to investigate the feasibility of a participatory model of community liaison among an occupational cohort of women at high-risk of HIV and sexually-transmitted infections in Mwanza City, northwest Tanzania in preparation for a Phase III vaginal microbicide trial. This approach was rooted in participatory action-orientated research and used tools adapted from participatory learning and action techniques. During the feasibility study, a mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern bars, restaurants, hotels and guesthouses was established in 10 city wards. Participatory mapping was carried out by project fieldworkers and wards divided into 78 geographical clusters of facilities in consultation with community members and study participants. Representatives at cluster and ward level were elected in a process facilitated by the site Community Liaison Officer and a site-level Community Advisory Committee established. A logical framework was used to guide the implementation, monitoring and evaluation of the community liaison system (CLS) within the broader feasibility study. The CLS was essential to the successful conduct of the feasibility study and has now been consolidated and expanded as part of the on-going MDP301 Phase III microbicide trial in Mwanza. The participatory model presented in this paper is likely to be generalisable to other vulnerable, stigmatised, at-risk study populations in resource-limited settings. PMID:18825513

  16. A model for community representation and participation in HIV prevention trials among women who engage in transactional sex in Africa.

    PubMed

    Shagi, Charles; Vallely, Andrew; Kasindi, Stella; Chiduo, Betty; Desmond, Nicola; Soteli, Selephina; Kavit, Natujwa; Vallely, Lisa; Lees, Shelley; Hayes, Richard; Ross, David

    2008-10-01

    Actively engaging communities in effective partnerships for the design and implementation of HIV prevention research is vital to the successful conduct of ethically robust, locally-appropriate clinical trials in developing countries. This is especially true in vulnerable at-risk sub-populations, where definitions of "community", "participation" and "representation" can be difficult to apply. This study was conducted to investigate the feasibility of a participatory model of community liaison among an occupational cohort of women at high-risk of HIV and sexually-transmitted infections in Mwanza City, northwest Tanzania in preparation for a Phase III vaginal microbicide trial. This approach was rooted in participatory action-orientated research and used tools adapted from participatory learning and action techniques. During the feasibility study, a mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern bars, restaurants, hotels and guesthouses was established in 10 city wards. Participatory mapping was carried out by project fieldworkers and wards divided into 78 geographical clusters of facilities in consultation with community members and study participants. Representatives at cluster and ward level were elected in a process facilitated by the site Community Liaison Officer and a site-level Community Advisory Committee established. A logical framework was used to guide the implementation, monitoring and evaluation of the community liaison system (CLS) within the broader feasibility study. The CLS was essential to the successful conduct of the feasibility study and has now been consolidated and expanded as part of the on-going MDP301 Phase III microbicide trial in Mwanza. The participatory model presented in this paper is likely to be generalisable to other vulnerable, stigmatised, at-risk study populations in resource-limited settings.

  17. Risk Behavior among Women enrolled in a Randomized Controlled Efficacy Trial of an Adenoviral Vector Vaccine to Prevent HIV Acquisition: the Step Study

    PubMed Central

    Novak, Richard M.; Metch, Barbara; Buchbinder, Susan; Cabello, Robinson; Donastorg, Yeycy; Figoroa, John-Peter; Adbul-Jauwad, Hend; Joseph, Patrice; Koenig, Ellen; Metzger, David; Sobieszycz, Magda; Tyndall, Mark; Zorilla, Carmen

    2013-01-01

    Objectives Report of risk behavior, HIV incidence, and pregnancy rates among women participating in the Step Study, a phase IIB trial of MRKAd5 HIV-1 gag/pol/nef vaccine in HIV-negative individuals who were at high risk of HIV-1. Design Prospective multicenter, double-blinded, placebo-controlled trial Methods Women were from North American (NA) and Caribbean and South America (CSA) sites. Risk behavior was collected at screening and 6-month intervals. Differences in characteristics between groups were tested with Chi-square, two-sided Fisher’s exact tests, and Wilcoxon rank sum tests. Generalized estimating equation models were used to assess behavioral change. Results Among 1134 enrolled women, the median number of male partners was 18; 73.8% reported unprotected vaginal sex, 15.9% unprotected anal sex and 10.8% evidence of a sexually transmitted infection in the 6 months prior to baseline. With 3344 person-years (p–y) of follow up, there were 15 incident HIV infections: incidence rate was 0.45 per 100/p-y (95% CI 0.25, 0.74). Crack cocaine use in both regions (relative risk [RR]=2.4 [1.7,3.3]) and in CSA, unprotected anal sex (RR=6.4 [3.8. 10.7]) and drug use (RR=4.1 [2.1, 8.0]) were baseline risk behaviors associated with HIV acquisition. There was a marked reduction in risk behaviors after study enrollment with some recurrence in unprotected vaginal sex. Of 963 non-sterilized women, 304 (31.6%) became pregnant. Conclusions Crack cocaine use and unprotected anal sex are important risk criteria to identify high-risk women for HIV efficacy trials. Pregnancy during the trial was a common occurrence and needs to be considered in trial planning for prevention trials in women. PMID:23807272

  18. Disclosure of HSV-2 Serological Test Results in the Context of an Adolescent HIV Prevention Trial in Kenya

    PubMed Central

    Hallfors, Denise Dion; Cho, Hyunsan; Mbai, Isabella; Millimo, Benson; Atieno, Carolyne; Okumu, David; Luseno, Winnie; Hartman, Shane; Halpern, Carolyn T.; Hobbs, Marcia M.

    2015-01-01

    Objectives HSV-2 biomarkers are often used in adolescent sub-Saharan HIV prevention studies, but evaluations of test performance and disclosure outcomes are rare in the published literature. Therefore, we investigated the proportion of ELISA-positive and indeterminant samples confirmed by Western blot (WB); the psychosocial response to disclosure; and whether reports of sexual behavior and HSV-2 symptoms are consistent with WB confirmatory results among adolescent orphans in Kenya. Methods In 2011, 837 Kenyan orphan youth in grades 7 and 8 enrolled in an HIV prevention clinical trial with HSV-2 biomarker outcomes. We used a modified algorithm for the Kalon HSV-2 ELISA to improve specificity; positive and indeterminate results were WB-tested. We developed culturally sensitive protocols for disclosing positive results and documented psychosocial responses, reports of sexual contact, and HSV-2 symptoms. Results 28 adolescents (3.3%) were identified as HSV-2 seropositive; 6 as indeterminate. Of these, 22 positive and all indeterminants were WB-tested; 20 and 5, respectively, were confirmed positive. Most youth reported moderate brief stress after disclosure; 22% reported longer and more severe distress. Boys were more likely to be in the latter category. Self-reported virginity was highly inconsistent with WB confirmed positives. Conclusions The higher than manufacturer cut-off for Kalon ELISA modestly reduced the rate of false positive test results but also increased false negatives. Investigators should consider the risk-benefit ratio in deciding whether or not to disclose HSV-2 results to adolescent participants under specific field conditions. PMID:26139208

  19. HPTN 071 (PopART): Rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment – a study protocol for a cluster randomised trial

    PubMed Central

    2014-01-01

    Background Effective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed. Mathematical modelling and the HIV Prevention Trials Network (HPTN) 052 trial results suggest that universal HIV testing combined with immediate antiretroviral treatment (ART) should substantially reduce incidence and may eliminate HIV as a public health problem. We describe the rationale and design of a trial to evaluate this hypothesis. Methods/Design A rigorously-designed trial of universal testing and treatment (UTT) interventions is needed because: i) it is unknown whether these interventions can be delivered to scale with adequate uptake; ii) there are many uncertainties in the models such that the population-level impact of these interventions is unknown; and ii) there are potential adverse effects including sexual risk disinhibition, HIV-related stigma, over-burdening of health systems, poor adherence, toxicity, and drug resistance. In the HPTN 071 (PopART) trial, 21 communities in Zambia and South Africa (total population 1.2 m) will be randomly allocated to three arms. Arm A will receive the full PopART combination HIV prevention package including annual home-based HIV testing, promotion of medical male circumcision for HIV-negative men, and offer of immediate ART for those testing HIV-positive; Arm B will receive the full package except that ART initiation will follow current national guidelines; Arm C will receive standard of care. A Population Cohort of 2,500 adults will be randomly selected in each community and followed for 3 years to measure the primary outcome of HIV incidence. Based on model projections, the trial will be well-powered to detect predicted effects on HIV incidence and secondary outcomes. Discussion Trial results, combined with modelling and cost data, will provide short-term and long-term estimates of cost-effectiveness of UTT interventions. Importantly, the three-arm design will enable assessment of how much could be achieved by

  20. Antiretroviral Drug Use in a Cohort of HIV-Uninfected Women in the United States: HIV Prevention Trials Network 064

    PubMed Central

    Chen, Iris; Clarke, William; Ou, San-San; Marzinke, Mark A.; Breaud, Autumn; Emel, Lynda M.; Wang, Jing; Hughes, James P.; Richardson, Paul; Haley, Danielle F.; Lucas, Jonathan; Rompalo, Anne; Justman, Jessica E.; Hodder, Sally L.; Eshleman, Susan H.

    2015-01-01

    Antiretroviral (ARV) drug use was analyzed in HIV-uninfected women in an observational cohort study conducted in 10 urban and periurban communities in the United States with high rates of poverty and HIV infection. Plasma samples collected in 2009–2010 were tested for the presence of 16 ARV drugs. ARV drugs were detected in samples from 39 (2%) of 1,806 participants: 27/181 (15%) in Baltimore, MD and 12/179 (7%) in Bronx, NY. The ARV drugs detected included different combinations of non-nucleoside reverse transcriptase inhibitors and protease inhibitors (1–4 drugs/sample). These data were analyzed in the context of self-reported data on ARV drug use. None of the 39 women who had ARV drugs detected reported ARV drug use at any study visit. Further research is needed to evaluate ARV drug use by HIV-uninfected individuals. PMID:26445283

  1. Lopinavir/Ritonavir versus Lamivudine peri-exposure prophylaxis to prevent HIV-1 transmission by breastfeeding: the PROMISE-PEP trial Protocol ANRS 12174

    PubMed Central

    2012-01-01

    Background Postnatal transmission of HIV-1 through breast milk remains an unsolved challenge in many resource-poor settings where replacement feeding is not a safe alternative. WHO now recommends breastfeeding of infants born to HIV-infected mothers until 12 months of age, with either maternal highly active antiretroviral therapy (HAART) or peri-exposure prophylaxis (PEP) in infants using nevirapine. As PEP, lamivudine showed a similar efficacy and safety as nevirapine, but with an expected lower rate of resistant HIV strains emerging in infants who fail PEP, and lower restrictions for future HIV treatment. Lopinavir/ritonavir (LPV/r) is an attractive PEP candidate with presumably higher efficacy against HIV than nevirapine or lamivudine, and a higher genetic barrier to resistance selection. It showed an acceptable safety profile for the treatment of very young HIV-infected infants. The ANRS 12174 study aims to compare the risk of HIV-1 transmission during and safety of prolonged infant PEP with LPV/r (40/10 mg twice daily if 2-4 kg and 80/20 mg twice daily if >4 kg) versus Lamivudine (7,5 mg twice daily if 2-4 kg, 25 mg twice daily if 4-8 kg and 50 mg twice daily if >8 kg) from day 7 until one week after cessation of BF (maximum 50 weeks of prophylaxis) to prevent postnatal HIV-1 acquisition between 7 days and 50 weeks of age. Methods The ANRS 12174 study is a multinational, randomised controlled clinical trial conducted on 1,500 mother-infant pairs in Burkina Faso, South Africa, Uganda and Zambia. We will recommend exclusive breastfeeding (EBF) until 26th week of life and cessation of breastfeeding at a maximum of 49 weeks in both trial arms. HIV-uninfected infants at day 7 (± 2 days) born to HIV-1 infected mothers not eligible for HAART who choose to breastfeed their infants. The primary endpoint is the acquisition of HIV-1 (as assessed by HIV-1 DNA PCR) between day 7 and 50 weeks of age. Secondary endpoints are safety (including resistance, adverse events and

  2. Advances in HIV Prevention for Serodiscordant Couples

    PubMed Central

    Muessig, Kathryn E.; Cohen, Myron S.

    2014-01-01

    Serodiscordant couples play an important role in maintaining the global HIV epidemic. This review summarizes biobehavioral and biomedical HIV prevention options for serodiscordant couples focusing on advances in 2013 and 2014, including World Health Organization guidelines and best-evidence for couples counseling, couples-based interventions, and the use of antiviral agents for prevention. In the past few years marked advances have been made in HIV prevention for serodiscordant couples and numerous ongoing studies are continuously expanding HIV prevention tools, especially in the area of pre-exposure prophylaxis. Uptake and adherence to antiviral therapy remains a key challenge. Additional research is needed to develop evidence-based interventions for couples, and especially for male-male couples. Randomized trials have demonstrated the prevention benefits of antiretroviral-based approaches among serodiscordant couples; however, residual transmission observed in recognized serodiscordant couples represents an important and resolvable challenge in HIV prevention. PMID:25145645

  3. Degrees of disclosure: a study of women's covert use of the diaphragm in an HIV prevention trial in sub-Saharan Africa.

    PubMed

    Sahin-Hodoglugil, Nuriye Nalan; van der Straten, Ariane; Cheng, Helen; Montgomery, Elizabeth T; Kacanek, Deborah; Mtetwa, Sibongile; Morar, Neetha; Munyoro, Jane; Padian, Nancy

    2009-11-01

    In sub-Saharan Africa more women are infected with HIV/AIDS than men and new prevention methods are urgently needed. One major attribute of female-initiated HIV prevention methods is that they can be used covertly, without a male partner's knowledge. Using mixed methods, we explored the predictors and dimensions of covert use of the diaphragm in a randomized controlled trial that tested its effectiveness for HIV prevention. The Methods for Improving Reproductive Health in Africa (MIRA) trial was conducted in Zimbabwe and South Africa, and data collection took place between September 2003 and January 2007. This study is a secondary analysis of quantitative and qualitative data from participants randomized to the intervention group, and their male partners. It includes survey data from 2316 women (mean age=28.3), 14 focus group discussions (FGD) conducted with 104 women, and 7 FGD and 10 in-depth interviews with 37 male partners. The median follow-up for trial participation was 21 months (range: 12-24). At their final visit, approximately 9% of women had never disclosed to their primary partners that they were using the diaphragm (covert use). In multivariate analysis, predictors of covert use included being older, not co-habiting with the partner, having a partner who did not use condoms, and being from South Africa. Qualitative analysis revealed that covert use was not dichotomous, but ranged along a continuum, which we categorized into five levels (i.e. full disclosure; mostly open use; occasional covert use; mostly covert use; and completely covert use). We discuss the critical role of the option of covert use for many women in the context of an HIV prevention trial, as well as gender power dynamics which may influence women's decisions about disclosure. PMID:19765879

  4. Comparing patterns of sexual risk among adolescent and young women in a mixed-method study in Tanzania: implications for adolescent participation in HIV prevention trials

    PubMed Central

    Tolley, Elizabeth E; Kaaya, Sylvia; Kaale, Anna; Minja, Anna; Bangapi, Doreen; Kalungura, Happy; Headley, Jennifer; Baumgartner, Joy Noel

    2014-01-01

    Introduction Despite the disproportionate impact of HIV on women, and adolescents in particular, those below age 18 years are underrepresented in HIV prevention trials due to ethical, safety and logistical concerns. This study examined and compared the sexual risk contexts of adolescent women aged 15–17 to young adult women aged 18–21 to determine whether adolescents exhibited similar risk profiles and the implications for their inclusion in future trials. Methods We conducted a two-phase, mixed-method study to assess the opportunities and challenges of recruiting and retaining adolescents (aged 15–17) versus young women (18–21) in Tanzania. Phase I, community formative research (CFR), used serial in-depth interviews with 11 adolescent and 12 young adult women from a range of sexual risk contexts in preparation for a mock clinical trial (MCT). For Phase II, 135 HIV-negative, non-pregnant adolescents and young women were enrolled into a six-month MCT to assess and compare differences in sexual and reproductive health (SRH) outcomes, including risky sexual behaviour, incident pregnancy, sexually transmitted infections (STIs), reproductive tract infections (RTIs) and HIV. Results In both research phases, adolescents appeared to be at similar, if not higher, risk than their young adult counterparts. Adolescents reported earlier sexual debut, and similar numbers of lifetime partners, pregnancy and STI/RTI rates, yet had lower perceived risk. Married women in the CFR appeared at particular risk but were less represented in the MCT. In addition, adolescents were less likely than their older counterparts to have accessed HIV testing, obtained gynaecological exams or used protective technologies. Conclusions Adolescent women under 18 are at risk of multiple negative SRH outcomes and they underuse preventive services. Their access to new technologies such as vaginal microbicides or pre-exposure prophylaxis (PrEP) may similarly be compromised unless greater effort is

  5. Estimates of Intraclass Correlation Coefficients from Longitudinal Group-Randomized Trials of Adolescent HIV/STI/Pregnancy Prevention Programs

    ERIC Educational Resources Information Center

    Glassman, Jill R.; Potter, Susan C.; Baumler, Elizabeth R.; Coyle, Karin K.

    2015-01-01

    Introduction: Group-randomized trials (GRTs) are one of the most rigorous methods for evaluating the effectiveness of group-based health risk prevention programs. Efficiently designing GRTs with a sample size that is sufficient for meeting the trial's power and precision goals while not wasting resources exceeding them requires estimates of the…

  6. Chieh Mei Ching Yi: A randomized controlled trial of a culturally tailored HIV prevention intervention for Chinese massage parlor women in Los Angeles.

    PubMed

    Takahashi, Lois M; Tobin, Karin E; To, Stacy; Ou, Samuel; Ma, Chui Hing Helen; Ao, Fiona Ka Wa; Candelario, Jury

    2013-12-01

    Asian heterosexual women in the U.S. have experienced relative rising HIV case rates, but there remain few studies and no evidence-based interventions that focus on this population. This study was a randomized controlled trial of a gender and ethnically tailored HIV prevention intervention for monolingual Chinese-speaking women who work as masseuses in Los Angeles. The intervention was two group-based sessions focused on HIV risk and prevention knowledge and condom skills. The control condition was a single-session HIV review. Participants were recruited using newspaper advertisements and referrals from agencies and massage schools. Two hundred women were randomly assigned to one of each condition. Retention in both conditions exceeded 90% at 3-month follow-up. Participants in both conditions demonstrated increases in knowledge on how to use male and female condoms. These effects were sustained at 3-month follow-up. The results highlight the possible efficacy of a one-workshop intervention in increasing HIV knowledge, but that more intensive participant interaction may be needed for improved condom use knowledge.

  7. Intermittent Preventive Treatment of Malaria in Pregnancy with Mefloquine in HIV-Negative Women: A Multicentre Randomized Controlled Trial

    PubMed Central

    Abdulla, Salim; Accrombessi, Manfred; Aponte, John J.; Akerey-Diop, Daisy; Basra, Arti; Briand, Valérie; Capan, Meskure; Cot, Michel; Kabanywanyi, Abdunoor M.; Kleine, Christian; Kremsner, Peter G.; Macete, Eusebio; Mackanga, Jean-Rodolphe; Massougbodgi, Achille; Mayor, Alfredo; Nhacolo, Arsenio; Pahlavan, Golbahar; Ramharter, Michael; Rupérez, María; Sevene, Esperança; Vala, Anifa; Zoleko-Manego, Rella; Menéndez, Clara

    2014-01-01

    Background Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by WHO to prevent malaria in African pregnant women. The spread of SP parasite resistance has raised concerns regarding long-term use for IPT. Mefloquine (MQ) is the most promising of available alternatives to SP based on safety profile, long half-life, and high efficacy in Africa. We evaluated the safety and efficacy of MQ for IPTp compared to those of SP in HIV-negative women. Methods and Findings A total of 4,749 pregnant women were enrolled in an open-label randomized clinical trial conducted in Benin, Gabon, Mozambique, and Tanzania comparing two-dose MQ or SP for IPTp and MQ tolerability of two different regimens. The study arms were: (1) SP, (2) single dose MQ (15 mg/kg), and (3) split-dose MQ in the context of long lasting insecticide treated nets. There was no difference on low birth weight prevalence (primary study outcome) between groups (360/2,778 [13.0%]) for MQ group and 177/1,398 (12.7%) for SP group; risk ratio [RR], 1.02 (95% CI 0.86–1.22; p = 0.80 in the ITT analysis). Women receiving MQ had reduced risks of parasitemia (63/1,372 [4.6%] in the SP group and 88/2,737 [3.2%] in the MQ group; RR, 0.70 [95% CI 0.51–0.96]; p = 0.03) and anemia at delivery (609/1,380 [44.1%] in the SP group and 1,110/2743 [40.5%] in the MQ group; RR, 0.92 [95% CI 0.85–0.99]; p = 0.03), and reduced incidence of clinical malaria (96/551.8 malaria episodes person/year [PYAR] in the SP group and 130/1,103.2 episodes PYAR in the MQ group; RR, 0.67 [95% CI 0.52–0.88]; p = 0.004) and all-cause outpatient attendances during pregnancy (850/557.8 outpatients visits PYAR in the SP group and 1,480/1,110.1 visits PYAR in the MQ group; RR, 0.86 [0.78–0.95]; p = 0.003). There were no differences in the prevalence of placental infection and adverse pregnancy outcomes between groups. Tolerability was poorer in the two MQ groups compared to SP

  8. Sexual scripting of heterosexual penile-anal intercourse amongst participants in an HIV prevention trial in South Africa, Uganda and Zimbabwe.

    PubMed

    Duby, Zoe; Hartmann, Miriam; Montgomery, Elizabeth T; Colvin, Christopher J; Mensch, Barbara; van der Straten, Ariane

    2016-01-01

    Sexual risk-taking is influenced by individual, interpersonal and social factors. This paper presents findings from a qualitative follow-up study to a clinical trial evaluating biomedical HIV prevention products among African women, explored participants' perceptions and experiences of heterosexual penile-anal intercourse, as well as the gendered power dynamics and relationship contexts in which this sexual behaviour occurs. In-depth interviews were conducted with 88 women from South Africa, Uganda and Zimbabwe. Findings reveal that despite its social stigmatisation, women engage in penile-anal intercourse for reasons including male pleasure, relationship security, hiding infidelity, menstruation, vaginal infections, money and beliefs that it will prevent HIV transmission. In addition, participants described experiences of non-consensual penile-anal intercourse. We used sexual scripting theory as an analytical framework with which to describe the sociocultural and relationship contexts and gendered power dynamics in which these practices occur. These data on the distinct individual, dyadic and social contexts of heterosexual penile-anal intercourse, and the specific factors that may contribute to women's HIV risk, make a unique contribution to our understanding of heterosexual behaviour in these sub-Saharan countries, thereby helping to inform both current and future HIV prevention efforts for women in the region.

  9. Correlates of HIV Acquisition in a Cohort of Black Men Who Have Sex with Men in the United States: HIV Prevention Trials Network (HPTN) 061

    PubMed Central

    Koblin, Beryl A.; Mayer, Kenneth H.; Eshleman, Susan H.; Wang, Lei; Mannheimer, Sharon; del Rio, Carlos; Shoptaw, Steven; Magnus, Manya; Buchbinder, Susan; Wilton, Leo; Liu, Ting-Yuan; Cummings, Vanessa; Piwowar-Manning, Estelle; Fields, Sheldon D.; Griffith, Sam; Elharrar, Vanessa; Wheeler, Darrell

    2013-01-01

    Background Black men who have sex with men (MSM) in the United States (US) are affected by HIV at disproportionate rates compared to MSM of other race/ethnicities. Current HIV incidence estimates in this group are needed to appropriately target prevention efforts. Methods From July 2009 to October 2010, Black MSM reporting unprotected anal intercourse with a man in the past six months were enrolled and followed for one year in six US cities for a feasibility study of a multi-component intervention to reduce HIV infection. HIV incidence based on HIV seroconversion was calculated as number of events/100 person-years. Multivariate proportional hazards modeling with time-dependent covariates was used to identify correlates of HIV acquisition. Results Of 1,553 Black MSM enrolled, 1,164 were HIV-uninfected at baseline and included in follow-up. Overall annual HIV incidence was 3.0% (95% confidence interval (CI): 2.0, 4.4%) and 5.9% among men ≤30 years old (95% CI: 3.6, 9.1%). Men ≤30 years old reported significantly higher levels of sexual risk and were more likely to have a sexually transmitted infection diagnosed during follow-up. Younger men also were more likely to not have a usual place for health care, not have visited a health care provider recently, and to have unmet health care needs. In multivariate analysis, age ≤30 years (hazard ratio (HR): 3.4; 95% CI: 1.4, 8.3) and unprotected receptive anal intercourse with HIV-positive or unknown status partners (HR: 4.1; 95% CI: 1.9, 9.1) were significantly associated with HIV acquisition. Conclusion In the largest cohort of prospectively-followed Black MSM in the US, HIV incidence was high, particularly among young men. Targeted, tailored and culturally appropriate HIV prevention strategies incorporating behavioral, social and biomedical based interventions are urgently needed to lower these rates. PMID:23922989

  10. Intermittent Preventive Treatment of Malaria in Pregnancy with Mefloquine in HIV-Infected Women Receiving Cotrimoxazole Prophylaxis: A Multicenter Randomized Placebo-Controlled Trial

    PubMed Central

    Abdulla, Salim; Aponte, John J.; Bulo, Helder; Kabanywanyi, Abdunoor M.; Katana, Abraham; Maculuve, Sonia; Mayor, Alfredo; Nhacolo, Arsenio; Otieno, Kephas; Pahlavan, Golbahar; Rupérez, María; Sevene, Esperança; Slutsker, Laurence; Vala, Anifa; Williamsom, John; Menéndez, Clara

    2014-01-01

    Background Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended for malaria prevention in HIV-negative pregnant women, but it is contraindicated in HIV-infected women taking daily cotrimoxazole prophylaxis (CTXp) because of potential added risk of adverse effects associated with taking two antifolate drugs simultaneously. We studied the safety and efficacy of mefloquine (MQ) in women receiving CTXp and long-lasting insecticide treated nets (LLITNs). Methods and Findings A total of 1,071 HIV-infected women from Kenya, Mozambique, and Tanzania were randomized to receive either three doses of IPTp-MQ (15 mg/kg) or placebo given at least one month apart; all received CTXp and a LLITN. IPTp-MQ was associated with reduced rates of maternal parasitemia (risk ratio [RR], 0.47 [95% CI 0.27–0.82]; p = 0.008), placental malaria (RR, 0.52 [95% CI 0.29–0.90]; p = 0.021), and reduced incidence of non-obstetric hospital admissions (RR, 0.59 [95% CI 0.37–0.95]; p = 0.031) in the intention to treat (ITT) analysis. There were no differences in the prevalence of adverse pregnancy outcomes between groups. Drug tolerability was poorer in the MQ group compared to the control group (29.6% referred dizziness and 23.9% vomiting after the first IPTp-MQ administration). HIV viral load at delivery was higher in the MQ group compared to the control group (p = 0.048) in the ATP analysis. The frequency of perinatal mother to child transmission of HIV was increased in women who received MQ (RR, 1.95 [95% CI 1.14–3.33]; p = 0.015). The main limitation of the latter finding relates to the exploratory nature of this part of the analysis. Conclusions An effective antimalarial added to CTXp and LLITNs in HIV-infected pregnant women can improve malaria prevention, as well as maternal health through reduction in hospital admissions. However, MQ was not well tolerated, limiting its potential for IPTp and indicating the need

  11. Triple-Antiretroviral Prophylaxis to Prevent Mother-To-Child HIV Transmission through Breastfeeding—The Kisumu Breastfeeding Study, Kenya: A Clinical Trial

    PubMed Central

    Thomas, Timothy K.; Masaba, Rose; Borkowf, Craig B.; Ndivo, Richard; Zeh, Clement; Misore, Ambrose; Otieno, Juliana; Jamieson, Denise; Thigpen, Michael C.; Bulterys, Marc; Slutsker, Laurence; De Cock, Kevin M.; Amornkul, Pauli N.; Greenberg, Alan E.; Fowler, Mary Glenn

    2011-01-01

    Background Effective strategies are needed for the prevention of mother-to-child HIV transmission (PMTCT) in resource-limited settings. The Kisumu Breastfeeding Study was a single-arm open label trial conducted between July 2003 and February 2009. The overall aim was to investigate whether a maternal triple-antiretroviral regimen that was designed to maximally suppress viral load in late pregnancy and the first 6 mo of lactation was a safe, well-tolerated, and effective PMTCT intervention. Methods and Findings HIV-infected pregnant women took zidovudine, lamivudine, and either nevirapine or nelfinavir from 34–36 weeks' gestation to 6 mo post partum. Infants received single-dose nevirapine at birth. Women were advised to breastfeed exclusively and wean rapidly just before 6 mo. Using Kaplan-Meier methods we estimated HIV-transmission and death rates from delivery to 24 mo. We compared HIV-transmission rates among subgroups defined by maternal risk factors, including baseline CD4 cell count and viral load. Among 487 live-born, singleton, or first-born infants, cumulative HIV-transmission rates at birth, 6 weeks, and 6, 12, and 24 mo were 2.5%, 4.2%, 5.0%, 5.7%, and 7.0%, respectively. The 24-mo HIV-transmission rates stratified by baseline maternal CD4 cell count <500 and ≥500 cells/mm3 were 8.4% (95% confidence interval [CI] 5.8%–12.0%) and 4.1% (1.8%–8.8%), respectively (p = 0.06); the corresponding rates stratified by baseline maternal viral load <10,000 and ≥10,000 copies/ml were 3.0% (1.1%–7.8%) and 8.7% (6.1%–12.3%), respectively (p = 0.01). None of the 12 maternal and 51 infant deaths (including two second-born infants) were attributed to antiretrovirals. The cumulative HIV-transmission or death rate at 24 mo was 15.7% (95% CI 12.7%–19.4%). Conclusions This trial shows that a maternal triple-antiretroviral regimen from late pregnancy through 6 months of breastfeeding for PMTCT is safe and feasible in a resource-limited setting. These

  12. Polyp Prevention Trial

    Cancer.gov

    The primary objective of the Polyp Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the large bowel.

  13. Assessing Odor Level when Using PrePex for HIV Prevention: A Prospective, Randomized, Open Label, Blinded Assessor Trial to Improve Uptake of Male Circumcision

    PubMed Central

    Mutabazi, Vincent; Bitega, Jean Paul; Ngeruka, Leon Muyenzi; Karema, Corine; Binagwaho, Agnes

    2015-01-01

    The PrePex is a WHO–prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex device and acts as the leading center of excellence providing training and formal guidelines. As part of the Government’s efforts to improve PrePex implementation, it made efforts to improve the psychological acceptability of device by men, thus increasing uptake with VMMC in sub-Saharan Africa. Some men who underwent the PrePex procedure complained of foreskin odor while wearing the PrePex 3–7 days after it was placed. This complaint was identified as potential risk for uptake of the device. Researchers from Rwanda assumed there is a possible relation between the level of foreskin odor and patient foreskin hygiene technique. The Government of Rwanda decided to investigate those assumptions in a scientific way and conduct a trial to test different hygiene-cleaning methods in order to increase the acceptability of PrePex and mitigate the odor concern. The main objective of the trial was to compare odor levels between three arms, having identical personal hygiene but different foreskin hygiene techniques using either clear water with soap during a daily shower, soapy water using a syringe, or chlorhexidine using a syringe. One hundred and one subjects were enrolled to the trial and randomly allocated into three trial arms. Using chlorhexidine solution daily almost completely eliminated odor, and was statistically significant more effective that the other two arms. The trial results suggest that odor from the foreskin, while wearing the PrePex device, could be related to the growth of anaerobic bacteria, which can be prevented by a chlorhexidine cleaning method. This finding can be used to increase acceptability by men when considering PrePex as one of the leading methods for HIV prevention in VMMC programs. Trial Registration Clinicaltrials.gov NCT02153658 PMID:26023772

  14. Neurological syndrome in an HIV-prevention trial participant randomized to daily tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) in Bondo, Kenya

    PubMed Central

    Owino, Fredrick; Mandala, Justin; Ambia, Julie; Agot, Kawango; Van Damme, Lut

    2013-01-01

    Side effects of antiretroviral drug use by HIV-positive patients have been extensively studied; however, there are limited data on the side effects of antiretroviral drugs used as an HIV prophylaxis among healthy, HIV-negative individuals. Here we report on an unusual neuropathy in a 24-year-old participant in the FEM-PrEP trial. This was a Phase III randomized, double blind, placebo-controlled trial to test the safety and effectiveness of tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) (TDF-FTC) to prevent HIV. At the eighth week of taking TDF-FTC with moderate adherence, the participant complained of mild paresthesiae, numbness, and a tingling sensation in her upper limbs that was associated with pain and cold. After an additional 4 days, she developed a disabling weakness of her upper limbs and tremors in her hands. The study product was discontinued, and within 2 weeks she was free of all symptoms. One month after restarting the drug, she complained of posture-dependent numbness of her upper limbs. Results of clinical and neurological exams, laboratory tests, and magnetic resonance imaging are described here. PMID:24353443

  15. Approaches to preventative and therapeutic HIV vaccines.

    PubMed

    Gray, Glenda E; Laher, Fatima; Lazarus, Erica; Ensoli, Barbara; Corey, Lawrence

    2016-04-01

    Novel strategies are being researched to discover vaccines to prevent and treat HIV-1. Non-efficacious preventative vaccine approaches include bivalent recombinant gp120 alone, HIV gene insertion into an Adenovirus 5 (Ad5) virus vector and the DNA prime/Ad5 boost vaccine regimen. However, the ALVAC-HIV prime/AIDSVAX® B/E gp120 boost regimen showed 31.2% efficacy at 3.5 years, and is being investigated as clade C constructs with an additional boost. Likewise, although multiple therapeutic vaccines have failed in the past, in a non-placebo controlled trial, a Tat vaccine demonstrated immune cell restoration, reduction of immune activation, and reduced HIV-1 DNA viral load. Monoclonal antibodies for passive immunization or treatment show promise, with VRC01 entering advanced clinical trials.

  16. Effects of a Social Network HIV/STD Prevention Intervention for Men Who Have Sex with Men in Russia and Hungary: A Randomized Controlled Trial

    PubMed Central

    Amirkhanian, Yuri A.; Kelly, Jeffrey A.; Takacs, Judit; McAuliffe, Timothy L.; Kuznetsova, Anna V.; Toth, Tamas P.; Mocsonaki, Laszlo; DiFranceisco, Wayne J.; Meylakhs, Anastasia

    2015-01-01

    Objective To test a novel social network HIV risk reduction intervention for MSM in Russia and Hungary, where same-sex behavior is stigmatized and men may best be reached through their social network connections. Design A 2-arm trial with 18 sociocentric networks of MSM randomized to the social network intervention or standard HIV/STD testing/counseling. Setting St. Petersburg, Russia and Budapest, Hungary. Participants 18 “seeds” from community venues invited the participation of their MSM friends who, in turn, invited their own MSM friends into the study, a process that continued outward until eighteen 3-ring sociocentric networks (mean size=35 members, n=626) were recruited. Intervention Empirically-identified network leaders were trained and guided to convey HIV prevention advice to other network members. Main Outcome and Measures Changes in sexual behavior from baseline to 3- and 12-month followup, with composite HIV/STD incidence measured at 12-months to corroborate behavior changes. Results There were significant reductions between baseline, first followup, and second followup in the intervention versus comparison arm for proportion of men engaging in any unprotected anal intercourse (P=.04); UAI with a nonmain partner (P=.04); and UAI with multiple partners (P=.002). The mean percentage of unprotected AI acts significantly declined (P=.001), as well as the mean number of UAI acts among men who initially had multiple partners (P=.05). Biological HIV/STD incidence was 15% in comparison condition networks and 9% in intervention condition networks. Conclusions Even where same-sex behavior is stigmatized, it is possible to reach MSM and deliver HIV prevention through their social networks. PMID:25565495

  17. Assessing Odor Level when Using PrePex for HIV Prevention: A Prospective, Randomized, Open Label, Blinded Assessor Trial to Improve Uptake of Male Circumcision.

    PubMed

    Mutabazi, Vincent; Bitega, Jean Paul; Ngeruka, Leon Muyenzi; Karema, Corine; Binagwaho, Agnes

    2015-01-01

    The PrePex is a WHO--prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex device and acts as the leading center of excellence providing training and formal guidelines. As part of the Government's efforts to improve PrePex implementation, it made efforts to improve the psychological acceptability of device by men, thus increasing uptake with VMMC in sub-Saharan Africa. Some men who underwent the PrePex procedure complained of foreskin odor while wearing the PrePex 3-7 days after it was placed. This complaint was identified as potential risk for uptake of the device. Researchers from Rwanda assumed there is a possible relation between the level of foreskin odor and patient foreskin hygiene technique. The Government of Rwanda decided to investigate those assumptions in a scientific way and conduct a trial to test different hygiene-cleaning methods in order to increase the acceptability of PrePex and mitigate the odor concern. The main objective of the trial was to compare odor levels between three arms, having identical personal hygiene but different foreskin hygiene techniques using either clear water with soap during a daily shower, soapy water using a syringe, or chlorhexidine using a syringe. One hundred and one subjects were enrolled to the trial and randomly allocated into three trial arms. Using chlorhexidine solution daily almost completely eliminated odor, and was statistically significant more effective that the other two arms. The trial results suggest that odor from the foreskin, while wearing the PrePex device, could be related to the growth of anaerobic bacteria, which can be prevented by a chlorhexidine cleaning method. This finding can be used to increase acceptability by men when considering PrePex as one of the leading methods for HIV prevention in VMMC programs.

  18. Assessing Odor Level when Using PrePex for HIV Prevention: A Prospective, Randomized, Open Label, Blinded Assessor Trial to Improve Uptake of Male Circumcision.

    PubMed

    Mutabazi, Vincent; Bitega, Jean Paul; Ngeruka, Leon Muyenzi; Karema, Corine; Binagwaho, Agnes

    2015-01-01

    The PrePex is a WHO--prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex device and acts as the leading center of excellence providing training and formal guidelines. As part of the Government's efforts to improve PrePex implementation, it made efforts to improve the psychological acceptability of device by men, thus increasing uptake with VMMC in sub-Saharan Africa. Some men who underwent the PrePex procedure complained of foreskin odor while wearing the PrePex 3-7 days after it was placed. This complaint was identified as potential risk for uptake of the device. Researchers from Rwanda assumed there is a possible relation between the level of foreskin odor and patient foreskin hygiene technique. The Government of Rwanda decided to investigate those assumptions in a scientific way and conduct a trial to test different hygiene-cleaning methods in order to increase the acceptability of PrePex and mitigate the odor concern. The main objective of the trial was to compare odor levels between three arms, having identical personal hygiene but different foreskin hygiene techniques using either clear water with soap during a daily shower, soapy water using a syringe, or chlorhexidine using a syringe. One hundred and one subjects were enrolled to the trial and randomly allocated into three trial arms. Using chlorhexidine solution daily almost completely eliminated odor, and was statistically significant more effective that the other two arms. The trial results suggest that odor from the foreskin, while wearing the PrePex device, could be related to the growth of anaerobic bacteria, which can be prevented by a chlorhexidine cleaning method. This finding can be used to increase acceptability by men when considering PrePex as one of the leading methods for HIV prevention in VMMC programs. PMID:26023772

  19. Rethinking Prevention of HIV Type 1 Infection

    PubMed Central

    Burns, David N.; Dieffenbach, Carl W.; Vermund, Sten H.

    2010-01-01

    Research on the prevention of human immunodeficiency virus (HIV)–1 infection is at a critical juncture. Major methodological challenges to performing prevention trials have emerged, and one after another promising biomedical interventions have failed to reduce the incidence of HIV-1 infection. Nevertheless, there is growing optimism that progress can be achieved in the near term. Mathematical modeling indicates that 2 new strategies, “test and treat” and preexposure prophylaxis, could have a major impact on the incidence of HIV-1 infection. Will our hopes be justified? We review the potential strengths and limitations of these antiretroviral “treatment as prevention” strategies and outline other new options for reducing the incidence of HIV-1 infection in the near term. By maximizing the potential of existing interventions, developing other effective strategies, and combining them in an optimal manner, we have the opportunity to bring the HIV-1 epidemic under control. PMID:20707698

  20. Strategies to retain participants in a long-term HIV prevention randomized controlled trial: Lessons from the MINTS-II study

    PubMed Central

    Horvath, Keith J.; Nygaard, Kate; Danilenko, Gene P.; Goknur, Sinan; Oakes, J. Michael; Rosser, B.R. Simon

    2012-01-01

    Achieving satisfactory retention in online HIV prevention trials typically have proved difficult, particularly over extended timeframes. The overall aim of this study was to assess factors associated with retention in the Men’s INTernet Study II (MINTS-II), a randomized controlled trial of a sexual risk reduction intervention for men who have sex with men. Participants were recruited via e-mails and banner advertisements in December, 2007 to participate in the MINTS-II Sexpulse intervention and followed over a 12-month period. Retention across the treatment and control arms was 85.2% at 12 months. Factors associated with higher retention included: randomization to the control arm, previous participation in a study by the research team, e-mail and telephone reminders to complete a survey once it was available to take, and fewer e-mail contacts between surveys. The results provide evidence that achieving satisfactory retention is possible in online HIV prevention trials, and suggest best practices for maximizing retention. PMID:21538084

  1. Randomized Controlled Clinical Trial of Zinc Supplementation to Prevent Immunological Failure in HIV-Positive Adults1,2

    PubMed Central

    Baum, Marianna K; Lai, Shenghan; Sales, Sabrina; Page, J. Bryan; Campa, Adriana

    2010-01-01

    Background Adequate zinc is critical for immune function; however, zinc deficiency occurs in >50% of HIV-infected adults. We examined the safety and efficacy of long-term zinc supplementation on HIV disease progression. Methods A prospective randomized controlled clinical trial was conducted with 231 HIV+ adults with low plasma zinc levels (<0.75 μg/ml), randomly assigned into zinc (12 mg of elemental zinc for women and 15 mg for men) or placebo, for 18 months. The primary endpoint was immunological failure. HIV-viral load and CD4+ cell count were determined every 6 months. Questionnaires, pill-counts, plasma zinc and C-reactive protein (hsCRP) were used to monitor adherence with study supplements and ART. Intent-to-treat analysis utilized multiple-event analysis, treating CD4+ cell count <200 cells/mm3 as recurrent immunological failure event. Cox proportional-hazard models and the general-linear model were used to analyze morbidity and mortality data. Results Zinc supplementation for 18 months reduced four-fold the likelihood of immunological failure, controlling for age, gender, lack of food, baseline CD4+ cell count, viral load, and antiretroviral therapy (RR=0.24[95%CI:0.10,0.56],p<0.002). Viral load indicated poor control with ART but was not affected by zinc supplementation. Zinc supplementation also reduced the rate of diarrhea by more than half (OR=0.4[95%CI:0.183-0.981],p=0.019) compared to placebo. There was no significant difference in mortality between the two groups. Conclusion This study demonstrated that long-term (18-month) zinc supplementation at nutritional levels delayed immunological failure and decreased diarrhea over time. This evidence supports the use of zinc supplementation as an adjunct therapy in HIV+ adult cohorts with poor viral control. Summary This study demonstrated that long-term (18-month) zinc supplementation at nutritional levels delayed immunological failure and decreased diarrhea over time. This evidence supports the use of

  2. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial

    PubMed Central

    McCormack, Sheena; Dunn, David T; Desai, Monica; Dolling, David I; Gafos, Mitzy; Gilson, Richard; Sullivan, Ann K; Clarke, Amanda; Reeves, Iain; Schembri, Gabriel; Mackie, Nicola; Bowman, Christine; Lacey, Charles J; Apea, Vanessa; Brady, Michael; Fox, Julie; Taylor, Stephen; Antonucci, Simone; Khoo, Saye H; Rooney, James; Nardone, Anthony; Fisher, Martin; McOwan, Alan; Phillips, Andrew N; Johnson, Anne M; Gazzard, Brian; Gill, Owen N

    2016-01-01

    ) in a similar population would need access to 1 year of PrEP to avert one HIV infection. We recorded no serious adverse drug reactions; 28 adverse events, most commonly nausea, headache, and arthralgia, resulted in interruption of PrEp. We detected no difference in the occurrence of sexually transmitted infections, including rectal gonorrhoea and chlamydia, between groups, despite a suggestion of risk compensation among some PrEP recipients. Interpretation In this high incidence population, daily tenofovir–emtricitabine conferred even higher protection against HIV than in placebo-controlled trials, refuting concerns that effectiveness would be less in a real-world setting. There was no evidence of an increase in other sexually transmitted infections. Our findings strongly support the addition of PrEP to the standard of prevention for men who have sex with men at risk of HIV infection. Funding MRC Clinical Trials Unit at UCL, Public Health England, and Gilead Sciences. PMID:26364263

  3. Evaluating the effectiveness of personal resilience and enrichment programme (PREP) for HIV prevention among female sex workers: a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Female sex workers (FSWs) are often considered as the vector, if not reservoir, of HIV and other sexually transmitted infections. Building upon the existing evidence on the role of psychological health in sexual health, the aim of this protocol is to describe a trial investigating the effectiveness of the Personal Resilience and Enrichment Programme (PREP), a resilience-promoting intervention that targets at psychological well-being i.e. self-esteem, self-efficacy and coping, to facilitate adaptation and ultimately safe sexual practices among FSWs, which could be an innovative strategy in controlling the spread of these infections. Methods A total of 132 FSWs will be recruited and randomly assigned to either the intervention or usual care (control) groups in a multi-centred randomised controlled trial. Based on the resilience framework, this intervention is comprised of six weekly sessions focused on the awareness, expression and management of emotions, identifying roles and personal strengths, and effective problem-solving skills. Complex intervention assessment on both intervention process and effectiveness will be adopted when the primary outcome reduction of sexual risk behaviour and other psychological outcomes include their perceived stress, self-esteem, self-efficacy, coping overall resilience, and psychological distress will be measured at baseline, post-treatment and 3-month post-intervention and differences assessed by ANOVA. The relationship of resilience factors, psychological health and HIV preventive behaviours will be evaluated using structural equation modelling. Discussion It is anticipated that this study will increase our understanding of the relationships between individual resilience attributes, positive adaptation, psychological health and sexual health practices. If successful, this programme will provide an innovative direction for HIV prevention by applying the personal resilience factors to promote both psychological well

  4. Delivering Prevention Interventions to People Living with HIV in Clinical Care Settings: Results of a Cluster Randomized Trial in Kenya, Namibia, and Tanzania.

    PubMed

    Bachanas, Pamela; Kidder, Daniel; Medley, Amy; Pals, Sherri L; Carpenter, Deborah; Howard, Andrea; Antelman, Gretchen; DeLuca, Nicolas; Muhenje, Odylia; Sheriff, Muhsin; Somi, Geoffrey; Katuta, Frieda; Cherutich, Peter; Moore, Janet

    2016-09-01

    We conducted a group randomized trial to assess the feasibility and effectiveness of a multi-component, clinic-based HIV prevention intervention for HIV-positive patients attending clinical care in Namibia, Kenya, and Tanzania. Eighteen HIV care and treatment clinics (six per country) were randomly assigned to intervention or control arms. Approximately 200 sexually active clients from each clinic were enrolled and interviewed at baseline and 6- and 12-months post-intervention. Mixed model logistic regression with random effects for clinic and participant was used to assess the effectiveness of the intervention. Of 3522 HIV-positive patients enrolled, 3034 (86 %) completed a 12-month follow-up interview. Intervention participants were significantly more likely to report receiving provider-delivered messages on disclosure, partner testing, family planning, alcohol reduction, and consistent condom use compared to participants in comparison clinics. Participants in intervention clinics were less likely to report unprotected sex in the past 2 weeks (OR = 0.56, 95 % CI 0.32, 0.99) compared to participants in comparison clinics. In Tanzania, a higher percentage of participants in intervention clinics (17 %) reported using a highly effective method of contraception compared to participants in comparison clinics (10 %, OR = 2.25, 95 % CI 1.24, 4.10). This effect was not observed in Kenya or Namibia. HIV prevention services are feasible to implement as part of routine care and are associated with a self-reported decrease in unprotected sex. Further operational research is needed to identify strategies to address common operational challenges including staff turnover and large patient volumes. PMID:26995678

  5. Delivering Prevention Interventions to People Living with HIV in Clinical Care Settings: Results of a Cluster Randomized Trial in Kenya, Namibia, and Tanzania

    PubMed Central

    Kidder, Daniel; Medley, Amy; Pals, Sherri L.; Carpenter, Deborah; Howard, Andrea; Antelman, Gretchen; DeLuca, Nicolas; Muhenje, Odylia; Sheriff, Muhsin; Somi, Geoffrey; Katuta, Frieda; Cherutich, Peter; Moore, Janet

    2016-01-01

    We conducted a group randomized trial to assess the feasibility and effectiveness of a multi-component, clinic-based HIV prevention intervention for HIV-positive patients attending clinical care in Namibia, Kenya, and Tanzania. Eighteen HIV care and treatment clinics (six per country) were randomly assigned to intervention or control arms. Approximately 200 sexually active clients from each clinic were enrolled and interviewed at baseline and 6- and 12-months post-intervention. Mixed model logistic regression with random effects for clinic and participant was used to assess the effectiveness of the intervention. Of 3522 HIV-positive patients enrolled, 3034 (86 %) completed a 12-month follow-up interview. Intervention participants were significantly more likely to report receiving provider-delivered messages on disclosure, partner testing, family planning, alcohol reduction, and consistent condom use compared to participants in comparison clinics. Participants in intervention clinics were less likely to report unprotected sex in the past 2 weeks (OR = 0.56, 95 % CI 0.32, 0.99) compared to participants in comparison clinics. In Tanzania, a higher percentage of participants in intervention clinics (17 %) reported using a highly effective method of contraception compared to participants in comparison clinics (10 %, OR = 2.25, 95 % CI 1.24, 4.10). This effect was not observed in Kenya or Namibia. HIV prevention services are feasible to implement as part of routine care and are associated with a self-reported decrease in unprotected sex. Further operational research is needed to identify strategies to address common operational challenges including staff turnover and large patient volumes. PMID:26995678

  6. Antiretroviral drug use and HIV drug resistance among HIV-infected Black men who have sex with men: HIV Prevention Trials Network 061

    PubMed Central

    Chen, Iris; Connor, Matthew B.; Clarke, William; Marzinke, Mark A.; Cummings, Vanessa; Breaud, Autumn; Fogel, Jessica M.; Laeyendecker, Oliver; Fields, Sheldon D.; Donnell, Deborah; Griffith, Sam; Scott, Hyman M.; Shoptaw, Steven; del Rio, Carlos; Magnus, Manya; Mannheimer, Sharon; Wheeler, Darrell P.; Mayer, Kenneth H.; Koblin, Beryl A.; Eshleman, Susan H.

    2015-01-01

    BACKGROUND HPTN 061 enrolled Black men who have sex with men in the United States. Some men with low/undetectable HIV RNA had unusual patterns of antiretroviral (ARV) drug use or had drugs detected in the absence of viral suppression. This report includes a comprehensive analysis of ARV drug use and drug resistance among men in HPTN 061 who were not virally suppressed. METHODS The analysis included 169 men who had viral loads >400 copies/mL at enrollment, including three with acute infection and 13 with recent infection. By self-report, 88 were previously diagnosed, including 31 in care; 137 men reported no ARV drug use. Samples from these 169 men and 23 seroconverters were analyzed with HIV genotyping and ARV drug assays. RESULTS Forty-eight (28%) of the 169 men had ≥1 drug resistance mutation (DRM); 19 (11%) had multi-class resistance. Sixty men (36%) had ≥1 ARV drug detected, 42 (70%) of whom reported no ARV drug use. Nine (23%) of 39 newly-infected men had ≥1 DRM; 10 had ≥1 ARV drug detected. Unusual patterns of ARV drugs were detected more frequently in newly-diagnosed men than previously-diagnosed men. The rate of transmitted drug resistance (TDR) was 23% based on HIV genotyping and self-reported ARV drug use, but was 12% after adjusting for ARV drug detection. CONCLUSIONS Many men in HPTN 061 had drug-resistant HIV and many were at risk of acquiring additional DRMs. ARV drug testing revealed unusual patterns of ARV drug use and provided a more accurate estimate of TDR. PMID:25861015

  7. PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial

    PubMed Central

    McCormack, Sheena; Ramjee, Gita; Kamali, Anatoli; Rees, Helen; Crook, Angela M; Gafos, Mitzy; Jentsch, Ute; Pool, Robert; Chisembele, Maureen; Kapiga, Saidi; Mutemwa, Richard; Vallely, Andrew; Palanee, Thesla; Sookrajh, Yuki; Lacey, Charles J; Darbyshire, Janet; Grosskurth, Heiner; Profy, Albert; Nunn, Andrew; Hayes, Richard; Weber, Jonathan

    2010-01-01

    Summary Background Innovative prevention strategies for HIV-1 transmission are urgently needed. PRO2000 vaginal gel was efficacious against HIV-1 transmission in studies in macaques; we aimed to assess efficacy and safety of 2% and 0·5% PRO2000 gels against vaginal HIV-1 transmission in women in sub-Saharan Africa. Methods Microbicides Development Programme 301 was a phase 3, randomised, double-blind, parallel-group trial, undertaken at 13 clinics in South Africa, Tanzania, Uganda, and Zambia. We randomly assigned sexually active women, aged 18 years or older (≥16 years in Tanzania and Uganda) without HIV-1 infection in a 1:1:1 ratio to 2% PRO2000, 0·5% PRO2000, or placebo gel groups for 52 weeks (up to 104 weeks in Uganda). Randomisation was done by computerised random number generator. Investigators and participants were masked to group assignment. The primary efficacy outcome was incidence of HIV-1 infection before week 52, which was censored for pregnancy and excluded participants without HIV-1 follow-up data or with HIV-1 infection at enrolment. HIV-1 status was established by rapid tests or ELISA at screening at 12 weeks, 24 weeks, 40 weeks, and 52 weeks, and confirmed in a central reference laboratory. The primary safety endpoint was an adverse event of grade 3 or worse. Use of 2% PRO2000 gel was discontinued on Feb 14, 2008, on the recommendation of the Independent Data Monitoring Committee because of low probability of benefit. This trial is registered at http://isrctn.org, number ISRCTN 64716212. Findings We enrolled 9385 of 15 818 women screened. 2591 (95%) of 2734 participants enrolled to the 2% PRO2000 group, 3156 (95%) of 3326 in the 0·5% PRO2000 group, and 3112 (94%) of 3325 in the placebo group were included in the primary efficacy analysis. Mean reported gel use at last sex act was 89% (95% CI 86–91). HIV-1 incidence was much the same between groups at study end (incidence per 100 woman-years was 4·5 [95% CI 3·8–5·4] for 0·5% PRO2000

  8. Effectiveness of a peer-led HIV prevention intervention in secondary schools in Rwanda: results from a non-randomized controlled trial

    PubMed Central

    2012-01-01

    Background While the HIV epidemic is levelling off in sub-Saharan Africa, it remains at an unacceptably high level. Young people aged 15-24 years remain particularly vulnerable, resulting in a regional HIV prevalence of 1.4% in young men and 3.3% in young women. This study assesses the effectiveness of a peer-led HIV prevention intervention in secondary schools in Rwanda on young people’s sexual behavior, HIV knowledge and attitudes. Methods In a non-randomized longitudinal controlled trial, fourteen schools were selected in two neighboring districts in Rwanda Bugesera (intervention) and Rwamagana (control). Students (n = 1950) in eight intervention and six control schools participated in three surveys (baseline, six and twelve months in the intervention). Analysis was done using linear and logistic regression using generalized estimation equations adjusted for propensity score. Results The overall retention rate was 72%. Time trends in sexual risk behavior (being sexually active, sex in last six months, condom use at last sex) were not significantly different in students from intervention and control schools, nor was the intervention associated with increased knowledge, perceived severity or perceived susceptibility. It did significantly reduce reported stigma. Conclusions Analyzing this and other interventions, we identified several reasons for the observed limited effectiveness of peer education: 1) intervention activities (spreading information) are not tuned to objectives (changing behavior); 2) young people prefer receiving HIV information from other sources than peers; 3) outcome indicators are not adequate and the context of the relationship in which sex occurs and the context in which sex occurs is ignored. Effectiveness of peer education may increase through integration in holistic interventions and redefining peer educators’ role as focal points for sensitization and referral to experts and services. Finally, we argue that a narrow focus on

  9. Can money prevent the spread of HIV? A review of cash payments for HIV prevention

    PubMed Central

    Pettifor, Audrey; MacPhail, Catherine; Nguyen, Nadia; Rosenberg, Molly

    2013-01-01

    Cash payments to improve health outcomes have been used for many years, however, their use for HIV prevention is new and the impact not yet well understood. We provide a brief background on the rationale behind using cash to improve health outcomes, review current studies completed or underway using cash for prevention of sexual transmission of HIV, and outline some key considerations on the use of cash payments to prevent HIV infections. We searched the literature for studies that implemented cash transfer programs and measured HIV or HIV-related outcomes. We identified 16 studies meeting our criteria; 10 are completed. The majority of studies have been conducted with adolescents in developing countries and payments are focused on addressing structural risk factors such as poverty. Most have seen reductions in sexual behavior and one large trial has documented a difference in HIV prevalence between young women getting cash transfers and those not. Cash transfer programs focused on changing risky sexual behaviors to reduce HIV risk suggest promise. The context in which programs are situated, the purpose of the cash transfer, and the population will all affect the impact of such programs; ongoing RCTs with HIV incidence endpoints will shed more light on the efficacy of cash payments as strategy for HIV prevention. PMID:22760738

  10. Preventing HIV Infection in Women

    PubMed Central

    Adimora, Adaora A.; Ramirez, Catalina; Auerbach, Judith D.; Aral, Sevgi O.; Hodder, Sally; Wingood, Gina; El-Sadr, Wafaa; Bukusi, Elizabeth Anne

    2014-01-01

    Although the number of new infections has declined recently, women still constitute almost half of the world's 34 million people with HIV infection, and HIV remains the leading cause of death among women of reproductive age. Prevention research has made considerable progress during the past few years in addressing the biological, behavioral and social factors that influence women's vulnerability to HIV infection. Nevertheless, substantial work still must be done in order to implement scientific advancements and to resolve the many questions that remain. This article highlights some of the recent advances and persistent gaps in HIV prevention research for women and outlines key research and policy priorities. PMID:23764631

  11. A Randomized Controlled Trial of POWER: An Internet-Based HIV Prevention Intervention for Black Bisexual Men.

    PubMed

    Fernandez, M Isabel; Hosek, Sybil G; Hotton, Anna L; Gaylord, Sanford E; Hernandez, Nilda; Alfonso, Sarah V; Joseph, Heather

    2016-09-01

    POWER is a theory-based, on-line HIV prevention intervention developed specifically for Black men who have sex with men and women (BMSMW), an understudied group significantly impacted by HIV. To test its efficacy, we recruited 224 BMSMW using chain referral methods and randomly assigned 108 to POWER and 103 to a health information comparison condition. Three months after the intervention, participants assigned to POWER had lower odds of reporting any condomless vaginal or condomless anal intercourse (CVAI) compared to those in the comparison group (aOR = 0.49; 95 % CI 0.25-0.98; p = 0.044). The intervention was associated with significantly lower odds of condomless anal intercourse with male partners (aOR = 0.55; 95 % CI 0.34-0.91; p = 0.020) but not with female partners and serodiscordant sex with male partners but not with female partners. Future studies are needed to replicate these findings in larger and more diverse samples of BMSMW and to understand the underlying mechanisms through which intervention efficacy was achieved.

  12. A Randomized Controlled Trial of POWER: An Internet-Based HIV Prevention Intervention for Black Bisexual Men.

    PubMed

    Fernandez, M Isabel; Hosek, Sybil G; Hotton, Anna L; Gaylord, Sanford E; Hernandez, Nilda; Alfonso, Sarah V; Joseph, Heather

    2016-09-01

    POWER is a theory-based, on-line HIV prevention intervention developed specifically for Black men who have sex with men and women (BMSMW), an understudied group significantly impacted by HIV. To test its efficacy, we recruited 224 BMSMW using chain referral methods and randomly assigned 108 to POWER and 103 to a health information comparison condition. Three months after the intervention, participants assigned to POWER had lower odds of reporting any condomless vaginal or condomless anal intercourse (CVAI) compared to those in the comparison group (aOR = 0.49; 95 % CI 0.25-0.98; p = 0.044). The intervention was associated with significantly lower odds of condomless anal intercourse with male partners (aOR = 0.55; 95 % CI 0.34-0.91; p = 0.020) but not with female partners and serodiscordant sex with male partners but not with female partners. Future studies are needed to replicate these findings in larger and more diverse samples of BMSMW and to understand the underlying mechanisms through which intervention efficacy was achieved. PMID:27085548

  13. Family Wellness, Not HIV Prevention

    PubMed Central

    Swendeman, Dallas; Flannery, Diane

    2010-01-01

    HIV exceptionalism (and disease-specific programs generally) garner both unbalanced funding and the most talented personnel, distorting local health priorities. In support of HIV exceptionalism, the successful mobilization of significant global health sector resources was not possible prior to HIV. Both sides of the debate have merits; rather than perpetuating polarization, we suggest that sustained improvements in global health require creating a prevention infrastructure to meet multiple health challenges experienced by local communities. We propose four fundamental shifts in HIV and disease prevention: (1) horizontally integrating prevention at one site locally, with priorities tailored to local health challenges and managed by local community leaders; (2) using a family wellness metaphor for services, not disease prevention; (3) implementing evidence-based prevention programs (EBPP) based on common principles, factors, and processes, rather than replication of specific programs; and (4) utilizing the expertise of private enterprise to re-design EBPP into highly attractive, engaging, and accessible experiences. PMID:19148744

  14. Preventing HIV Infection among Youth.

    ERIC Educational Resources Information Center

    Alcohol, Drug Abuse, and Mental Health Administration (DHHS/PHS), Rockville, MD. Office for Substance Abuse Prevention.

    This document notes that a recent threat to American's youth is the risk of infection from the human immunodeficiency virus (HIV). It views youth at high risk for alcohol or other drug use as also being, in all probability, at highest risk for exposure to HIV, and suggests that programs set up to prevent adolescents from becoming involved with…

  15. Long Term Follow-up of Children in the HIVNET 012 Perinatal HIV Prevention Trial: Five-Year Growth and Survival

    PubMed Central

    Owor, Maxensia; Mwatha, Anthony; Donnell, Deborah; Musoke, Philippa; Mmiro, Francis; Allen, Melissa; Jackson, J Brooks; Fowler, Mary Glenn; Guay, Laura A

    2014-01-01

    Objectives To describe five year growth, survival and long-term safety among children exposed to nevirapine or zidovudine in an African perinatal prevention trial, HIVNET 012. Methods All study children who were alive at eighteen months of age were eligible for an extended follow-up study. Children whose families consented were enrolled and evaluated every six months from 24 to 60 months. At each visit, history, physical exam and growth measures were taken. From these measurements Z scores based on World Health Organization (WHO) standards were computed. Serious adverse event data were collected. Data from the initial and extended follow-up cohorts were included in the analysis. Results 528 study children were alive at age 18 months, and 491 (426 HIV uninfected; 65 infected) were enrolled into the follow-up study. Both exposed but uninfected children and HIV infected children were substantially below WHO growth standards for weight and height. Head circumference Z scores for uninfected children were comparable to WHO norms. Five-year survival rates were 93% for uninfected children versus 43% for infected children. Long-term safety and growth outcomes in the two study arms were similar. Conclusions Both infected and uninfected children in the five-year HIVNET 012 follow-up showed poor height and weight growth outcomes, underscoring the need for early nutritional interventions to improve long-term growth of all infants born to HIV-infected women in resource limited settings. Likewise, the low five year survival among HIV infected children support the importance of early initiation of antiretroviral therapy. Both peripartum nevirapine and zidovudine were safe. PMID:24121753

  16. Antiviral agents and HIV prevention: controversies, conflicts, and consensus

    PubMed Central

    Cohen, Myron S.; Muessig, Kathryn E.; Smith, M. Kumi; Powers, Kimberly A.; Kashuba, Angela D.M.

    2013-01-01

    Antiviral agents can be used to prevent HIV transmission before exposure as preexpo-sure prophylaxis (PrEP), after exposure as postexposure prophylaxis, and as treatment of infected people for secondary prevention. Considerable research has shed new light on antiviral agents for PrEP and for prevention of secondary HIV transmission. While promising results have emerged from several PrEP trials, the challenges of poor adherence among HIV-negative clients and possible increase in sexual risk behaviors remain a concern. In addition, a broader pipeline of antiviral agents for PrEP that focuses on genital tract pharmacology and safety and resistance issues must be developed. Antiretroviral drugs have also been used to prevent HIV transmission from HIV-infected patients to their HIV-discordant sexual partners. The HIV Prevention Trials Network 052 trial demonstrated nearly complete prevention of HIV transmission by early treatment of infection, but the generalizability of the results to other risk groups – including intravenous drug users and MSM – has not been determined. Most importantly, the best strategy for use of antiretroviral agents to reduce the spread of HIV at either the individual level or the population level has not been developed, and remains the ultimate goal of this area of investigation. PMID:22507927

  17. Vaginal Practices and Associations with Barrier Methods and Gel Use Among Sub-Saharan African Women Enrolled in an HIV Prevention Trial

    PubMed Central

    Cheng, Helen; Chidanyika, Agnes; De Bruyn, Guy; Padian, Nancy

    2010-01-01

    Vaginal practices may interfere with the use and/or the effectiveness of female-initiated prevention methods. We investigated whether vaginal practices differed by randomization group in a phase III trial of the diaphragm with lubricant gel (MIRA) in Sub-Saharan Africa (n = 4925), and if they were associated with consistent use of study methods. At baseline, vaginal practices were commonly reported: vaginal washing (82.77%), wiping (56.47%) and insertion of dry or absorbent materials (20.58%). All three practices decreased during the trial. However, women in the intervention group were significantly more likely to report washing or wiping during follow-up compared to those in the control group. Additionally, washing, wiping, and insertion, were all independently and inversely associated with consistent diaphragm and gel use and with condom use as well, regardless of study arm. A better understanding of the socio-cultural context in which these practices are embedded could improve educational strategies to address these potentially modifiable behaviors, and may benefit future HIV prevention interventions of vaginal methods. PMID:20352318

  18. Vaginal practices and associations with barrier methods and gel use among Sub-Saharan African women enrolled in an HIV prevention trial.

    PubMed

    van der Straten, Ariane; Cheng, Helen; Chidanyika, Agnes; De Bruyn, Guy; Padian, Nancy

    2010-06-01

    Vaginal practices may interfere with the use and/or the effectiveness of female-initiated prevention methods. We investigated whether vaginal practices differed by randomization group in a phase III trial of the diaphragm with lubricant gel (MIRA) in Sub-Saharan Africa (n = 4925), and if they were associated with consistent use of study methods. At baseline, vaginal practices were commonly reported: vaginal washing (82.77%), wiping (56.47%) and insertion of dry or absorbent materials (20.58%). All three practices decreased during the trial. However, women in the intervention group were significantly more likely to report washing or wiping during follow-up compared to those in the control group. Additionally, washing, wiping, and insertion, were all independently and inversely associated with consistent diaphragm and gel use and with condom use as well, regardless of study arm. A better understanding of the socio-cultural context in which these practices are embedded could improve educational strategies to address these potentially modifiable behaviors, and may benefit future HIV prevention interventions of vaginal methods. PMID:20352318

  19. Effectiveness of Circle of Life, an HIV-Preventive Intervention for American Indian Middle School Youths: A Group Randomized Trial in a Northern Plains Tribe

    PubMed Central

    Whitesell, Nancy Rumbaugh; Keane, Ellen M.; Desserich, Jennifer A.; Giago, Cindy; Sam, Angela; Mitchell, Christina M.

    2014-01-01

    Objectives. We assessed the effectiveness of Circle of Life (COL), an HIV-preventive intervention developed specifically for American Indian and Alaska Native (AI/AN) middle school youths. Methods. By partnering with a tribal community, we conducted a longitudinal wait-listed group randomized trial with 635 seventh and eighth graders in 13 schools of a Northern Plains tribe. We surveyed participants at baseline, 3 months, and 12 months from 2006 to 2007. Results. COL was found to increase HIV knowledge in the short term, but had no effect on sexual activity compared with those who did not receive it. However, COL was found to be effective for delaying the onset of sexual activity, with the greatest reduction in risk occurring for those receiving COL at early ages. Conclusions. Community partnership was key to successful project design, implementation, and analysis. The project confirmed the importance of the timing of interventions in early adolescence. COL may be a key resource for reducing sexual risk among AI/AN youths. PMID:24754555

  20. Maternal and infant antiretroviral regimens to prevent postnatal HIV-1 transmission: 48-week follow-up of the BAN randomised controlled trial

    PubMed Central

    Jamieson, Denise J; Chasela, Charles S; Hudgens, Michael G; King, Caroline C; Kourtis, Athena P; Kayira, Dumbani; Hosseinipour, Mina C; Kamwendo, Deborah D; Ellington, Sascha R; Wiener, Jeffrey B; Fiscus, Susan A; Tegha, Gerald; Mofolo, Innocent A; Sichali, Dorothy S; Adair, Linda S; Knight, Rodney J; Martinson, Francis; Kacheche, Zebrone; Soko, Alice; Hoffman, Irving; van der Horst, Charles

    2013-01-01

    Summary Background In resource-limited settings where no safe alternative to breastfeeding exists, WHO recommends that antiretroviral prophylaxis be given to either HIV-infected mothers or infants throughout breastfeeding. We assessed the effect of 28 weeks of maternal or infant antiretroviral prophylaxis on postnatal HIV infection at 48 weeks. Methods The Breastfeeding, Antiretrovirals, and Nutrition (BAN) Study was undertaken in Lilongwe, Malawi, between April 21, 2004, and Jan 28, 2010. 2369 HIV-infected breastfeeding mothers with a CD4 count of 250 cells per μL or more and their newborn babies were randomly assigned with a variable-block design to one of three, 28-week regimens: maternal triple antiretroviral (n=849); daily infant nevirapine (n=852); or control (n=668). Patients and local clinical staff were not masked to treatment allocation, but other study investigators were. All mothers and infants received one dose of nevirapine (mother 200 mg; infant 2 mg/kg) and 7 days of zidovudine (mother 300 mg; infants 2 mg/kg) and lamivudine (mothers 150 mg; infants 4 mg/kg) twice a day. Mothers were advised to wean between 24 weeks and 28 weeks after birth. The primary endpoint was HIV infection by 48 weeks in infants who were not infected at 2 weeks and in all infants randomly assigned with censoring at loss to follow-up. This trial is registered with ClinicalTrials.gov, number NCT00164736. Findings 676 mother–infant pairs completed follow-up to 48 weeks or reached an endpoint in the maternal-antiretroviral group, 680 in the infant-nevirapine group, and 542 in the control group. By 32 weeks post partum, 96% of women in the intervention groups and 88% of those in the control group reported no breastfeeding since their 28-week visit. 30 infants in the maternal-antiretroviral group, 25 in the infant-nevirapine group, and 38 in the control group became HIV infected between 2 weeks and 48 weeks of life; 28 (30%) infections occurred after 28 weeks (nine in maternal

  1. HIV / AIDS: Symptoms, Diagnosis, Prevention and Treatment

    MedlinePlus

    Skip Navigation Bar Home Current Issue Past Issues HIV / AIDS HIV / AIDS: Symptoms , Diagnosis, Prevention and Treatment Past Issues / ... Most people who have become recently infected with HIV will not have any symptoms. They may, however, ...

  2. HIV prevention strategies in Africa.

    PubMed

    Menting, A

    2000-01-01

    This paper concerns the administration of governmental and nongovernmental programs for the prevention of HIV/AIDS in Africa. A 1986 government campaign in the prevention of HIV in Senegal has been initiated and has been guided consistently. The Society for Women and AIDS in Africa (SWAA) is a nongovernmental organization (NGO) which assembles young population, women, and communities, towards their goal to prevent HIV infection. Marocaine de Lutte Contre le SIDA (ALCS), another NGO in Morocco believes that early intervention and education could help prevent further spread of infection. ALCS focused on the education of sex workers and the use of condoms. They also work with a group of men to promote safe sex and tackle the need for better testing facilities. In Uganda, the focus of the organization is to control the high incidence found in couples with only one infected partner. Another organization incorporates accurate HIV/AIDS information during prayers and other religious activities. Another approach was adopted by teaching English in secondary schools with AIDS information, values on education, family, and employment as content. An NGO in Cape Town was established to form loose cooperative to exchange information and resources within the community. An ongoing nationwide campaign for HIV prevention and control especially among high-risk groups and an effort on STD treatment is being organized.

  3. The SHAZ! Project: Results from a Pilot Randomized Trial of a Structural Intervention to Prevent HIV among Adolescent Women in Zimbabwe

    PubMed Central

    Dunbar, Megan S.; Kang Dufour, Mi-Suk; Lambdin, Barrot; Mudekunye-Mahaka, Imelda; Nhamo, Definate; Padian, Nancy S.

    2014-01-01

    Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ!) was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control). The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own income [IOR = 2.05 vs. COR = 1.67, p = 0.02]. Additionally, within the Intervention arm there was a lower risk of transactional sex [IOR = 0.64, 95% CI (0.50, 0.83)], and a higher likelihood of using a condom with their current partner [IOR = 1.79, 95% CI (1.23, 2.62)] over time compared to baseline. There was also evidence of fewer unintended pregnancies among intervention participants [HR = 0.61, 95% CI (0.37, 1.01)], although this relationship achieved only marginal statistical significance. Several important challenges in this study included the coordination with vocational training programs, the political and economic instability of the area at the time of the study, and the difficulty in creating a true standard of care control arm. Overall the results of the SHAZ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants, and lessons for further economic livelihoods interventions with adolescent females. Further work is needed to refine the intervention model, and

  4. HIV prevention research: taking stock and the way forward.

    PubMed

    Hayes, Richard; Kapiga, Saidi; Padian, Nancy; McCormack, Sheena; Wasserheit, Judith

    2010-10-01

    Previous papers in this supplement have reviewed the evidence of the effectiveness of alternative HIV prevention methods from randomized controlled trials and other studies. This paper draws together the main conclusions from these reviews. A conceptual framework is presented that maps the proximal and distal determinants of sexual HIV transmission and helps to identify the stages in the causal pathway at which each intervention approach acts. The advances, gaps and challenges emerging from the reviews of individual intervention methods are summarized and cross-cutting themes identified. Approximately 90% of HIV prevention trials have found no effect on HIV incidence and we explore the alternative explanations for the large number of 'flat' trials. We conclude that there is no single explanation for these flat results, which may be due to interventions that are ineffective or inappropriately targeted or implemented, or to factors related to the design or conduct of trials. We examine the lessons from these flat results and provide recommendations on what should be done differently in future trials. HIV prevention remains of critical importance in an era of expanded delivery of antiretroviral therapy. In future HIV prevention research, it is important that resources are used as efficiently as possible to provide rigorous evidence of the effectiveness of a wider array of complementary prevention tools. PMID:21042056

  5. HIV PREVENTION RESEARCH: TAKING STOCK AND THE WAY FORWARD

    PubMed Central

    Hayes, Richard; Kapiga, Saidi; Padian, Nancy; McCormack, Sheena; Wasserheit, Judith

    2011-01-01

    Previous papers in this supplement have reviewed the evidence of the effectiveness of alternative HIV prevention methods from randomised controlled trials and other studies. This paper draws together the main conclusions from these reviews. A conceptual framework is presented that maps the proximal and distal determinants of sexual HIV transmission and helps to identify the stages in the causal pathway at which each intervention approach acts. The advances, gaps and challenges emerging from the reviews of individual intervention methods are summarised and cross-cutting themes identified. Approximately 90% of HIV prevention trials have found no effect on HIV incidence and we explore the alternative explanations for the large number of “flat” trials. We conclude that there is no single explanation for these flat results which may be due to interventions that are ineffective or inappropriately targeted or implemented, or to factors related to the design or conduct of trials. We examine the lessons from these flat results and provide recommendations on what should be done differently in future trials. HIV prevention remains of critical importance in an era of expanded delivery of antiretroviral therapy. In future HIV prevention research, it is important that resources are used as efficiently as possible to provide rigorous evidence of the effectiveness of a wider array of complementary prevention tools. PMID:21042056

  6. The flawed reliance on randomized controlled trials in studies of HIV behavioral prevention interventions for people who inject drugs and other populations

    PubMed Central

    Friedman, Samuel R.; Perlman, David C.; Ompad, Danielle C.

    2015-01-01

    This article discusses ways in which randomized controlled trials do not accurately measure the impact of HIV behavioral interventions. This is because: 1.Such trials measure the wrong outcomes. Behavior change may have little to do with changes in HIV incidence since behavior change in events between HIV-concordant people have no impact on incidence. Even more important, the comparison of HIV incidence rates between study arms of individual-level RCTs does not measure the true outcome of interest—whether or not the intervention reduces HIV transmission at the community level. This is because this comparison cannot measure the extent to which the intervention stops transmission by HIV-infected people in the study to those outside it. (And this is made even worse if HIV-infected are excluded from the evaluation of the intervention.) 2. There are potential harms implicit in most cognitively-oriented behavioral interventions that are not measured in current practice and may not be measurable using RCTs. Intervention trials often reinforce norms and values of individual self-protection. They rarely if ever measure whether doing this reduces community trust, solidarity, cohesion, organization, or activism in ways that might facilitate HIV transmission. 3. Many interventions are not best conceived of as interventions with individuals but rather with networks, cultures of risks, or communities. As such, randomizing individuals leads to effective interventions that diffuse protection through a community; but these are evaluated as ineffective because the changes diffuse to the control arm, which leads to systematic and erroneous reductions in the evaluated effectiveness as RCTs measure it. The paper ends by discussing research designs that are superior to individual-level RCTs at measuring whether an intervention reduces or increases new HIV transmission. PMID:26222900

  7. Project HOPE: Online Social Network Changes in an HIV Prevention Randomized Controlled Trial for African American and Latino Men Who Have Sex With Men

    PubMed Central

    Holloway, Ian; Jaganath, Devan; Rice, Eric; Westmoreland, Drew; Coates, Thomas

    2014-01-01

    Objectives. We examined whether and how an HIV prevention diffusion-based intervention spread throughout participants’ online social networks and whether changes in social network ties were associated with increased HIV prevention and testing behaviors. Methods. We randomly assigned 112 primarily racial/ethnic minority men who have sex with men (MSM) to receive peer-delivered HIV (intervention) or general health (control) information over 12 weeks through closed Facebook groups. We recorded participants’ public Facebook friend networks at baseline (September 2010) and follow-up (February 2011), and assessed whether changes in network growth were associated with changes in health engagement and HIV testing. Results. Within-group ties increased in both conditions from baseline to follow-up. Among the intervention group, we found a significant positive relation between increased network ties and using social media to discuss sexual behaviors. We found a positive trending relationship between increased network ties and likelihood of HIV testing, follow-up for test results, and participation in online community discussions. No significant differences were seen within control groups. Conclusions. Among high-risk MSM, peer-led social media HIV prevention interventions can increase community cohesion. These changes appear to be associated with increased HIV prevention and testing behaviors. PMID:25033137

  8. Risk, HIV, and STD prevention.

    PubMed

    1999-06-01

    The risk of becoming infected with HIV and other sexually transmitted diseases (STDs) is discussed. The concept of risk is defined in three ways: the risk of exposure to an infectious agent, the risk of infection after exposure, and the risk of severe consequences after infection. Determining the most effective STD prevention intervention for a person involves assessing his or her beliefs regarding each type of risk and adapting the discussion of STD prevention accordingly. Preventive behavior questions should be phrased conditionally to indicate both use, and lack of use, of precautionary behaviors. This will aid a counselor's assessment of a client's beliefs and the resultant behavior. Some STDs, such as herpes simplex and chlamydia, are more common than HIV, increase susceptibility to HIV by two to six times, and should not be omitted from the discussion of risk of infection.

  9. HIV prevention transformed: the new prevention research agenda.

    PubMed

    Padian, Nancy S; McCoy, Sandra I; Karim, Salim S Abdool; Hasen, Nina; Kim, Julia; Bartos, Michael; Katabira, Elly; Bertozzi, Stefano M; Schwartländer, Bernhard; Cohen, Myron S

    2011-07-16

    We have entered a new era in HIV prevention whereby priorities have expanded from biomedical discovery to include implementation, effectiveness, and the effect of combination prevention at the population level. However, gaps in knowledge and implementation challenges remain. In this Review we analyse trends in the rapidly changing landscape of HIV prevention, and chart a new path for HIV prevention research that focuses on the implementation of effective and efficient combination prevention strategies to turn the tide on the HIV pandemic. PMID:21763938

  10. Adolescent Abstinence and Unprotected Sex in CyberSenga, an Internet-Based HIV Prevention Program: Randomized Clinical Trial of Efficacy

    PubMed Central

    Ybarra, Michele L.; Bull, Sheana S.; Prescott, Tonya L.; Korchmaros, Josephine D.; Bangsberg, David R.; Kiwanuka, Julius P.

    2013-01-01

    youth in the short term and, with the booster, may also promote HIV preventive behavior among sexually active youth in the longer term. Trial Registration NCT00906178. PMID:23967069

  11. [Defining an ethics for preventive trials].

    PubMed

    Chippaux, J-P

    2008-04-01

    for the benefit of the population at stake. In this respect, if trials for prevention are now well codified both on ethical and methodological aspects, trials for prophylaxis (filariasis with ivermectin, schistosomiasis with praziquantel, malaria with intermittent "preventive" treatment or HIV with antiretroviral treatment, for example) still remain a difficult issue at both ethical and methodological levels.

  12. Family-based prevention of mental health problems in children affected by HIV and AIDS: an open trial

    PubMed Central

    Betancourt, Theresa S.; Ng, Lauren C.; Kirk, Catherine M.; Munyanah, Morris; Mushashi, Christina; Ingabire, Charles; Teta, Sharon; Beardslee, William R.; Brennan, Robert T.; Zahn, Ista; Stulac, Sara; Cyamatare, Felix R.; Sezibera, Vincent

    2014-01-01

    Objective The objective of this study is to assess the feasibility and acceptability of an intervention to reduce mental health problems and bolster resilience among children living in households affected by caregiver HIV in Rwanda. Design Pre-post design, including 6-month follow-up. Methods The Family Strengthening Intervention (FSI) aims to reduce mental health problems among HIV-affected children through improved child–caregiver relationships, family communication and parenting skills, HIV psychoeducation and connections to resources. Twenty families (N=39 children) with at least one HIV-positive caregiver and one child 7–17 years old were enrolled in the FSI. Children and caregivers were administered locally adapted and validated measures of child mental health problems, as well as measures of protective processes and parenting. Assessments were administered at pre and postintervention, and 6-month follow-up. Multilevel models accounting for clustering by family tested changes in outcomes of interest. Qualitative interviews were completed to understand acceptability, feasibility and satisfaction with the FSI. Results Families reported high satisfaction with the FSI. Caregiver-reported improvements in family connectedness, good parenting, social support and children's pro-social behaviour (P<0.05) were sustained and strengthened from postintervention to 6-month follow-up. Additional improvements in caregiver-reported child perseverance/self-esteem, depression, anxiety and irritability were seen at follow-up (P<.05). Significant decreases in child-reported harsh punishment were observed at postintervention and follow-up, and decreases in caregiver reported harsh punishment were also recorded on follow-up (P<0.05). Conclusion The FSI is a feasible and acceptable intervention that shows promise for improving mental health symptoms and strengthening protective factors among children and families affected by HIV in low-resource settings. PMID:24991909

  13. Treating High-grade Lesions to Prevent Anal Cancer in HIV-infected People

    Cancer.gov

    This study, called the ANCHOR trial, will investigate whether screening and prevention methods similar to those used to prevent cervical cancer can help prevent anal cancer in HIV-infected men and women.

  14. A Randomized Controlled Trial of a Parent-Centered Intervention in Preventing Substance Use and HIV Risk Behaviors in Hispanic Adolescents

    ERIC Educational Resources Information Center

    Prado, Guillermo; Pantin, Hilda; Briones, Ervin; Schwartz, Seth J.; Feaster, Daniel; Huang, Shi; Sullivan, Summer; Tapia, Maria I.; Sabillon, Eduardo; Lopez, Barbara; Szapocznik, Jose

    2007-01-01

    The present study evaluated the efficacy of Familias Unidas + Parent-Preadolescent Training for HIV Prevention (PATH), a Hispanic-specific, parent-centered intervention, in preventing adolescent substance use and unsafe sexual behavior. Two hundred sixty-six 8th-grade Hispanic adolescents and their primary caregivers were randomly assigned to 1 of…

  15. HIV transmission and 24-month survival in a randomized trial of HAART to prevent MTCT during pregnancy and breastfeeding in Botswana (The Mma Bana Study)

    PubMed Central

    Shapiro, Roger L.; Kitch, Douglas; Ogwu, Anthony; Hughes, Michael D.; Lockman, Shahin; Powis, Kathleen; Souda, Sajini; Moffat, Claire; Moyo, Sikhulile; McIntosh, Kenneth; van Widenfelt, Erik; Zwerski, Sheryl; Mazhani, Loeto; Makhema, Joseph; Essex, Max

    2014-01-01

    Objectives Highly active antiretroviral therapy (HAART) for prevention of mother-to-child HIV transmission (MTCT) may impact long-term survival of mothers and children. Design Randomized clinical trial. Methods HIV–infected pregnant women with CD4 ≥200 cells/mm3 were randomly assigned to abacavir, zidovudine, lamivudine (Arm A) or lopinavir–ritonavir, zidovudine–lamivudine (Arm B) from week 26–34 gestation through planned weaning by 6 months postpartum. Women with baseline CD4 <200 received nevirapine–zidovudine–lamivudine indefinitely (Obs arm), as did randomized women later qualifying for treatment. Results Among 560 randomized and 170 observational women enrolled, there were 14 deaths (1.9%); 1 antenatally (Obs), 3 from delivery though 6 months postpartum (1 Arm A, 2 Obs), and 10 from 6–24 months postpartum (5 Arm A, 3 Arm B, 2 Obs). Time to death or CD4 <200 was shorter in Arm A vs. B (p=0.03). Of 709 live-born children, 97% breastfed for median 5.8 months. Of 37 (5.2%) deaths by 24 months, 9 were before breastfeeding initiated (3 Arm A, 2 Arm B, 4 Obs); 6 while breastfeeding (1 Arm A, 2 Arm B, 3 Obs); and 22 after weaning (9 Arm A, 11 Arm B, 2 Obs). Only 8 children (1.1%) were HIV-infected at 24 months (6 Arm A, 1 Arm B, 1 Obs), all before 6 months. Conclusions Low MTCT was maintained through extended follow-up in all arms. Disease progression appeared slower after discontinuing protease inhibitor-based HAART, but a concerning number of maternal deaths occurred after stopping either regimen. Strategies to improve maternal and child survival in the post-intervention period are required. PMID:24180000

  16. Developing family interventions for adolescent HIV prevention in South Africa

    PubMed Central

    Kuo, Caroline; Atujuna, Millicent; Mathews, Catherine; Stein, Dan J.; Hoare, Jacqueline; Beardslee, William; Operario, Don; Cluver, Lucie; K. Brown, Larry

    2016-01-01

    ABSTRACT Adolescents and young people account for 40% of all new HIV infections each year, with South Africa one of the hardest hit countries, and having the largest population of people living with HIV. Although adolescent HIV prevention has been delivered through diverse modalities in South Africa, and although family-based approaches for adolescent HIV prevention have great potential for highly affected settings such as South Africa, there is a scarcity of empirically tested family-based adolescent HIV preventive interventions in this setting. We therefore conducted focus groups and in-depth interviews with key informants including clinicians, researchers, and other individuals representing organizations providing HIV and related health services to adolescents and parents (N = 82). We explored family perspectives and interactions around topics such as communication about sex, HIV, and relationships. Participants described aspects of family interactions that presented both challenges and opportunities for family-based adolescent HIV prevention. Parent–child communication on sexual topics were taboo, with these conversations perceived by some adults as an invitation for children to engage in HIV risk behavior. Parents experienced social sanctions for discussing sex and adolescents who asked about sex were often viewed as disrespectful and needing discipline. However, participants also identified context-appropriate strategies for addressing family challenges around HIV prevention including family meetings, communal parenting, building efficacy around parent–adolescent communication around sexual topics, and the need to strengthen family bonding and positive parenting. Findings indicate the need for a family intervention and identify strategies for development of family-based interventions for adolescent HIV prevention. These findings will inform design of a family intervention to be tested in a randomized pilot trial (ClinicalTrials.gov #NCT02432352). PMID

  17. Developing family interventions for adolescent HIV prevention in South Africa.

    PubMed

    Kuo, Caroline; Atujuna, Millicent; Mathews, Catherine; Stein, Dan J; Hoare, Jacqueline; Beardslee, William; Operario, Don; Cluver, Lucie; K Brown, Larry

    2016-01-01

    Adolescents and young people account for 40% of all new HIV infections each year, with South Africa one of the hardest hit countries, and having the largest population of people living with HIV. Although adolescent HIV prevention has been delivered through diverse modalities in South Africa, and although family-based approaches for adolescent HIV prevention have great potential for highly affected settings such as South Africa, there is a scarcity of empirically tested family-based adolescent HIV preventive interventions in this setting. We therefore conducted focus groups and in-depth interviews with key informants including clinicians, researchers, and other individuals representing organizations providing HIV and related health services to adolescents and parents (N = 82). We explored family perspectives and interactions around topics such as communication about sex, HIV, and relationships. Participants described aspects of family interactions that presented both challenges and opportunities for family-based adolescent HIV prevention. Parent-child communication on sexual topics were taboo, with these conversations perceived by some adults as an invitation for children to engage in HIV risk behavior. Parents experienced social sanctions for discussing sex and adolescents who asked about sex were often viewed as disrespectful and needing discipline. However, participants also identified context-appropriate strategies for addressing family challenges around HIV prevention including family meetings, communal parenting, building efficacy around parent-adolescent communication around sexual topics, and the need to strengthen family bonding and positive parenting. Findings indicate the need for a family intervention and identify strategies for development of family-based interventions for adolescent HIV prevention. These findings will inform design of a family intervention to be tested in a randomized pilot trial (ClinicalTrials.gov #NCT02432352). PMID:26916841

  18. Effects on condom use of an HIV prevention programme 36 months postintervention: a cluster randomized controlled trial among Bahamian youth

    PubMed Central

    Chen, X; Stanton, B; Gomez, P; Lunn, S; Deveaux, L; Brathwaite, N; Li, X; Marshall, S; Cottrell, L; Harris, C

    2010-01-01

    Summary Data are lacking on long-term effects of HIV behavioural intervention programmes. In this study, we report intervention effects 36 months postintervention on condom use and relevant outcome variables from the theory-based programme ‘Focus on Youth in the Caribbean’ (FOYC). Participants (1360 sixth-grade youth) were randomized by school into: (1) FOYC, plus one of two brief parent interventions or (2) the control condition ‘Wondrous Wetlands’, plus a brief parent intervention. Mixed effect analysis demonstrated significant programme effects, including enhanced HIV/AIDS knowledge (effect size D = 0.44, 95% confidence interval [CI]: 0.43, 0.46), increased self-efficacy of (D = 0.42, 95% CI: 0.30, 0.54), skills for (D = 0.62, 95% CI: 0.56, 0.64) and intention to use a condom (D = 0.20, 95% CI: 0.03, 0.37). Youth who received FOYC plus the parental monitoring intervention had higher condom use rates (odds ratio = 1.49, 95% CI: 0.97, 2.28). Feedback effects from key variables were also detected, supporting the sustained effect. PMID:21097734

  19. Developmental implications of HIV prevention during adolescence: Examination of the long-term impact of HIV prevention interventions delivered in randomized controlled trials in grade six and in grade 10

    PubMed Central

    Dinaj-Koci, Veronica; Chen, Xinguang; Deveaux, Lynette; Lunn, Sonya; Li, Xiaoming; Wang, Bo; Braithwaite, Nanika; Marshall, Sharon; Gomez, Perry; Stanton, Bonita

    2015-01-01

    Dramatic changes occur in abstract reasoning, physical maturation, familial relationships and risk exposure during adolescence. It is probable that delivery of behavioral interventions addressing decision-making during the pre-adolescent period and later in adolescence would result in different impacts. We evaluated the intervention effects of an HIV prevention program (Bahamian Focus on Older Youth, BFOOY) administered to grade 10 Bahamian youth and parents to target HIV protective and risk behaviors. We also examined the effects of prior exposure to a similar intervention (Focus on Youth in the Caribbean, FOYC) four years earlier. At six months post-intervention, receipt of BFOOY by youth unexposed to FOYC increased HIV knowledge and condom-use skills. Differences based on BFOOY exposure were not present among FOYC-exposed youth, whose knowledge and condom-use skills were already higher than those of unexposed youth. Youth receiving both interventions displayed a carryover effect from FOYC, demonstrating the highest scores six months post-intervention. PMID:26217066

  20. A typology of structural approaches to HIV prevention

    PubMed Central

    Tsai, Alexander C.

    2012-01-01

    Renewed enthusiasm for biomedical HIV prevention strategies has followed the recent publication of several high-profile HIV antiretroviral therapy-based HIV prevention trials. In a recent article, Roberts & Matthews (2012) accurately note some of the shortcomings of these individually targeted approaches to HIV prevention and advocate for increased emphasis on structural interventions that have more fundamental effects on the population distribution of HIV. However, they make some implicit assumptions about the extent to which structural interventions are user-independent and more sustainable than biomedical or behavioral interventions. In this article, I elaborate a simple typology of structural interventions along these two axes and suggest that they may be neither user-independent nor sustainable and therefore subject to the same sustainability concerns, costs, and potential unintended consequences as biomedical and behavioral interventions. PMID:22877933

  1. Modifications of a large HIV prevention clinical trial to fit changing realities: A case study of the Breastfeeding, Antiretroviral, and Nutrition (BAN) Protocol in Lilongwe, Malawi

    PubMed Central

    van der Horst, Charles; Chasela, Charles; Ahmed, Yusuf; Hoffman, Irving; Hosseinipour, Mina; Knight, Rodney; Fiscus, Susan; Hudgens, Michael; Kazembe, Peter; Bentley, Margaret; Adair, Linda; Piwoz, Ellen; Martinson, Francis; Duerr, Ann; Kourtis, Athena; Loeliger, A. Edde; Tohill, Beth; Ellington, Sascha; Jamieson, Denise

    2009-01-01

    In order to evaluate strategies to reduce HIV transmission through breast milk and optimize both maternal and infant health among HIV-infected women and their infants, we designed and implemented a large, randomized clinical trial in Lilongwe, Malawi. The development of protocols for large, randomized clinical trials is a complicated and lengthy process often requiring alterations to the original research design. Many factors lead to delays and changes, including study site-specific priorities, new scientific information becoming available, the involvement of national and international human subject committees and monitoring boards, and alterations in medical practice and guidance at local, national, and international levels. When planning and implementing a clinical study in a resource-limited setting, additional factors must be taken into account, including local customs and program needs, language and socio-cultural barriers, high background rates of malnutrition and endemic diseases, extreme poverty, lack of personnel, and limited infrastructure. Investigators must be prepared to modify the protocol as necessary in order to ensure participant safety and successful implementation of study procedures. This paper describes the process of designing, implementing, and subsequently modifying the Breastfeeding, Antiretrovirals, and Nutrition, (BAN) study, a large, ongoing, randomized breastfeeding intervention trial of HIV-infected women and their infants conducted at a single site in Lilongwe, Malawi. We highlight some of the successes, challenges, and lessons learned at different stages during the conduct of the trial. PMID:18805510

  2. Current HIV clinical trial design issues.

    PubMed

    Lange, J M

    1995-01-01

    Aids-free time and survival time of people with HIV infection has gradually increased since the first clinical trial of zidovudine(AZT) in 1987. This change in pattern of disease course has, however, made it difficult for current clinical trials to rely on "hard" clinical end points, such as progression to AIDS or death, to demonstrate antiretroviral efficacy. These trials must continue for a number of years and enroll large numbers of patients; as a result, maintaining patients on protocolled therapy is difficult to achieve. Furthermore, patients can be prevented from reaching clinical end points by prophylaxis of opportunistic infections. Combined with the move toward treating individuals earlier in the course of infection, current clinical trials using "hard" clinical end points are unlikely to demonstrate drug efficacy. The concept of using "soft" clinical end points and laboratory end points such as decline in CD4 cell count to a threshold value, was first introduced in study EACG 020 of patients with early stage infection, and made it possible for this study to demonstrate the efficacy of AZT in this patient population. Further accurate markers of disease progression are required for current clinical trials. There is growing consensus that the primary end point of any antiviral drug study should be the effect of the drug on the virus itself. It is now possible to quantify viral burden and to assess the amount of virus present in different tissues. To validate viral load as a marker of disease progression, it is necessary to achieve a profound and long-term reduction in viral load. It is very likely that this will be achieved only in studies of multiple combination therapy at early stages of infection. Moreover, clinical trials are required to validate the use of viral load. In the meantime, regulatory authorities should be encouraged to license drugs on the basis of viral load data with the provision of intense post-licensing follow-up.

  3. Combination implementation for HIV prevention: moving from evidence to population-level impact

    PubMed Central

    Chang, Larry W; Serwadda, David; Quinn, Thomas C; Wawer, Maria J; Gray, Ronald H; Reynolds, Steven J

    2013-01-01

    Summary The promise of combination HIV prevention—the application of multiple HIV prevention interventions to maximize population-level impact—has never been greater. However, to succeed in achieving significant reductions in HIV incidence, an additional concept needs to be considered—combination implementation. Combination implementation for HIV prevention is defined here as the pragmatic, localized application of evidence-based strategies to realize high sustained uptake and quality of HIV prevention interventions. This review explores diverse implementation strategies including HIV testing and counseling models, task shifting, linkage to and retention in care, antiretroviral therapy support, behavior change, demand creation, and structural interventions and discusses how they could be used in the provision of HIV prevention interventions such as medical male circumcision and treatment as prevention. Only through careful consideration of how to implement and operationalize HIV prevention interventions will the HIV community be able to move from clinical trial evidence to population-level impact. PMID:23257232

  4. Preparatory studies for possible HIV vaccine trials in northern Thailand.

    PubMed

    Nelson, K E; Beyrer, C; Natpratan, C; Eiumtrakul, S; Celentano, D D; Khamboonruang, C

    1994-01-01

    We studied several populations of human immunodeficiency virus (HIV)-seronegative individuals from northern Thailand who were believed to be at relatively high risk of HIV infection in order to assess their potential suitability for inclusion in a preventive HIV vaccine trial. Included were female commercial sex workers (CSWs), male sexually transmitted disease (STD) clinic patients, male conscripts into the Royal Thai Army (RTA), and men who were recently discharged from the army. We evaluated their HIV prevalence, their interest in study participation, their compliance with prospective follow-up, and their HIV incidence. Among 1068 female CSWs the baseline HIV prevalence was 38.3%; of 659 HIV seronegatives 395 (59.9%) agreed to enrollment in the study. Follow-up at 6-9 months was 73.2%; it was 58% in brothel-based CSWs and 85% in non-brothel-based CSWs. Overall HIV incidence in CSWs was 8.2 per 100 person-years; incidence was 29 per 100 person-years in brothel-based CSWs and 4 per 100 person-years in non-brothel-based CSWs. Among 1031 male STD clinic patients, baseline HIV prevalence was 15.9%, follow-up was successful in 98.1%, and HIV incidence was 4.0 per 100 person-years. Among four cohorts of RTA conscripts who entered the military in 1991 and 1993, baseline HIV prevalence has been about 12%, follow-up about 90%, and HIV incidence has varied from 1.2-3.2 per 100 person-years. Discharged RTA conscripts have had baseline HIV prevalence of about 13%, successful follow-up of 94%, and an HIV incidence of about 5 per 100 person-years.(ABSTRACT TRUNCATED AT 250 WORDS)

  5. Discrepancies in diagnosis of incident HIV infection between antibody- and DNA-based tests in a phase III prevention trial in southern Africa.

    PubMed

    Montgomery, E T; van der Pol, B; van der Straten, A; Ramjee, G; de Bruyn, G; Chipato, T; Blanchard, K; Padian, N S

    2012-09-01

    Dried blood spots (DBS) are widely used to test for HIV in a variety of research and service delivery settings; however, uniform guidelines regarding collection, storage and DNA extraction processes have neither been developed nor evaluated. Previously published reports suggested DBS may be stored at room temperature for up to 60 days, and intensive stability tests have shown that DBS can withstand high temperatures, humidity and freeze-thawing. During the implementation of a large randomized controlled trial (RCT) in southern Africa, with HIV acquisition as the primary endpoint, we observed 65 instances when DBS samples collected from the same day as a positive HIV antibody test yielded negative DNA polymerase chain reaction (PCR) results. The source of this discrepancy may have been due to inadequate specimen volume, filter paper or DNA extraction procedures, but were most likely due to storage conditions that have been reported as acceptable in other settings. PMID:23033520

  6. Reducing lost to follow-up in a large clinical trial of prevention of mother-to-child transmission of HIV: The Breastfeeding, Antiretrovirals and Nutrition (BAN) study experience

    PubMed Central

    Sellers, Christopher J; Lee, Hana; Chasela, Charles; Kayira, Dumbani; Soko, Alice; Mofolo, Innocent; Ellington, Sascha; Hudgens, Michael G; Kourtis, Athena P; King, Caroline C; Jamieson, Denise J; van der Horst, Charles

    2014-01-01

    Background/Aims Retaining patients in prevention of mother-to-child transmission of HIV studies can be challenging in resource limited settings, where high lost to follow-up (LTFU) rates have been reported. In this paper, we describe the effectiveness of methods used to encourage retention in the Breastfeeding, Antiretrovirals, and Nutrition (BAN) study and analyze factors associated with LTFU in the study. Methods The BAN clinical trial was designed to evaluate the efficacy of 3 different mother-to-child HIV transmission prevention strategies. Lower than expected participant retention prompted enhanced efforts to reduce LTFU during the conduct of the trial. Following study completion, we employed regression modeling to determine predictors of perfect attendance and variables associated with being LTFU. Results During the study, intensive tracing efforts were initiated after the first 1686 mother-infant pairs had been enrolled, and 327 pairs were missing. Sixty of these pairs were located and had complete data obtained. Among the 683 participants enrolling after initiation of intensive tracing efforts, the LTFU rate was 3.4%. At study's end, 290 (12.2%) of the 2369 mother-infant pairs were LTFU. Among successfully traced missing pairs, relocation was common and three were deceased. Log-binomial regression modeling revealed higher maternal hemoglobin and older maternal age to be significant predictors of perfect attendance. These factors and the presence of food insecurity were also significantly associated with lower rates of LTFU. Conclusions In this large HIV prevention trial, intensive tracing efforts centered on reaching study participants at their homes succeeded in finding a substantial proportion of LTFU participants, and were very effective in preventing further LTFU during the remainder of the trial. The association between food insecurity and lower rates of LTFU is likely related to the study's provision of nutritional support, including a family maize

  7. Non-Antiretroviral Microbicides for HIV Prevention

    PubMed Central

    Scott, Yanille; Dezzutti, Charlene S.

    2016-01-01

    Non-antiretroviral microbicide candidates were previously explored as a female-controlled method of preventing sexual transmission of HIV. These products contained non-HIV specific active compounds that were ultimately found to disrupt the vaginal epithelium, cause increased immune activation in the female genital tract, disturb vaginal flora, and/or cause other irritation that precluded their use as vaginal microbicides. Due to the failure of these first-generation candidates, there was a shift in focus to developing HIV pre-exposure prophylaxis and microbicides containing small-molecule antiretrovirals. Even with the limited success of the antiretroviral-based microbicides in clinical evaluations and no commercially available products, there has been significant progress in microbicide research. The lessons learned from previous trials have given rise to more rigorous preclinical evaluation that aims to be better at predicting microbicide efficacy and safety and to novel formulation and delivery technologies. These advances have resulted in renewed interest in developing non-antiretroviral-based microbicides, such as broadly neutralizing antibodies (for example, VRC01) and anti-viral proteins (for example, Griffithsin), as options for persons not wanting to use antiretroviral drugs, and for their potential to prevent multiple sexually transmitted infections. PMID:27438574

  8. Weighing the Gold in the Gold Standard: Challenges in HIV Prevention Research

    PubMed Central

    PADIAN, Nancy S.; McLOY, Sandra I.; BALKUS, Jennifer E.; WASSERHEIT, Judith N.

    2013-01-01

    Objective(s) Few HIV prevention interventions have been evaluated in randomized controlled trials (RCTs). We examined design, implementation, and contextual considerations that may limit detection of a positive or adverse effect in HIV prevention trials. Design A systematic review of late phase RCTs for prevention of sexual transmission of HIV that 1) randomly allocated intervention and comparison groups; 2) evaluated interventions to prevent sexual transmission in non-pregnant populations; and 3) reported HIV incidence as the primary or secondary outcome. Methods PubMed/MEDLINE, other electronic databases, and electronic conference proceedings of recent HIV/AIDS-related conferences were searched to identify published or unpublished trials meeting the inclusion criteria. Descriptive, methodological, and contextual factors were abstracted from each trial. Results The review included 36 HIV prevention RCTs reporting on 38 unique interventions. Only six RCTs, all evaluating biomedical interventions, demonstrated definitive effects on HIV incidence. Five of the six RCTs significantly reduced HIV infection: all three male circumcision trials, one trial of STI treatment and care, and one vaccine trial. One microbicide trial of nonoxynol-9 gel produced adverse results. Lack of statistical power, poor adherence, and diluted versions of the intervention in comparison groups may have been important issues for the other trials that demonstrated “flat” results. Conclusions Almost 90% of HIV prevention trials had “flat” results, which may be attributable to trial design and/or implementation. The HIV prevention community must not only examine evidence from significant RCTs, but must also examine flat trials, and address design and implementation issues that limit detection of an effect. PMID:20179575

  9. HIV prevention transformed: the new prevention research agenda

    PubMed Central

    Padian, Nancy S.; McCoy, Sandra I.; Karim, Salim Abdool; Hasen, Nina; Kim, Julia; Bartos, Michael; Katabira, Elly; Bertozzi, Stefano; Schwartländer, Bernhard; Cohen, Myron S.

    2013-01-01

    SUMMARY We have entered a new era in HIV prevention whereby priorities have expanded from biomedical discovery to include implementation, effectiveness, and the effect of combination prevention at the population level. However, gaps in knowledge and implementation challenges remain. In this Review we analyse trends in the rapidly changing landscape of HIV prevention, and chart a new path for HIV prevention research that focuses on the implementation of effective and efficient combination prevention strategies to turn the tide on the HIV pandemic. PMID:21763938

  10. How Should HIV Vaccine Efficacy Trials Be Conducted? Diverse U.S. Communities Speak Out

    ERIC Educational Resources Information Center

    Kegeles, Susan M.; Johnson, Mallory O.; Strauss, Ronald P.; Ralston, Brady; Hays, Robert B.; Metzger, David S.; McLellan-Lemal, Eleanor; MacQueen, Kathleen M.

    2006-01-01

    Developing an effective vaccine remains a critical long-term approach to HIV prevention. Every efficacy trial should be responsive to the concerns of participating communities because the successful development of an HIV preventive vaccine will require long-term involvement of people who have been marginalized and who distrust the government and…

  11. eHealth interventions for HIV prevention

    PubMed Central

    Noar, Seth M.; Willoughby, Jessica Fitts

    2015-01-01

    The rapidly changing media landscape and proliferation of new technologies creates vast new opportunities for HIV prevention. The fast growth of the relatively new eHealth field is a testament to the excitement and promise of these new technologies. eHealth interventions in HIV prevention tested to date include computer- and Internet-based interventions; chat room interventions; text messaging interventions; and social media. The current article provides a brief review of these types of interventions in HIV prevention, including their unique advantages and evidence of efficacy. Implications for future research in the eHealth HIV prevention field are discussed. PMID:22519523

  12. "The difference that makes a difference": highlighting the role of variable contexts within an HIV Prevention Community Randomised Trial (HPTN 071/PopART) in 21 study communities in Zambia and South Africa.

    PubMed

    Bond, Virginia; Chiti, Bwalya; Hoddinott, Graeme; Reynolds, Lindsey; Schaap, Ab; Simuyaba, Melvin; Ndubani, Rhoda; Viljoen, Lario; Simwinga, Musonda; Fidler, Sarah; Hayes, Richard; Ayles, Helen; Seeley, Janet

    2016-01-01

    This paper explores contextual heterogeneity within a community randomised trial HPTN 071 (Population Effects of Antiretroviral Treatment to Reduce HIV Transmission) carried out in 21 study communities (12 Zambian, 9 South African). The trial evaluates the impact of a combination HIV prevention package (including household-based HIV counselling and testing and anti-retroviral treatment (ART) eligibility regardless of CD4-count) on HIV incidence. The selection, matching and randomisation of study communities relied on key epidemiological and demographic variables and community and stakeholder support. In 2013, following the selection of study communities, a "Broad Brush Survey" (BBS) approach was used to rapidly gather qualitative data on each study community, prior to the implementation of the trial intervention. First-year process indicator intervention data (2014-2015) were collected during the household-based intervention by community lay workers. Using an open/closed typology of urban communities (indicating more or less heterogeneity), this qualitative inquiry presents key features of 12 Zambian communities using a list of four meta-indicators (physical features, social organisation, networks and community narratives). These indicators are then compared with four intervention process indicators in a smaller set of four study communities. The process indicators selected for this analysis indicate response to the intervention (uptake) amongst adults. The BBS qualitative data are used to interpret patterns of similarity and variability in the process indicators across four communities. We found that meta-indicators of local context helped to interpret patterns of similarity and variability emerging across and within the four communities. Features especially significant for influencing heterogeneity in process indicators include proportion of middle-class residents, proximity to neighbouring communities and town centre, the scale of the informal economy

  13. "The difference that makes a difference": highlighting the role of variable contexts within an HIV Prevention Community Randomised Trial (HPTN 071/PopART) in 21 study communities in Zambia and South Africa.

    PubMed

    Bond, Virginia; Chiti, Bwalya; Hoddinott, Graeme; Reynolds, Lindsey; Schaap, Ab; Simuyaba, Melvin; Ndubani, Rhoda; Viljoen, Lario; Simwinga, Musonda; Fidler, Sarah; Hayes, Richard; Ayles, Helen; Seeley, Janet

    2016-01-01

    This paper explores contextual heterogeneity within a community randomised trial HPTN 071 (Population Effects of Antiretroviral Treatment to Reduce HIV Transmission) carried out in 21 study communities (12 Zambian, 9 South African). The trial evaluates the impact of a combination HIV prevention package (including household-based HIV counselling and testing and anti-retroviral treatment (ART) eligibility regardless of CD4-count) on HIV incidence. The selection, matching and randomisation of study communities relied on key epidemiological and demographic variables and community and stakeholder support. In 2013, following the selection of study communities, a "Broad Brush Survey" (BBS) approach was used to rapidly gather qualitative data on each study community, prior to the implementation of the trial intervention. First-year process indicator intervention data (2014-2015) were collected during the household-based intervention by community lay workers. Using an open/closed typology of urban communities (indicating more or less heterogeneity), this qualitative inquiry presents key features of 12 Zambian communities using a list of four meta-indicators (physical features, social organisation, networks and community narratives). These indicators are then compared with four intervention process indicators in a smaller set of four study communities. The process indicators selected for this analysis indicate response to the intervention (uptake) amongst adults. The BBS qualitative data are used to interpret patterns of similarity and variability in the process indicators across four communities. We found that meta-indicators of local context helped to interpret patterns of similarity and variability emerging across and within the four communities. Features especially significant for influencing heterogeneity in process indicators include proportion of middle-class residents, proximity to neighbouring communities and town centre, the scale of the informal economy

  14. HIV Prevention Readiness in Undergraduates and Inmates.

    ERIC Educational Resources Information Center

    Antonio, Michael E.; And Others

    Prevention of Human Immunodeficiency Virus (HIV) transmission is increasingly an international priority. Education of high-risk populations, such as incarcerated individuals, is particularly important in thwarting the spread of HIV. To address this concern, the attitudes, beliefs, and knowledge of inmates concerning HIV and AIDS related issues are…

  15. Opportunity Knocks: HIV Prevention in Primary Care.

    PubMed

    Thrun, Mark W

    2014-06-01

    Expansions in health care coverage, a comprehensive framework for HIV prevention and care, electronic medical records, and novel HIV prevention modalities create a current opportunity to change the trajectory of the HIV epidemic in the United States. HIV is increasingly disproportionately found in populations historically at higher risk, including gay men and other men who have sex with men, transgender women, injection drug users, and persons of color. This underscores the need for providers to identify persons at higher risk for HIV and assure the provision of screening and prevention services. In turn, universal screening for HIV-testing every adolescent and adult at least once in their lifetime-will increasingly be necessary to find the infrequent cases of HIV in lower risk populations. In both these domains, primary care providers will play a unique role in complementing traditional providers of HIV prevention and care services by increasing the proportion of their patients who have been screened for HIV, opening dialogues around sexual health, including asking about sexual orientation and gender identity, and prescribing antivirals as pre- and postexposure prophylaxis for their non-HIV-infected patients. Primary care providers must understand and embrace their importance along the HIV prevention and care continuum. PMID:26789615

  16. Preventing the spread of HIV infection.

    PubMed

    Perry, Nicky

    Approximately 96,000 people are living with HIV in the UK, a quarter of whom are unaware they are infected. While in some parts of the world the number of people newly infected with HIV has fallen, in the UK in 2011 there was a rise in the number of men who have sex with men being diagnosed. HIV prevention strategies are a public health priority, while ongoing research into HIV testing in all clinical settings remains a priority. This article explores preventive measures that can be used to reduce the spread of HIV and offers advice on how nurses can contribute to these.

  17. Project VOGUE: A partnership for increasing HIV knowledge and HIV vaccine trial awareness among House Ball leaders in Western New York

    PubMed Central

    Alio, Amina P.; Fields, Sheldon D.; Humes, Damon L.; Bunce, Catherine A.; Wallace, Stephaun E.; Lewis, Cindi; Elder, Heather; Wakefield, Steven; Keefer, Michael C.

    2014-01-01

    Men who sleep with men (MSM) and transgender individuals of color, the largest demographic in the House Ball community (HBC) are amongst the group at highest risk for HIV infection in the United States. The HBC have limited access to culturally appropriate HIV education. This study aimed to develop a partnership with HBC leaders to uncover strategies for increasing HIV prevention knowledge, including participation in HIV vaccine trials. To this end a research institution-community-HBC partnership was established. In-depth qualitative and quantitative data were collected from the 14 HBC leaders in western New York, revealing that knowledge of HIV and related vaccine trials was limited. Barriers to increasing HIV knowledge included fear of peer judgment, having inaccurate information about HIV, and lack of education. Among the HBC, community partnerships will further aid in the development of future HIV prevention programs and increase individuals’ willingness to participate in future HIV vaccine trials. PMID:25642120

  18. Effectiveness of a Theory-Based Risk Reduction HIV Prevention Program for Rural Vietnamese Adolescents

    ERIC Educational Resources Information Center

    Kaljee, Linda M.; Genberg, Becky; Riel, Rosemary; Cole, Matthew; Tho, Le Huu; Thoa, Le Thi Kim; Stanton, Bonita; Li, Xiaoming; Minh, Tuong Tan

    2005-01-01

    As of April 2003, 64,801 HIV cases have been documented in Vietnam (Policy Project 2003), 53.9% of which are among individuals 20-29 years of age. Although HIV education efforts have increased, there remains a need for proven effective programs. We present findings from a randomized-controlled effectiveness trial of an HIV prevention program for…

  19. Antibodies for HIV Prevention in young women

    PubMed Central

    Abdool Karim, Salim S.; Karim, Quarraisha Abdool; Baxter, Cheryl

    2016-01-01

    Purpose of review Young women in sub-Saharan Africa bear a disproportionate HIV burden. They urgently require new HIV prevention approaches that women can use. This review provides an overview of the use of antiretrovirals for HIV pre-exposure prophylaxis (PrEP), highlighting some of the challenges with this technology and explores the potential role of monoclonal antibodies (mAbs) for HIV prevention in women. Recent findings Recent findings on the initial steps in viral entry and establishment of a productive local infectious nidus in the vaginal epithelium has provided important clues for HIV prevention in the female genital tract. Topical and oral formulations of antiretroviral drugs have been shown to prevent HIV infection in women with varying levels of success, depending principally on adherence. Further, a number of new broad and potent mAbs have been isolated over the last 5 years. Non-human primate studies demonstrate that broadly neutralizing HIV mAbs can protect rhesus macaques from SHIV infection. These findings have created newfound enthusiasm for passive immunization as a potential prevention strategy for women. Summary If potent broadly neutralising mAbs are effective in preventing HIV infection in women, it could fill an important gap in HIV prevention technologies for young women, especially in Africa. PMID:25700207

  20. HIV/AIDS Prevention Program Evaluation Report.

    ERIC Educational Resources Information Center

    Amaro, Hortensia; Barker, Marybeth; Cassisy, Theresa; Hardy-Fanta, Carol; Hereen, Tim; Levenson, Suzette; McCloskey, Lois; Melendez, Michael

    This report addresses the four research objectives that were established by the Massachusetts Primary Prevention Group (MPPG) and the Massachusetts Department of Public Health's HIV/AIDS Bureau. The objectives were to: (1) review and summarize literature that formally evaluated HIV prevention interventions; (2) describe how currently funded…

  1. A Clinical Trial to Introduce Voluntary Medical Male Circumcision for HIV Prevention in Areas of High Prevalence in the Dominican Republic

    PubMed Central

    Brito, Maximo O.; Lerebours, Leonel; Volquez, Claudio; Basora, Emmanuel; Khosla, Shaveta; Lantigua, Flavia; Flete, Roberto; Rosario, Riqui; Rodriguez, Luis A.; Fernandez, Mathius; Donastorg, Yeycy; Bailey, Robert C.

    2015-01-01

    Background Voluntary Medical Male Circumcision (VMMC) is an effective strategy to reduce the risk of HIV infection. Studies conducted in the Dominican Republic (DR) suggest that acceptability of VMMC among men may be as high as 67%. The goal of this clinical trial was to assess the acceptability, uptake and safety for VMMC services in two areas of high HIV prevalence in the country. Methods This was a single-arm, non-randomized, pragmatic clinical trial. Study personnel received background information about the risks and benefits of VMMC and practical training on the surgical technique. A native speaking research assistant administered a questionnaire of demographics, sexual practices and knowledge about VMMC. One week after the surgery, participants returned for wound inspection and to answer questions about their post-surgical experience. Results 539 men consented for the study. Fifty seven were excluded from participation for medical or anatomical reasons and 28 decided not to have the procedure after providing consent. A total of 454 men were circumcised using the Forceps Guided Method Under Local Anesthesia. The rate of adverse events (AE) was 4.4% (20% moderate, 80% mild). There were no serious AEs and all complications resolved promptly with treatment. Eighty eight percent of clients reported being “very satisfied” and 12% were “somewhat satisfied” with the outcome at the one-week postoperative visit. Conclusions Recruitment and uptake were satisfactory. Client satisfaction with VMMC was high and the rate of AEs was low. Roll out of VMMC in targeted areas of the DR is feasible and should be considered. Trial Registration ClinicalTrials.gov NCT02337179 PMID:26367187

  2. Nondisclosure of HIV Status in a Clinical Trial Setting: Antiretroviral Drug Screening Can Help Distinguish Between Newly Diagnosed and Previously Diagnosed HIV Infection

    PubMed Central

    Marzinke, Mark A.; Clarke, William; Wang, Lei; Cummings, Vanessa; Liu, Ting-Yuan; Piwowar-Manning, Estelle; Breaud, Autumn; Griffith, Sam; Buchbinder, Susan; Shoptaw, Steven; del Rio, Carlos; Magnus, Manya; Mannheimer, Sharon; Fields, Sheldon D.; Mayer, Kenneth H.; Wheeler, Darrell P.; Koblin, Beryl A.; Eshleman, Susan H.; Fogel, Jessica M.

    2014-01-01

    In The HIV Prevention Trials Network 061 study, 155 human immunodeficiency virus (HIV)–infected men reported no prior HIV diagnosis; 83 of those men had HIV RNA levels of <1000 copies/mL at enrollment. Antiretroviral drug testing revealed that 65 of the 83 (78.3%) men were on antiretroviral treatment. Antiretroviral drug testing can help distinguish between newly diagnosed and previously diagnosed HIV infection. PMID:24092804

  3. HIV prevention: integrating biomedical and behevioral interventions.

    PubMed

    Del Rio, Carlos

    Recommendations for HIV prevention in clinical care settings by an IAS-USA panel were recently published. They include recommendations on HIV testing, antiretroviral therapy initiation, risk-reduction counseling, and antiretroviral therapy adherence counseling for HIV-infected individuals. For individuals at risk for HIV infection, recommendations for preexposure prophylaxis, other risk-reduction strategies, adherence counseling, and postexposure prophylaxis are included. Many HIV-infected individuals in the United States are not fully engaged in HIV care and are not virologically suppressed, thus a crucial component of efforts to reduce HIV transmission is moving patients through the HIV care continuum. This article summarizes an IAS-USA continuing education webinar presented by Carlos del Rio, MD, in September 2014.

  4. Pre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! Study): protocol for a pragmatic clinical trial at public healthcare clinics in Brazil

    PubMed Central

    Grangeiro, Alexandre; Couto, Márcia Thereza; Peres, Maria Fernanda; Luiz, Olinda; Zucchi, Eliana Miura; de Castilho, Euclides Ayres; Estevam, Denize Lotufo; Alencar, Rosa; Wolffenbüttel, Karina; Escuder, Maria Mercedes; Calazans, Gabriela; Ferraz, Dulce; Arruda, Érico; Corrêa, Maria da Gloria; Amaral, Fabiana Rezende; Santos, Juliane Cardoso Villela; Alvarez, Vivian Salles; Kietzmann, Tiago

    2015-01-01

    Introduction Few results from programmes based on combination prevention methods are available. We propose to analyse the degree of protection provided by postexposure prophylaxis (PEP) for consensual sexual activity at healthcare clinics, its compensatory effects on sexual behaviour; and the effectiveness of combination prevention methods and pre-exposure prophylaxis (PrEP), compared with exclusively using traditional methods. Methods and analysis A total of 3200 individuals aged 16 years or older presenting for PEP at 5 sexually transmitted disease (STD)/HIV clinics in 3 regions of Brazil will be allocated to one of two groups: the PEP group—individuals who come to the clinic within 72 h after a sexual exposure and start PEP; and the non-PEP group—individuals who come after 72 h but within 30 days of exposure and do not start PEP. Clinical follow-up will be conducted initially for 6 months and comprise educational interventions based on information and counselling for using prevention methods, including PrEP. In the second study phase, individuals who remain HIV negative will be regrouped according to the reported use of prevention methods and observed for 18 months: only traditional methods; combined methods; and PrEP. Effectiveness will be analysed according to the incidence of HIV, syphilis and hepatitis B and C and protected sexual behaviour. A structured questionnaire will be administered to participants at baseline and every 6 months thereafter. Qualitative methods will be employed to provide a comprehensive understanding of PEP-seeking behaviour, preventive choices and exposure to HIV. Ethics and dissemination This study will be conducted in accordance with the resolution of the School of Medicine Research Ethics Commission of Universidade de São Paulo (protocol no. 251/14). The databases will be available for specific studies, after management committee approval. Findings will be presented to researchers, health managers and civil

  5. Strategies for universalistic and targeted HIV prevention.

    PubMed

    Des Jarlais, D C; Padian, N

    1997-10-01

    The controversy over "targeted" versus "universalistic" programs for HIV prevention has persisted throughout the history of the HIV/AIDS epidemic in the United States and in some European countries. Building on previous analyses, we outline methods for integrating universalistic and targeted HIV prevention programming. The outline considers possible synergy between targeted and universalistic programs, rather than a forced choice between the two. Components within this framework include a continuum of the intensity of targeted programs, specification of local risk behavior populations, categories of risk behavior, and HIV seroprevalence within local risk-behavior populations. Given the scarce resources currently available, preventing all new HIV infections is not a realistic public health goal, but with better use of current scientific knowledge, it should be possible to greatly reduce the rate of new HIV infections. PMID:9358108

  6. Increasing the Efficiency of Prevention Trials by Incorporating Baseline Covariates.

    PubMed

    Zhang, Min; Gilbert, Peter B

    2010-01-01

    Most randomized efficacy trials of interventions to prevent HIV or other infectious diseases have assessed intervention efficacy by a method that either does not incorporate baseline covariates, or that incorporates them in a non-robust or inefficient way. Yet, it has long been known that randomized treatment effects can be assessed with greater efficiency by incorporating baseline covariates that predict the response variable. Tsiatis et al. (2007) and Zhang et al. (2008) advocated a semiparametric efficient approach, based on the theory of Robins et al. (1994), for consistently estimating randomized treatment effects that optimally incorporates predictive baseline covariates, without any parametric assumptions. They stressed the objectivity of the approach, which is achieved by separating the modeling of baseline predictors from the estimation of the treatment effect. While their work adequately justifies implementation of the method for large Phase 3 trials (because its optimality is in terms of asymptotic properties), its performance for intermediate-sized screening Phase 2b efficacy trials, which are increasing in frequency, is unknown. Furthermore, the past work did not consider a right-censored time-to-event endpoint, which is the usual primary endpoint for a prevention trial. For Phase 2b HIV vaccine efficacy trials, we study finite-sample performance of Zhang et al.'s (2008) method for a dichotomous endpoint, and develop and study an adaptation of this method to a discrete right-censored time-to-event endpoint. We show that, given the predictive capacity of baseline covariates collected in real HIV prevention trials, the methods achieve 5-15% gains in efficiency compared to methods in current use. We apply the methods to the first HIV vaccine efficacy trial. This work supports implementation of the discrete failure time method for prevention trials. PMID:21152074

  7. Risk appraisal and HIV prevention.

    PubMed

    Odets, W

    1996-09-01

    Previous HIV prevention efforts, particularly for gay men, focused largely on the elimination of risk through condom use or abstinence. However, as evidenced by current levels of new HIV seroconversions, gay men are still practicing unprotected anal sex. Many public health officials previously attributed this behavior to continued ignorance, chemically-induced impairment, malice, or psychopathology. Evidence now demonstrates that these factors have had little influence on risky behaviors. Researchers are finding that what is absent from the risk elimination strategy are the feelings about trust, intimacy, and sexual communication. Exercising harm reduction approaches that weigh the relative value of the activity and the costs of taking the risks is a better strategy. Client-centered counseling is a key means of facilitating this harm reduction approach. Designed to address some of the psychosocial issues, client-centered counseling takes into account an individual's experience of the risks and benefits involved, and allows the client to weigh personal values against potential risks. However, the strategy can be flawed when educators are not properly trained. Counselors and educators may find client-centered approaches uncomfortable if they have not examined their own value systems. Respect for clients, their values, and their efforts are necessary for effective client-centered counseling.

  8. An HIV-Preventive Intervention for Youth Living with HIV

    ERIC Educational Resources Information Center

    Lightfoot, Marguerita; Rotheram-Borus, Mary Jane; Tevendale, Heather

    2007-01-01

    As the number of youth infected with HIV rises, secondary prevention programs are needed to help youth living with HIV meet three goals: (1) increase self-care behaviors, medical adherence, and health-related interactions; (2) reduce transmission acts; and (3) enhance their quality of life. This article describes an intervention program for youth…

  9. Cancer prevention in HIV-infected populations.

    PubMed

    Goncalves, Priscila H; Montezuma-Rusca, Jairo M; Yarchoan, Robert; Uldrick, Thomas S

    2016-02-01

    People living with human immunodeficiency virus (HIV) are living longer since the advent of effective combined antiretroviral therapy (cART). While cART substantially decreases the risk of developing some cancers, HIV-infected individuals remain at high risk for Kaposi sarcoma, lymphoma, and several solid tumors. Currently HIV-infected patients represent an aging group, and malignancies have become a leading cause of morbidity and mortality. Tailored cancer-prevention strategies are needed for this population. In this review we describe the etiologic agents and pathogenesis of common malignancies in the setting of HIV, as well as current evidence for cancer prevention strategies and screening programs. PMID:26970136

  10. Preventing Mother-to-Child Transmission of HIV during Childbirth

    MedlinePlus

    HIV and Pregnancy Preventing Mother-to-Child Transmission of HIV During Childbirth (Last updated 8/17/2015; last ... the risk of mother-to-child transmission of HIV reduced during childbirth? During childbirth, women with HIV ...

  11. CROI 2016: Hot Spots in HIV Infection and Advances in HIV Prevention.

    PubMed

    Buchbinder, Susan P; Liu, Albert Y

    2016-01-01

    The 2016 Conference on Retroviruses and Opportunistic Infections (CROI) highlighted hot spots in HIV infection. Men who have sex with men (MSM), transgender populations, people who inject drugs, fisherfolk, migrants, adolescents, and older adults are heavily impacted in a number of regions. Stigma contributes to risk behaviors and HIV acquisition across populations. HIV testing is a crucial first step in the HIV care continuum, and several large community-based surveys are underway in Africa to increase HIV testing, linkage to care, and uptake of antiretroviral treatment. Advances in preexposure prophylaxis (PrEP) featured prominently at CROI 2016. Two large efficacy trials of a vaginal ring containing the investigational drug dapivirine demonstrated efficacy and safety in preventing HIV infections in women in Africa. Data on the safety of long-acting injectable PrEP and several investigational PrEP drugs and formulations were also presented. Knowledge and use of PrEP among MSM in the United States appears to be increasing, and high uptake was seen among black MSM when provided as part of a culturally tailored support program. The use of broadly neutralizing antibodies for HIV prevention is a novel and promising approach to be evaluated in efficacy trials. PMID:27398859

  12. Effectiveness of Peer Support on Care Engagement and Preventive Care Intervention Utilization among Pre-Antiretroviral Therapy, HIV-Infected Adults in Rakai, Uganda: a Randomized Trial

    PubMed Central

    Chang, Larry W.; Nakigozi, Gertrude; Billioux, Veena G; Gray, Ronald H.; Serwadda, David; Quinn, Thomas C.; Wawer, Maria J; Bollinger, Robert C.; Reynolds, Steven J.

    2015-01-01

    442 pre-ART, HIV-infected adults were randomized to peer support consisting of structured home visits to promote clinic attendance and preventive care intervention use or standard of care. At baseline, 62% reported previously visiting an HIV clinic, 45% reported taking cotrimoxazole prophylaxis, and 31% were “care-naïve” (no previous clinic visit and not on cotrimoxazole). After one year, intervention participants were more likely to report being in care (92% vs 84%; PRR 1.09, p=0.039), on cotrimoxazole (89% vs 81%; PRR 1.10, p=0.047), and safe water vessel adherence (23% vs 14%; PRR 1.64, p=0.024). The effect was observed only among care-naïve participants (n=139) with 83% intervention vs 53% controls reporting being in HIV care (PRR 1.47, p=0.006), 78% vs 58% on cotrimoxazole (PRR 1.35, p=0.04), and 20% vs 4% safe water vessel adherence (PRR 5.78, p=0.017). Peer support may be an effective intervention to facilitate pre-ART care compliance in this important population. PMID:26271815

  13. Clinical Trials | Division of Cancer Prevention

    Cancer.gov

    Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |

  14. New ways of preventing HIV infection: thinking simply, simply thinking

    PubMed Central

    Short, R.V

    2006-01-01

    HIV infection is the greatest health crisis in human history. It continues to spread unchecked among the poor in the developing world because we have failed to design simple preventative methods that are available and affordable to those living on under $2 a day. Five new methods are discussed. (i) A natural microbicide. Intravaginal lime or lemon juice has been used for centuries as a traditional contraceptive. The juice can also kill HIV in the laboratory, but clinical trials are needed to see if vaginal application is acceptable, safe and effective. (ii) Intravaginal oestrogen. Monkeys can be protected from Simian immunodeficiency virus (SIV) infection by keratinizing the vagina with topical oestrogen. If women take the oral contraceptive pill vaginally it retains its contraceptive efficacy, and the oestrogen it contains should thicken the vagina and protect against HIV infection. Clinical trials are needed. (iii) Male circumcision. Removal of the inner foreskin removes the main site of HIV entry into the penis, resulting in a sevenfold reduction in susceptibility to infection. The practice needs to be promoted. (iv) Post-coital penile hygiene. Wiping the penis immediately after intercourse with lime or lemon juice or vinegar should kill the virus before it has had a chance to infect. A clinical trial of efficacy is needed. (v) PhotoVoice. Asking schoolchildren in developing countries to photograph their impressions of HIV/AIDS is a powerful way of getting them to discuss the subject openly, and develop their own preventative strategies. PMID:16627296

  15. Clinical Trials Management | Division of Cancer Prevention

    Cancer.gov

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

  16. Antiretroviral treatment of HIV-1 prevents transmission of HIV-1: where do we go from here?

    PubMed Central

    Cohen, Myron S; Smith, M Kumi; Muessig, Kathryn E; Hallett, Timothy B; Powers, Kimberly A; Kashuba, Angela D

    2013-01-01

    Antiretroviral drugs that inhibit viral replication were expected to reduce transmission of HIV by lowering the concentration of HIV in the genital tract. In 11 of 13 observational studies, antiretroviral therapy (ART) provided to an HIV-infected index case led to greatly reduced transmission of HIV to a sexual partner. In the HPTN 052 randomised controlled trial, ART used in combination with condoms and counselling reduced HIV transmission by 96·4%. Evidence is growing that wider, earlier initiation of ART could reduce population-level incidence of HIV. However, the full benefits of this strategy will probably need universal access to very early ART and excellent adherence to treatment. Challenges to this approach are substantial. First, not all HIV-infected individuals can be located, especially people with acute and early infection who are most contagious. Second, the ability of ART to prevent HIV transmission in men who have sex with men (MSM) and people who use intravenous drugs has not been shown. Indeed, the stable or increased incidence of HIV in MSM in some communities where widespread use of ART has been established emphasises the concern that not enough is known about treatment as prevention for this crucial population. Third, although US guidelines call for immediate use of ART, such guidelines have not been embraced worldwide. Some experts do not believe that immediate or early ART is justified by present evidence, or that health-care infrastructure for this approach is sufficient. These concerns are very difficult to resolve. Ongoing community-based prospective trials of early ART are likely to help to establish the population-level benefit of ART, and—if successful—to galvanise treatment as prevention. PMID:24152938

  17. Rush to judgment: the STI-treatment trials and HIV in sub-Saharan Africa

    PubMed Central

    Stillwaggon, Eileen; Sawers, Larry

    2015-01-01

    Introduction The extraordinarily high incidence of HIV in sub-Saharan Africa led to the search for cofactor infections that could explain the high rates of transmission in the region. Genital inflammation and lesions caused by sexually transmitted infections (STIs) were a probable mechanism, and numerous observational studies indicated several STI cofactors. Nine out of the ten randomized controlled trials (RCTs), however, failed to demonstrate that treating STIs could lower HIV incidence. We evaluate all 10 trials to determine if their design permits the conclusion, widely believed, that STI treatment is ineffective in reducing HIV incidence. Discussion Examination of the trials reveals critical methodological problems sufficient to account for statistically insignificant outcomes in nine of the ten trials. Shortcomings of the trials include weak exposure contrast, confounding, non-differential misclassification, contamination and effect modification, all of which consistently bias the results toward the null. In any future STI-HIV trial, ethical considerations will again require weak exposure contrast. The complexity posed by HIV transmission in the genital microbial environment means that any future STI-HIV trial will face confounding, non-differential misclassification and effect modification. As a result, it is unlikely that additional trials would be able to answer the question of whether STI control reduces HIV incidence. Conclusions Shortcomings in published RCTs render invalid the conclusion that treating STIs and other cofactor infections is ineffective in HIV prevention. Meta-analyses of observational studies conclude that STIs can raise HIV transmission efficiency two- to fourfold. Health policy is always implemented under uncertainty. Given the known benefits of STI control, the irreparable harm from not treating STIs and the likely decline in HIV incidence resulting from STI control, it is appropriate to expand STI control programmes and to use funds

  18. Feasibility and suitability of targeting young gay men for HIV vaccine efficacy trials.

    PubMed

    Scheer, S; Douglas, J M; Vittinghoff, E; Bartholow, B N; McKirnan, D; Judson, F N; MacQueen, K M; Buchbinder, S

    1999-02-01

    We evaluated factors affecting the feasibility of including young high-risk HIV-negative gay and bisexual men in preventive HIV vaccine trials using data from the U.S. Centers for Disease Control and Prevention Collaborative HIV Seroincidence Study. Of 2189 men enrolled in this study, 17% were <25 years of age. HIV seroincidence was 4.2/100 person-years (95% confidence interval [CI], 2.6-7.0) in young men compared with 2.0/100 person-years (95% CI, 1.4-2.6) for older men. Compared with men 25 and older, young men were more likely to report several high-risk behaviors, to perceive themselves to be at risk for HIV infection, and to report that their risk behavior might be increased by participation in an HIV vaccine trial. The majority of both young men (69%) and older men (74%) expressed willingness in participate in HIV vaccine trials. Young men were less likely to answer questions about vaccine concepts correctly and were more likely to be lost to follow-up. Young gay and bisexual men are important candidates for future HIV vaccine trials, but they may need targeted approaches to recruitment, retention, education about trial concepts prior to enrollment, and behavioral interventions during the trial.

  19. The Cost-Effectiveness of Tuberculosis Preventive Therapy for HIV-Infected Individuals in Southern India: A Trial-Based Analysis

    PubMed Central

    Pho, Mai T.; Swaminathan, Soumya; Kumarasamy, Nagalingeswaran; Losina, Elena; Ponnuraja, C.; Uhler, Lauren M.; Scott, Callie A.; Mayer, Kenneth H.; Freedberg, Kenneth A.; Walensky, Rochelle P.

    2012-01-01

    Background Regimens for isoniazid-based preventive therapy (IPT) for tuberculosis (TB) in HIV-infected individuals have not been widely adopted given concerns regarding efficacy, adherence and drug resistance. Further, the cost-effectiveness of IPT has not been studied in India. Methods We used an HIV/TB model to project TB incidence, life expectancy, cost and incremental cost-effectiveness of six months of isoniazid plus ethambutol (6EH), thirty-six months of isoniazid (36H) and no IPT for HIV-infected patients in India. Model input parameters included a median CD4 count of 324 cells/mm3, and a rate ratio of developing TB of 0.35 for 6EH and 0.22 for 36H at three years as compared to no IPT. Results of 6EH and 36H were also compared to six months of isoniazid (6H), three months of isoniazid plus rifampin (3RH) and three months of isoniazid plus rifapentine (3RPTH). Results Projected TB incidence decreased in the 6EH and 36H regimens by 51% and 62% respectively at three-year follow-up compared to no IPT. Without IPT, projected life expectancy was 136.1 months at a lifetime per person cost of $5,630. 6EH increased life expectancy by 0.8 months at an additional per person cost of $100 (incremental cost-effectiveness ratio (ICER) of $1,490/year of life saved (YLS)). 36H further increased life expectancy by 0.2 months with an additional per person cost of $55 (ICER of $3,120/YLS). The projected clinical impact of 6EH was comparable to 6H and 3RH; however when compared to these other options, 6EH was no longer cost-effective given the high cost of ethambutol. Results were sensitive to baseline CD4 count and adherence. Conclusions Three, six and thirty-six-month regimens of isoniazid-based therapy are effective in preventing TB. Three months of isoniazid plus rifampin and six-months of isoniazid are similarly cost-effective in India, and should be considered part of HIV care. PMID:22558301

  20. Predictors of Self-Efficacy for HIV Prevention Among Hispanic Women in South Florida

    PubMed Central

    Villegas, Natalia; Cianelli, Rosina; Gonzalez-Guarda, Rosa; Kaelber, Lorena; Ferrer, Lilian; Peragallo, Nilda

    2012-01-01

    Self-efficacy is a critical element for HIV prevention, however little is known about the predictors of self-efficacy for HIV prevention among Hispanic women. In this cross-sectional study we assessed if age, living with a partner, employment status, HIV knowledge, self-esteem, and intimate partner violence (IPV) predicted self-efficacy for HIV prevention in 548 Hispanic women in South Florida who participated in a randomized controlled trial (SEPA). The majority of Hispanic women reported high levels of self-efficacy for HIV prevention. Women who were older, living with a partner, with less HIV knowledge, and a history of IPV reported significantly lower levels of self-efficacy for HIV prevention. HIV knowledge was the most important predictor of self-efficacy for HIV prevention. Employment was not a significant predictor of self-efficacy for HIV prevention. Predictors identified in the study can be used to identify high-risk Hispanic women who are in need of HIV prevention interventions. PMID:22795758

  1. Economics of antiretroviral treatment vs. circumcision for HIV prevention.

    PubMed

    Bärnighausen, Till; Bloom, David E; Humair, Salal

    2012-12-26

    The HIV Prevention Trials Network (HPTN) 052 study, which showed the effectiveness of antiretroviral treatment in reducing HIV transmission, has been hailed as a "game changer" in the fight against HIV, prompting calls for scaling up treatment as prevention (TasP). However, it is unclear how TasP can be financed, given flat-lining support for global HIV programs. We assess whether TasP is indeed a game changer or if comparable benefits are obtainable at similar or lower cost by increasing coverage of medical male circumcision (MMC) and antiretroviral treatment (ART) at CD4 <350/μL. We develop a new mathematical model and apply it to South Africa, finding that high ART coverage combined with high MMC coverage provides approximately the same HIV incidence reduction as TasP, for $5 billion less over 2009-2020. MMC outperforms ART significantly in cost per infection averted ($1,096 vs. $6,790) and performs comparably in cost per death averted ($5,198 vs. $5,604). TasP is substantially less cost effective at $8,375 per infection and $7,739 per death averted. The prevention benefits of HIV treatment are largely reaped with high ART coverage. The most cost-effective HIV prevention strategy is to expand MMC coverage and then scale up ART, but the most cost-effective HIV-mortality reduction strategy is to scale up MMC and ART jointly. TasP is cost effective by commonly used absolute benchmarks but it is far less cost effective than MMC and ART. Given South Africa's current annual ART spending, the $5 billion in savings offered by MMC and ART over TasP in the next decade, for similar health benefits, challenges the widely hailed status of TasP as a game changer.

  2. Antiretroviral Therapy for the Prevention of HIV-1 Transmission.

    PubMed

    Cohen, Myron S; Chen, Ying Q; McCauley, Marybeth; Gamble, Theresa; Hosseinipour, Mina C; Kumarasamy, Nagalingeswaran; Hakim, James G; Kumwenda, Johnstone; Grinsztejn, Beatriz; Pilotto, Jose H S; Godbole, Sheela V; Chariyalertsak, Suwat; Santos, Breno R; Mayer, Kenneth H; Hoffman, Irving F; Eshleman, Susan H; Piwowar-Manning, Estelle; Cottle, Leslie; Zhang, Xinyi C; Makhema, Joseph; Mills, Lisa A; Panchia, Ravindre; Faesen, Sharlaa; Eron, Joseph; Gallant, Joel; Havlir, Diane; Swindells, Susan; Elharrar, Vanessa; Burns, David; Taha, Taha E; Nielsen-Saines, Karin; Celentano, David D; Essex, Max; Hudelson, Sarah E; Redd, Andrew D; Fleming, Thomas R

    2016-09-01

    Background An interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission. Methods We randomly assigned 1763 index participants to receive either early or delayed ART. In the early-ART group, 886 participants started therapy at enrollment (CD4+ count, 350 to 550 cells per cubic millimeter). In the delayed-ART group, 877 participants started therapy after two consecutive CD4+ counts fell below 250 cells per cubic millimeter or if an illness indicative of the acquired immunodeficiency syndrome (i.e., an AIDS-defining illness) developed. The primary study end point was the diagnosis of genetically linked HIV-1 infection in the previously HIV-1-negative partner in an intention-to-treat analysis. Results Index participants were followed for 10,031 person-years; partners were followed for 8509 person-years. Among partners, 78 HIV-1 infections were observed during the trial (annual incidence, 0.9%; 95% confidence interval [CI], 0.7 to 1.1). Viral-linkage status was determined for 72 (92%) of the partner infections. Of these infections, 46 were linked (3 in the early-ART group and 43 in the delayed-ART group; incidence, 0.5%; 95% CI, 0.4 to 0.7) and 26 were unlinked (14 in the early-ART group and 12 in the delayed-ART group; incidence, 0.3%; 95% CI, 0.2 to 0.4). Early ART was associated with a 93% lower risk of linked partner infection than was delayed ART (hazard ratio, 0.07; 95% CI, 0.02 to 0.22). No linked infections were observed when HIV-1 infection was stably suppressed by ART in the index participant. Conclusions The early initiation of ART led to a sustained

  3. A perspective on progress and gaps in HIV prevention science.

    PubMed

    Kiser, Patrick F; Mesquita, Pedro M M; Herold, Betsy C

    2012-11-01

    In the past few years, the transdisciplinary field of HIV prevention has reached several milestones. Topically applied tenofovir gel provided significant protection from sexual transmission of HIV in a large-scale clinical trial and oral Truvada (emtricitabine/tenofovir disoproxil fumarate) was recently approved for preexposure prophylaxis (PrEP) following two successful clinical trials in men and women. These achievements are tempered by the disappointing results of other clinical trials, which highlight the complexities of prevention research. In this perspective, we discuss scientific and developmental gaps for topical chemoprophylaxis of the sexual transmission of HIV, which depends on the complex interactions between the pharmacokinetics and pharmacodynamics of drugs, formulation and delivery systems, anatomic site of transmission, and host mucosal immune defenses. Despite the considerable time and resources devoted to unraveling the initial steps in sexual transmission of HIV, current knowledge is based on animal models and human explanted tissue, which may not fully recapitulate what happens clinically. Understanding these events, including the role that sex hormones, semen, and mucosal secretions play in transmission, and the interplay between innate immunity, the mucosal environment, and drug efficacy is paramount. This drives some of the most pressing questions in the field. PMID:22966871

  4. HIV prevention and research considerations for women in sub-Saharan Africa: moving toward biobehavioral prevention strategies.

    PubMed

    Harrison, Abigail

    2014-09-01

    This paper addresses current and emerging HIV prevention strategies for women in Sub-Saharan Africa, in light of recent trial results and ongoing research. What are the major opportunities and challenges for widespread implementation of new and emerging HIV prevention strategies? The paper discusses the major individual, social and structural factors that underpin women's disproportionate risk for HIV infection, with attention to gender, adolescents as a vulnerable population, and the need to engage men. Also, the influence of these factors on the ultimate success of both behavioral and biomedical HIV prevention technologies for women in sub-Saharan Africa is discussed. Finally, the paper examined how the new and emerging biobehavioral prevention strategies served as tools to empower women to adopt healthy HIV preventive and reproductive health behaviors. PMID:26050373

  5. HIV prevention and research considerations for women in sub-Saharan Africa: moving toward biobehavioral prevention strategies.

    PubMed

    Harrison, Abigail

    2014-09-01

    This paper addresses current and emerging HIV prevention strategies for women in Sub-Saharan Africa, in light of recent trial results and ongoing research. What are the major opportunities and challenges for widespread implementation of new and emerging HIV prevention strategies? The paper discusses the major individual, social and structural factors that underpin women's disproportionate risk for HIV infection, with attention to gender, adolescents as a vulnerable population, and the need to engage men. Also, the influence of these factors on the ultimate success of both behavioral and biomedical HIV prevention technologies for women in sub-Saharan Africa is discussed. Finally, the paper examined how the new and emerging biobehavioral prevention strategies served as tools to empower women to adopt healthy HIV preventive and reproductive health behaviors.

  6. HIV Vaccine-Induced Sero-Reactivity: A Challenge for Trial Participants, Researchers, and Physicians

    PubMed Central

    Voronin, Yegor; Zinszner, Helene; Karg, Carissa; Brooks, Katie; Coombs, Robert; Hural, John; Holt, Renee; Fast, Pat; Allen, Mary; Allen, Mary; Busch, Michael; Fast, Pat; Fruth, Ulrich; Golding, Hana; Khurana, Surender; Mulenga, Joseph; Peel, Sheila; Schito, Marco; Voronin, Yegor; Barnabas, Nomampondo; Bentsen, Christopher; Graham, Barney; Gray, Glenda; Levin, Andrew; McCluskey, Margaret; O'Connell, Robert; Snow, Bill; Ware, Mark

    2015-01-01

    Antibody-inducing vaccines are a major focus in the preventive HIV vaccine field. Because the most common tests for HIV infection rely on detecting antibodies to HIV, they may also detect antibodies induced by a candidate HIV vaccine. The detection of vaccine-induced antibodies to HIV by serological tests is most commonly referred to as vaccine-induced sero-reactivity (VISR). VISR can be misinterpreted as a sign of HIV infection in a healthy study participant. In a participant who has developed vaccine-induced antibodies, accurate diagnosis of HIV infection (or lack thereof) may require specialized tests and algorithms (differential testing) that are usually not available in community settings. Organizations sponsoring clinical testing of preventive HIV vaccine candidates have an ethical obligation not only to inform healthy volunteers about the potential problems associated with participating in a clinical trial but also to help manage any resulting issues. This article explores the scope of VISR-related issues that become increasingly prevalent as the search for an effective HIV vaccine continues and will be paramount once a preventive vaccine is deployed. We also describe ways in which organizations conducting HIV vaccine trials have addressed these issues and outline areas where more work is needed. PMID:25649349

  7. Transgender HIV prevention: a qualitative needs assessment.

    PubMed

    Bockting, W O; Robinson, B E; Rosser, B R

    1998-08-01

    Although clinical experience and preliminary research suggest that some transgender people are at significant risk for HIV, this stigmatized group has so far been largely ignored in HIV prevention. As part of the development of HIV prevention education targeting the transgender population, focus groups of selected transgender individuals assessed their HIV risks and prevention needs. Data were gathered in the following four areas: (1) the impact of HIV/AIDS on transgender persons; (2) risk factors; (3) information and services needed; and (4) recruitment strategies. Findings indicated that HIV/AIDS compounds stigmatization related to transgender identity, interferes with sexual experimentation during the transgender 'coming out' process, and may interfere with obtaining sex reassignment. Identified transgender-specific risk factors include: sexual identity conflict, shame and isolation, secrecy, search for affirmation, compulsive sexual behaviour, prostitution, and sharing needles while injecting hormones. Community involvement, peer education and affirmation of transgender identity were stressed as integral components of a successful intervention. Education of health professionals about transgender identity and sexuality and support groups for transgender people with HIV/AIDS are urgently needed.

  8. A Cluster Randomized Controlled Trial of an Adolescent HIV Prevention Program among Bahamian Youth: Effect at 12 Months Post-Intervention

    PubMed Central

    Chen, Xinguang; Lunn, Sonya; Deveaux, Lynette; Li, Xioaming; Brathwaite, Nanika; Cottrell, Lesley; Stanton, Bonita

    2014-01-01

    Background Behavioral interventions based on the Protection Motivation Theory (PMT) have been demonstrated to reduce HIV risk behavior among mid- and older adolescents in different settings across the globe but have not been evaluated among Caribbean nations and have received limited evaluation among pre-adolescents. Objective To determine 1) the effectiveness among pre-adolescents in The Bahamas of a PMT-based HIV prevention program “Focus on Youth in the Caribbean” (FOYC) and 2) the role of the targeted PMT constructs in intervention effect. Methods 1,360 sixth grade youth (10-11 years of age) from 15 urban schools in New Providence, The Bahamas were randomized by school to receive either FOYC or a control condition. Data collected at baseline, six and 12 months post intervention were analyzed. A five-step scheme was used to assess sexual behavior progression, ranging from “1” = “a virgin without intention to have sex” to” 5″ = “having sex without a condom”. Group-based trajectory analysis was utilized in assessing the program effect. Results Two sexual behavior progression patterns were detected: slow progressors and quick progressors. Receiving FOYC reduced the likelihood for adolescents to become quick progressors (adjusted OR = 0.77, 95% CI: 0.64-1.00). The observed effectiveness was especially impacted by a subset of the targeted PMT constructs. Conclusion FOYC effectively delays sexual risk among Bahamian pre-adolescents. The group-based trajectory analysis provides an analytical approach for assessing interventions among adolescents with low rates and diverse progression patterns of sexual activity. PMID:19116781

  9. Willingness to Participate in HIV Therapeutic Vaccine Trials among HIV-Infected Patients on ART in China

    PubMed Central

    Dong, Yuan; Shen, Xiaoxing; Guo, Ruizhang; Liu, Baochi; Zhu, Lingyan; Wang, Jing; Zhang, Linxia; Sun, Jun; Zhang, Xiaoyan; Xu, Jianqing

    2014-01-01

    Background More and more HIV therapeutic vaccines will enter clinical trials; however, little is known about the willingness to participate (WTP) in HIV therapeutic vaccine trials among HIV-positive individuals. Objective To investigate the WTP in HIV therapeutic vaccine trials among Chinese HIV-infected patients. Methods We conducted a cross-sectional survey on HIV-positive inpatients and outpatients at Shanghai Public Health Center. A total of 447 participants were recruited into this study. Following an introduction with general information on HIV therapeutic vaccine and its potential effectiveness and side effects, each participant completed a questionnaire in a self-administered form. The questionnaires covered demographics, high-risk behaviors, clinical characteristics and willingness to participate in HIV therapeutic vaccine trial. Results The overall willingness to participate in HIV therapeutic vaccine trials was 91.5%. Interestingly, multivariate logistic regression analyses demonstrated that the willingness was higher for those sexually infected by HIV (odds ratio [OR]: 4.36; 95% confidence interval [CI]: 1.53–12.41), diagnosed as HIV-1 infection for greater than 5 years (OR: 7.12, 95% CI: 1.83–27.76), and with the presence of infectious complications (OR: 2.75; 95% CI: 1.02–7.45). The primary reason for participation was to delay or reduce antiretroviral treatment (ART) and to avoid ART side effects (76.6%), and then followed by delaying disease progression (74.9%), increasing immune response to suppress opportunistic infections (57.7%) and preventing the development of drug resistance (37.1%). Reasons for unwillingness to participate mainly included concern for safety (37.0%), lack of knowledge on therapeutic vaccine (33.3%), and satisfaction with ART effectiveness (22.2%). Conclusions The WTP in HIV therapeutic vaccine trials was high among HIV-infected Chinese patients. HIV+ subjects who acquired infection through sexual contact and who were

  10. Learning from a cluster randomized controlled trial to improve healthcare workers’ access to prevention and care for tuberculosis and HIV in Free State, South Africa: the pivotal role of information systems

    PubMed Central

    Yassi, Annalee; Adu, Prince A.; Nophale, Letshego; Zungu, Muzimkhulu

    2016-01-01

    Background Occupational tuberculosis (TB) continues to plague the healthcare workforce in South Africa. A 2-year cluster randomized controlled trial was therefore launched in 27 public hospitals in Free State province, to better understand how a combined workforce and workplace program can improve health of the healthcare workforce. Objective This mid-term evaluation aimed to analyze how well the intervention was being implemented, seek evidence of impact or harm, and draw lessons. Methods Both intervention and comparison sites had been instructed to conduct bi-annual and issue-based infection control assessments (when healthcare workers [HCW] are diagnosed with TB) and offer HCWs confidential TB and HIV counseling and testing, TB treatment and prophylaxis for HIV-positive HCWs. Intervention sites were additionally instructed to conduct quarterly workplace assessments, and also offer HCWs HIV treatment at their occupational health units (OHUs). Trends in HCW mortality, sick-time, and turnover rates (2005–2014) were analyzed from the personnel salary database (‘PERSAL’). Data submitted by the OHUs were also analyzed. Open-ended questionnaires were then distributed to OHU HCWs and in-depth interviews conducted at 17 of the sites to investigate challenges encountered. Results OHUs reported identifying and treating 23 new HCW cases of TB amongst the 1,372 workers who used the OHU for HIV and/or TB services; 39 new cases of HIV were also identified and 108 known-HIV-positive HCWs serviced. Although intervention-site workforces used these services significantly more than comparison-site healthcare staff (p<0.001), the data recorded were incomplete for both the intervention and comparison OHUs. An overall significant decline in mortality and turnover rates was documented over this period, but no significant differences between intervention and comparison sites; sick-time data proved unreliable. Severe OHU workload as well as residual confidentiality concerns

  11. Research shows targeted HIV prevention succeeds.

    PubMed

    2002-03-01

    Systematic reviews of HIV prevention intervention literature for the target populations of African-Americans, Latinos, youths, and men who have sex with men in the United States shows that targeted interventions work in reducing HIV risk behaviors. Interventions that succeeded were culturally sensitive, of longer duration, and included skills training, according to a project supported by the Surgeon General's Leadership Campaign on AIDS and teh California HealthCare Foundation in Oakland. PMID:12206092

  12. Government priorities for preventing HIV / AIDS.

    PubMed

    Ainsworth, M

    1998-08-01

    No cure has been found for HIV/AIDS. Therefore, until one is found which is affordable and feasible for use in developing countries, preventing HIV infection is the best way to combat the HIV/AIDS pandemic. All of the many biological characteristics of HIV which affect its rate of spread in a population can be affected through individual behavior. The two most important behaviors which spread HIV are having sexual intercourse with an HIV-infected sex partner without using a condom and sharing unsterilized drug injecting equipment. Strategies to reduce risky behavior include providing information, lowering the costs of condom use and safe injecting behavior, and raising the costs of risky behavior. The costs of condom use include the financial and time costs of buying the condoms, the potential inconvenience and social embarrassment of buying and using them, and reduced pleasure among some users. IV drug users face the problems of getting into and remaining in drug treatment programs, and obtaining sterile injecting equipment. Government priorities in preventing HIV/AIDS and mobilizing political support against AIDS are discussed.

  13. HIV prevention in Mexican schools: prospective randomised evaluation of intervention

    PubMed Central

    Walker, Dilys; Gutierrez, Juan Pablo; Torres, Pilar; Bertozzi, Stefano M

    2006-01-01

    Objective To assess effects on condom use and other sexual behaviour of an HIV prevention programme at school that promotes the use of condoms with and without emergency contraception. Design Cluster randomised controlled trial. Setting 40 public high schools in the state of Morelos, Mexico. Participants 10 954 first year high school students. Intervention Schools were randomised to one of three arms: an HIV prevention course that promoted condom use, the same course with emergency contraception as back-up, or the existing sex education course. Self administered anonymous questionnaires were completed at baseline, four months, and 16 months. Students at intervention schools received a 30 hour course (over 15 weeks) on HIV prevention and life skills, designed in accordance with guidelines of the joint United Nations programme on HIV/AIDS. Two extra hours of education on emergency contraception were given to students in the condom promotion with contraception arm. Main outcome measures Primary outcome measure was reported condom use. Other outcomes were reported sexual activity; knowledge and attitudes about HIV and emergency contraception; and attitudes and confidence about condom use. Results Intervention did not affect reported condom use. Knowledge of HIV improved in both intervention arms and knowledge of emergency contraception improved in the condom promotion with contraception arm. Reported sexual behaviour was similar in the intervention arms and the control group. Conclusion A rigorously designed, implemented, and evaluated HIV education course based in public high schools did not reduce risk behaviour, so such courses need to be redesigned and evaluated. Addition of emergency contraception did not decrease reported condom use or increase risky sexual behaviour but did increase reported use of emergency contraception. PMID:16682420

  14. Randomized Trial of Periodic Presumptive Treatment With High-Dose Intravaginal Metronidazole and Miconazole to Prevent Vaginal Infections in HIV-negative Women

    PubMed Central

    McClelland, R. Scott; Balkus, Jennifer E.; Lee, Jeannette; Anzala, Omu; Kimani, Joshua; Schwebke, Jane; Bragg, Vivian; Lensing, Shelly; Kavak, Lale

    2015-01-01

    Background. Vaginal infections are common, frequently recur, and may increase women's risk for sexually transmitted infections (STIs). We tested the efficacy of a novel regimen to prevent recurrent vaginal infections. Methods. Human immunodeficiency virus (HIV)–negative women 18–45 years old with 1 or more vaginal infections, including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), or Trichomonas vaginalis (TV), were randomly assigned to receive vaginal suppositories containing metronidazole 750 mg plus miconazole 200 mg or matching placebo for 5 consecutive nights each month for 12 months. Primary endpoints, evaluated every 2 months, were BV (Gram stain) and VVC (positive wet mount and culture). Results. Participants (N = 234) were randomly assigned to the intervention (N = 118) or placebo (N = 116) arm. Two hundred seventeen (93%) women completed an end-of-study evaluation. The intervention reduced the proportion of visits with BV compared to placebo (21.2% vs 32.5%; relative risk [RR] 0.65, 95% confidence interval [CI] .48–.87). In contrast, the proportion of visits with VVC was similar in the intervention (10.4%) versus placebo (11.3%) arms (RR 0.92, 95% CI .62–1.37). Conclusions. Monthly treatment with intravaginal metronidazole plus miconazole reduced the proportion of visits with BV during 12 months of follow-up. Further study will be important to determine whether this intervention can reduce women's risk of STIs. PMID:25526757

  15. Internalized heterosexism among HIV-positive, gay-identified men: implications for HIV prevention and care.

    PubMed

    Johnson, Mallory O; Carrico, Adam W; Chesney, Margaret A; Morin, Stephen F

    2008-10-01

    Internalized heterosexism (IH), or the internalization of societal antihomosexual attitudes, has been consistently linked to depression and low self-esteem among gay men, and it has been inconclusively associated with substance use and sexual risk in gay and bisexual men. Using structural equation modeling, the authors tested a model framed in social action theory (C. K. Ewart, 1991, 2004) in which IH is associated with HIV transmission risk and poor adherence to HIV antiretroviral therapy (ART) through the mechanisms of negative affect and stimulant use. Data from a sample of 465 gay-identified men interviewed as part of an HIV risk reduction behavioral trial were used to test the fit of the model. Results support the hypothesized model in which IH was associated with unprotected receptive (but not insertive) anal intercourse with HIV-negative or unknown HIV status partners, and with ART nonadherence indirectly via increased negative affect and more regular stimulant use. The model accounted for 15% of the variance in unprotected receptive anal intercourse and 17% of the variance in ART nonadherence. Findings support the potential utility of addressing IH in HIV prevention and treatment with HIV-positive gay men.

  16. Project ORE: A Friendship-Based Intervention to Prevent HIV/STI in Urban African American Adolescent Females

    ERIC Educational Resources Information Center

    Dolcini, M. Margaret; Harper, Gary W.; Boyer, Cherrie B.; Pollack, Lance M.

    2010-01-01

    There is an urgent need for continued innovation in the design of HIV/STI prevention interventions for African American females, a group at high risk for STIs and HIV. In particular, attention to social development and to culture is needed. The present study reports on a group randomized controlled trial of a friendship-based HIV/STI prevention…

  17. The Past, Present, and Future of HIV Prevention: Integrating Behavioral, Biomedical, and Structural Intervention Strategies for the Next Generation of HIV Prevention

    PubMed Central

    Rotheram-Borus, Mary Jane; Swendeman, Dallas; Chovnick, Gary

    2010-01-01

    In the past 25 years, the field of HIV prevention research has been transformed repeatedly. Today, effective HIV prevention requires a combination of behavioral, biomedical, and structural intervention strategies. Risk of transmitting or acquiring HIV is reduced by consistent male and female-condom use, reductions in concurrent and/or sequential sexual and needle-sharing partners, male circumcision, and treatment with antiretroviral medications. At least 144 behavioral prevention programs have been found effective in reducing HIV transmission acts; however, scale up of these programs has not occurred outside of the United States. A series of recent failures of HIV-prevention efficacy trials for biomedical innovations such as HIV vaccines, treating herpes simplex 2 and other sexually transmitted infections, and diaphragm and microbicide barriers highlights the need for behavioral strategies to accompany biomedical strategies. This challenges prevention researchers to reconceptualize how cost-effective, useful, realistic, and sustainable prevention programs will be designed, delivered, tested, and diffused. The next generation of HIV prevention science must draw from the successes of existing evidence-based interventions and the expertise of the market sector to integrate preventive innovations and behaviors into everyday routines. PMID:19327028

  18. The past, present, and future of HIV prevention: integrating behavioral, biomedical, and structural intervention strategies for the next generation of HIV prevention.

    PubMed

    Rotheram-Borus, Mary Jane; Swendeman, Dallas; Chovnick, Gary

    2009-01-01

    In the past 25 years, the field of HIV prevention research has been transformed repeatedly. Today, effective HIV prevention requires a combination of behavioral, biomedical, and structural intervention strategies. Risk of transmitting or acquiring HIV is reduced by consistent male- and female-condom use, reductions in concurrent and/or sequential sexual and needle-sharing partners, male circumcision, and treatment with antiretroviral medications. At least 144 behavioral prevention programs have been found effective in reducing HIV transmission acts; however, scale up of these programs has not occurred outside of the United States. A series of recent failures of HIV-prevention efficacy trials for biomedical innovations such as HIV vaccines, treating herpes simplex 2 and other sexually transmitted infections, and diaphragm and microbicide barriers highlights the need for behavioral strategies to accompany biomedical strategies. This challenges prevention researchers to reconceptualize how cost-effective, useful, realistic, and sustainable prevention programs will be designed, delivered, tested, and diffused. The next generation of HIV prevention science must draw from the successes of existing evidence-based interventions and the expertise of the market sector to integrate preventive innovations and behaviors into everyday routines. PMID:19327028

  19. The effectiveness of HIV prevention and the epidemiological context.

    PubMed Central

    Grassly, N. C.; Garnett, G. P.; Schwartländer, B.; Gregson, S.; Anderson, R. M.

    2001-01-01

    Planning an intervention to prevent infections with the human immunodeficiency virus (HIV) should be guided by local epidemiological and socioeconomic conditions. The socioeconomic setting and existing public service capacity determine whether an intervention can have a significant outcome in terms of a reduction in a defined risk. The epidemiological context determines whether such risk reduction translates into a measurable impact on HIV incidence. Measurement of variables describing the epidemiological context can be used to determine the local suitability of interventions, thereby guiding planners and policy-makers in their choice of intervention. Such measurements also permit the retrospective analysis of the impact of interventions where HIV incidence was not recorded. The epidemiological context is defined for four different categories of intervention, shown to be effective in lower-income countries by randomized controlled trials. Appropriate indicators for the epidemiological context and methodological guidelines for their measurement are proposed. Their use in the transfer of a successful intervention from one context to another and in scaling up the effort to control HIV infection is explored. These indicators should provide a useful resource for those involved in planning HIV prevention interventions. PMID:11799444

  20. Combination HIV Prevention among MSM in South Africa: Results from Agent-based Modeling

    PubMed Central

    Brookmeyer, Ron; Boren, David; Baral, Stefan D.; Bekker, Linda- Gail; Phaswana-Mafuya, Nancy; Beyrer, Chris; Sullivan, Patrick S.

    2014-01-01

    HIV prevention trials have demonstrated the effectiveness of a number of behavioral and biomedical interventions. HIV prevention packages are combinations of interventions and offer potential to significantly increase the effectiveness of any single intervention. Estimates of the effectiveness of prevention packages are important for guiding the development of prevention strategies and for characterizing effect sizes before embarking on large scale trials. Unfortunately, most research to date has focused on testing single interventions rather than HIV prevention packages. Here we report the results from agent-based modeling of the effectiveness of HIV prevention packages for men who have sex with men (MSM) in South Africa. We consider packages consisting of four components: antiretroviral therapy for HIV infected persons with CD4 count <350; PrEP for high risk uninfected persons; behavioral interventions to reduce rates of unprotected anal intercourse (UAI); and campaigns to increase HIV testing. We considered 163 HIV prevention packages corresponding to different intensity levels of the four components. We performed 2252 simulation runs of our agent-based model to evaluate those packages. We found that a four component package consisting of a 15% reduction in the rate of UAI, 50% PrEP coverage of high risk uninfected persons, 50% reduction in persons who never test for HIV, and 50% ART coverage over and above persons already receiving ART at baseline, could prevent 33.9% of infections over 5 years (95% confidence interval, 31.5, 36.3). The package components with the largest incremental prevention effects were UAI reduction and PrEP coverage. The impact of increased HIV testing was magnified in the presence of PrEP. We find that HIV prevention packages that include both behavioral and biomedical components can in combination prevent significant numbers of infections with levels of coverage, acceptance and adherence that are potentially achievable among MSM in

  1. Combination HIV prevention among MSM in South Africa: results from agent-based modeling.

    PubMed

    Brookmeyer, Ron; Boren, David; Baral, Stefan D; Bekker, Linda-Gail; Phaswana-Mafuya, Nancy; Beyrer, Chris; Sullivan, Patrick S

    2014-01-01

    HIV prevention trials have demonstrated the effectiveness of a number of behavioral and biomedical interventions. HIV prevention packages are combinations of interventions and offer potential to significantly increase the effectiveness of any single intervention. Estimates of the effectiveness of prevention packages are important for guiding the development of prevention strategies and for characterizing effect sizes before embarking on large scale trials. Unfortunately, most research to date has focused on testing single interventions rather than HIV prevention packages. Here we report the results from agent-based modeling of the effectiveness of HIV prevention packages for men who have sex with men (MSM) in South Africa. We consider packages consisting of four components: antiretroviral therapy for HIV infected persons with CD4 count <350; PrEP for high risk uninfected persons; behavioral interventions to reduce rates of unprotected anal intercourse (UAI); and campaigns to increase HIV testing. We considered 163 HIV prevention packages corresponding to different intensity levels of the four components. We performed 2252 simulation runs of our agent-based model to evaluate those packages. We found that a four component package consisting of a 15% reduction in the rate of UAI, 50% PrEP coverage of high risk uninfected persons, 50% reduction in persons who never test for HIV, and 50% ART coverage over and above persons already receiving ART at baseline, could prevent 33.9% of infections over 5 years (95% confidence interval, 31.5, 36.3). The package components with the largest incremental prevention effects were UAI reduction and PrEP coverage. The impact of increased HIV testing was magnified in the presence of PrEP. We find that HIV prevention packages that include both behavioral and biomedical components can in combination prevent significant numbers of infections with levels of coverage, acceptance and adherence that are potentially achievable among MSM in

  2. Social justice and HIV vaccine research in the age of pre-exposure prophylaxis and treatment as prevention.

    PubMed

    Bailey, Theodore C; Sugarman, Jeremy

    2013-09-01

    The advent of pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP) as means of HIV prevention raises issues of justice concerning how most fairly and equitably to apportion resources in support of the burgeoning variety of established HIV treatment and prevention measures and further HIV research, including HIV vaccine research. We apply contemporary approaches to social justice to assess the ethical justification for allocating resources in support of HIV vaccine research given competing priorities to support broad implementation of HIV treatment and prevention measures, including TasP and PrEP. We argue that there is prima facie reason to believe that a safe and effective preventive HIV vaccine would offer a distinct set of ethically significant benefits not provided by current HIV treatment or prevention methods. It is thereby possible to justify continued support for HIV vaccine research despite tension with priorities for treatment, prevention, and other research. We then consider a counter-argument to such a justification based on the uncertainty of successfully developing a safe and effective preventive HIV vaccine. Finally, we discuss how HIV vaccine research might now be ethically designed and conducted given the new preventive options of TasP and PrEP, focusing on the ethically appropriate standard of prevention for HIV vaccine trials.

  3. HIV-prevention science at a crossroads: advances in reducing sexual risk

    PubMed Central

    Vermund, Sten H.; Allen, Katherine L.; Karim, Quarraisha Abdool

    2010-01-01

    Purpose of review We review the current state of evidence-based prevention strategies for reducing sexual transmission of HIV. The combined programmatic and scientific efforts through 2008 to reduce sexual transmission of HIV have failed to reduce substantially the global pandemic. Recent findings Prevention interventions to reduce HIV infection target behavioral, biomedical, and structural risk factors. Some of these prevention strategies have been evaluated in randomized clinical trials (RCTs) with HIV seroincidence endpoints. When RCTs are not feasible, a variety of observational and quasiexperimental research approaches can provide insight as to program effectiveness of specific strategies. Only five RCTs have demonstrated a notable decrease in sexually acquired HIV incidence. These include the Mwanza study of syndromic management of sexually transmitted diseases and three male circumcision trials in East Africa; a microbicide trial reported in 2009 shows substantial promise for the efficacy of PRO 2000 (0.5% gel). Summary The combined programmatic and scientific efforts to reduce sexual transmission of HIV have made incremental progress. New prevention tools are needed to stem the continued spread of HIV, though microbicides and vaccines will take many more years to develop, test, and deploy. Combination strategies of existing modalities should be tested to evaluate the potential for more proximate prevention benefits. PMID:19532063

  4. Combination prevention: a deeper understanding of effective HIV prevention.

    PubMed

    Hankins, Catherine A; de Zalduondo, Barbara O

    2010-10-01

    Evidence-informed and human rights-based combination prevention combines behavioural, biomedical, and structural interventions to address both the immediate risks and underlying causes of vulnerability to HIV infection, and the pathways that link them. Because these are context-specific, no single prescription or standard package will apply universally. Anchored in 'know your epidemic' estimates of where the next 1000 infections will occur and 'know your response' analyses of resource allocation and programming gaps, combination prevention strategies seek to realign programme priorities for maximum effect to reduce epidemic reproductive rates at local, regional, and national levels. Effective prevention means tailoring programmes to local epidemics and ensuring that components are delivered with the intensity, quality, and scale necessary to achieve intended effects. Structural interventions, addressing the social, economic, cultural, and legal constraints that create HIV risk environments and undermine the agency of individuals to protect themselves and others, are also public goods in their own right. Applying the principles of combination prevention systematically and consistently in HIV programme planning, with due attention to context, can increase HIV programme effectiveness. Better outcome and impact measurement using multiple methods and data triangulation can build the evidence base on synergies between the components of combination prevention at individual, group, and societal levels, facilitating iterative knowledge translation within and among programmes. PMID:21042055

  5. Use of antiretrovirals for HIV prevention: what do we know and what don't we know?

    PubMed

    Baeten, Jared M; Grant, Robert

    2013-06-01

    Pre-exposure prophylaxis (PrEP), in which HIV uninfected persons with ongoing HIV risk use antiretroviral medications as chemoprophylaxis against sexual HIV acquisition, is a promising new HIV prevention strategy. Proof-of-concept that PrEP, as oral or vaginal topical tenofovir-based products, protects against sexual HIV acquisition has been demonstrated in clinical trials conducted among men who have sex with men and heterosexual men and women. The degree of HIV protection in these trials was strongly related to the level of adherence to PrEP. Many questions are yet unanswered--including how to motivate uptake of and sustain adherence to PrEP for HIV prevention, how much PrEP use is enough to achieve HIV protection, and the potential of "next-generation" PrEP agents to improve on this effective technology. PMID:23494772

  6. An empiric risk scoring tool for identifying high-risk heterosexual HIV-1 serodiscordant couples for targeted HIV-1 prevention

    PubMed Central

    KAHLE, Erin M.; HUGHES, James P.; LINGAPPA, Jairam R.; JOHN-STEWART, Grace; CELUM, Connie; NAKKU-JOLOBA, Edith; NJUGUNA, Stella; MUGO, Nelly; BUKUSI, Elizabeth; MANONGI, Rachel; BAETEN, Jared M.

    2012-01-01

    Background and objectives Heterosexual HIV-1 serodiscordant couples are increasingly recognized as an important source of new HIV-1 infections in sub-Saharan Africa. A simple risk assessment tool could be useful for identifying couples at highest risk for HIV-1 transmission. Methods Using data from three prospective studies of HIV-1 serodiscordant couples from seven African countries and standard methods for development of clinical prediction rules, we derived and validated a risk scoring tool developed from multivariate modeling and composed of key predictors for HIV-1 risk that could be measured in standard research and clinical settings. Results The final risk score included age of the HIV-1 uninfected partner, married and/or cohabiting partnership, number of children, unprotected sex, uncircumcised male HIV-1 uninfected partner, and plasma HIV-1 RNA in the HIV-1 infected partner. The maximum risk score was 12, scores ≥5 were associated with an annual HIV-1 incidence of >3%, and couples with a score ≥6 accounted for only 28% of the population but 67% of HIV-1 transmissions. The area under the curve for predictive ability of the score was 0.74 (95% CI 0.70–0.78). Internal and external validation showed similar predictive ability of the risk score, even when plasma viral load was excluded from the risk score. Conclusions A discrete combination of clinical and behavioral characteristics defines highest-risk HIV-1 serodiscordant couples. Discriminating highest-risk couples for HIV-1 prevention programs and clinical trials using a validated risk score could improve research efficiency and maximize the impact of prevention strategies for reducing HIV-1 transmission. PMID:23187945

  7. Selectively willing and conditionally able: HIV vaccine trial participation among women at "high risk" of HIV infection.

    PubMed

    Voytek, Chelsea D; Jones, Kevin T; Metzger, David S

    2011-08-18

    Efficacy studies of investigational HIV vaccines require enrollment of individuals at 'high risk' for HIV. This paper examines participation in HIV vaccine trials among women at 'high risk' for HIV acquisition. In-depth interviews were conducted with 17 African-American women who use crack cocaine and/or exchange sex for money/drugs to elicit attitudes toward medical research and motivators and deterrents to HIV vaccine trial participation. Interviews were digitally recorded and transcribed; data were coded and compiled into themes. Most women expressed favorable attitudes toward medical research in general. Motivators for trial participation included compensation; personal benefits including information, social services, and the possibility that the trial vaccine could prevent HIV; and altruism. Deterrents included: dislike of needles; distrust; concern about future consequences of participating. In addition, contingencies, care-giving responsibilities, and convenience issues constituted barriers which could impede participation. Respondents described varied, complex perspectives, and individual cases illustrate how these themes played out as women contemplated trial participation. Understanding factors which influence vaccine research participation among women at 'high risk' can aid sites to tailor recruitment procedures to local contexts. Concerns about future reactions can be addressed through sustained community education. Convenience barriers can be ameliorated by providing rides to study visits when necessary, and/or conducting study visits in accessible neighborhood locations. Women in this sample thought carefully about enrolling in HIV vaccine trials given the structural constraints within which they lived. Further research is needed regarding structural factors which influence personal agency and individuals' thinking about research participation.

  8. Effectiveness of condoms in preventing HIV transmission.

    PubMed

    Pinkerton, S D; Abramson, P R

    1997-05-01

    The consistent use of latex condoms continues to be advocated for primary prevention of HIV infection despite limited quantitative evidence regarding the effectiveness of condoms in blocking the sexual transmission of HIV. Although recent meta-analyses of condom effectiveness suggest that condoms are 60 to 70% effective when used for HIV prophylaxis, these studies do not isolate consistent condom use, and therefore provide only a lower bound on the true effectiveness of correct and consistent condom use. A reexamination of HIV seroconversion studies suggests that condoms are 90 to 95% effective when used consistently, i.e. consistent condom users are 10 to 20 times less likely to become infected when exposed to the virus than are inconsistent or non-users. Similar results are obtained utilizing model-based estimation techniques, which indicate that condoms decrease the per-contact probability of male-to-female transmission of HIV by about 95%. Though imperfect, condoms provide substantial protection against HIV infection. Condom promotion therefore remains an important international priority in the fight against AIDS.

  9. Combination HIV prevention options for young women in Africa.

    PubMed

    Baxter, Cheryl; Abdool Karim, Salim

    2016-07-01

    Although the number of new HIV infections has declined by over 30% in the past decade, the number of people who acquire HIV each year remains unacceptably high. In 2014 the Joint United Nations Programme on HIV/AIDS (UNAIDS) estimated that there were about 2 million new HIV infections. The virus continues to spread, particularly in key populations, such as men who have sex with men (MSM), transgender individuals, sex workers and people who inject drugs. In Africa, young women have the highest HIV incidence rates. Scaling up known efficacious HIV prevention strategies for these groups at high risk is therefore a high priority. HIV prevention has generally been targeted at HIV-negative individuals or in some instances, entire communities. Prevention efforts are, however, shifting from a narrow focus on HIV-uninfected persons to a continuum of prevention that includes both HIV-negative and HIV-positive individuals. Given that a single HIV prevention intervention is unlikely to be able to alter the epidemic trajectory as HIV epidemics in communities are complex and comprise a mosaic of different risk factors and different routes of transmission, there is need to provide combination prevention. Hence, a mix of behavioural, biomedical and structural HIV prevention options is likely to be needed to alter the course of the HIV epidemic. The combination of HIV prevention interventions needed will vary depending on cultural context, the population targeted and the stage of the epidemic. This paper reviews the available HIV prevention strategies for young women and discusses new HIV prevention approaches in development. PMID:27399041

  10. The use of cash transfers for HIV prevention--are we there yet?

    PubMed

    Taaffe, Jessica; Cheikh, Nejma; Wilson, David

    2016-01-01

    Poverty and social inequality are significant drivers of the HIV epidemic and are risk factors for acquiring HIV. As such, many individuals worldwide are at risk for new HIV infection, especially young women in East and Southern Africa. By addressing these drivers, social protection programmes may mitigate the impact of poverty and social inequality on HIV risk. There is reason to believe that social protection can be used successfully for HIV prevention; social protection programmes, including cash transfers, have led to positive health outcomes and behaviour in other contexts, and they have been used successfully to promote education and increased income and employment opportunities. Furthermore, cash transfers have influenced sexual behaviour of young women and girls, thereby decreasing sexual risk factors for HIV infection. When HIV outcomes have been measured, several randomised controlled trials have shown that indirectly, cash transfers have led to reduced HIV prevalence and incidence. In these studies, school attendance and safer sexual health were directly incentivised through the cash transfer, yet there was a positive effect on HIV outcomes. In this review, we discuss the growth of social protection programmes, their benefits and impact on health, education and economic potential, and how these outcomes may affect HIV risk. We also review the studies that have shown that cash transfers can lead to reduced HIV infection, including study limitations and what questions still remain with regard to using cash transfers for HIV prevention.

  11. The use of cash transfers for HIV prevention--are we there yet?

    PubMed

    Taaffe, Jessica; Cheikh, Nejma; Wilson, David

    2016-01-01

    Poverty and social inequality are significant drivers of the HIV epidemic and are risk factors for acquiring HIV. As such, many individuals worldwide are at risk for new HIV infection, especially young women in East and Southern Africa. By addressing these drivers, social protection programmes may mitigate the impact of poverty and social inequality on HIV risk. There is reason to believe that social protection can be used successfully for HIV prevention; social protection programmes, including cash transfers, have led to positive health outcomes and behaviour in other contexts, and they have been used successfully to promote education and increased income and employment opportunities. Furthermore, cash transfers have influenced sexual behaviour of young women and girls, thereby decreasing sexual risk factors for HIV infection. When HIV outcomes have been measured, several randomised controlled trials have shown that indirectly, cash transfers have led to reduced HIV prevalence and incidence. In these studies, school attendance and safer sexual health were directly incentivised through the cash transfer, yet there was a positive effect on HIV outcomes. In this review, we discuss the growth of social protection programmes, their benefits and impact on health, education and economic potential, and how these outcomes may affect HIV risk. We also review the studies that have shown that cash transfers can lead to reduced HIV infection, including study limitations and what questions still remain with regard to using cash transfers for HIV prevention. PMID:27002355

  12. Can a pill prevent HIV? Negotiating the biomedicalisation of HIV prevention.

    PubMed

    Young, Ingrid; Flowers, Paul; McDaid, Lisa

    2016-03-01

    This article examines how biomedicalisation is encountered, responded to and negotiated within and in relation to new biomedical forms of HIV prevention. We draw on exploratory focus group discussions on pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP) to examine how the processes of biomedicalisation are affected by and affect the diverse experiences of communities who have been epidemiologically framed as 'vulnerable' to HIV and towards whom PrEP and TasP will most likely be targeted. We found that participants were largely critical of the perceived commodification of HIV prevention as seen through PrEP, although this was in tension with the construction of being medical consumers by potential PrEP candidates. We also found how deeply entrenched forms of HIV stigma and homophobia can shape and obfuscate the consumption and management of HIV-related knowledge. Finally, we found that rather than seeing TasP or PrEP as 'liberating' through reduced levels of infectiousness or risk of transmission, social and legal requirements of responsibility in relation to HIV risk reinforced unequal forms of biomedical self-governance. Overall, we found that the stratifying processes of biomedicalisation will have significant implications in how TasP, PrEP and HIV prevention more generally are negotiated. PMID:26498141

  13. Adolescent Self-Consent for Biomedical HIV Prevention Research

    PubMed Central

    Gilbert, Amy Lewis; Knopf, Amelia S.; Fortenberry, J. Dennis; Hosek, Sybil G.; Kapogiannis, Bill G.; Zimet, Gregory D.

    2015-01-01

    Purpose The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multi-site demonstration project and phase II safety study of HIV pre-exposure prophylaxis with 15-17 year old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113, so as to inform future biomedical HIV prevention research with high-risk adolescent populations. Methods Participants included seventeen researchers at thirteen sites in twelve states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process. Results A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified; and ATN113 was ultimately implemented in 7 of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations. Conclusions The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations. PMID:26095412

  14. The role of sexually transmitted infections in male circumcision effectiveness against HIV – insights from clinical trial simulation

    PubMed Central

    Desai, Kamal; Boily, Marie-Claude; Garnett, Geoff P; Mâsse, Benoît R; Moses, Stephen; Bailey, Robert C

    2006-01-01

    Background A landmark randomised trial of male circumcision (MC) in Orange Farm, South Africa recently showed a large and significant reduction in risk of HIV infection, reporting MC effectiveness of 61% (95% CI: 34%–77%). Additionally, two further randomised trials of MC in Kisumu, Kenya and Rakai, Uganda were recently stopped early to report 53% and 48% effectiveness, respectively. Since MC may protect against both HIV and certain sexually transmitted infections (STI), which are themselves cofactors of HIV infection, an important question is the extent to which this estimated effectiveness against HIV is mediated by the protective effect of circumcision against STI. The answer lies in the trial data if the appropriate statistical analyses can be identified to estimate the separate efficacies against HIV and STI, which combine to determine overall effectiveness. Objectives and Methods Focusing on the MC trial in Kisumu, we used a stochastic prevention trial simulator (1) to determine whether statistical analyses can validly estimate efficacy, (2) to determine whether MC efficacy against STI alone can produce large effectiveness against HIV and (3) to estimate the fraction of all HIV infections prevented that are attributable to efficacy against STI when both efficacies combine. Results Valid estimation of separate efficacies against HIV and STI as well as MC effectiveness is feasible with available STI and HIV trial data, under Kisumu trial conditions. Under our parameter assumptions, high overall effectiveness of MC against HIV was observed only with a high MC efficacy against HIV and was not possible on the basis of MC efficacy against STI alone. The fraction of all HIV infections prevented which were attributable to MC efficacy against STI was small, except when efficacy of MC specifically against HIV was very low. In the three MC trials which reported between 48% and 61% effectiveness (combining STI and HIV efficacies), the fraction of HIV infections

  15. Topical application of entry inhibitors as "virustats" to prevent sexual transmission of HIV infection

    PubMed Central

    Lederman, Michael M; Jump, Robin; Pilch-Cooper, Heather A; Root, Michael; Sieg, Scott F

    2008-01-01

    With the continuing march of the AIDS epidemic and little hope for an effective vaccine in the near future, work to develop a topical strategy to prevent HIV infection is increasingly important. This stated, the track record of large scale "microbicide" trials has been disappointing with nonspecific inhibitors either failing to protect women from infection or even increasing HIV acquisition. Newer strategies that target directly the elements needed for viral entry into cells have shown promise in non-human primate models of HIV transmission and as these agents have not yet been broadly introduced in regions of highest HIV prevalence, they are particularly attractive for prophylaxis. We review here the agents that can block HIV cellular entry and that show promise as topical strategies or "virustats" to prevent mucosal transmission of HIV infection PMID:19094217

  16. Prostate Cancer Prevention: Concepts and Clinical Trials.

    PubMed

    Hamilton, Zachary; Parsons, J Kellogg

    2016-04-01

    Prevention is an important treatment strategy for diminishing prostate cancer morbidity and mortality and is applicable to both early- and late-stage disease. There are three basic classifications of cancer prevention: primary (prevention of incident disease), secondary (identification and treatment of preclinical disease), and tertiary (prevention of progression or recurrence). Based on level I evidence, 5-alpha reductase inhibitors (5-ARIs) should be considered in selected men to prevent incident prostate cancer. Level I evidence also supports the consideration of dutasteride, a 5-ARI, for tertiary prevention in active surveillance and biochemical recurrence patients. Vitamins and supplements, including selenium or vitamin E, have not been proven in clinical trials to prevent prostate cancer and in the case of Vitamin E has been found to increase the risk of incident prostate cancer. Ongoing and future trials may further elucidate the role of diet and immunotherapy for prevention of prostate cancer. PMID:26957512

  17. Survival in prostate cancer prevention trial detailed

    Cancer.gov

    In the NCI-sponsored Prostate Cancer Prevention Trial, initial findings from a decade ago showed that the drug finasteride significantly reduced the risk of prostate cancer, but among those who did develop prostate cancer, paradoxically, the drug was asso

  18. Defining success with HIV pre-exposure prophylaxis: A prevention-effective adherence paradigm

    PubMed Central

    Haberer, Jessica E.; Bangsberg, David R.; Baeten, Jared M.; Curran, Kathryn; Koechlin, Florence; Amico, K. Rivet; Anderson, Peter; Mugo, Nelly; Venter, Francois; Goicochea, Pedro; Caceres, Carlos; O’Reilly, Kevin

    2015-01-01

    Clinical trial data have shown that oral pre-exposure prophylaxis (PrEP) is efficacious when taken as prescribed; however, PrEP adherence is complex and must be understood within the context of variable risk for HIV infection and use of other HIV prevention methods. Different levels of adherence may be needed in different populations to achieve HIV prevention, and the optimal methods for achieving the necessary adherence for both individual and public health benefits are unknown. Guidance for PrEP use must consider these questions to determine the success of PrEP-based HIV prevention programs. In this article, we propose a new paradigm for understanding and measuring PrEP adherence, termed prevention-effective adherence, which incorporates dynamic HIV acquisition risk behaviors and the use of HIV alternative prevention strategies. We discuss the need for daily PrEP use only during periods of risk for HIV exposure, describe key issues for measuring and understanding relevant behaviors, review lessons from another health prevention field (i.e., family planning), and provide guidance for prevention-effective PrEP use. Moreover, we challenge emerging calls for sustained, near perfect PrEP adherence regardless of risk exposure and offer a more practical and public health-focused vision for this prevention intervention. PMID:26103095

  19. Capacity building for HIV / AIDS prevention.

    PubMed

    Loughran, L

    1995-07-01

    Some organizations involved in programs to prevent HIV/AIDS have considerable skill and experience, while others have only minimal skill and experience with which to achieve project goals. Some organizations consistently deliver high quality services when and where individuals and communities need them, while others have neither the infrastructure nor experience to sustain their efforts independently. No single nongovernmental organization (NGO) can do all that is needed to prevent and control HIV/AIDS. NGOs need to instead learn what are their real capacities to deliver services. The success and quality of HIV/AIDS prevention programs depend upon long-term investments to build the technical and organizational capacities of the public, private, and NGO institutions which deliver services. These investments are made to enhance the ability of organizations and national programs to design, manage, evaluate, and sustain their own prevention programs. Capacity building is defined with discussion of skill building, organizational development, and networking. The author also discusses constraints, capacity building as a controversial component of development programs, evaluating capacity building, and accountability. PMID:12291829

  20. An STD/HIV prevention intervention framework.

    PubMed

    Cohen, D A; Scribner, R

    2000-01-01

    Historically, interventions to prevent STD/HIV transmission have been categorized by program methodology rather than defining the content and nature of the intervention. A new taxonomy is needed to help expand the scope of interventions that can be used to prevent STD and HIV transmission. The taxonomy defines two major types of interventions, individual-level and structural level. The former targets risk factors attributable to individuals. Structural interventions target conditions outside the control of the individual. Individual-level interventions focus on counseling, screening, and treatment. They include psychological and biological interventions. Structural-level interventions address accessibility of relevant consumer products (condoms, needles), physical structures (e.g. blighted and abandoned housing, lighting, design of social facilities), social structures (policies that facilitate or constrain behaviors such as supervision of youth, and enforcement of alcohol beverage laws); and media messages (messages and images in the broadcast and print media that portray high-risk behaviors as positive and without serious consequences). A new taxonomy not only clarifies the content of preventive interventions but highlights neglected strategies involving individual biological interventions and structural interventions to prevent STD/HIV transmission.

  1. ‘It’s not about money, it’s about my health’: determinants of participation and adherence among women in an HIV-HSV2 prevention trial in Johannesburg, South Africa

    PubMed Central

    MacPhail, Catherine; Delany-Moretlwe, Sinead; Mayaud, Philippe

    2012-01-01

    High levels of adherence in clinical trials are essential for producing accurate intervention efficacy estimates. Adherence to clinical trial products and procedures is dependent on the motivations that drive participants. Data are presented to document reasons for trial participation and adherence to daily aciclovir for HSV-2 and HIV-1 genital shedding suppression among 300 HIV-1/HSV-2 seropositive women in South Africa. In-depth interviews after exit from the trial with 31 randomly selected women stratified by age and time since HIV diagnosis confirmed high levels of adherence measured during the trial. Main reasons for trial participation were related to seeking high-quality health care, which explains high levels of adherence in both study arms. Concerns that women would abuse reimbursements, fabricate data, and share or dump pills were not corroborated. Altruism is not a primary motivator in these settings where access to quality services is an issue. This study provides further evidence that good adherence of daily medication is possible in developing countries, particularly where study activities resonate with participants or fill an unmet need. PMID:22936844

  2. Preventing HIV transmission in "priority" countries.

    PubMed

    Finger, W R

    1993-05-01

    A recent $168 million 5-year cooperative agreement funded by the US Agency for International Development combines elements of its earlier AIDSTECH and AIDSCOM projects under the AIDS Control and Prevention Project (AIDSCAP). Instead of working to effect broad-scale behavior change toward the prevention of HIV transmission, AIDSCAP strategically targets locations for condom distribution, behavior change messages, and the treatment of sexually transmitted diseases. In Lagos and the states of Cross River and Jigawa where the AIDS epidemic is firmly established, for example, AIDSCAP is intervening to increase condom demand and accessibility; alter sexual behaviors which carry a high risk for HIV transmission; and reduce the prevalence of STDs which enhance the transmission of HIV. The project began in fall of 1991 and has expanded to include Ethiopia, Kenya, Malawi, Nigeria, Rwanda, Senegal, Brazil, Haiti, Jamaica, India, and Thailand; limited assistance is also provided to 7 other African countries, 4 Latin America countries, and 1 in Asia. 4 more countries are in the final stages of negotiations to be included in the project. The USAID mission in the host country and the government must invite AIDSCAP involvement in order for the country to attain priority status. Countries are selected based on the HIV prevalence rate, population size and distribution, level of commitment to HIV prevention/control, capacity to respond to the AIDSCAP plan of action, level of other donor support, the USAID Mission's development priorities, and the Mission's commitment of substantial funds from its own budget. Once involved, AIDSCAP is mandated to implement interventions through in-country agencies. PMID:12344871

  3. The couple approach to HIV / AIDS prevention.

    PubMed

    Alvarez, R O

    1995-01-01

    In 1995, the Philippine Overseas Employment Administration reported that there were 360,000 documented contract workers deployed to various international destinations, 33.1% of whom were sea-based contract workers. It is accepted in Philippine society that seamen stationed abroad for several months remain sexually active. They often have unprotected sexual intercourse with several male and female sex partners, exposing themselves and their partners to the risk of acquiring sexually transmitted infections. The Department of Health has therefore given some priority to involve overseas workers in AIDS education efforts. Seamen, in particular, have been found to engage in high-risk behaviors based upon the recognized routes of HIV transmission. The ISSA developed and implemented a project to address the HIV/AIDS education needs of this group of men and their partners. ISSA's HIV/AIDS Education and Prevention project used the couple approach in its activities, noting that couples and partners must work together to practice safer sex measures. The project involved 60 seamen and 60 women who were either wives or girlfriends of the seamen; more than half of the participants were husband-wife couples. The project functioned upon the premise that both partners have to be well-informed about HIV/AIDS in order to practice effective prevention measures.

  4. PrEP as Peri-conception HIV Prevention for Women and Men.

    PubMed

    Heffron, Renee; Pintye, Jillian; Matthews, Lynn T; Weber, Shannon; Mugo, Nelly

    2016-06-01

    Daily oral tenofovir (TDF)-based pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy and recommended for men and women with substantial risk of HIV acquisition. The peri-conception period, the stage prior to pregnancy when condom use is necessarily reduced, has elevated HIV risk that can be mitigated by PrEP use. Data from a randomized trial suggest that peri-conception PrEP use by HIV-seronegative women does not increase the risk of pregnancy loss, birth defects or congenital anomalies, preterm birth, or infant growth faltering. Women considering PrEP use throughout pregnancy must weigh the known increased risk of HIV acquisition with unknown risks of drug effects on infant growth. PrEP has been used safely by HIV-seronegative men with HIV-seropositive female partners who have become pregnant. As an effective user-controlled HIV prevention strategy, PrEP offers autonomy and empowerment for HIV prevention and can be recommended alongside antiretroviral therapy, fertility screening, vaginal self-insemination, intercourse timed to peak fertility, medically assisted reproduction, and other safer conception strategies to provide multiple options. The integration of PrEP into safer conception programs is warranted and will safely reduce HIV transmission to women, men, and children during the peri-conception period.

  5. Prevention of HIV/AIDS Education in Rural Communities II.

    ERIC Educational Resources Information Center

    Torabi, Mohammad R., Ed.

    1997-01-01

    This second special issue of the Health Education Monograph Series on HIV/AIDS Prevention in Rural Communities presents seven articles: (1) "Preventing Maternal-Infant Transmission of HIV: Social and Ethical Issues" (James G. Anderson, Marilyn M. Anderson, and Tara Booth); (2) "HIV Infection in Diverse Rural Population: Migrant Farm Workers in…

  6. Engaging local businesses in HIV prevention efforts: the consumer perspective.

    PubMed

    Phillips-Guzman, Christina M; Martinez-Donate, Ana P; Hovell, Melbourne F; Blumberg, Elaine J; Sipan, Carol L; Rovniak, Liza S; Kelley, Norma J

    2011-07-01

    Participation of different community sectors, including the private business sector, is necessary to fight the HIV/AIDS epidemic. Local businesses may be reluctant to participate in HIV prevention because of fear of negative customer reactions and loss of revenue. This study examines the extent to which residents of two communities in San Diego, California, would support HIV prevention initiatives in local businesses. A population-based household survey (N = 200) is conducted in two communities with higher versus lower risk for HIV. The survey includes questions regarding the acceptability of HIV prevention activities, such as condom and brochure distribution in businesses, and history of exposure to HIV prevention activities in local businesses. Most residents agree that (a) business involvement in prevention activities would reduce HIV (92%), (b) free or low-cost condoms available in businesses could prevent the spread of HIV (90.9%) and increase condom accessibility (87%), and (c) they would prefer to shop at businesses that supported HIV prevention versus those that did not (87.4%). These findings suggest that HIV prevention in local businesses would be supported by residents and would be unlikely to adversely affect business profits. This information could be used to design interventions to engage local businesses in HIV-prevention efforts.

  7. Pharmacological considerations for tenofovir and emtricitabine to prevent HIV infection

    PubMed Central

    Anderson, Peter L.; Kiser, Jennifer J.; Gardner, Edward M.; Rower, Joseph E.; Meditz, Amie; Grant, Robert M.

    2011-01-01

    The use of antiretroviral medications in HIV-negative individuals as pre-exposure prophylaxis (PrEP) is a promising approach to prevent HIV infection. Tenofovir disoproxil fumarate (TDF) and emtricitabine exhibit desirable properties for PrEP including: favourable pharmacokinetics that support infrequent dosing; few major drug-drug or drug-food interactions; an excellent clinical safety record; and pre-clinical evidence for efficacy. Several large, randomized, controlled clinical trials are evaluating the safety and efficacy of TDF and emtricitabine for this new indication. A thorough understanding of variability in drug response will help determine future investigations in the field and/or implementation into clinical care. Because tenofovir and emtricitabine are nucleos(t)ide analogues, the HIV prevention and toxicity effects depend on the triphosphate analogue formed intracellularly. This review identifies important cellular pharmacology considerations for tenofovir and emtricitabine, which include drug penetration into relevant tissues and cell types, race/ethnicity/pharmacogenetics, gender, cellular activation state and appropriate episodic or alternative dosing strategies based on pharmacokinetic principles. The current state of knowledge in these areas is summarized and the future utility of intracellular pharmacokinetics/pharmacodynamics for the PrEP field is discussed. PMID:21118913

  8. Responsibility for HIV prevention: patterns of attribution among HIV-seropositive gay and bisexual men.

    PubMed

    Offer, Claudine; Grinstead, Olga; Goldstein, Ellen; Mamary, Edward; Alvarado, Nicholas; Euren, Jason; Woods, William J

    2007-02-01

    The Seroconversion Narratives for AIDS Prevention (SNAP) study elicited narratives from recently infected seropositive gay and bisexual men that described the circumstances of their own seroconversion. This analysis of the narratives explored participants' attributions of responsibility for HIV prevention before and after they became infected. Before becoming infected with HIV, responsibility for prevention was often attributed to HIV-negative individuals themselves. These retrospective attributions revealed themes that included feelings of negligence, a sense of consequences, followed by regret. After seroconversion, responsibility for HIV prevention was primarily attributed to HIV-positive individuals themselves. Themes within these attributions included pledges to avoid HIV transmission, a strong sense of burden related to the possibility of infecting someone, and risk reduction strategies that they implemented in an attempt to avoid HIV transmission. Greater understanding of ideas related to responsibility has the potential to increase the effectiveness of HIV prevention interventions. PMID:17411387

  9. Planning for pre-exposure prophylaxis to prevent HIV transmission: challenges and opportunities

    PubMed Central

    2010-01-01

    There are currently several ongoing or planned trials evaluating the efficacy of pre-exposure prophylaxis (PrEP) as a preventative approach to reducing the transmission of HIV. PrEP may prove ineffective, demonstrate partial efficacy, or show high efficacy and have the potential to reduce HIV infection in a significant way. However, in addition to the trial results, it is important that issues related to delivery, implementation and further research are also discussed. As a part of the ongoing discussion, in June 2009, the Bill & Melinda Gates Foundation sponsored a Planning for PrEP conference with stakeholders to review expected trial results, outline responsible educational approaches, and develop potential delivery and implementation strategies. The conference reinforced the need for continued and sustained dialogue to identify where PrEP implementation may fit best within an integrated HIV prevention package. This paper identifies the key action points that emerged from the Planning for PrEP meeting. PMID:20624303

  10. Choosing Alzheimer's disease prevention clinical trial populations.

    PubMed

    Grill, Joshua D; Monsell, Sarah E

    2014-03-01

    To assist investigators in making design choices, we modeled Alzheimer's disease prevention clinical trials. We used longitudinal Clinical Dementia Rating Scale Sum of Boxes data, retention rates, and the proportions of trial-eligible cognitively normal participants age 65 and older in the National Alzheimer's Coordinating Center Uniform Data Set to model trial sample sizes, the numbers needed to enroll to account for drop out, and the numbers needed to screen to successfully complete enrollment. We examined how enrichment strategies affected each component of the model. Relative to trials enrolling 65-year-old individuals, trials enriching for older (minimum 70 or 75) age required reduced sample sizes, numbers needed to enroll, and numbers needed to screen. Enriching for subjective memory complaints reduced sample sizes and numbers needed to enroll more than age enrichment, but increased the number needed to screen. We conclude that Alzheimer's disease prevention trials can enroll elderly participants with minimal effect on trial retention and that enriching for older individuals with memory complaints might afford efficient trial designs.

  11. HIV treatment as prevention: how scientific discovery occurred and translated rapidly into policy for the global response.

    PubMed

    Cohen, Myron S; Holmes, Charles; Padian, Nancy; Wolf, Megan; Hirnschall, Gottfried; Lo, Ying-Ru; Goosby, Eric

    2012-07-01

    In 2011 interim results of HIV Prevention Trials Network study 052, a National Institutes of Health study designed to test the effectiveness of antiretroviral treatment against the spread of HIV, were reported. These results showed that in a stable relationship in which one member of the couple was infected with HIV, treatment of the infected partner with antiretroviral drugs, combined with couples counseling and condom use, resulted in a 96 percent reduction in sexual transmission of HIV-1. This finding led to the use of antiretroviral treatment as a cornerstone of HIV prevention. Independent advisory committees of the President's Emergency Plan for AIDS Relief (PEPFAR) and the World Health Organization (WHO) have since issued analyses that set the stage for broader use of antiretroviral agents in treatment and prevention. This article describes the separate PEPFAR and WHO recommendations and outlines the design of prospective new trials to test how best to maximize the benefits of early treatment for prevention. PMID:22778333

  12. Placing contraception at the centre of the HIV prevention agenda.

    PubMed

    Crankshaw, Tamaryn L; Smit, Jennifer A; Beksinska, Mags E

    2016-07-01

    Over the past decade, the global response to the HIV epidemic has been unprecedented, and enormous progress has been made. Significant investment in the roll out of antiretroviral treatment (ART) and efforts to increase treatment coverage have greatly reduced the number of AIDS-related deaths worldwide. There are a growing number of promising innovations to expand the HIV prevention mix. However, the reach of these interventions is still very limited in adolescent girls and young women (15-24 years) and the full realisation of the intervention mandates has not yet been achieved. The HIV prevention field has been criticised for the tendency to adopt a narrow focus. The Fast-Track Strategy offers a unique opportunity for the HIV prevention field to broaden its gaze and to begin to identify synergies (and efficiencies) with prevention approaches from other global development priorities, namely sexual and reproductive health and rights (SRHR). This paper applies a SRHR lens to HIV prevention by highlighting the critical relationship between unintended pregnancy and HIV, and seeks to expand on earlier debates that prevention of HIV and prevention of unintended pregnancy are inextricably linked, complementary activities with interrelated and common goals. We call for the prioritisation of prevention of unintended pregnancy amongst two overlapping population groups - girls and young women (15-24 years old) and women living with HIV - as a key tactic to accomplish the Joint United Nations Programme on HIV/AIDS (UNAIDS) Fast-Track Strategy and as a way to fully realise existing HIV prevention efforts. We discuss the intersecting pathways between HIV prevention and unintended pregnancy prevention and build a case for contraception to be placed at the centre of the HIV prevention agenda. PMID:27399045

  13. Major Trials | Division of Cancer Prevention

    Cancer.gov

    The studies listed below represent the first major clinical trials to evaluate risk reduction for people at high risk of breast, prostate, lung, colorectal, ovarian, cervical, and lung cancer. Analysis of the data gathered from these large trials continues to contribute valuable understanding about related issues, including screening, patient-reported symptoms, quality of life, nutrient impact, population/ethnicity differences, study design and implementation, and many others.  | Information on landmark clinical trials that evaluated cancer prevention interventions and cancer screening tests.

  14. Antiretroviral Therapy as HIV Prevention: Status and Prospects

    PubMed Central

    Venkatesh, Kartik K.

    2010-01-01

    As antiretroviral treatment of HIV infection has become increasingly accessible, attention has focused on whether these drugs can used for prevention because of increased tolerability of newer medications, decreased cost, and the limitations of other approaches. We review the status of antiretroviral HIV prevention, including chemoprophylaxis, as well as the effects of treatment of infected individuals on prevention. It is possible that the life-saving agents that have transformed the natural history of AIDS can be a critical component of HIV prevention efforts, but their ultimate role in affecting HIV transmission dynamics remains to be defined. PMID:20724682

  15. Effects of a Health Behavior Change Model-Based HIV/STI Prevention Intervention on Condom Use among Heterosexual Couples: A Randomized Trial

    ERIC Educational Resources Information Center

    Harvey, S. Marie; Kraft, Joan Marie; West, Stephen G.; Taylor, Aaron B.; Pappas-DeLuca, Katina A.; Beckman, Linda J.

    2009-01-01

    This study examines an intervention for heterosexual couples to prevent human immunodeficiency virus/sexually transmitted infections. It also evaluates the effect of the intervention, which is based on current models of health behavior change, on intermediate outcomes (individual and relationship factors) and consistency of condom use. Eligible…

  16. Effects of an HIV peer prevention intervention on sexual and injecting risk behaviors among injecting drug users and their risk partners in Thai Nguyen, Vietnam: a randomized controlled trial.

    PubMed

    Go, Vivian F; Frangakis, Constantine; Le Minh, Nguyen; Latkin, Carl A; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy; Zelaya, Carla; Vu, Pham The; Chen, Yong; Celentano, David D; Quan, Vu Minh

    2013-11-01

    Globally, 30% of new HIV infections outside sub-Saharan Africa involve injecting drug users (IDU) and in many countries, including Vietnam, HIV epidemics are concentrated among IDU. We conducted a randomized controlled trial in Thai Nguyen, Vietnam, to evaluate whether a peer oriented behavioral intervention could reduce injecting and sexual HIV risk behaviors among IDU and their network members. 419 HIV-negative index IDU aged 18 years or older and 516 injecting and sexual network members were enrolled. Each index participant was randomly assigned to receive a series of six small group peer educator-training sessions and three booster sessions in addition to HIV testing and counseling (HTC) (intervention; n = 210) or HTC only (control; n = 209). Follow-up, including HTC, was conducted at 3, 6, 9 and 12 months post-intervention. The proportion of unprotected sex dropped significantly from 49% to 27% (SE (difference) = 3%, p < 0.01) between baseline and the 3-month visit among all index-network member pairs. However, at 12 months, post-intervention, intervention participants had a 14% greater decline in unprotected sex relative to control participants (Wald test = 10.8, df = 4, p = 0.03). This intervention effect is explained by trial participants assigned to the control arm who missed at least one standardized HTC session during follow-up and subsequently reported increased unprotected sex. The proportion of observed needle/syringe sharing dropped significantly between baseline and the 3-month visit (14% vs. 3%, SE (difference) = 2%, p < 0.01) and persisted until 12 months, but there was no difference across trial arms (Wald test = 3.74, df = 3, p = 0.44).

  17. Antiretroviral therapy for prevention of HIV transmission in HIV-discordant couples

    PubMed Central

    Anglemyer, Andrew; Rutherford, George W; Horvath, Tara; Baggaley, Rachel C; Egger, Matthias; Siegfried, Nandi

    2014-01-01

    Background Antiretroviral drugs have been shown to reduce risk of mother-to-child transmission of human immunodeficiency virus (HIV) and are also widely used for post-exposure prophylaxis for parenteral and sexual exposures. Sexual transmission may be lower in couples in which one partner is infected with HIV and the other is not and the infected partner is on antiretroviral therapy (ART). Objectives To determine if ART use in an HIV-infected member of an HIV-discordant couple is associated with lower risk of HIV transmission to the uninfected partner compared to untreated discordant couples. Search methods We used standard Cochrane methods to search electronic databases and conference proceedings with relevant search terms without limits to language. Selection criteria Randomised controlled trials (RCT), cohort studies and case-control studies of HIV-discordant couples in which the HIV-infected member of the couple was being treated or not treated with ART Data collection and analysis Abstracts of all trials identified by electronic or bibliographic scanning were examined independently by two authors. We initially identified 3,833 references and examined 87 in detail for study eligibility. Data were abstracted independently using a standardised abstraction form. Main results One RCT and nine observational studies were included in the review. These ten studies identified 2,112 episodes of HIV transmission, 1,016 among treated couples and 1,096 among untreated couples. The rate ratio for the single randomised controlled trial was 0.04 [95% CI 0.00, 0.27]. All index partners in this study had CD4 cell counts at baseline of 350–550 cells/µL. Similarly, the summary rate ratio for the nine observational studies was 0.58 [95% CI 0.35, 0.96], with substantial heterogeneity (I2=64%). After excluding two studies with inadequate person-time data, we estimated a summary rate ratio of 0.36 [95%CI 0.17, 0.75] with substantial heterogeneity (I2=62%). We also performed

  18. Prevention of atherosclerosis in patients living with HIV

    PubMed Central

    De Lorenzo, Ferruccio; Boffito, Marta; Collot-Teixeira, Sophie; Gazzard, Brian; McGregor, John L; Shotliff, Kevin; Xiao, Han

    2009-01-01

    Investigational product: Rosuvastatin (Crestor®; Astra Zeneca). Active ingredients: Rosuvastatin (5 mg). Study title: Prevention of Atherosclerosis in Patients Living with HIV. Phase of study: Phase III. Aims: Primary aim: To assess whether rosuvastatin therapy could slow the progression of the carotid intima-media thickness (C-IMT; as measured by the change in the mean IMT of the near and far walls of the distal common carotid arteries) over 2 years in HIV-infected patients (HIV-IP). Secondary aims: To assess whether rosuvastatin therapy could reduce highly sensitive C reactive protein (hs-CRP) inflammatory marker that is increased in HIV-IP.To assess the effect of rosuvastatin therapy on serum lipid levels (total cholesterol [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol and triglycerides [TG]) and apolipoproteins (APO A1, APO B and APO B/A1).To assess the safety of rosuvastatin in HIV-IP through the evaluation of clinical laboratory analyses (liver function tests and creatine kinase) and adverse events (AEs). Study design: Two-year randomized, double-blind, placebo-controlled, parallel group study. Planned sample size: 320 HIV-IP. Summary of eligibility criteria: HIV-IP who are aged between 30 and 60 years, with a CD4 count. greater than 200 cells/mm3. Patients must be stable on combination antiretroviral therapy (cART) for at least 12 months and have a 10-year CVD risk of less than 20% (using the Framingham risk score). Number of study centers: One. Duration of treatment: Two years (5 mg rosuvastatin or placebo once daily). Dose and route of administration: Oral rosuvastatin (5 mg) once daily. The incidence of cardiovascular disease (CVD) in HIV-IP is at least three times higher than in the general population and further increases each year with combination anti-retroviral therapy (cART). The carotid atherosclerosis progression rate is 10 times higher in HIV-IP than in uninfected individuals. The aim of this study

  19. Reputationally Strong HIV Prevention Programs: Lessons from the Front Line

    ERIC Educational Resources Information Center

    Eke, Agatha N.; Mezoff, Jane S.; Duncan, Ted; Sogolow, Ellen D.

    2006-01-01

    Although HIV prevention researchers have conducted numerous controlled outcome studies to evaluate the effectiveness of theory-based interventions aimed at reducing HIV risk behaviors, many HIV risk reduction interventions are conducted not by researchers but by staff in local health departments or community-based organizations (CBOs). Despite…

  20. Efficacy of a Preventive Intervention for Youths Living with HIV.

    ERIC Educational Resources Information Center

    Rotheram-Borus, Mary Jane; Lee, Martha B.; Murphy, Debra A.; Futterman, Donna; Duan, Naihua; Birnbaum, Jeffrey M.; Lightfoot, Marguerita

    2001-01-01

    Examined HIV transmission behaviors and health practices among HIV-infected youths over 15 months following participation in a preventive intervention that emphasized coping with HIV and reducing risky behaviors. The intervention resulted in increases in social support coping and reductions in risky sexual and lifestyle behaviors specifically…

  1. South African HIV-1 vaccine candidates - the journey from the bench to clinical trials.

    PubMed

    Williamson, Anna-Lise; Rybiki, Ed; Shephard, Enid; Gray, Glenda; Bekker, Linda-Gail; Downing, Katrina; Williamson, Carolyn

    2012-06-01

    Around 2.5 million people become infected with human immunodeficiency virus (HIV) each year. This extraordinary toll in human life and public health worldwide will only be reversed with effective prevention. Vaccination is regarded as the most effective way to prevent infectious disease. However, there are many challenges to overcome before a successful prophylactic HIV vaccine will be available. We are participating in a global effort to develop and test candidate HIV vaccines. Two candidate prophylactic HIV vaccines that were designed and developed at the University of Cape Town (UCT) entered phase 1 clinical trials in the USA and South Africa in 2009, after a 9-year development period. In addition to the vaccines in clinical trial, there is a pipeline of candidate HIV-1 subtype C vaccines including virus-like particles, novel DNA vaccines, capripoxvirus and Bacillus Calmette-Guérin (BCG)-vectored vaccines. This article describes the history of HIV vaccine research at UCT, and the partnerships that made the project possible.

  2. Prevention for positives: challenges and opportunities for integrating prevention into HIV case management.

    PubMed

    Mitchell, C G; Linsk, N L

    2001-10-01

    Despite nearly 20 years of HIV prevention efforts, rates of new HIV infection persist at an alarming rate. As successful antiretroviral medications enable many HIV infected persons to live longer, healthier lives, interventions are necessary to support ongoing prevention and reduced risk behaviors. This article describes a survey that was used to assess the opportunities and challenges related to the integration of prevention screening into the work of HIV/AIDS case managers. The article describes the survey, reports the findings (N = 101), and concludes with a discussion of issues that must be addressed prior to incorporating prevention screening into HIV/AIDS case management.

  3. Engaging Transgender People in NIH-Funded HIV/AIDS Clinical Trials Research.

    PubMed

    Siskind, Rona L; Andrasik, Michele; Karuna, Shelly T; Broder, Gail B; Collins, Clare; Liu, Albert; Lucas, Jonathan Paul; Harper, Gary W; Renzullo, Philip O

    2016-08-15

    In 2009, the National Institutes of Health recognized the need to expand knowledge of lesbian, gay, bisexual, and transgender (LGBT) health and commissioned the Institute of Medicine to report on the health of these populations in the United States. The resulting Institute of Medicine publication called for more knowledge of the health of LGBT populations, as well as improved methodologies to reach them, more LGBT-focused research, and enhanced training programs and cultural competency of physicians and researchers. Several of the National Institutes of Health-funded HIV/AIDS clinical trials networks, including the Adolescent Medicine Trials Network for HIV/AIDS Interventions, HIV Prevention Trials Network, HIV Vaccine Trials Network, and Microbicide Trials Network, have focused attention on engaging transgender (TG) individuals in research. They have identified issues that transcend the nature of research (ie, treatment or prevention, adult or adolescent) and have adopted various approaches to effectively engage the TG community. Each network has recognized the importance of developing partnerships to build trust with and seek input from TG individuals on research plans and policies. They have established standing advisory groups and convened consultations for this purpose. To ensure that trial data are reflective of the participants they are seeking to enroll, they have reviewed and revised data collection forms to incorporate the 2-step method of collecting sex at birth and gender identity as 2 independent variables, and some have also revised research protocol templates and policies for concept development to ensure that they are appropriate for the inclusion of TG participants. The networks have also initiated trainings to enhance cultural sensitivity and developed a range of materials and resources for network and clinical research site staff. They continue to identify TG-specific research needs in an effort to be more responsive to and improve the health of

  4. Engaging Transgender People in NIH-Funded HIV/AIDS Clinical Trials Research

    PubMed Central

    Andrasik, Michele; Karuna, Shelly T.; Broder, Gail B.; Collins, Clare; Liu, Albert; Lucas, Jonathan Paul; Harper, Gary W.; Renzullo, Philip O.

    2016-01-01

    Abstract: In 2009, the National Institutes of Health recognized the need to expand knowledge of lesbian, gay, bisexual, and transgender (LGBT) health and commissioned the Institute of Medicine to report on the health of these populations in the United States. The resulting Institute of Medicine publication called for more knowledge of the health of LGBT populations, as well as improved methodologies to reach them, more LGBT-focused research, and enhanced training programs and cultural competency of physicians and researchers. Several of the National Institutes of Health–funded HIV/AIDS clinical trials networks, including the Adolescent Medicine Trials Network for HIV/AIDS Interventions, HIV Prevention Trials Network, HIV Vaccine Trials Network, and Microbicide Trials Network, have focused attention on engaging transgender (TG) individuals in research. They have identified issues that transcend the nature of research (ie, treatment or prevention, adult or adolescent) and have adopted various approaches to effectively engage the TG community. Each network has recognized the importance of developing partnerships to build trust with and seek input from TG individuals on research plans and policies. They have established standing advisory groups and convened consultations for this purpose. To ensure that trial data are reflective of the participants they are seeking to enroll, they have reviewed and revised data collection forms to incorporate the 2-step method of collecting sex at birth and gender identity as 2 independent variables, and some have also revised research protocol templates and policies for concept development to ensure that they are appropriate for the inclusion of TG participants. The networks have also initiated trainings to enhance cultural sensitivity and developed a range of materials and resources for network and clinical research site staff. They continue to identify TG-specific research needs in an effort to be more responsive to and improve

  5. Is participation in HIV vaccine trials a health promoting behaviour?

    PubMed

    Kafaar, Z; Kagee, A; Lesch, A; Swartz, L

    2007-11-01

    Health behaviours are individual acts by which people aim to preserve or enhance their health. Theories commonly used to understand health behaviour include the Health Belief Model, the Theories of Reasoned Action and Planned Behaviour, the Transtheoretical Model of Change, Social Cognitive Theory and Problem-Behaviour Theory. Targets for health-promotion interventions include exercise, smoking cessation and condom use. Some behaviours that may contribute to changes in population health, however, are not health behaviours as traditionally understood. For example, participating in an HIV vaccine trial may have the potential to contribute long-term to lowering HIV incidence. To what extent, though, can or should we apply models of health behaviour to HIV vaccine trial participation? This article grapples with the theoretical challenges facing social scientists who conduct research related to HIV vaccine trial participation. We initially consider decision making regarding trial participation from both the participant and investigator perspectives, before considering how these alternate decision-making narratives might impact on the conduct of HIV vaccine trials. We conclude by arguing that social scientists need to move beyond a narrow focus on health promotion theory and to engage in the interrelated scientific activities of theory testing and theory building.

  6. Personalized Biobehavioral HIV Prevention for Women and Adolescent Girls

    PubMed Central

    Teitelman, Anne M.; Bevilacqua, Amanda W.; Jemmott, Loretta Sweet

    2013-01-01

    Background: Women and adolescent girls bear a significant burden of the global HIV pandemic. Both behavioral and biomedical prevention approaches have been shown to be effective. In order to foster the most effective combination HIV-prevention approaches for women and girls, it is imperative to understand the unique biological, social, and structural considerations that increase vulnerability to acquiring HIV within this population. Primary Study Objective: The purpose of this article is to propose novel ideas for personalized biobehavioral HIV prevention for women and adolescent girls. The central argument is that we must transcend unilevel solutions for HIV prevention toward comprehensive, multilevel combination HIV prevention packages to actualize personalized biobehavioral HIV prevention. Our hope is to foster transnational dialogue among researchers, practitioners, educators, and policy makers toward the actualization of the proposed recommendations. Methods: We present a commentary organized to review biological, social, and structural factors that increase vulnerability to HIV acquisition among women and adolescent girls. The overview is followed by recommendations to curb HIV rates in the target population in a sustainable manner. Results: The physiology of the lower female reproductive system biologically increases HIV risk among women and girls. Social (eg, intimate partner violence) and structural (eg, gender inequality) factors exacerbate this risk by increasing the likelihood of viral exposure. Our recommendations for personalized biobehavioral HIV prevention are to (1) create innovative mechanisms for personalized HIV risk—reduction assessments; (2) develop mathematical models of local epidemics; (3) prepare personalized, evidence-based combination HIV risk—reduction packages; (4) structure gender equity into society; and (5) eliminate violence (both physical and structural) against women and girls. Conclusions: Generalized programs and

  7. Chemoprophylaxis for HIV Prevention: New Opportunities and New Questions

    PubMed Central

    Mayer, Kenneth H.; Venkatesh, Kartik K.

    2010-01-01

    Growing data suggest that antiretrovirals can be used as an effective means of HIV prevention. This paper reviews the current status and future clinical prospects of utilizing antiretroviral chemoprophylaxis before and after high-risk HIV exposure to prevent HIV transmission. The discussion about using antiretrovirals as a means of primary HIV prevention has moved to the forefront of public health discourse because of a growing evidence base, the increased tolerability of the medications, the decreased cost, the ever expanding formulary, and the limitations of other approaches. PMID:21406981

  8. Transactional sex and prevalence of STIs: a cross-sectional study of MSM and transwomen screened for an HIV prevention trial

    PubMed Central

    Solomon, Marc M; Nureña, César R; Tanur, Judith M; Montoya, Orlando; Grant, Robert M; McConnell, J Jeff

    2015-01-01

    Introduction Few studies have characterised the degree of engagement in transactional sex among men and trans-gender women who have sex with men and explored its association with sexually transmitted infections and human immunodeficiency virus in Ecuador. Method We screened 642 men who have sex with men and transgender women for a pre-exposure prophylaxis clinical trial (iPrEx) in Guayaquil, Ecuador, 2007–2009. We analysed the association of degree of engagement in transactional sex and prevalence of sexually transmitted infections including human immunodeficiency virus using chi-square and analysis of variance tests. Results Although just 6.2% of those who screened self-identified as sex workers, 52.1% reported having engaged in transactional sex. Compared to those who had never been paid for sex, those who had been paid were more likely to have a sexually transmitted infection (56.6% vs. 45.0%, p =0.007) and trended towards a higher human immunodeficiency virus prevalence (16.6% vs. 10.4%, p =0.082) at screening. Transgender women compared to other men who have sex with men were more likely to have sexually transmitted infections diagnosed at screening (75.6% vs. 50.0%, p =0.001). Discussion Transactional sex is practiced widely but occasionally among the men who have sex with men and trans-gender women in Guayaquil who screened for the iPrEx study; however, engaging in transactional sex may not lead to a sex worker self-identification. Both transactional sex and being a transgender woman are associated with sexually transmitted infections prevalence. PMID:25520017

  9. Transactional sex and prevalence of STIs: a cross-sectional study of MSM and transwomen screened for an HIV prevention trial.

    PubMed

    Solomon, Marc M; Nureña, César R; Tanur, Judith M; Montoya, Orlando; Grant, Robert M; McConnell, J Jeff

    2015-10-01

    Few studies have characterised the degree of engagement in transactional sex among men and transgender women who have sex with men and explored its association with sexually transmitted infections and human immunodeficiency virus in Ecuador. We screened 642 men who have sex with men and transgender women for a pre-exposure prophylaxis clinical trial (iPrEx) in Guayaquil, Ecuador, 2007-2009. We analysed the association of degree of engagement in transactional sex and prevalence of sexually transmitted infections including human immunodeficiency virus using chi-square and analysis of variance tests. Although just 6.2% of those who screened self-identified as sex workers, 52.1% reported having engaged in transactional sex. Compared to those who had never been paid for sex, those who had been paid were more likely to have a sexually transmitted infection (56.6% vs. 45.0%, p = 0.007) and trended towards a higher human immunodeficiency virus prevalence (16.6% vs. 10.4%, p = 0.082) at screening. Transgender women compared to other men who have sex with men were more likely to have sexually transmitted infections diagnosed at screening (75.6% vs. 50.0%, p = 0.001). Transactional sex is practiced widely but occasionally among the men who have sex with men and transgender women in Guayaquil who screened for the iPrEx study; however, engaging in transactional sex may not lead to a sex worker self-identification. Both transactional sex and being a transgender woman are associated with sexually transmitted infections prevalence.

  10. EFFECT OF HIV PREVENTION AND TREATMENT PROGRAM ON HIV AND HCV TRANSMISSION AND HIV MORTALITY AT AN INDONESIAN NARCOTIC PRISON.

    PubMed

    Nelwan, Erni J; Indrati, Agnes K; Isa, Ahmad; Triani, Nurlita; Alam, Nisaa Nur; Herlan, Maria S; Husen, Wahid; Pohan, Herdiman T; Alisjahbana, Bachti; Meheus, Andre; Van Crevel, Reinout; van der Ven, Andre Jam

    2015-09-01

    Validated data regarding HIV-transmission in prisons in developing countries is scarce. We examined sexual and injecting drug use behavior and HIV and HCV transmission in an Indonesian narcotic prison during the implementation of an HIV prevention and treatment program during 2004-2007 when the Banceuy Narcotic Prison in Indonesia conducted an HIV transmission prevention program to provide 1) HIV education, 2) voluntary HIV testing and counseling, 3) condom supply, 4) prevention of rape and sexual violence, 5) antiretroviral treatment for HIV-positive prisoners and 6) methadone maintenance treatment. During a first survey that was conducted between 2007 and 2009, new prisoners entered Banceuy Narcotics Prison were voluntary tested for HIV and HCV-infection after written informed consent was obtained. Information regarding sexual and injecting risk behavior and physical status were also recorded at admission to the prison. Participants who tested negative for both HIV and HCV during the first survey were included in a second survey conducted during 2008-2011. During both surveys, data on mortality among HIV-seropositive patients were also recorded. All HIV-seropositive participants receive treatment for HIV. HIV/ AIDS-related deaths decreased: 43% in 2006, 18% in 2007, 9% in 2008 and 0% in 2009. No HIV and HCV seroconversion inside Banceuy Narcotic Prison were found after a median of 23 months imprisonment (maximum follow-up: 38 months). Total of 484.8 person-years observation was done. Participants reported HIV transmission risk-behavior in Banceuy Prison during the second survey was low. After implementation of HIV prevention and treatment program, no new HIV or HCV cases were detected and HIV-related mortality decreased. PMID:26863859

  11. EFFECT OF HIV PREVENTION AND TREATMENT PROGRAM ON HIV AND HCV TRANSMISSION AND HIV MORTALITY AT AN INDONESIAN NARCOTIC PRISON.

    PubMed

    Nelwan, Erni J; Indrati, Agnes K; Isa, Ahmad; Triani, Nurlita; Alam, Nisaa Nur; Herlan, Maria S; Husen, Wahid; Pohan, Herdiman T; Alisjahbana, Bachti; Meheus, Andre; Van Crevel, Reinout; van der Ven, Andre Jam

    2015-09-01

    Validated data regarding HIV-transmission in prisons in developing countries is scarce. We examined sexual and injecting drug use behavior and HIV and HCV transmission in an Indonesian narcotic prison during the implementation of an HIV prevention and treatment program during 2004-2007 when the Banceuy Narcotic Prison in Indonesia conducted an HIV transmission prevention program to provide 1) HIV education, 2) voluntary HIV testing and counseling, 3) condom supply, 4) prevention of rape and sexual violence, 5) antiretroviral treatment for HIV-positive prisoners and 6) methadone maintenance treatment. During a first survey that was conducted between 2007 and 2009, new prisoners entered Banceuy Narcotics Prison were voluntary tested for HIV and HCV-infection after written informed consent was obtained. Information regarding sexual and injecting risk behavior and physical status were also recorded at admission to the prison. Participants who tested negative for both HIV and HCV during the first survey were included in a second survey conducted during 2008-2011. During both surveys, data on mortality among HIV-seropositive patients were also recorded. All HIV-seropositive participants receive treatment for HIV. HIV/ AIDS-related deaths decreased: 43% in 2006, 18% in 2007, 9% in 2008 and 0% in 2009. No HIV and HCV seroconversion inside Banceuy Narcotic Prison were found after a median of 23 months imprisonment (maximum follow-up: 38 months). Total of 484.8 person-years observation was done. Participants reported HIV transmission risk-behavior in Banceuy Prison during the second survey was low. After implementation of HIV prevention and treatment program, no new HIV or HCV cases were detected and HIV-related mortality decreased.

  12. A "big data" approach to HIV epidemiology and prevention.

    PubMed

    Young, Sean D

    2015-01-01

    The recent availability of "big data" from social media and mobile technologies provides promise for development of new tools and methods to address the HIV epidemic. This manuscript presents recent work in this growing area of bioinformatics, digital epidemiology, and disease modeling, describes how it can be applied to address HIV prevention, and presents issues that need to be addressed prior to implementing a mobile technology big-data approach to HIV prevention. PMID:25449693

  13. Bridging the Divide: HIV Prevention Research and Black Men Who Have Sex With Men

    PubMed Central

    Chandler, Christian; Powell, Borris; Humes, Damon; Wakefield, Steven; Kripke, Katharine; Eckstein, Daniel

    2014-01-01

    Objectives. We obtained contextual information regarding documented barriers to HIV clinical trial participation among Black men who have sex with men (MSM), and explored current preventive HIV clinical trial attitudes, beliefs, and perceptions among Black MSM leaders in the United States. Methods. We conducted 2 focus groups with Black MSM leaders attending an annual African American MSM Leadership Conference on HIV/AIDS. Focus group questions explored biomedical research perceptions and attitudes, barriers to participation in biomedical prevention research, and steps that need to be taken to address these barriers. A feedback and member checking (participants presented with final themes to provide feedback and guidance) session was also held at the 2012 conference. Results. Three distinct themes emerged regarding Black MSM engagement and participation in HIV vaccine research: (1) community-based organizations as true partners, (2) investment in the Black gay community, and (3) true efforts to inform and educate the community. Conclusions. A key focus for improving efforts to engage the Black MSM community in preventive HIV clinical trials is building and maintaining equitable and reciprocal partnerships among research institutions, Black-led AIDS service organizations and community-based organizations, and community members. PMID:24524520

  14. Highly active antiretroviral treatment for the prevention of HIV transmission

    PubMed Central

    2010-01-01

    In 2007 an estimated 33 million people were living with HIV; 67% resided in sub-Saharan Africa, with 35% in eight countries alone. In 2007, there were about 1.4 million HIV-positive tuberculosis cases. Globally, approximately 4 million people had been given highly active antiretroviral therapy (HAART) by the end of 2008, but in 2007, an estimated 6.7 million were still in need of HAART and 2.7 million more became infected with HIV. Although there has been unprecedented investment in confronting HIV/AIDS - the Joint United Nations Programme on HIV/AIDS estimates $13.8 billion was spent in 2008 - a key challenge is how to address the HIV/AIDS epidemic given limited and potentially shrinking resources. Economic disparities may further exacerbate human rights issues and widen the increasingly divergent approaches to HIV prevention, care and treatment. HIV transmission only occurs from people with HIV, and viral load is the single greatest risk factor for all modes of transmission. HAART can lower viral load to nearly undetectable levels. Prevention of mother to child transmission offers proof of the concept of HAART interrupting transmission, and observational studies and previous modelling work support using HAART for prevention. Although knowing one's HIV status is key for prevention efforts, it is not known with certainty when to start HAART. Building on previous modelling work, we used an HIV/AIDS epidemic of South African intensity to explore the impact of testing all adults annually and starting persons on HAART immediately after they are diagnosed as HIV positive. This theoretical strategy would reduce annual HIV incidence and mortality to less than one case per 1000 people within 10 years and it would reduce the prevalence of HIV to less than 1% within 50 years. To explore HAART as a prevention strategy, we recommend further discussions to explore human rights and ethical considerations, clarify research priorities and review feasibility and acceptability

  15. Substance Use and HIV Prevention for Youth in Correctional Facilities

    ERIC Educational Resources Information Center

    Mouttapa, Michele; Watson, Donnie W.; McCuller, William J.; Reiber, Chris; Tsai, Winnie

    2009-01-01

    Evidence-based programs for substance use and HIV prevention (SUHIP) were adapted for high-risk juveniles detained at 24-hour secure correctional facilities. In this pilot study, comparisons were made between adolescents who received the SUHIP intervention and a control group on changes in: (1) knowledge of HIV prevention behaviors, (2) attitudes…

  16. Getting Personal: Progress and Pitfalls in HIV Prevention among Latinas

    ERIC Educational Resources Information Center

    Amaro, Hortensia; Raj, Anita; Reed, Elizabeth; Ulibarri, Monica

    2011-01-01

    This article first presents the political, personal, and epidemiological context of Hortensia Amaro's 1988 publication in "Psychology of Women Quarterly" ("PWQ"), "Considerations for Prevention of HIV Infection Among Hispanic Women" (Amaro, 1988). Second, it provides a brief summary of progress in HIV prevention with Latinas. The third section…

  17. Evaluation of the Positive Prevention HIV/STD Curriculum

    ERIC Educational Resources Information Center

    LaChausse, Robert G.

    2006-01-01

    This study evaluated the effectiveness of Positive Prevention, a theory-based, HIV/STD prevention education curriculum for high school youth. Three hundred fifty-three students participated in a longitudinal experimental design to determine the impact of the curriculum on HIV/AIDS knowledge, self-efficacy to abstain from sex, self-efficacy of…

  18. Making the Connections: Why Literacy Matters for HIV Prevention

    ERIC Educational Resources Information Center

    Medel-Anonuevo, Carolyn; Cheick, Diarra Mahamadou

    2007-01-01

    This issue in the "Literacy Matters" looks at the relationship between literacy and HIV prevention education. It is the result of the UNESCO Institute for Lifelong Learning's work on examining the contribution of non-formal education (NFE) to HIV prevention, carried out in collaboration with the Association for the Development of Education in…

  19. Passing the baton: Community-based ethnography to design a randomized clinical trial on the effectiveness of oral pre-exposure prophylaxis for HIV prevention among Black men who have sex with men.

    PubMed

    Garcia, Jonathan; Colson, Paul W; Parker, Caroline; Hirsch, Jennifer S

    2015-11-01

    Although HIV interventions and clinical trials increasingly report the use of mixed methods, studies have not reported on the process through which ethnographic or qualitative findings are incorporated into RCT designs. We conducted a community-based ethnography on social and structural factors that may affect the acceptance of and adherence to oral pre-exposure prophylaxis (PrEP) among Black men who have sex with men (BMSM). We then devised the treatment arm of an adherence clinical trial drawing on findings from the community-based ethnography. This article describes how ethnographic findings informed the RCT and identifies distilled themes and findings that could be included as part of an RCT. The enhanced intervention includes in-person support groups, online support groups, peer navigation, and text message reminders. By describing key process-related facilitators and barriers to conducting meaningful mixed methods research, we provide important insights for the practice of designing clinical trials for 'real-world' community settings.

  20. Acceptability of HIV vaccine trials in high-risk heterosexual cohorts in Mombasa, Kenya.

    PubMed

    Jackson, D J; Martin, H L; Bwayo, J J; Nyange, P M; Rakwar, J P; Kashonga, F; Mandaliya, K; Ndinya-Achola, J O; Kreiss, J K

    1995-11-01

    The acceptability of a theoretical human immunodeficiency virus (HIV) vaccine trial was investigated in HIV-negative commercial sex workers and trucking company employees in Mombasa, Kenya. The 206 women and 201 men who completed questionnaires were already enrolled in a prospective cohort study of high-risk heterosexuals. 95% of men and 98% of women surveyed agreed that acquired immunodeficiency syndrome (AIDS) is a major problem in Kenya; however, only 14% and 6%, respectively, considered themselves at personal risk of infection. Only 4% of male and 1% of female respondents stated they would refuse an HIV vaccine of proven safety and efficacy. However, 91% of women but only 67% of men indicated they would participate in a double-blind, placebo-controlled vaccine trial that involved vaccine-induced HIV seropositivity and prolonged follow-up. The main concerns about participation in such a trial were the positive HIV blood test result and fear of acquiring HIV from the vaccine. 9% of men and 6% of women anticipated they would decrease their condom use as a result of participation in such a trial, and 9% of men and 3% of women thought they would increase their number of sexual partners. Anticipated higher risk behavior was significantly associated with male gender, but not with age, education, history of prostitution or of sex with prostitutes, or current condom use. If and when vaccine trials become possible, this high-risk cohort would comprise an ideal target population; however, concurrent counseling about the need to continue preventive behavioral measures would be a necessity.

  1. Couples-focused behavioral interventions for prevention of HIV: Systematic review of the state of evidence

    PubMed Central

    Burton, Jennifer; Darbes, Lynae A.; Operario, Don

    2009-01-01

    HIV is frequently transmitted in the context of partners in a committed relationship, thus couples-focused HIV prevention interventions are a potentially promising modality for reducing infection. We conducted a systematic review of studies testing whether couples-focused behavioral prevention interventions reduce HIV transmission and risk behavior. We included studies using randomized controlled trial designs, quasi-randomized controlled trials and nonrandomized controlled studies. We searched five electronic databases and screened 7628 records. Six studies enrolling 1,084 couples met inclusion criteria and were included in this review. Results across studies consistently indicated that couples-focused programs reduced unprotected sexual intercourse and increased condom use compared with control groups. However, studies were heterogeneous in population, type of intervention, comparison groups, and outcomes measures, and so meta-analysis to calculate pooled effects was inappropriate. Although couples-based approaches to HIV prevention appear initially promising, additional research is necessary to build a stronger theoretical and methodological basis for couples-based HIV prevention, and future interventions must pay closer attention to homosexual couples, adolescents and young people in relationships. PMID:18843530

  2. Antiretroviral Therapy in Prevention of HIV and TB: Update on Current Research Efforts

    PubMed Central

    Granich, Reuben; Gupta, Somya; Sutha, Amitabh B; Smyth, Caoimhe; Hoos, David; Vitoria, Marco; Simao, Mariangela; Hankins, Catherine; Schwartlander, Bernard; Ridzon, Renee; Bazin, Brigitte; Williams, Brian; Lo, Ying-Ru; McClure, Craig; Montaner, Julio; Hirnschall, Gottfried

    2011-01-01

    There is considerable scientific evidence supporting the use of antiretroviral therapy (ART) in prevention of human immunodeficiency virus (HIV) and tuberculosis (TB) infections. The complex nature of the HIV and TB prevention responses, resource constraints, remaining questions about cost and feasibility, and the need to use a solid evidence base to make policy decisions, and the implementation challenges to translating trial data to operational settings require a well-organised and coordinated response to research in this area. To this end, we aimed to catalogue the ongoing and planned research activities that evaluate the impact of ART plus other interventions on HIV- and/or TB-related morbidity, mortality, risk behaviour, HIV incidence and transmission. Using a limited search methodology, 50 projects were identified examining ART as prevention, representing 5 regions and 52 countries with a global distribution. There are 24 randomised controlled clinical trials with at least 12 large randomised individual or community cluster trials in resource-constrained settings that are in the planning or early implementation stages. There is considerable heterogeneity between studies in terms of methodology, interventions and geographical location. While the identified studies will undoubtedly advance our understanding of the efficacy and effectiveness of ART for prevention, some key questions may remain unanswered or only partially answered. The large number and wide variety of research projects emphasise the importance of this research issue and clearly demonstrate the potential for synergies, partnerships and coordination across funding agencies. PMID:21999779

  3. Getting PrEPared for HIV Prevention Navigation: Young Black Gay Men Talk About HIV Prevention in the Biomedical Era.

    PubMed

    Mutchler, Matt G; McDavitt, Bryce; Ghani, Mansur A; Nogg, Kelsey; Winder, Terrell J A; Soto, Juliana K

    2015-09-01

    Biomedical HIV prevention strategies, such as pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), represent new opportunities to reduce critically high HIV infection rates among young black men who have sex with men (YBMSM). We report results of 24 dyadic qualitative interviews (N=48), conducted in Los Angeles, CA, exploring how YBMSM and their friends view PrEP and PEP. Interviews were analyzed using a grounded theory approach. Participants had widely divergent levels of knowledge about these prevention methods. Misconceptions and mistrust regarding PrEP were common, and concerns were expressed about PrEP-related stigma and the potential for gossip among peers who might assume a person on PrEP was HIV-positive. Yet participants also framed PrEP and PEP as valuable new options within an expanded "tool kit" of HIV prevention strategies that created possibilities for preventing new HIV infections, dating men with a different HIV status, and decreased anxiety about exposure to HIV. We organized themes around four main areas: (1) information and misinformation about biomedical HIV prevention; (2) expectations about PrEP, sexual behavior, and stigma; (3) gossip, disclosure, and "spreading the word" about PrEP and PEP; and (4) the roles of PrEP and PEP in an expanded HIV prevention tool kit. The findings suggest a need for guidance in navigating the increasingly complex array of HIV-prevention options available to YBMSM. Such "prevention navigation" could counter misconceptions and address barriers, such as stigma and mistrust, while helping YBMSM make informed selections from among expanded HIV prevention options.

  4. Getting PrEPared for HIV Prevention Navigation: Young Black Gay Men Talk About HIV Prevention in the Biomedical Era

    PubMed Central

    McDavitt, Bryce; Ghani, Mansur A.; Nogg, Kelsey; Winder, Terrell J.A.; Soto, Juliana K.

    2015-01-01

    Abstract Biomedical HIV prevention strategies, such as pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), represent new opportunities to reduce critically high HIV infection rates among young black men who have sex with men (YBMSM). We report results of 24 dyadic qualitative interviews (N=48), conducted in Los Angeles, CA, exploring how YBMSM and their friends view PrEP and PEP. Interviews were analyzed using a grounded theory approach. Participants had widely divergent levels of knowledge about these prevention methods. Misconceptions and mistrust regarding PrEP were common, and concerns were expressed about PrEP-related stigma and the potential for gossip among peers who might assume a person on PrEP was HIV-positive. Yet participants also framed PrEP and PEP as valuable new options within an expanded “tool kit” of HIV prevention strategies that created possibilities for preventing new HIV infections, dating men with a different HIV status, and decreased anxiety about exposure to HIV. We organized themes around four main areas: (1) information and misinformation about biomedical HIV prevention; (2) expectations about PrEP, sexual behavior, and stigma; (3) gossip, disclosure, and “spreading the word” about PrEP and PEP; and (4) the roles of PrEP and PEP in an expanded HIV prevention tool kit. The findings suggest a need for guidance in navigating the increasingly complex array of HIV-prevention options available to YBMSM. Such “prevention navigation” could counter misconceptions and address barriers, such as stigma and mistrust, while helping YBMSM make informed selections from among expanded HIV prevention options. PMID:26121564

  5. Getting PrEPared for HIV Prevention Navigation: Young Black Gay Men Talk About HIV Prevention in the Biomedical Era.

    PubMed

    Mutchler, Matt G; McDavitt, Bryce; Ghani, Mansur A; Nogg, Kelsey; Winder, Terrell J A; Soto, Juliana K

    2015-09-01

    Biomedical HIV prevention strategies, such as pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), represent new opportunities to reduce critically high HIV infection rates among young black men who have sex with men (YBMSM). We report results of 24 dyadic qualitative interviews (N=48), conducted in Los Angeles, CA, exploring how YBMSM and their friends view PrEP and PEP. Interviews were analyzed using a grounded theory approach. Participants had widely divergent levels of knowledge about these prevention methods. Misconceptions and mistrust regarding PrEP were common, and concerns were expressed about PrEP-related stigma and the potential for gossip among peers who might assume a person on PrEP was HIV-positive. Yet participants also framed PrEP and PEP as valuable new options within an expanded "tool kit" of HIV prevention strategies that created possibilities for preventing new HIV infections, dating men with a different HIV status, and decreased anxiety about exposure to HIV. We organized themes around four main areas: (1) information and misinformation about biomedical HIV prevention; (2) expectations about PrEP, sexual behavior, and stigma; (3) gossip, disclosure, and "spreading the word" about PrEP and PEP; and (4) the roles of PrEP and PEP in an expanded HIV prevention tool kit. The findings suggest a need for guidance in navigating the increasingly complex array of HIV-prevention options available to YBMSM. Such "prevention navigation" could counter misconceptions and address barriers, such as stigma and mistrust, while helping YBMSM make informed selections from among expanded HIV prevention options. PMID:26121564

  6. Empowering Peer Group Leaders for HIV Prevention in Malawi

    PubMed Central

    McCreary, Linda L.; Kaponda, Chrissie P. N.; Davis, Kristina; Kalengamaliro, Mary; Norr, Kathleen F.

    2013-01-01

    Purpose Behavioral change interventions using peer group leaders are effective and widely used, but few studies have examined how being a peer group leader affects the leaders. This study describes how participants felt being a peer group leader affected their lives. Design This descriptive qualitative study interviewed 18 experienced peer group leaders who had conducted a multisession human immunodeficiency virus (HIV) prevention peer group intervention in rural Malawi. Methods We used inductive content analysis and comparisons within and between cases. Findings: Three major themes were identified. All leaders said they experienced personal changes in their knowledge, attitudes, or HIV prevention behaviors. They described interacting with family, neighbors, and friends, and speaking at church or community meetings, to discuss HIV prevention issues. They increased their self-efficacy to engage others in sensitive HIV prevention issues, developed a self-identity as a change agent, and came to be recognized in their community as trustworthy advisors about HIV and acquired immunodeficiency syndrome. These three themes, taken together, form the meta-theme of psychological empowerment. Conclusion Being a peer group leader empowered the leaders as change agents for HIV prevention and had impacts in the community after the intervention ended, potentially increasing the long-term effectiveness and cost effectiveness of peer group interventions. Clinical Relevance Healthcare workers and community volunteers who led HIV prevention sessions continued HIV prevention activities in the community and workplace after the program ended. Training health workers as volunteer HIV prevention leaders offers a strategy to bring HIV prevention to limited-resource settings, despite health worker shortages. PMID:23590557

  7. Characteristics of HIV-1 Discordant Couples Enrolled in a Trial of HSV-2 Suppression to Reduce HIV-1 Transmission: The Partners Study

    PubMed Central

    Lingappa, Jairam R.; Kahle, Erin; Mugo, Nelly; Mujugira, Andrew; Magaret, Amalia; Baeten, Jared; Bukusi, Elizabeth A.; Cohen, Craig R.; Katabira, Elly; Ronald, Allan; Kiarie, James; Farquhar, Carey; Stewart, Grace John; Makhema, Joseph; Essex, M.; Were, Edwin; Fife, Kenneth; deBruyn, Guy; Gray, Glenda; McIntyre, James; Manongi, Rachel; Kapiga, Saidi; Coetzee, David; Allen, Susan; Inambao, Mubiana; Kayitenkore, Kayitesi; Karita, Etienne; Kanweka, William; Delany, Sinead; Rees, Helen; Vwalika, Bellington; Coombs, Robert W.; Morrow, Rhoda; Whittington, William; Corey, Lawrence; Wald, Anna; Celum, Connie

    2009-01-01

    Background The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort. Methods HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count ≥250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed. Results Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2–9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (<5%), except for Trichomonas vaginalis in 14% of HIV-1 infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma RNA was 4.2 log10 copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log10 copies/mL; p<0.001) and CD4 count (−0.25 and −0.55 log10 copies/mL for CD4 350–499 and >500 relative to <350, respectively, p<0.001). Conclusions The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission. Trial Registration ClinicalTrials.gov NCT

  8. HIV prevention and low-income Chilean women: machismo, marianismo and HIV misconceptions.

    PubMed

    Cianelli, Rosina; Ferrer, Lilian; McElmurry, Beverly J

    2008-04-01

    Socio-cultural factors and HIV-related misinformation contribute to the increasing number of Chilean women living with HIV. In spite of this, and to date, few culturally specific prevention activities have been developed for this population. The goal of the present study was to elicit the perspectives of low-income Chilean women regarding HIV and relevant socio-cultural factors, as a forerunner to the development of a culturally appropriate intervention. As part of a mixed-methods study, fifty low-income Chilean women participated in a survey and twenty were selected to participate in prevention, in-depth interviews. Results show evidence of widespread misinformation and misconceptions related to HIV/AIDS. Machismo and marianismo offer major barriers to prevention programme development. Future HIV prevention should stress partner communication, empowerment and improving the education of women vulnerable to HIV.

  9. Transgender People and HIV Prevention: What We Know and What We Need to Know, a Call to Action

    PubMed Central

    Grinsztejn, Beatriz; El-Sadr, Wafaa M.

    2016-01-01

    Abstract: Transgender people have been disproportionally affected by HIV, particularly transgender women. Their increased vulnerability to HIV is due to multiple issues, including biological (eg, increased efficiency of HIV transmission through receptive anal sex), epidemiological (eg, increased likelihood of having HIV-infected partners), structural (eg, social stigma limiting employment options), and individual factors (eg, internalized stigma leading to depression and substance use and risk-taking behaviors). There have been limited culturally appropriate HIV prevention interventions for transgender people, with many key prevention studies (eg, the iPrEx PrEP study) enrolling transgender women in a study focusing on men who have sex with men. This has resulted in limited understanding of the optimal ways to decrease transgender people's risk for HIV acquisition. The current supplement of JAIDS is designed to review what is known about HIV prevention for transgender people and to highlight new insights and best practices. The study reviews recent epidemiologic data, the pharmacology of HIV prophylactic agents in individuals who may be using exogenous hormones, and several recent multi-component interventions designed to address the lived experience of transgender people. Additionally, the study reviews the work going on at the NIH to address transgender health in general and HIV prevention in specific, as well as two important papers related to clinical trial design issues and the ethical conduct of research in this frequently disenfranchised population. It is the hope of the HIV Prevention Trials Network (HPTN) that this supplement will promote new knowledge around transgender health and the requisite issues that need to be addressed in order to conduct optimal clinical trials. The ultimate hope is that the information distilled in this supplement will inform investigators, clinicians, and public health officials in order to design further research to develop

  10. Transgender People and HIV Prevention: What We Know and What We Need to Know, a Call to Action.

    PubMed

    Mayer, Kenneth H; Grinsztejn, Beatriz; El-Sadr, Wafaa M

    2016-08-15

    Transgender people have been disproportionally affected by HIV, particularly transgender women. Their increased vulnerability to HIV is due to multiple issues, including biological (eg, increased efficiency of HIV transmission through receptive anal sex), epidemiological (eg, increased likelihood of having HIV-infected partners), structural (eg, social stigma limiting employment options), and individual factors (eg, internalized stigma leading to depression and substance use and risk-taking behaviors). There have been limited culturally appropriate HIV prevention interventions for transgender people, with many key prevention studies (eg, the iPrEx PrEP study) enrolling transgender women in a study focusing on men who have sex with men. This has resulted in limited understanding of the optimal ways to decrease transgender people's risk for HIV acquisition. The current supplement of JAIDS is designed to review what is known about HIV prevention for transgender people and to highlight new insights and best practices. The study reviews recent epidemiologic data, the pharmacology of HIV prophylactic agents in individuals who may be using exogenous hormones, and several recent multi-component interventions designed to address the lived experience of transgender people. Additionally, the study reviews the work going on at the NIH to address transgender health in general and HIV prevention in specific, as well as two important papers related to clinical trial design issues and the ethical conduct of research in this frequently disenfranchised population. It is the hope of the HIV Prevention Trials Network (HPTN) that this supplement will promote new knowledge around transgender health and the requisite issues that need to be addressed in order to conduct optimal clinical trials. The ultimate hope is that the information distilled in this supplement will inform investigators, clinicians, and public health officials in order to design further research to develop optimal

  11. HIV vaccine trial willingness among injection and non-injection drug users in two urban centres, Barcelona and San Francisco.

    PubMed

    Etcheverry, M Florencia; Lum, Paula J; Evans, Jennifer L; Sanchez, Emilia; de Lazzari, Elisa; Mendez-Arancibia, Eva; Sierra, Ernesto; Gatell, José M; Page, Kimberly; Joseph, Joan

    2011-02-24

    Being able to recruit high-risk volunteers who are also willing to consider future participation in vaccine trials are critical features of vaccine preparedness studies. We described data from two cohorts of injection- and non-injection drug users in Barcelona, Spain [Red Cross centre] and in San Francisco, USA, [UFO-VAX study] at high risk of HIV/HCV infection to assess behaviour risk exposure and willingness to participate in future preventive HIV vaccine trials. We successfully identified drug-using populations that would be eligible for future HIV vaccine efficacy trials, based on reported levels of risk during screening and high levels of willingness to participate. In both groups, Red Cross and UFO-VAX respectively, HCV infection was highly prevalent at baseline (41% and 34%), HIV baseline seroprevalence was 4.2% and 1.5%, and high levels of willingness were seen (83% and 78%). PMID:21241735

  12. HIV vaccine trial willingness among injection and non-injection drug users in two urban centres, Barcelona and San Francisco.

    PubMed

    Etcheverry, M Florencia; Lum, Paula J; Evans, Jennifer L; Sanchez, Emilia; de Lazzari, Elisa; Mendez-Arancibia, Eva; Sierra, Ernesto; Gatell, José M; Page, Kimberly; Joseph, Joan

    2011-02-24

    Being able to recruit high-risk volunteers who are also willing to consider future participation in vaccine trials are critical features of vaccine preparedness studies. We described data from two cohorts of injection- and non-injection drug users in Barcelona, Spain [Red Cross centre] and in San Francisco, USA, [UFO-VAX study] at high risk of HIV/HCV infection to assess behaviour risk exposure and willingness to participate in future preventive HIV vaccine trials. We successfully identified drug-using populations that would be eligible for future HIV vaccine efficacy trials, based on reported levels of risk during screening and high levels of willingness to participate. In both groups, Red Cross and UFO-VAX respectively, HCV infection was highly prevalent at baseline (41% and 34%), HIV baseline seroprevalence was 4.2% and 1.5%, and high levels of willingness were seen (83% and 78%).

  13. HIV Prevention for Adults With Criminal Justice Involvement: A Systematic Review of HIV Risk-Reduction Interventions in Incarceration and Community Settings

    PubMed Central

    Dumont, Dora; Operario, Don

    2014-01-01

    We summarized and appraised evidence regarding HIV prevention interventions for adults with criminal justice involvement. We included randomized and quasi-randomized controlled trials that evaluated an HIV prevention intervention, enrolled participants with histories of criminal justice involvement, and reported biological or behavioral outcomes. We used Cochrane methods to screen 32 271 citations from 16 databases and gray literature. We included 37 trials enrolling n = 12 629 participants. Interventions were 27 psychosocial, 7 opioid substitution therapy, and 3 HIV-testing programs. Eleven programs significantly reduced sexual risk taking, 4 reduced injection drug risks, and 4 increased testing. Numerous interventions may reduce HIV-related risks among adults with criminal justice involvement. Future research should consider process evaluations, programs involving partners or families, and interventions integrating biomedical, psychosocial, and structural approaches. PMID:25211725

  14. HIV prevention for adults with criminal justice involvement: a systematic review of HIV risk-reduction interventions in incarceration and community settings.

    PubMed

    Underhill, Kristen; Dumont, Dora; Operario, Don

    2014-11-01

    We summarized and appraised evidence regarding HIV prevention interventions for adults with criminal justice involvement. We included randomized and quasi-randomized controlled trials that evaluated an HIV prevention intervention, enrolled participants with histories of criminal justice involvement, and reported biological or behavioral outcomes. We used Cochrane methods to screen 32,271 citations from 16 databases and gray literature. We included 37 trials enrolling n = 12,629 participants. Interventions were 27 psychosocial, 7 opioid substitution therapy, and 3 HIV-testing programs. Eleven programs significantly reduced sexual risk taking, 4 reduced injection drug risks, and 4 increased testing. Numerous interventions may reduce HIV-related risks among adults with criminal justice involvement. Future research should consider process evaluations, programs involving partners or families, and interventions integrating biomedical, psychosocial, and structural approaches. PMID:25211725

  15. The Use of Technology to Advance HIV Prevention for Couples.

    PubMed

    Mitchell, Jason W

    2015-12-01

    The majority of HIV prevention studies and programs have targeted individuals or operated at the community level. This has also been the standard approach when incorporating technology (e.g., web-based, smartphones) to help improve HIV prevention efforts. The tides have turned for both approaches: greater attention is now focusing on couple-based HIV prevention and using technology to help improve these efforts for maximizing reach and potential impact. To assess the extent that technology has been used to help advance HIV prevention with couples, a literature review was conducted using four databases and included studies that collected data from 2000 to early 2015. Results from this review suggest that technology has primarily been used to help advance HIV prevention with couples as a tool for (1) recruitment and data collection and (2) intervention development. Challenges and limitations of conducting research (e.g., validity of dyadic data) along with future directions for how technology (e.g., mHealth, wearable sensors) can be used to advance HIV prevention with couples are then discussed. Given the growing and near ubiquitous use of the Internet and smartphones, further efforts in the realm of mHealth (e.g., applications or "apps") and eHealth are needed to develop novel couple-focused HIV-preventive interventions. PMID:26412083

  16. Use of agent-based simulations to design and interpret HIV clinical trials.

    PubMed

    Cuadros, Diego F; Abu-Raddad, Laith J; Awad, Susanne F; García-Ramos, Gisela

    2014-07-01

    In this study, we illustrate the utility of an agent-based simulation to inform a trial design and how this supports outcome interpretation of randomized controlled trials (RCTs). We developed agent-based Monte Carlo models to simulate existing landmark HIV RCTs, such as the Partners in Prevention HSV/HIV Transmission Study. We simulated a variation of this study using valacyclovir therapy as the intervention, and we used a male circumcision RCT based on the Rakai Male Circumcision Trial. Our results indicate that a small fraction (20%) of the simulated Partners in Prevention HSV/HIV Transmission Study realizations rejected the null hypothesis, which was no effect from the intervention. Our results also suggest that an RCT designed to evaluate the effectiveness of a more potent drug regimen for HSV-2 suppression (valacyclovir therapy) is more likely to identify the efficacy of the intervention. For the male circumcision RCT simulation, the greater biological effect of the male circumcision yielded a major fraction (81%) of RCT realizations' that rejects the null hypothesis, which was no effect from the intervention. Our study highlights how agent-based simulations synthesize individual variation in the epidemiological context of the RCT. This methodology will be particularly useful for designing RCTs aimed at evaluating combination prevention interventions in community-based RCTs, wherein an intervention׳s effectiveness is challenging to predict. PMID:24792492

  17. Conceptualizing Community Mobilization for HIV Prevention: Implications for HIV Prevention Programming in the African Context

    PubMed Central

    Lippman, Sheri A.; Maman, Suzanne; MacPhail, Catherine; Twine, Rhian; Peacock, Dean; Kahn, Kathleen; Pettifor, Audrey

    2013-01-01

    Introduction Community mobilizing strategies are essential to health promotion and uptake of HIV prevention. However, there has been little conceptual work conducted to establish the core components of community mobilization, which are needed to guide HIV prevention programming and evaluation. Objectives We aimed to identify the key domains of community mobilization (CM) essential to change health outcomes or behaviors, and to determine whether these hypothesized CM domains were relevant to a rural South African setting. Method We studied social movements and community capacity, empowerment and development literatures, assessing common elements needed to operationalize HIV programs at a community level. After synthesizing these elements into six essential CM domains, we explored the salience of these CM domains qualitatively, through analysis of 10 key informant in-depth-interviews and seven focus groups in three villages in Bushbuckridge. Results CM domains include: 1) shared concerns, 2) critical consciousness, 3) organizational structures/networks, 4) leadership (individual and/or institutional), 5) collective activities/actions, and 6) social cohesion. Qualitative data indicated that the proposed domains tapped into theoretically consistent constructs comprising aspects of CM processes. Some domains, extracted from largely Western theory, required little adaptation for the South African context; others translated less effortlessly. For example, critical consciousness to collectively question and resolve community challenges functioned as expected. However, organizations/networks, while essential, operated differently than originally hypothesized - not through formal organizations, but through diffuse family networks. Conclusions To date, few community mobilizing efforts in HIV prevention have clearly defined the meaning and domains of CM prior to intervention design. We distilled six CM domains from the literature; all were pertinent to mobilization in rural

  18. A randomized controlled trial of a culturally congruent intervention to increase condom use and HIV testing among heterosexually active immigrant Latino men.

    PubMed

    Rhodes, Scott D; McCoy, Thomas P; Vissman, Aaron T; DiClemente, Ralph J; Duck, Stacy; Hergenrather, Kenneth C; Foley, Kristie Long; Alonzo, Jorge; Bloom, Fred R; Eng, Eugenia

    2011-11-01

    This randomized controlled trial tested the efficacy of an HIV prevention intervention to increase condom use and HIV testing among Spanish-speaking, heterosexually active immigrant Latino men. A community-based participatory research partnership developed the intervention and selected the study design. Following baseline data collection, 142 immigrant Latino men were randomized to the HIV prevention intervention or the cancer education intervention. Three-month follow-up data were collected from 139 participants, for a 98% retention rate. Mean age of participants was 31.6 years and 60% reported being from Mexico. Adjusting for baseline behaviors, relative to their peers in the cancer education comparison, participants in the HIV prevention intervention were more likely to report consistent condom use and receiving an HIV test. Community-based interventions for immigrant Latino men that are built on state of the art prevention science and developed in partnership with community members can greatly enhance preventive behaviors and may reduce HIV infection.

  19. Effects of PREPARE, a Multi-component, School-Based HIV and Intimate Partner Violence (IPV) Prevention Programme on Adolescent Sexual Risk Behaviour and IPV: Cluster Randomised Controlled Trial.

    PubMed

    Mathews, Catherine; Eggers, Sander M; Townsend, Loraine; Aarø, Leif E; de Vries, Petrus J; Mason-Jones, Amanda J; De Koker, Petra; McClinton Appollis, Tracy; Mtshizana, Yolisa; Koech, Joy; Wubs, Annegreet; De Vries, Hein

    2016-09-01

    Young South Africans, especially women, are at high risk of HIV. We evaluated the effects of PREPARE, a multi-component, school-based HIV prevention intervention to delay sexual debut, increase condom use and decrease intimate partner violence (IPV) among young adolescents. We conducted a cluster RCT among Grade eights in 42 high schools. The intervention comprised education sessions, a school health service and a school sexual violence prevention programme. Participants completed questionnaires at baseline, 6 and 12 months. Regression was undertaken to provide ORs or coefficients adjusted for clustering. Of 6244 sampled adolescents, 55.3 % participated. At 12 months there were no differences between intervention and control arms in sexual risk behaviours. Participants in the intervention arm were less likely to report IPV victimisation (35.1 vs. 40.9 %; OR 0.77, 95 % CI 0.61-0.99; t(40) = 2.14) suggesting the intervention shaped intimate partnerships into safer ones, potentially lowering the risk for HIV. PMID:27142057

  20. Is Sex Like Driving? HIV Prevention and Risk Compensation*

    PubMed Central

    Wilson, Nicholas L.; Xiong, Wentao; Mattson, Christine L.

    2015-01-01

    Risk compensation has been called the “Achilles’ heel” of HIV prevention policies (Cassell et al 2006). This paper examines the behavioral response to male circumcision, a major HIV prevention policy currently being implemented throughout much of Sub-Saharan Africa. Contrary to the presumption of risk compensation, we find that the response due to the perceived reduction in HIV transmission appears to have been a reduction in risky sexual behavior. We suggest a mechanism for this finding: circumcision may reduce fatalism about acquiring HIV/AIDS and increase the salience of the tradeoff between engaging in additional risky behavior and avoiding acquiring HIV. We also find what appears to be a competing effect that does not operate through the circumcision recipient’s belief about the reduction in the risk of acquiring HIV. PMID:26997745

  1. An Automated HIV-1 Env-Pseudotyped Virus Production for Global HIV Vaccine Trials

    PubMed Central

    Fuss, Martina; Mazzotta, Angela S.; Sarzotti-Kelsoe, Marcella; Ozaki, Daniel A.; Montefiori, David C.; von Briesen, Hagen; Zimmermann, Heiko; Meyerhans, Andreas

    2012-01-01

    Background Infections with HIV still represent a major human health problem worldwide and a vaccine is the only long-term option to fight efficiently against this virus. Standardized assessments of HIV-specific immune responses in vaccine trials are essential for prioritizing vaccine candidates in preclinical and clinical stages of development. With respect to neutralizing antibodies, assays with HIV-1 Env-pseudotyped viruses are a high priority. To cover the increasing demands of HIV pseudoviruses, a complete cell culture and transfection automation system has been developed. Methodology/Principal Findings The automation system for HIV pseudovirus production comprises a modified Tecan-based Cellerity system. It covers an area of 5×3 meters and includes a robot platform, a cell counting machine, a CO2 incubator for cell cultivation and a media refrigerator. The processes for cell handling, transfection and pseudovirus production have been implemented according to manual standard operating procedures and are controlled and scheduled autonomously by the system. The system is housed in a biosafety level II cabinet that guarantees protection of personnel, environment and the product. HIV pseudovirus stocks in a scale from 140 ml to 1000 ml have been produced on the automated system. Parallel manual production of HIV pseudoviruses and comparisons (bridging assays) confirmed that the automated produced pseudoviruses were of equivalent quality as those produced manually. In addition, the automated method was fully validated according to Good Clinical Laboratory Practice (GCLP) guidelines, including the validation parameters accuracy, precision, robustness and specificity. Conclusions An automated HIV pseudovirus production system has been successfully established. It allows the high quality production of HIV pseudoviruses under GCLP conditions. In its present form, the installed module enables the production of 1000 ml of virus-containing cell culture supernatant per

  2. Masculine ideology, norms, and HIV prevention among young Black men

    PubMed Central

    Hall, Naomi M.; Applewhite, Sheldon

    2014-01-01

    This study examines the relationship between masculine ideology, adherence to norms, and HIV prevention among young Black heterosexual and gay men on the campus of a historically Black college/university. The data from four focus groups and nine individual interviews (N = 35) were aggregated and two recurring themes emerged: sexual communication, and mate availability. Additional themes related to HIV prevention were stigma, protection, and testing. The importance of investigating masculinity with young men is highlighted and implications for professionals working with college students to prevent the transmission of HIV are included. PMID:25525415

  3. Modeling HIV-1 Mucosal Transmission and Prevention in Humanized Mice.

    PubMed

    Veselinovic, Milena; Charlins, Paige; Akkina, Ramesh

    2016-01-01

    The new generation humanized mice (hu-mice) that permit continuous de novo generation of human hematopoietic cells have led to novel strategies in studying HIV-1 pathogenesis, prevention and therapies. HIV-1 infection of hu-mice results in chronic viremia and CD4+ T cell loss, thus mimicking key aspects of the disease progression. In addition, the new generation hu-mice are permissive for HIV-1 sexual transmission by vaginal and rectal routes thus allowing in vivo efficacy testing of new anti-HIV-1 drugs for prevention. Two leading models are currently being used, namely the hu-HSC mice and the BLT mice. Here we describe the methodology for generating both hu-HSC and BLT mice and their use in the study of HIV-1 transmission and prevention of infection by topical and oral administration of anti-retroviral drugs. Practical aspects of the methodologies are emphasized.

  4. HIV Prevention Messages Targeting Young Latino Immigrant MSM.

    PubMed

    Solorio, Rosa; Norton-Shelpuk, Pamela; Forehand, Mark; Martinez, Marcos; Aguirre, Joel

    2014-01-01

    Young Latino immigrant men who have sex with men (MSM) are at risk for HIV and for delayed diagnosis. A need exists to raise awareness about HIV prevention in this population, including the benefits of timely HIV testing. This project was developed through collaboration between University of WA researchers and Entre Hermanos, a community-based organization serving Latinos. Building from a community-based participatory research approach, the researchers developed a campaign that was executed by Activate Brands, based in Denver, Colorado. The authors (a) describe the development of HIV prevention messages through the integration of previously collected formative data; (b) describe the process of translating these messages into PSAs, including the application of a marketing strategy; (c) describe testing the PSAs within the Latino MSM community; and (c) determine a set of important factors to consider when developing HIV prevention messages for young Latino MSM who do not identify as gay.

  5. HIV Prevention Messages Targeting Young Latino Immigrant MSM

    PubMed Central

    Solorio, Rosa; Forehand, Mark; Aguirre, Joel

    2014-01-01

    Young Latino immigrant men who have sex with men (MSM) are at risk for HIV and for delayed diagnosis. A need exists to raise awareness about HIV prevention in this population, including the benefits of timely HIV testing. This project was developed through collaboration between University of WA researchers and Entre Hermanos, a community-based organization serving Latinos. Building from a community-based participatory research approach, the researchers developed a campaign that was executed by Activate Brands, based in Denver, Colorado. The authors (a) describe the development of HIV prevention messages through the integration of previously collected formative data; (b) describe the process of translating these messages into PSAs, including the application of a marketing strategy; (c) describe testing the PSAs within the Latino MSM community; and (c) determine a set of important factors to consider when developing HIV prevention messages for young Latino MSM who do not identify as gay. PMID:24864201

  6. HIV Prevention Messages Targeting Young Latino Immigrant MSM.

    PubMed

    Solorio, Rosa; Norton-Shelpuk, Pamela; Forehand, Mark; Martinez, Marcos; Aguirre, Joel

    2014-01-01

    Young Latino immigrant men who have sex with men (MSM) are at risk for HIV and for delayed diagnosis. A need exists to raise awareness about HIV prevention in this population, including the benefits of timely HIV testing. This project was developed through collaboration between University of WA researchers and Entre Hermanos, a community-based organization serving Latinos. Building from a community-based participatory research approach, the researchers developed a campaign that was executed by Activate Brands, based in Denver, Colorado. The authors (a) describe the development of HIV prevention messages through the integration of previously collected formative data; (b) describe the process of translating these messages into PSAs, including the application of a marketing strategy; (c) describe testing the PSAs within the Latino MSM community; and (c) determine a set of important factors to consider when developing HIV prevention messages for young Latino MSM who do not identify as gay. PMID:24864201

  7. HIV prevention for Black women: structural barriers and opportunities.

    PubMed

    Newman, Peter A; Williams, Charmaine C; Massaquoi, Notisha; Brown, Marsha; Logie, Carmen

    2008-08-01

    Black women bear a disproportionate burden of HIV/AIDS in North America. The purpose of this investigation was to explore Black Canadian women's perspectives on HIV risk and prevention. Four 90-minute focus groups (n=26) and six key informant interviews were conducted in Toronto with Black women of African and Caribbean descent and low socioeconomic status. Data analysis revealed a number of potent barriers to existing HIV preventive interventions: stigma, cultural disconnections, lack of engagement of Black religious institutions, and multiple intersecting forms of discrimination. Recommended HIV prevention opportunities included the Black church, mainstreaming, health care providers, and ethno-specific agencies. HIV prevention strategies for North American Black women, rather than focusing on HIV and individual risk behaviors, may benefit from a primary focus on social and structural factors (e.g., promoting gender equality, economic opportunity, women-controlled prevention technologies and combating racism in health care) thereby integrating HIV prevention into the larger context of community health and survival.

  8. Integrating HIV Care and HIV Prevention: Legal, Policy, and Programmatic Recommendations

    PubMed Central

    Remien, Robert H.; Berkman, Alan; Myer, Landon; Bastos, Francisco I.; Kagee, Ashraf; El-Sadr, Wafaa

    2009-01-01

    Since the start of the HIV epidemic we have witnessed significant advances in our understanding of the impact of HIV disease worldwide. Further, breakthroughs in treatment and the rapid expansion of HIV care and treatment programs in heavily impacted countries over the past five years are potentially critical assets in a comprehensive approach to controlling the continued spread of HIV globally. A strategic approach to controlling the epidemic requires continued and comparable expansion and integration of care, treatment, and prevention programs. As every new infection involves transmission, whether vertically or horizontally, from a person already living with HIV/AIDS (PLWHA), integration of HIV prevention into HIV care settings has the potential to prevent thousands of new infections, as well as improve the lives of PLWHAs. In this paper, we highlight how to better utilize opportunities created by the antiretroviral (ARV) roll-out to achieve more effective prevention, particularly in Sub Saharan Africa. We offer specific recommendations for action in the domains of healthcare policy and practice in order to better utilize the advances in HIV treatment to advance HIV prevention. PMID:18641470

  9. HIV risk and preventive interventions in transgender women sex workers

    PubMed Central

    Poteat, Tonia; Wirtz, Andrea L; Radix, Anita; Borquez, Annick; Silva-Santisteban, Alfonso; Deutsch, Madeline B; Khan, Sharful Islam; Winter, Sam; Operario, Don

    2015-01-01

    Worldwide, transgender women who engage in sex work have a disproportionate risk for HIV compared with natal male and female sex workers. We reviewed recent epidemiological research on HIV in transgender women and show that transgender women sex workers (TSW) face unique structural, interpersonal, and individual vulnerabilities that contribute to risk for HIV. Only six studies of evidence-based prevention interventions were identified, none of which focused exclusively on TSW. We developed a deterministic model based on findings related to HIV risks and interventions. The model examines HIV prevention approaches in TSW in two settings (Lima, Peru and San Francisco, CA, USA) to identify which interventions would probably achieve the UN goal of 50% reduction in HIV incidence in 10 years. A combination of interventions that achieves small changes in behaviour and low coverage of biomedical interventions was promising in both settings, suggesting that the expansion of prevention services in TSW would be highly effective. However, this expansion needs appropriate sustainable interventions to tackle the upstream drivers of HIV risk and successfully reach this population. Case studies of six countries show context-specific issues that should inform development and implementation of key interventions across heterogeneous settings. We summarise the evidence and knowledge gaps that affect the HIV epidemic in TSW, and propose a research agenda to improve HIV services and policies for this population. PMID:25059941

  10. Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention.

    PubMed

    Fowler, Mary G; Qin, Min; Fiscus, Susan A; Currier, Judith S; Flynn, Patricia M; Chipato, Tsungai; McIntyre, James; Gnanashanmugam, Devasena; Siberry, George K; Coletti, Anne S; Taha, Taha E; Klingman, Karin L; Martinson, Francis E; Owor, Maxensia; Violari, Avy; Moodley, Dhayendre; Theron, Gerhard B; Bhosale, Ramesh; Bobat, Raziya; Chi, Benjamin H; Strehlau, Renate; Mlay, Pendo; Loftis, Amy J; Browning, Renee; Fenton, Terence; Purdue, Lynette; Basar, Michael; Shapiro, David E; Mofenson, Lynne M

    2016-11-01

    Background Randomized-trial data on the risks and benefits of antiretroviral therapy (ART) as compared with zidovudine and single-dose nevirapine to prevent transmission of the human immunodeficiency virus (HIV) in HIV-infected pregnant women with high CD4 counts are lacking. Methods We randomly assigned HIV-infected women at 14 or more weeks of gestation with CD4 counts of at least 350 cells per cubic millimeter to zidovudine and single-dose nevirapine plus a 1-to-2-week postpartum "tail" of tenofovir and emtricitabine (zidovudine alone); zidovudine, lamivudine, and lopinavir-ritonavir (zidovudine-based ART); or tenofovir, emtricitabine, and lopinavir-ritonavir (tenofovir-based ART). The primary outcomes were HIV transmission at 1 week of age in the infant and maternal and infant safety. Results The median CD4 count was 530 cells per cubic millimeter among 3490 primarily black African HIV-infected women enrolled at a median of 26 weeks of gestation (interquartile range, 21 to 30). The rate of transmission was significantly lower with ART than with zidovudine alone (0.5% in the combined ART groups vs. 1.8%; difference, -1.3 percentage points; repeated confidence interval, -2.1 to -0.4). However, the rate of maternal grade 2 to 4 adverse events was significantly higher with zidovudine-based ART than with zidovudine alone (21.1% vs. 17.3%, P=0.008), and the rate of grade 2 to 4 abnormal blood chemical values was higher with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%, P=0.03). Adverse events did not differ significantly between the ART groups (P>0.99). A birth weight of less than 2500 g was more frequent with zidovudine-based ART than with zidovudine alone (23.0% vs. 12.0%, P<0.001) and was more frequent with tenofovir-based ART than with zidovudine alone (16.9% vs. 8.9%, P=0.004); preterm delivery before 37 weeks was more frequent with zidovudine-based ART than with zidovudine alone (20.5% vs. 13.1%, P<0.001). Tenofovir-based ART was associated

  11. “Speaking the Dialect”: Understanding Public Discourse in the Aftermath of an HIV Vaccine Trial Shutdown

    PubMed Central

    Logie, Carmen; James, LLana; Charles, Tamicka; Maxwell, John; Salam, Khaled; Woodford, Michael

    2011-01-01

    Objectives. We investigated how persons from key populations at higher risk of HIV exposure interpreted the process and outcomes of the Step Study HIV-1 vaccine trial, which was terminated early, and implications for willingness to participate in and community support for HIV vaccine research. Methods. We used qualitative methods and a community-based approach in 9 focus groups (n = 72) among ethnically and sexually diverse populations and 6 semistructured key informant interviews in Ontario, Canada, in 2007 to 2008. Results. Participants construed social meaning from complex clinical and biomedical phenomena. Social representations and mental models emerged in fears of vaccine-induced infection, conceptualizations of unfair recruitment practices and increased risk behaviors among trial participants, and questioning of informed consent. Narratives of altruism and the common good demonstrated support for future trials. Conclusions. Public discourse on HIV vaccine trials is a productive means of interpreting complex clinical trial processes and outcomes in the context of existing beliefs and experiences regarding HIV vaccines, medical research, and historical disenfranchisement. Strategic engagement with social representations and mental models may promote meaningful community involvement in biomedical HIV prevention research. PMID:21778490

  12. Behavior change interventions to prevent HIV infection among women living in low and middle income countries: a systematic review.

    PubMed

    McCoy, Sandra I; Kangwende, Rugare A; Padian, Nancy S

    2010-06-01

    We conducted a systematic review of behavioral change interventions to prevent the sexual transmission of HIV among women and girls living in low- and middle-income countries. PubMed/MEDLINE, Web of Science, the Cochrane Library, and other databases and bibliographies were systematically searched for trials using randomized or quasi-experimental designs to evaluate behavioral interventions with HIV infection as an outcome. We identified 11 analyses for inclusion reporting on eight unique interventions. Interventions varied widely in intensity, duration, and delivery as well as by target population. Only two analyses showed a significant protective effect on HIV incidence among women and only three of ten analyses that measured behavioral outcomes reduced any measure of HIV-related risk behavior. Ongoing research is needed to determine whether behavior change interventions can be incorporated as independent efficacious components in HIV prevention packages for women or simply as complements to biomedical prevention strategies. PMID:19949847

  13. Just Say Maybe: Working with Uncertainties in HIV Prevention Education

    ERIC Educational Resources Information Center

    Frankham, Jo

    2003-01-01

    The article focuses on a key aspect of the experiences of young gay men and considers how their responses might inform HIV prevention education for all young people. The article first outlines key representations of same-sex desire and of HIV/AIDS through which young gay men learn various certainties about gay men, gay sex and AIDS. As a…

  14. Mothers' Voices: Enhancing Mother-Child Communication for HIV Prevention

    ERIC Educational Resources Information Center

    Silitsky, Cindy; Jones, Sande Gracia

    2004-01-01

    Parents are an important component of HIV prevention efforts for adolescents. The purpose of this study was to work with a community-based organization, Mothers' Voices South Florida, to evaluate the effectiveness of their educational program that teaches mothers how to talk to their children about HIV and safer sexual practices. Questionnaires…

  15. HIV Prevention for Adolescents: Where Do We Go from Here?

    ERIC Educational Resources Information Center

    Lightfoot, Marguerita

    2012-01-01

    The World Health Organization estimates that 50% of the 30 million HIV infections worldwide occurred in young people between the ages of 15 and 24 years. In the United States, national statistics estimate that almost 40% of new HIV cases occur in youth ages 13-29 (Centers for Disease Control and Prevention, 2011). Therefore, a focus on preventing…

  16. School-Based HIV Prevention: A Multidisciplinary Approach.

    ERIC Educational Resources Information Center

    Kerr, Dianne L.; And Others

    This manual was written to help school-based professionals implement school health education programs to prevent the spread of the human immunodeficiency virus (HIV). The manual provides a framework and plan to promote an interdisciplinary approach to HIV education in schools. The manual begins with a review of basic facts about acquired immune…

  17. Asserting a Positive Role: HIV-Positive People in Prevention

    ERIC Educational Resources Information Center

    Allan, Brent; Leonard, William

    2005-01-01

    The best HIV prevention programs--those that effect change on a multiplicity of levels by changing knowledge, attitudes, and behaviors and that are sustained over time--are also those that place HIV-positive people at the center of program design, implementation, and evaluation.

  18. 78 FR 43055 - Accelerating Improvements in HIV Prevention and Care in the United States Through the HIV Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-18

    ... July 18, 2013 Part III The President Executive Order 13649--Accelerating Improvements in HIV Prevention and Care in the United States Through the HIV Care Continuum Initiative #0; #0; #0; Presidential... Improvements in HIV Prevention and Care in the United States Through the HIV Care Continuum Initiative By...

  19. Nosocomial HIV infection: epidemiology and prevention--a global perspective.

    PubMed

    Ganczak, Maria; Barss, Peter

    2008-01-01

    Because, globally, HIV is transmitted mainly by sexual practices and intravenous drug use and because of a long asymptomatic period, healthcare-associated HIV transmission receives little attention even though an estimated 5.4% of global HIV infections result from contaminated injections alone. It is an important personal issue for healthcare workers, especially those who work with unsafe equipment or have insufficient training. They may acquire HIV occupationally or find themselves before courts, facing severe penalties for causing HIV infections. Prevention of blood-borne nosocomial infections such as HIV differs from traditional infection control measures such as hand washing and isolation and requires a multidisciplinary approach. Since there has not been a review of healthcare-associated HIV contrasting circumstances in poor and rich regions of the world, the aim of this article is to review and compare the epidemiology of HIV in healthcare facilities in such settings, followed by a consideration of general approaches to prevention, specific countermeasures, and a synthesis of approaches used in infection control, injury prevention, and occupational safety. These actions concentrated on identifying research on specific modes of healthcare-associated HIV transmission and on methods of prevention. Searches included studies in English and Russian cited in PubMed and citations in Google Scholar in any language. MeSH keywords such as nosocomial, hospital-acquired, iatrogenic, healthcare associated, occupationally acquired infection and HIV were used together with mode of transmission, such as "HIV and hemodialysis". References of relevant articles were also reviewed. The evidence indicates that while occasional incidents of healthcare-related HIV infection in high-income countries continue to be reported, the situation in many low-income countries is alarming, with transmission ranging from frequent to endemic. Viral transmission in health facilities occurs by

  20. Getting to zero the biomedical way in Africa: outcomes of deliberation at the 2013 Biomedical HIV Prevention Forum in Abuja, Nigeria

    PubMed Central

    2014-01-01

    Background Over the last few decades, biomedical HIV prevention research had engaged multiple African stakeholders. There have however been few platforms to enable regional stakeholders to engage with one another. In partnership with the World AIDS Campaign International, the Institute of Public Health of Obafemi Awolowo University, and the National Agency for the Control of AIDS in Nigeria, the New HIV Vaccine and Microbicide Advocacy Society hosted a forum on biomedical HIV prevention research in Africa. Stakeholders’ present explored evidences related to biomedical HIV prevention research and development in Africa, and made recommendations to inform policy, guidelines and future research agenda. Discussion The BHPF hosted 342 participants. Topics discussed included the use of antiretrovirals for HIV prevention, considerations for biomedical HIV prevention among key populations; HIV vaccine development; HIV cure; community and civil society engagement; and ethical considerations in implementation of biomedical HIV prevention research. Participants identified challenges for implementation of proven efficacious interventions and discovery of other new prevention options for Africa. Concerns raised included limited funding by African governments, lack of cohesive advocacy and policy agenda for biomedical HIV prevention research and development by Africa, varied ethical practices, and limited support to communities’ capacity to actively engaged with clinical trial conducts. Participants recommended that the African Government implement the Abuja +12 declaration; the civil society build stronger partnerships with diverse stakeholders, and develop a coherent advocacy agenda that also enhances community research literacy; and researchers and sponsors of trials on the African continent establish a process for determining appropriate standards for trial conduct on the continent. Conclusion By highlighting key considerations for biomedical HIV prevention research and

  1. Engineering behaviour change in an epidemic: the epistemology of NIH-funded HIV prevention science.

    PubMed

    Green, Adam; Kolar, Kat

    2015-05-01

    Social scientific and public health literature on National Institutes of Health-funded HIV behavioural prevention science often assumes that this body of work has a strong biomedical epistemological orientation. We explore this assumption by conducting a systematic content analysis of all NIH-funded HIV behavioural prevention grants for men who have sex with men between 1989 and 2012. We find that while intervention research strongly favours a biomedical orientation, research into the antecedents of HIV risk practices favours a sociological, interpretive and structural orientation. Thus, with respect to NIH-funded HIV prevention science, there exists a major disjunct in the guiding epistemological orientations of how scientists understand HIV risk, on the one hand, and how they engineer behaviour change in behavioural interventions, on the other. Building on the extant literature, we suggest that the cause of this disjunct is probably attributable not to an NIH-wide positivist orientation, but to the specific standards of evidence used to adjudicate HIV intervention grant awards, including randomised controlled trials and other quantitative measures of intervention efficacy. PMID:25565009

  2. Engineering behaviour change in an epidemic: the epistemology of NIH-funded HIV prevention science.

    PubMed

    Green, Adam; Kolar, Kat

    2015-05-01

    Social scientific and public health literature on National Institutes of Health-funded HIV behavioural prevention science often assumes that this body of work has a strong biomedical epistemological orientation. We explore this assumption by conducting a systematic content analysis of all NIH-funded HIV behavioural prevention grants for men who have sex with men between 1989 and 2012. We find that while intervention research strongly favours a biomedical orientation, research into the antecedents of HIV risk practices favours a sociological, interpretive and structural orientation. Thus, with respect to NIH-funded HIV prevention science, there exists a major disjunct in the guiding epistemological orientations of how scientists understand HIV risk, on the one hand, and how they engineer behaviour change in behavioural interventions, on the other. Building on the extant literature, we suggest that the cause of this disjunct is probably attributable not to an NIH-wide positivist orientation, but to the specific standards of evidence used to adjudicate HIV intervention grant awards, including randomised controlled trials and other quantitative measures of intervention efficacy.

  3. Cost-effective production of a vaginal protein microbicide to prevent HIV transmission.

    PubMed

    Ramessar, Koreen; Rademacher, Thomas; Sack, Markus; Stadlmann, Johannes; Platis, Dimitris; Stiegler, Gabriela; Labrou, Nikos; Altmann, Fritz; Ma, Julian; Stöger, Eva; Capell, Teresa; Christou, Paul

    2008-03-11

    A series of small-molecule microbicides has been developed for vaginal delivery to prevent heterosexual HIV transmission, but results from human clinical trials have been disappointing. Protein-based microbicides, such as HIV-specific monoclonal antibodies, have been considered as an alternative approach. Despite their promising safety profile and efficacy, the major drawback of such molecules is the economy of large-scale production in mammalian cells, the current system of choice. Here, we show that an alternative biomanufacturing platform is now available for one of the most promising anti-HIV antibodies (2G12). Our data show that the HIV-neutralization capability of the antibody is equal to or superior to that of the same antibody produced in CHO cells. We conclude that this protein production system may provide a means to achieve microbicide ingredient manufacture at costs that would allow product introduction and manufacture in the developing world.

  4. Considerations for a Human Rights Impact Assessment of a Population Wide Treatment for HIV Prevention Intervention.

    PubMed

    Hanefeld, Johanna; Bond, Virginia; Seeley, Janet; Lees, Shelley; Desmond, Nicola

    2015-12-01

    Increasing attention is being paid to the potential of anti-retroviral treatment (ART) for HIV prevention. The possibility of eliminating HIV from a population through a universal test and treat intervention, where all people within a population are tested for HIV and all positive people immediately initiated on ART, as part of a wider prevention intervention, was first proposed in 2009. Several clinical trials testing this idea are now in inception phase. An intervention which relies on universally testing the entire population for HIV will pose challenges to human rights, including obtaining genuine consent to testing and treatment. It also requires a context in which people can live free from fear of stigma, discrimination and violence, and can access services they require. These challenges are distinct from the field of medical ethics which has traditionally governed clinical trials and focuses primarily on patient researcher relationship. This paper sets out the potential impact of a population wide treatment as prevention intervention on human rights. It identifies five human right principles of particular relevance: participation, accountability, the right to health, non-discrimination and equality, and consent and confidentiality. The paper proposes that explicit attention to human rights can strengthen a treatment as prevention intervention, contribute to mediating likely health systems challenges and offer insights on how to reach all sections of the population.

  5. Broadly Neutralizing Anti-HIV Antibodies Prevent HIV Infection of Mucosal Tissue Ex Vivo

    PubMed Central

    Scott, Yanille M.; Park, Seo Young

    2015-01-01

    Broadly neutralizing monoclonal antibodies (nAbs) specific for HIV are being investigated for use in HIV prevention. Due to their ability to inhibit HIV attachment to and entry into target cells, nAbs may be suitable for use as topical HIV microbicides. As such, they would present an alternative intervention for individuals who may not benefit from using antiretroviral-based products for HIV prevention. We theorize that nAbs can inhibit viral transmission through mucosal tissue, thus reducing the incidence of HIV infection. The efficacy of the PG9, PG16, VRC01, and 4E10 antibodies was evaluated in an ex vivo human model of mucosal HIV transmission. nAbs reduced HIV transmission, causing 1.5- to 2-log10 reductions in HIV replication in ectocervical tissues and ≈3-log10 reductions in HIV replication in colonic tissues over 21 days. These antibodies demonstrated greater potency in colonic tissues, with a 50-fold higher dose being required to reduce transmission in ectocervical tissues. Importantly, nAbs retained their potency and reduced viral transmission in the presence of whole semen. No changes in tissue viability or immune activation were observed in colonic or ectocervical tissue after nAb exposure. Our data suggest that topically applied nAbs are safe and effective against HIV infection of mucosal tissue and support further development of nAbs as a topical microbicide that could be used for anal as well as vaginal protection. PMID:26596954

  6. Digital gaming for HIV prevention with young adolescents.

    PubMed

    Enah, Comfort; Moneyham, Linda; Vance, David E; Childs, Gwendolyn

    2013-01-01

    The search for intervention strategies appropriate for young adolescents has recently led to the use of digital games. Digital gaming interventions are promising because they may be developmentally appropriate for adolescent populations. The gaming approach also capitalizes on an inherent interest to adolescents and circumvents traditional barriers to access to prevention interventions faced in some geographical areas. Notwithstanding, research on gaming in HIV prevention is quite limited. In this review article, we examine the need for contextually relevant HIV prevention interventions among young adolescents. From this, we provide a theoretical framework for exploring contextually relevant HIV risk factors and a foundation for gathering and using input from the target population to adapt an existing game or to create a developmentally appropriate and contextually relevant HIV prevention game. PMID:22871481

  7. Antiretroviral Prophylaxis for HIV-1 Prevention among Heterosexual Men and Women

    PubMed Central

    Baeten, Jared M.; Donnell, Deborah; Ndase, Patrick; Mugo, Nelly R.; Campbell, James D.; Wangisi, Jonathan; Tappero, Jordan W.; Bukusi, Elizabeth A.; Cohen, Craig R.; Katabira, Elly; Ronald, Allan; Tumwesigye, Elioda; Were, Edwin; Fife, Kenneth H.; Kiarie, James; Farquhar, Carey; John-Stewart, Grace; Kakia, Aloysious; Odoyo, Josephine; Mucunguzi, Akasiima; Nakku-Joloba, Edith; Twesigye, Rogers; Ngure, Kenneth; Apaka, Cosmas; Tamooh, Harrison; Gabona, Fridah; Mujugira, Andrew; Panteleeff, Dana; Thomas, Katherine K.; Kidoguchi, Lara; Krows, Meighan; Revall, Jennifer; Morrison, Susan; Haugen, Harald; Emmanuel-Ogier, Mira; Ondrejcek, Lisa; Coombs, Robert W.; Frenkel, Lisa; Hendrix, Craig; Bumpus, Namandjé N.; Bangsberg, David; Haberer, Jessica E.; Stevens, Wendy S.; Lingappa, Jairam R.; Celum, Connie

    2013-01-01

    Introduction Antiretroviral pre-exposure prophylaxis (PrEP) reduces the incidence of acquisition of human immunodeficiency virus type 1 (HIV-1) in men who have sex with men and is a promising approach for preventing HIV-1 in heterosexual populations. Methods We conducted a randomized, three-arm trial of oral antiretroviral PrEP among heterosexual couples from Kenya and Uganda in which one member was HIV-1 seronegative and the other HIV-1 seropositive. Seronegative partners were randomly assigned to once-daily tenofovir (TDF), combination emtricitabine/tenofovir (FTC/TDF), or matching placebo and followed monthly for up to 36 months. At enrollment, HIV-1 seropositive partners were not eligible for antiretroviral therapy under national guidelines. All couples received standard HIV-1 treatment and prevention services, including individual and couples risk-reduction counseling and condoms. Results 4758 couples were enrolled; for 62%, the HIV-1 seronegative partner was male. For HIV-1 seropositive participants, the median CD4 count was 495 cells/μL (interquartile range 375–662). Of 82 post-randomization HIV-1 infections, 17 were among those assigned TDF (incidence 0.65 per 100 person-years), 13 among those assigned FTC/TDF (incidence 0.50 per 100 person-years), and 52 among those assigned placebo (incidence 1.99 per 100 person-years), indicating a 67% relative reduction in HIV-1 incidence for TDF (95% CI 44 to 81, p<0.001) and 75% for FTC/TDF (95% CI 55 to 87, p<0.001). HIV-1 protective effects of FTC/TDF and TDF were not significantly different (p=0.23), and both study medications significantly reduced HIV-1 incidence in both men and women. The rate of serious medical events was similar across the study arms. Conclusions Oral TDF and FTC/TDF provided substantial protection against HIV-1 acquisition in heterosexual men and women, with comparable efficacy of TDF and FTC/TDF. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number NCT00557245) PMID

  8. An exploratory study of HIV-prevention advocacy by persons in HIV care in Uganda

    PubMed Central

    Tumwine, Christopher; Nannungi, Annet; Ssegujja, Eric; Nekesa, Nicolate; Ssali, Sarah; Atuyambe, Lynn; Ryan, Gery; Wagner, Glenn

    2013-01-01

    To explore how people living with HIV (PLHIV) and in care encourage others to adopt HIV-protective behaviours, we conducted in-depth interviews with a purposive sample of 40 HIV clinic patients in Kampala, Uganda. Content analysis was used to examine the message content, trigger events, and outcomes of HIV-prevention advocacy events initiated by the HIV clients with members of their social networks. The content themes included encouraging specific behaviours, such as HIV testing and treatment, condom use and non-promiscuity, as well as more general cautionary messages about protecting oneself from HIV infection. Common triggers for bringing up HIV-prevention advocacy information in a discussion or conversation included: wanting to prevent the targeted person from ‘falling into the same problems,’ wanting to benefit oneself with regard to avoiding re-infection, out of concern that the target would engage in higher-risk behaviour, due to observed changes in the target’s health, and to convey information after receiving treatment at the clinic. The participants mostly reported positive or neutral responses to these advocacy events; negative responses were rare. Interventions to empower PLHIV to be agents of change could represent a new frontier for HIV prevention. PMID:24910590

  9. Preventing sexual transmission of HIV: anti-HIV bioregulatory and homeostatic components of commercial sexual lubricants.

    PubMed

    Nguyen, D; Lee, H; Poast, J; Cloyd, M W; Baron, S

    2004-01-01

    Certain safe over-the-counter (OTC) sexual lubricants such as Astroglide, KY Liquid, Replens, Vagisil, ViAmor, and Wet Stuff inhibit both cell-free HIV and the production of HIV by infected leukocytes in vitro even in the presence of seminal fluid. To identify which components of the lubricants were active against HIV, we tested five components (glycerin, methylparaben, propylparaben, polyquaternium-32, and propylene glycol). The paraben preservatives and propylene glycol in the lubricants did not inhibit HIV, while the common natural homeostatic metabolite, glycerin, and the thickener polyquaternium-32 did strongly inactivate infectious HIV and HIV-infected leukocytes. Activity against HIV and HIV-infected cells by glycerin was stable through 24 hours at 37 degrees C. Glycerin and polyquaternium-32 were active at minimum concentrations of approximately 2% and 0.01%, respectively--well within the highest FDA safety guidelines. Both active components disrupted infected leukocytes within 5 minutes which resulted in inhibition of infectious HIV production by infected leukocytes of greater than 25 to 100-fold. These components do not disrupt vaginal epithelial cells in vivo. These components also rapidly inactivate cell-free HIV by 10- to 30-fold. Thus, we may conclude that the active components of the OTC lubricants are glycerin and polyquaternium-32. Using these components, OTC sexual lubricants could be reformulated to optimize their anti-HIV activity. Furthermore, clinical trials of these lubricants and components seem to be indicated because of their FDA safety level, wide availability, and low cost.

  10. Preventing sexual transmission of HIV: anti-HIV bioregulatory and homeostatic components of commercial sexual lubricants.

    PubMed

    Nguyen, D; Lee, H; Poast, J; Cloyd, M W; Baron, S

    2004-01-01

    Certain safe over-the-counter (OTC) sexual lubricants such as Astroglide, KY Liquid, Replens, Vagisil, ViAmor, and Wet Stuff inhibit both cell-free HIV and the production of HIV by infected leukocytes in vitro even in the presence of seminal fluid. To identify which components of the lubricants were active against HIV, we tested five components (glycerin, methylparaben, propylparaben, polyquaternium-32, and propylene glycol). The paraben preservatives and propylene glycol in the lubricants did not inhibit HIV, while the common natural homeostatic metabolite, glycerin, and the thickener polyquaternium-32 did strongly inactivate infectious HIV and HIV-infected leukocytes. Activity against HIV and HIV-infected cells by glycerin was stable through 24 hours at 37 degrees C. Glycerin and polyquaternium-32 were active at minimum concentrations of approximately 2% and 0.01%, respectively--well within the highest FDA safety guidelines. Both active components disrupted infected leukocytes within 5 minutes which resulted in inhibition of infectious HIV production by infected leukocytes of greater than 25 to 100-fold. These components do not disrupt vaginal epithelial cells in vivo. These components also rapidly inactivate cell-free HIV by 10- to 30-fold. Thus, we may conclude that the active components of the OTC lubricants are glycerin and polyquaternium-32. Using these components, OTC sexual lubricants could be reformulated to optimize their anti-HIV activity. Furthermore, clinical trials of these lubricants and components seem to be indicated because of their FDA safety level, wide availability, and low cost. PMID:15786693

  11. Informing Comprehensive HIV Prevention: A Situational Analysis of the HIV Prevention and Care Context, North West Province South Africa

    PubMed Central

    Lippman, Sheri A.; Treves-Kagan, Sarah; Gilvydis, Jennifer M.; Naidoo, Evasen; Khumalo-Sakutukwa, Gertrude; Darbes, Lynae; Raphela, Elsie; Ntswane, Lebogang; Barnhart, Scott

    2014-01-01

    Objective Building a successful combination prevention program requires understanding the community’s local epidemiological profile, the social community norms that shape vulnerability to HIV and access to care, and the available community resources. We carried out a situational analysis in order to shape a comprehensive HIV prevention program that address local barriers to care at multiple contextual levels in the North West Province of South Africa. Method The situational analysis was conducted in two sub-districts in 2012 and guided by an adaptation of WHO’s Strategic Approach, a predominantly qualitative method, including observation of service delivery points and in-depth interviews and focus groups with local leaders, providers, and community members, in order to recommend context-specific HIV prevention strategies. Analysis began during fieldwork with nightly discussions of findings and continued with coding original textual data from the fieldwork notebooks and a select number of recorded interviews. Results We conducted over 200 individual and group interviews and gleaned four principal social barriers to HIV prevention and care, including: HIV fatalism, traditional gender norms, HIV-related stigma, and challenges with communication around HIV, all of which fuel the HIV epidemic. At the different levels of response needed to stem the epidemic, we found evidence of national policies and programs that are mitigating the social risk factors but little community-based responses that address social risk factors to HIV. Conclusions Understanding social and structural barriers to care helped shape our comprehensive HIV prevention program, which address the four ‘themes’ identified into each component of the program. Activities are underway to engage communities, offer community-based testing in high transmission areas, community stigma reduction, and a positive health, dignity and prevention program for stigma reduction and improve communication skills

  12. Behavioral and Biomedical Combination Strategies for HIV Prevention

    PubMed Central

    Bekker, Linda-Gail; Beyrer, Chris; Quinn, Thomas C.

    2012-01-01

    Around 2.5 million people become infected with HIV each year. This extraordinary toll on human life and public health worldwide will only be reversed with effective prevention. What’s more, in the next few years, it is likely at least, that no single prevention strategy will be sufficient to contain the spread of the disease. There is a need for combination prevention as there is for combination treatment, including biomedical, behavioral, and structural interventions. Expanded HIV prevention must be grounded in a systematic analysis of the epidemic’s dynamics in local contexts. Although 85% of HIV is transmitted sexually, effective combinations of prevention have been shown for people who inject drugs. Combination prevention should be based on scientifically derived evidence, with input and engagement from local communities that fosters the successful integration of care and treatment. PMID:22908192

  13. AIDS Exceptionalism: On the Social Psychology of HIV Prevention Research.

    PubMed

    Fisher, William A; Kohut, Taylor; Fisher, Jeffrey D

    2009-12-01

    The current analysis considers the HIV prevention research record in the social sciences. We do so with special reference to what has been termed "AIDS Exceptionalism"- departures from standard public health practice and prevention research priorities in favor of alternative approaches to prevention that, it has been argued, emphasize individual rights at the expense of public health protection. In considering this issue, we review the historical context of the HIV epidemic; empirically demonstrate a pattern of prevention research characterized by systematic neglect of prevention interventions for HIV-infected persons; and articulate a rationale for "Prevention for Positives," supportive prevention efforts tailored to the needs of HIV+ individuals. We then propose a social psychological conceptualization of processes that appear to have influenced developments in HIV prevention research and directed its focus to particular target populations. Our concluding section considers whether there are social and research policy lessons to be learned from the record of HIV prevention research that might improve our ability to addresses effectively, equitably, and in timely fashion future epidemics that play out, as HIV does, at the junction of biology and behavior. At the first quarter century of the AIDS epidemic, it is important to weigh our accomplishments against our failures in the fight against AIDS…Future historians will conclude that we cannot escape responsibility for our failure to use effective, scientifically proven strategies to control the AIDS epidemic…They will also likely regard as tragic those instances when we allowed scarce resources to be used to support ideologically driven "prevention" that only served a particular political agenda.Editorial: A Quarter Century of AIDS. American Journal of Public Health. (Stall & Mills, 2006, p. 961).

  14. Global prevention of HIV infection for neglected populations: men who have sex with men.

    PubMed

    Beyrer, Chris

    2010-05-15

    The global epidemiology of human immunodeficiency virus (HIV) infection among men who have sex with men (MSM) suggests both reemergent spread among men in resource-sufficient countries since 2000 and emerging epidemics among MSM in resource-limited countries. Both epidemic contexts are evidence of the current limits of prevention of HIV infection in MSM. A range of evidence-based preventive interventions exist, but few new interventions have shown efficacy among MSM. Circumcision has not been investigated for MSM. New interventions are needed. Trials of preexposure prophylaxis are pending and may markedly alter the prevention landscape. For MSM in developing countries, basic services for prevention of HIV infection have yet to reach the large majority of men. Homophobia and discrimination limit access of MSM to prevention services and markedly increase vulnerability, as does criminalization of same-sex behavior. Decriminalization of same-sex behavior is a structural intervention for prevention of HIV infection and has recently been embraced by a nonbinding statement from the United Nations.

  15. Positive images: primary prevention for people with HIV.

    PubMed

    Senterfitt, W

    1998-06-01

    The Los Angeles City Council authorized a pilot project targeting the prevention needs of HIV-positive city residents. The Positive Images Program offers a drop-in support group program and a chat line for seropositives to talk anonymously about their HIV status and general living. The differences that were found during the discussion groups, among male and female responses, are discussed. The program is viewed as a powerful step toward enlisting seropositives in the primary prevention of HIV and offering easy access to a facilitated discussion of emotionally charged issues. It is designed to allow a deeper understanding of the attitudes and behaviors needed to help stem the epidemic's growth.

  16. Latino recruitment and retention strategies: community-based HIV prevention.

    PubMed

    McQuiston, C; Uribe, L

    2001-04-01

    Latinos are disproportionately affected by HIV/AIDS. The need for community-based AIDS prevention programs that are culture specific is well recognized. Lay Health Advisor (LHA) interventions are a culturally appropriate way to provide information about HIV/AIDS to community members. LHA programs use natural helpers in the community to disseminate information through their social networks. Natural helpers are community members who informally provide support to their neighbors and to whom others naturally turn for advice. This paper reports the recruitment and retention experiences of a Lay Health Advisor Program: Protegiendo Nuestra Familia (Protecting Our Family) for prevention of HIV/AIDS among Latinos in North Carolina.

  17. AIDS Exceptionalism: On the Social Psychology of HIV Prevention Research

    PubMed Central

    Fisher, William A.; Kohut, Taylor; Fisher, Jeffrey D.

    2013-01-01

    The current analysis considers the HIV prevention research record in the social sciences. We do so with special reference to what has been termed “AIDS Exceptionalism”— departures from standard public health practice and prevention research priorities in favor of alternative approaches to prevention that, it has been argued, emphasize individual rights at the expense of public health protection. In considering this issue, we review the historical context of the HIV epidemic; empirically demonstrate a pattern of prevention research characterized by systematic neglect of prevention interventions for HIV-infected persons; and articulate a rationale for “Prevention for Positives,” supportive prevention efforts tailored to the needs of HIV+ individuals. We then propose a social psychological conceptualization of processes that appear to have influenced developments in HIV prevention research and directed its focus to particular target populations. Our concluding section considers whether there are social and research policy lessons to be learned from the record of HIV prevention research that might improve our ability to addresses effectively, equitably, and in timely fashion future epidemics that play out, as HIV does, at the junction of biology and behavior. At the first quarter century of the AIDS epidemic, it is important to weigh our accomplishments against our failures in the fight against AIDS…Future historians will conclude that we cannot escape responsibility for our failure to use effective, scientifically proven strategies to control the AIDS epidemic…They will also likely regard as tragic those instances when we allowed scarce resources to be used to support ideologically driven “prevention” that only served a particular political agenda. Editorial: A Quarter Century of AIDS. American Journal of Public Health. (Stall & Mills, 2006, p. 961) PMID:23667386

  18. International clinical trials of HIV vaccines: II. phase I trial of an HIV-1 synthetic peptide vaccine evaluating an accelerated immunization schedule in Yunnan, China.

    PubMed

    Li, D; Forrest, B D; Li, Z; Xue, P; Hanson, C V; Duan, S; Cheng, H; Li, M; Wang, C Y; Koff, W C

    1997-06-01

    A Phase 1, double-blind, placebo controlled trial was conducted in Longchuan County, China, to evaluate the safety and immunogenicity of a prototype HIV-1 synthetic peptide vaccine in a target population at risk for HIV infection, and to establish the infrastructure for future large-scale HIV vaccine efficacy trials. Subjects were randomly assigned to receive 100 microg or 500 microg of vaccine or alum placebo, and were given three injections at an accelerated 0, 1, and 2 month schedule. The vaccine was well tolerated with no significant local or systemic reactions observed in any subjects. Fifty-five percent (100 microg dose) and 64% (500 microg dose) of subjects who received the vaccine produced binding antibody to the immunogen as determined by ELISA. However, HIV-1 (MN) neutralizing antibody was detected in only 23% (3/13) of subjects with detectable HIV-1 specific binding antibody. It was concluded that this prototype HIV-1 synthetic peptide vaccine was well tolerated, safe and immunogenic, and that a 0, 1, 2 month schedule was not as effective in stimulating HIV-1 specific neutralizing antibodies compared with previous trials utilizing a 0, 1, 6 month schedule. Finally, this trial demonstrated that well-designed HIV vaccine trials can be performed at this clinical trials site in Yunnan, China, and that this site should be considered for conducting larger safety, immunogenicity and efficacy trials of candidate HIV vaccines.

  19. Domestic violence among adolescents in HIV prevention research in Tanzania: Participant experiences and measurement issues

    PubMed Central

    Baumgartner, Joy Noel; Kaaya, Sylvia; Karungula, Happy; Kaale, Anna; Headley, Jennifer; Tolley, Elizabeth

    2014-01-01

    Objectives Under-representation of female adolescents in HIV clinical trials may inhibit their access to future prevention technologies. Domestic violence, broadly defined as violence perpetrated by intimate partners and/or family members, may affect trial participation. This study describes violence in the lives of adolescents and young women in Tanzania, explores use of the Women’s Experience with Battering (WEB) Scale to measure battering, and examines the associations between battering and socio-demographic and HIV risk factors. Methods Community formative research (CFR) and a mock clinical trial (MCT) were conducted to examine the challenges of recruiting younger (15-17) versus older (18-21) participants into HIV prevention trials. The CFR included qualitative interviews with 23 participants and there were 135 MCT participants. The WEB was administered in both the CFR and MCT. Results Nineteen CFR participants experienced physical/sexual violence and 17% scored positive for battering. All married participants reported partner-related domestic violence, and half scored positive for battering. Many believed beatings were normal. None of the single participants scored positive on battering, but one-third reported abuse by relatives. Among MCT participants, 15% scored positive for battering; most perpetrators were relatives. Younger participants were more likely to report battering. Conclusions Adolescents experienced high rates of domestic violence and the WEB captured battering from both partners and relatives. The level of familial violence was unexpected and has implications for parental roles in study recruitment. Addressing adolescent abuse in HIV prevention trials and in the general population should be a public health priority. PMID:24740725

  20. HIV prevention in prisons and jails: obstacles and opportunities.

    PubMed Central

    Polonsky, S; Kerr, S; Harris, B; Gaiter, J; Fichtner, R R; Kennedy, M G

    1994-01-01

    High rates of human immunodeficiency virus (HIV) infection among jail and prison inmates suggest that HIV prevention efforts should focus on incarcerated populations. Overcrowding, the high prevalence of injection drug use, and other high-risk behaviors among inmates create a prime opportunity for public health officials to affect the course of the HIV epidemic if they can remedy these problems. Yet, along with the opportunity, there are certain obstacles that correctional institutions present to public health efforts. The various jurisdictions have differing approaches to HIV prevention and control. Whether testing should be mandatory or voluntary, whether housing should be integrated or segregated by HIV serostatus, and whether condoms, bleach, or clean needles should be made available to the prisoners, are questions hotly debated by public health and correctional officials. Even accurate assessment of risk-taking within the institutions leads to controversy, as asking questions could imply acceptance of the very behaviors correctional officials are trying to prevent. Education and risk-reduction counseling are the least controversial and most widely employed modes of prevention, but the effectiveness of current prevention efforts in reducing HIV transmission in this high-risk population is largely undetermined. PMID:7938381

  1. A Network-Individual-Resource Model for HIV Prevention

    PubMed Central

    Johnson, Blair T.; Redding, Colleen A.; DiClemente, Ralph J.; Mustanski, Brian S.; Dodge, Brian M.; Sheeran, Paschal; Warren, Michelle R.; Zimmerman, Rick S.; Fisher, William A.; Conner, Mark T.; Carey, Michael P.; Fisher, Jeffrey D.; Stall, Ronald D.; Fishbein, Martin

    2014-01-01

    HIV is transmitted through dyadic exchanges of individuals linked in transitory or permanent networks of varying sizes. To optimize prevention efficacy, a complementary theoretical perspective that bridges key individual level elements with important network elements can be a foundation for developing and implementing HIV interventions with outcomes that are more sustainable over time and have greater dissemination potential. Toward that end, we introduce a Network-Individual-Resource (NIR) model for HIV prevention that recognizes how exchanges of resources between individuals and their networks underlies and sustains HIV-risk behaviors. Individual behavior change for HIV prevention, then, may be dependent on increasing the supportiveness of that individual's relevant networks for such change. Among other implications, an NIR model predicts that the success of prevention efforts depends on whether the prevention efforts (1) prompt behavior changes that can be sustained by the resources the individual or their networks possess; (2) meet individual and network needs and are consistent with the individual's current situation/developmental stage; (3) are trusted and valued; and (4) target high HIV-prevalence networks. PMID:20862606

  2. Translation of biomedical prevention strategies for HIV: Prospects and pitfalls

    PubMed Central

    Vermund, Sten H.; Tique, José A.; Cassell, Holly M.; Johnson, Megan E.; Ciampa, Philip J.; Audet, Carolyn M.

    2013-01-01

    Early achievements in biomedical approaches for HIV prevention included physical barriers (condoms), clean injection equipment (both for medical use and for injection drug users), blood and blood product safety, and prevention of mother to child transmission. In recent years, antiretroviral drugs to reduce risk of transmission (when the infected person takes the medicines; treatment as prevention or TasP) or reduce risk of acquisition (when the seronegative person takes them; pre-exposure prophylaxis or PrEP) have proven efficacious. Circumcision of men has also been a major tool relevant for higher prevalence regions such as sub-Saharan Africa. Well-established prevention strategies in the control of sexually transmitted diseases and tuberculosis are highly relevant for HIV (i.e., screening, linkage to care, early treatment, and contact tracing). Unfortunately, only slow progress is being made in some available HIV prevention strategies such as family planning for HIV-infected women who do not want more children and prevention mother-to-child HIV transmission. Current studies seek to integrate strategies into approaches that combine biomedical, behavioral, and structural methods to achieve prevention synergies. This review identifies the major biomedical approaches demonstrated to be efficacious that are now available. We also highlight the need for behavioral risk reduction and adherence as essential components of any biomedical approach. PMID:23673881

  3. Evaluation of a regional pilot program to prevent mother-infant HIV transmission--Thailand, 1998-2000.

    PubMed

    2001-07-20

    Worldwide, approximately 2.2 million women and 600,000 infants are infected with human immunodeficiency virus (HIV) each year. Extended zidovudine prophylaxis and other antiretroviral and obstetric interventions and the avoidance of breast-feeding have reduced dramatically mother-infant HIV transmission in countries with adequate health-care resources. However, in developing countries, where the impact of HIV is greatest, implementation has been limited by the complexity and expense of these interventions. In Thailand, where approximately 15,000 infants are born to HIV-infected women each year, the Ministry of Public Health (MOPH) has collaborated with other organizations to identify simpler and more cost-effective interventions to reduce mother-infant HIV transmission. In 1998, a placebo-controlled clinical trial in Thailand using a simplified zidovudine regimen from 36 weeks' gestation until delivery reduced the risk for mother-infant transmission by 50%. In 1998, MOPH initiated a pilot program to prevent mother-infant HIV transmission in region 7, a rural area in northeastern Thailand with an antenatal HIV prevalence of approximately 1%, to assess program feasibility, effectiveness, and acceptability. This report summarizes an evaluation of the 2-year pilot program, which indicated that acceptance of HIV testing and adherence to zidovudine were high and HIV transmission was reduced. The findings demonstrate the feasibility of implementing programs to prevent mother-infant HIV transmission on a large scale in a developing country.

  4. 77 FR 23733 - CDC/HRSA Advisory Committee on HIV and STD Prevention and Treatment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-20

    ...) Enhancing Hepatitis Prevention Treatment and Care in the United States; (2) Integrating HIV Prevention and..., CDC, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, 1600 Clifton Road,...

  5. MTV's "Staying Alive" global campaign promoted interpersonal communication about HIV and positive beliefs about HIV prevention.

    PubMed

    Geary, Cynthia Waszak; Burke, Holly McClain; Castelnau, Laure; Neupane, Shailes; Sall, Yacine Ba; Wong, Emily; Tucker, Heidi Toms

    2007-02-01

    In 2002 MTV launched a global multicomponent HIV prevention campaign, "Staying Alive," reaching over 166 countries worldwide. An evaluation of this campaign focused on three diverse sites: Kathmandu, Nepal; São Paulo, Brazil; and Dakar, Senegal. Data were collected before and after campaign implementation through population-based household surveys. Using linear regression techniques, our evaluation examined the effects of campaign exposure on interpersonal communication about HIV and the effects of campaign exposure and interpersonal communication on beliefs about HIV prevention. We found a consistent positive effect of exposure on interpersonal communication across all sites, though there were differences among sites with regard to whom the respondent talked about HIV. We also found a consistent positive effect of exposure on HIV prevention beliefs across sites when interpersonal communication was simultaneously entered into the model. Finally, in two sites we found a relationship between interpersonal communication and HIV prevention beliefs, controlling for exposure, though again, the effects differed by the type of person the communication was with. These similar findings in three diverse sites provide ecological validity of the findings that "Staying Alive" promoted interpersonal communication and influenced young people's beliefs about HIV prevention in a positive way, evidence for the potential of a global media campaign to have an impact on social norms.

  6. MTV's "Staying Alive" global campaign promoted interpersonal communication about HIV and positive beliefs about HIV prevention.

    PubMed

    Geary, Cynthia Waszak; Burke, Holly McClain; Castelnau, Laure; Neupane, Shailes; Sall, Yacine Ba; Wong, Emily; Tucker, Heidi Toms

    2007-02-01

    In 2002 MTV launched a global multicomponent HIV prevention campaign, "Staying Alive," reaching over 166 countries worldwide. An evaluation of this campaign focused on three diverse sites: Kathmandu, Nepal; São Paulo, Brazil; and Dakar, Senegal. Data were collected before and after campaign implementation through population-based household surveys. Using linear regression techniques, our evaluation examined the effects of campaign exposure on interpersonal communication about HIV and the effects of campaign exposure and interpersonal communication on beliefs about HIV prevention. We found a consistent positive effect of exposure on interpersonal communication across all sites, though there were differences among sites with regard to whom the respondent talked about HIV. We also found a consistent positive effect of exposure on HIV prevention beliefs across sites when interpersonal communication was simultaneously entered into the model. Finally, in two sites we found a relationship between interpersonal communication and HIV prevention beliefs, controlling for exposure, though again, the effects differed by the type of person the communication was with. These similar findings in three diverse sites provide ecological validity of the findings that "Staying Alive" promoted interpersonal communication and influenced young people's beliefs about HIV prevention in a positive way, evidence for the potential of a global media campaign to have an impact on social norms. PMID:17411389

  7. Paediatric HIV: Progress on Prevention, Treatment and Cure

    PubMed Central

    Kim, Maria H; Ahmed, Saeed; Abrams, Elaine J.

    2015-01-01

    Purpose of review This review provides an update on current developments with prevention, treatment and cure strategies in the field of pediatric HIV. Recent findings/Summary There has been tremendous progress in the prevention and treatment of pediatric HIV infection. With new strategies for prevention of mother-to-child transmission, we are growing ever closer towards elimination of pediatric HIV, though challenges with retention of pregnant woman and their HIV-exposed infants remain. Ongoing vigilance regarding the potential hazards of in utero ART exposure to infants continues with no significant alarms yet identified. Though cure has not been achieved, evidence of the impact of early treatment on reducing HIV-1 reservoir size with subsequent prolonged remission has enlivened efforts to rapidly identify and treat HIV-infected newborns. There is an increasing array of treatment options for pediatric patients and reassuring evidence regarding long-term complications of ART. Unfortunately, despite evidence suggesting the benefit of early treatment, timely identification and treatment of children remains a challenge. Better strategies for effective case-finding and engagement in care are urgently needed in addition to an improved understanding of how to retain HIV-positive children and adolescents on treatment. However, further emboldened by recent international commitments and robust global support, the future is hopeful. PMID:26709366

  8. Adherence to Antiretroviral Therapy for the Success of Emerging Interventions to Prevent HIV Transmission: A Wake up Call

    PubMed Central

    Nachega, Jean B; Uthman, Olalekan A; Mills, Edward J; Quinn, Thomas C

    2012-01-01

    Despite recent successes in several HIV prevention trials, the epidemic continues to increase in many countries. The most successful biomedical interventions to prevent HIV have been the use of Antiretroviral Therapy (ART) to Prevent Mother-To-Child Transmission (PMTCT), and sexual transmission via microbicides, PreExposure Prophylaxis (PrEP), and treatment of the infected person within discordant couples. In addition medical male circumcision has also been shown to be highly effective in prevention of HIV acquisition. However, emerging data demonstrate that adherence to several of these prevention interventions is critical. ART adherence during and after pregnancy has been shown to be significantly below that recommended for adequate virologic suppression, particularly during the postpartum period. Five recent PrEP trials also demonstrate that the success of PrEP as a public health intervention will necessitate monitoring ART adherence and will include additional interventions to improve or maintain adherence to optimal levels. New successes in HIV prevention research have been tempered by suboptimal adherence. There is a critical need to define practical and effective adherence monitoring strategies as well as controlled trials of adherence interventions in the era of PrEP, Treatment as Prevention (TasP), and PMTCT to maximize their benefit. PMID:24032088

  9. HIV prevention among female sex workers in Africa.

    PubMed

    Scheibe, A; Drame, F M; Shannon, K

    2012-01-01

    Sex work occurs to meet the demand for sexual services and is a universal phenomenon. In Africa sex work takes many forms and is an important source of income for many women. Yet sex worker reproductive health needs remain largely unmet. The criminalisation of sex work; community and service provider stigma; violence; substance use and limited access to health services and prevention commodities contribute to the high HIV burden evident among female sex workers in Africa. Following UNAIDS' three pillar approach to HIV prevention and sex work we present an overview of current opportunities, barriers and suggestions to improve HIV prevention policy and programming for sex work in Africa. Universal access to a comprehensive package of HIV services is the first pillar. Reproductive health commodities; voluntary and anonymous HIV counselling and testing; treatment of sexually transmitted infections, HIV and opportunistic infections; harm reduction for substance use and psychosocial support services make up the recommended package of services. The second pillar is a sex worker-supportive environment. The inclusion of sex worker programmes within national HIV strategic planning; sex worker-led community mobilisation and the establishment of sex work community networks (comprised of sex workers, health service providers, law enforcers and other stakeholders) enable effective programme implementation and are recommended. The reduction of sex worker vulnerability and addressing structural issues form the final pillar. The decriminalisation of sex work; development of supportive policy; gender equality and economic development are key factors that need to be addressed to increase sex worker resilience. Evidence supports the public health benefit of human rights based approaches to HIV prevention; moralistic and restrictive policy and laws towards sex work are harmful and should be removed. The establishment of these pillars will increase sex worker safety and enhance the

  10. Rethinking HIV prevention to prepare for oral PrEP implementation for young African women

    PubMed Central

    Celum, Connie L; Delany-Moretlwe, Sinead; McConnell, Margaret; van Rooyen, Heidi; Bekker, Linda-Gail; Kurth, Ann; Bukusi, Elizabeth; Desmond, Chris; Morton, Jennifer; Baeten, Jared M

    2015-01-01

    Introduction HIV incidence remains high among young women in sub-Saharan Africa in spite of scale-up of HIV testing, behavioural interventions, antiretroviral treatment and medical male circumcision. There is a critical need to critique past approaches and learn about the most effective implementation of evidence-based HIV prevention strategies, particularly emerging interventions such as pre-exposure prophylaxis (PrEP). Discussion Women in sub-Saharan Africa are at increased risk of HIV during adolescence and into their 20s, in part due to contextual factors including gender norms and relationship dynamics, and limited access to reproductive and sexual health services. We reviewed behavioural, behavioural economic and biomedical approaches to HIV prevention for young African women, with a particular focus on the barriers, opportunities and implications for implementing PrEP in this group. Behavioural interventions have had limited impact in part due to not effectively addressing the context, broader sexual norms and expectations, and structural factors that increase risk and vulnerability. Of biomedical HIV prevention strategies that have been tested, daily oral PrEP has the greatest evidence for protection, although adherence was low in two placebo-controlled trials in young African women. Given high efficacy and effectiveness in other populations, demonstration projects of open-label PrEP in young African women are needed to determine the most effective delivery models and whether women at substantial risk are motivated and able to use oral PrEP with sufficient adherence to achieve HIV prevention benefits. Conclusions Social marketing, adherence support and behavioural economic interventions should be evaluated as part of PrEP demonstration projects among young African women in terms of their effectiveness in increasing demand and optimizing uptake and effective use of PrEP. Lessons learned through evaluations of implementation strategies for delivering oral Pr

  11. Systematic Review of Abstinence-Plus HIV Prevention Programs in High-Income Countries

    PubMed Central

    Underhill, Kristen; Operario, Don; Montgomery, Paul

    2007-01-01

    Background Abstinence-plus (comprehensive) interventions promote sexual abstinence as the best means of preventing HIV, but also encourage condom use and other safer-sex practices. Some critics of abstinence-plus programs have suggested that promoting safer sex along with abstinence may undermine abstinence messages or confuse program participants; conversely, others have suggested that promoting abstinence might undermine safer-sex messages. We conducted a systematic review to investigate the effectiveness of abstinence-plus interventions for HIV prevention among any participants in high-income countries as defined by the World Bank. Methods and Findings Cochrane Collaboration systematic review methods were used. We included randomized and quasi-randomized controlled trials of abstinence-plus programs for HIV prevention among any participants in any high-income country; trials were included if they reported behavioural or biological outcomes. We searched 30 electronic databases without linguistic or geographical restrictions to February 2007, in addition to contacting experts, hand-searching conference abstracts, and cross-referencing papers. After screening 20,070 abstracts and 325 full published and unpublished papers, we included 39 trials that included approximately 37,724 North American youth. Programs were based in schools (10), community facilities (24), both schools and community facilities (2), health care facilities (2), and family homes (1). Control groups varied. All outcomes were self-reported. Quantitative synthesis was not possible because of heterogeneity across trials in programs and evaluation designs. Results suggested that many abstinence-plus programs can reduce HIV risk as indicated by self-reported sexual behaviours. Of 39 trials, 23 found a protective program effect on at least one sexual behaviour, including abstinence, condom use, and unprotected sex (baseline n = 19,819). No trial found adverse program effects on any behavioural outcome

  12. A network-individual-resource model for HIV prevention.

    PubMed

    Johnson, Blair T; Redding, Colleen A; DiClemente, Ralph J; Mustanski, Brian S; Dodge, Brian; Sheeran, Paschal; Warren, Michelle R; Zimmerman, Rick S; Fisher, William A; Conner, Mark T; Carey, Michael P; Fisher, Jeffrey D; Stall, Ronald D; Fishbein, Martin

    2010-12-01

    HIV is transmitted through dyadic exchanges of individuals linked in transitory or permanent networks of varying sizes. A theoretical perspective that bridges key individual level elements with important network elements can be a complementary foundation for developing and implementing HIV interventions with outcomes that are more sustainable over time and have greater dissemination potential. Toward that end, we introduce a Network-Individual-Resource (NIR) model for HIV prevention that recognizes how exchanges of resources between individuals and their networks underlies and sustains HIV-risk behaviors. Individual behavior change for HIV prevention, then, may be dependent on increasing the supportiveness of that individual's relevant networks for such change. Among other implications, an NIR model predicts that the success of prevention efforts depends on whether the prevention efforts (1) prompt behavior changes that can be sustained by the resources the individual or their networks possess; (2) meet individual and network needs and are consistent with the individual's current situation/developmental stage; (3) are trusted and valued; and (4) target high HIV-prevalence networks. PMID:20862606

  13. Mass media as an HIV-prevention strategy: using culturally sensitive messages to reduce HIV-associated sexual behavior of at-risk African American youth.

    PubMed

    Romer, Daniel; Sznitman, Sharon; DiClemente, Ralph; Salazar, Laura F; Vanable, Peter A; Carey, Michael P; Hennessy, Michael; Brown, Larry K; Valois, Robert F; Stanton, Bonita F; Fortune, Thierry; Juzang, Ivan

    2009-12-01

    The evidence base and theoretical frameworks for mass media HIV-prevention campaigns in the United States are not well-developed. We describe an intervention approach using culturally sensitive mass media messages to enhance protective beliefs and behavior of African American adolescents at risk for HIV. This approach exploits the potential that mass media messages have, not only to reach a large segment of the adolescent population and thereby support normative change, but also to engage the most vulnerable segments of this audience to reduce HIV-associated risk behaviors. The results from an ongoing HIV-prevention trial implemented in 2 medium-sized cities in the United States illustrate the effectiveness of this intervention approach. PMID:19833995

  14. Mass Media as an HIV-Prevention Strategy: Using Culturally Sensitive Messages to Reduce HIV-Associated Sexual Behavior of At-Risk African American Youth

    PubMed Central

    Sznitman, Sharon; DiClemente, Ralph; Salazar, Laura F.; Vanable, Peter A.; Carey, Michael P.; Hennessy, Michael; Brown, Larry K.; Valois, Robert F.; Stanton, Bonita F.; Fortune, Thierry; Juzang, Ivan

    2009-01-01

    The evidence base and theoretical frameworks for mass media HIV-prevention campaigns in the United States are not well-developed. We describe an intervention approach using culturally sensitive mass media messages to enhance protective beliefs and behavior of African American adolescents at risk for HIV. This approach exploits the potential that mass media messages have, not only to reach a large segment of the adolescent population and thereby support normative change, but also to engage the most vulnerable segments of this audience to reduce HIV-associated risk behaviors. The results from an ongoing HIV-prevention trial implemented in 2 medium-sized cities in the United States illustrate the effectiveness of this intervention approach. PMID:19833995

  15. Effectiveness of HIV prevention for women: what is working?

    PubMed

    Gil-Llario, María Dolores; Ballester-Arnal, Rafael; Giménez-García, Cristina; Salmerón-Sánchez, Pedro

    2014-10-01

    The HIV-AIDS remains a public health problem which disproportionally affects women. However, prevention strategies have rarely considered their specific efficacy for them. For this reason, this study examines the differential effectiveness of six intervention elements based on socio-cognitive theories addressing young women. A controlled between-groups design examined the change in risk profile among 167 young Spanish women (mean age 21.3 years old) involved in five sexual risk prevention interventions (informative talk, attitudinal discussion, role-play, fear induction and informative website) and one control non-intervening group (waiting list). Our findings support the differential efficacy of some HIV preventive intervention elements comparing others for women. In particular, the attitudinal discussion stands out followed by the informative talk and the role play. Contrarily, the fear induction component did not reveal relevant improvements. This study provides new evidence related to HIV prevention. Particularly, the higher efficacy of motivational components for these young Spanish women is revealed.

  16. Counseling for HIV Prevention: Clinical Interventions and HIV Antibody Testing.

    ERIC Educational Resources Information Center

    Craig, Donald H.; And Others

    1996-01-01

    Describes some developmental foundations for HIV counseling. Asserts that, in both formal sessions and moments of opportunity, educators, clinicians, and counselors can use the counseling relationship to promote healthy behavior change. This clinical process depends on careful self-appraisal, good counseling skills, and responsiveness to the…

  17. Uptake of Workplace HIV Counselling and Testing: A Cluster-Randomised Trial in Zimbabwe

    PubMed Central

    Corbett, Elizabeth L; Dauya, Ethel; Matambo, Ronnie; Cheung, Yin Bun; Makamure, Beauty; Bassett, Mary T; Chandiwana, Steven; Munyati, Shungu; Mason, Peter R; Butterworth, Anthony E; Godfrey-Faussett, Peter; Hayes, Richard J

    2006-01-01

    Background HIV counselling and testing is a key component of both HIV care and HIV prevention, but uptake is currently low. We investigated the impact of rapid HIV testing at the workplace on uptake of voluntary counselling and testing (VCT). Methods and Findings The study was a cluster-randomised trial of two VCT strategies, with business occupational health clinics as the unit of randomisation. VCT was directly offered to all employees, followed by 2 y of open access to VCT and basic HIV care. Businesses were randomised to either on-site rapid HIV testing at their occupational clinic (11 businesses) or to vouchers for off-site VCT at a chain of free-standing centres also using rapid tests (11 businesses). Baseline anonymised HIV serology was requested from all employees. HIV prevalence was 19.8% and 18.4%, respectively, at businesses randomised to on-site and off-site VCT. In total, 1,957 of 3,950 employees at clinics randomised to on-site testing had VCT (mean uptake by site 51.1%) compared to 586 of 3,532 employees taking vouchers at clinics randomised to off-site testing (mean uptake by site 19.2%). The risk ratio for on-site VCT compared to voucher uptake was 2.8 (95% confidence interval 1.8 to 3.8) after adjustment for potential confounders. Only 125 employees (mean uptake by site 4.3%) reported using their voucher, so that the true adjusted risk ratio for on-site compared to off-site VCT may have been as high as 12.5 (95% confidence interval 8.2 to 16.8). Conclusions High-impact VCT strategies are urgently needed to maximise HIV prevention and access to care in Africa. VCT at the workplace offers the potential for high uptake when offered on-site and linked to basic HIV care. Convenience and accessibility appear to have critical roles in the acceptability of community-based VCT. PMID:16796402

  18. HIV and smoking: associated risks and prevention strategies.

    PubMed

    Kariuki, Wanjiku; Manuel, Jennifer I; Kariuki, Ngaruiya; Tuchman, Ellen; O'Neal, Johnnie; Lalanne, Genevieve A

    2016-01-01

    High rates of smoking among persons living with HIV (PLWH) may reduce the effectiveness of HIV treatment and contribute to significant morbidity and mortality. Factors associated with smoking in PLWH include mental health comorbidity, alcohol and drug use, health-related quality of life, smoking among social networks and supports, and lack of access to care. PLWH smokers are at a higher risk of numerous HIV-associated infections and non-HIV related morbidity, including a decreased response to antiretroviral treatment, impaired immune functioning, reduced cognitive functioning, decreased lung functioning, and cardiovascular disease. Seventeen smoking cessation interventions were identified, of which seven were randomized controlled trials. The most effective studies combined behavioral and pharmacotherapy treatments that incorporated comprehensive assessments, multiple sessions, and cognitive-behavioral and motivational strategies. Smoking cessation interventions that are tailored to the unique needs of diverse samples and incorporate strategies to reduce the risk of relapse are essential to advancing health outcomes in PLWH. PMID:26766919

  19. HIV and smoking: associated risks and prevention strategies

    PubMed Central

    Kariuki, Wanjiku; Manuel, Jennifer I; Kariuki, Ngaruiya; Tuchman, Ellen; O’Neal, Johnnie; Lalanne, Genevieve A

    2016-01-01

    High rates of smoking among persons living with HIV (PLWH) may reduce the effectiveness of HIV treatment and contribute to significant morbidity and mortality. Factors associated with smoking in PLWH include mental health comorbidity, alcohol and drug use, health-related quality of life, smoking among social networks and supports, and lack of access to care. PLWH smokers are at a higher risk of numerous HIV-associated infections and non-HIV related morbidity, including a decreased response to antiretroviral treatment, impaired immune functioning, reduced cognitive functioning, decreased lung functioning, and cardiovascular disease. Seventeen smoking cessation interventions were identified, of which seven were randomized controlled trials. The most effective studies combined behavioral and pharmacotherapy treatments that incorporated comprehensive assessments, multiple sessions, and cognitive-behavioral and motivational strategies. Smoking cessation interventions that are tailored to the unique needs of diverse samples and incorporate strategies to reduce the risk of relapse are essential to advancing health outcomes in PLWH. PMID:26766919

  20. Reframing HIV prevention for gay men in the United States.

    PubMed

    Halkitis, Perry N

    2010-11-01

    The HIV epidemic in the United States has affected at least two generations of gay men. Despite numerous efforts to intervene on this public health crisis, HIV infections continue to escalate, especially among young men. This condition is compounded by an ever-growing number of gay men who are aging and living with HIV. We must enact an innovative and proactive vision and framework for HIV prevention that moves us beyond the undertakings rooted in social-cognitive paradigms that have informed this work for the past 25 years. A new framework for HIV prevention must give voice to gay men; must consider the totality of their lives; must delineate the underlying logic, which directs their relation to sex and HIV; and must concurrently respect their diverse life experiences. This approach should be rooted in a biopsychosocial paradigm, should be informed by both theory and practice, and should be directed by three theoretical lenses--a theory of syndemics, developmental theories, and contextual understandings of HIV disease. Taken together, these elements are a call to action for research and practice psychologists who are working to improve the lives of gay men. PMID:21058777

  1. HIV prevention in the Hispanic community: sex, culture, and empowerment.

    PubMed

    Marín, Barbara VanOss

    2003-07-01

    To address the serious HIV epidemic in the Hispanic community in the United States, the underlying causes of the epidemic must be addressed. Marginalization, including homophobia, poverty, and racism, as well as cultural factors such as machismo and sexual silence disempower people, making HIV prevention difficult. This article reviews evidence for the impact of marginalization and cultural factors on HIV risk and proposes a cycle of disempowerment. Three examples of empowerment interventions developed specifically for Hispanics (targeting heterosexuals, women, and gay men) are presented, and how these interventions address disempowerment is discussed. One intervention is used to illustrate principles of developing culturally appropriate interventions.

  2. The Global HIV Archive: Facilitating the Transition from Science to Practice of Efficacious HIV Prevention Interventions*

    PubMed Central

    Card, Josefina J.; Newman, Emily N.; Golden, Rachel E.; Kuhn, Tamara; Lomonaco, Carmela

    2014-01-01

    This paper describes the development, content, and capabilities of the online Global HIV Archive (GHA). With the goal of facilitating widespread adaptation and appropriate use of efficacious HIV prevention programs throughout the globe, GHA has: first, expanded and updated the search for HIV prevention programs originating in low-resource countries; second, identified those meritorious HIV prevention programs meeting established efficacy criteria of technical merit, replicability, and positive outcomes; third, prepared both implementation and evaluation materials from the efficacious programs for public use; fourth, developed interactive wizards or capacity-building tools to facilitate appropriate program selection, implementation, and adaptation; and, fifth, made the efficacious programs and accompanying wizards available to health practitioners throughout the globe in both printed and online formats. PMID:24563820

  3. Compendium of HIV Prevention Interventions with Evidence of Effectiveness. From CDC's HIV/AIDS Prevention Research Synthesis Project.

    ERIC Educational Resources Information Center

    Centers for Disease Control and Prevention (DHHS/PHS), Atlanta, GA.

    This publication was developed in response to requests by prevention service providers and planners, for science-based interventions that work in HIV/AIDS prevention. All interventions came from behavioral or social studies that had both intervention and control/comparison groups and positive results for behavioral or health outcomes. The document…

  4. Interventions to Prevent Sexually Transmitted Infections, Including HIV Infection

    PubMed Central

    Cates, Willard

    2011-01-01

    The Centers for Disease Control and Prevention (CDC) Sexually Transmitted Disease (STD) Treatment Guidelines were last updated in 2006. To update the “Clinical Guide to Prevention Services” section of the 2010 CDC STD Treatment Guidelines, we reviewed the recent science with reference to interventions designed to prevent acquisition of STDs, including human immunodeficiency virus (HIV) infection. Major interval developments include (1) licensure and uptake of immunization against genital human papillomavirus, (2) validation of male circumcision as a potent prevention tool against acquisition of HIV and some other sexually transmitted infections (STIs), (3) failure of a promising HIV vaccine candidate to afford protection against HIV acquisition, (4) encouragement about the use of antiretroviral agents as preexposure prophylaxis to reduce risk of HIV and herpes simplex virus acquisition, (5) enhanced emphasis on expedited partner management and rescreening for persons infected with Chlamydia trachomatis and Neisseria gonorrhoeae, (6) recognition that behavioral interventions will be needed to address a new trend of sexually transmitted hepatitis C among men who have sex with men, and (7) the availability of a modified female condom. A range of preventive interventions is needed to reduce the risks of acquiring STI, including HIV infection, among sexually active people, and a flexible approach targeted to specific populations should integrate combinations of biomedical, behavioral, and structural interventions. These would ideally involve an array of prevention contexts, including (1) communications and practices among sexual partners, (2) transactions between individual clients and their healthcare providers, and (3) comprehensive population-level strategies for prioritizing prevention research, ensuring accurate outcome assessment, and formulating health policy. PMID:22080271

  5. 78 FR 45246 - Office of Clinical and Preventive Services National HIV Program: Enhanced HIV/AIDS Screening and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-26

    ... increasing routine HIV screening for adults as per 2006 Centers for Disease Control and Prevention (CDC..., surveillance, Healthy People 2020 Objectives, and other HIV disease control activities; (2) Design and... HUMAN SERVICES Indian Health Service Office of Clinical and Preventive Services National HIV...

  6. Antiretroviral Therapy to Prevent HIV Acquisition in Serodiscordant Couples in a Hyperendemic Community in Rural South Africa

    PubMed Central

    Oldenburg, Catherine E.; Bärnighausen, Till; Tanser, Frank; Iwuji, Collins C.; De Gruttola, Victor; Seage, George R.; Mimiaga, Matthew J.; Mayer, Kenneth H.; Pillay, Deenan; Harling, Guy

    2016-01-01

    Background. Antiretroviral therapy (ART) was highly efficacious in preventing human immunodeficiency virus (HIV) transmission in stable serodiscordant couples in the HPTN-052 study, a resource-intensive randomized controlled trial with near-perfect ART adherence and mutual HIV status disclosure among all participating couples. However, minimal evidence exists of the effectiveness of ART in preventing HIV acquisition in stable serodiscordant couples in “real-life” population-based settings in hyperendemic communities of sub-Saharan Africa, where health systems are typically resource-poor and overburdened, adherence to ART is often low, and partners commonly do not disclose their HIV status to each other. Methods. Data arose from a population-based open cohort in KwaZulu-Natal, South Africa. A total of 17 016 HIV-uninfected individuals present between January 2005 and December 2013 were included. Interval-censored time-updated proportional hazards regression was used to assess how the ART status affected HIV transmission risk in stable serodiscordant relationships. Results. We observed 1619 HIV seroconversions in 17 016 individuals, over 60 349 person-years follow-up time. During the follow-up period, 1846 individuals had an HIV-uninfected and 196 had an HIV-infected stable partner HIV incidence was 3.8/100 person-years (PY) among individuals with an HIV-infected partner (95% confidence interval [CI], 2.3–5.6), 1.4/100 PY (.4–3.5) among those with HIV-infected partners receiving ART, and 5.6/100 PY (3.5–8.4) among those with HIV-infected partners not receiving ART. Use of ART was associated with a 77% decrease in HIV acquisition risk among serodiscordant couples (adjusted hazard ratio, 0.23; 95% CI, .07–.80). Conclusions. ART initiation was associated with a very large reduction in HIV acquisition in serodiscordant couples in rural KwaZulu-Natal. However, this “real-life” effect was substantially lower than the effect observed in the HPTN-052

  7. Antiretroviral Agents Used by HIV-Uninfected Persons for Prevention: Pre- and Postexposure Prophylaxis

    PubMed Central

    Grant, Robert M.

    2010-01-01

    Prophylactic use of antimicrobial agents and microbicides has been proven for many infections, including surgical, gastrointestinal, upper respiratory, and meningococcal infections. Antiretroviral therapy for pregnant women prevents mother-to-child transmission of human immunodeficiency virus (HIV), which has become rare in settings where access to therapy is widespread. Postexposure prophylaxis after needlestick injury or significant sexual exposure is recommended on the basis of animal studies and case-control observational studies, although use of these interventions is limited to those who recognize exposure, have access, and have the power to use the interventions. Clinical trials are evaluating whether regular or preexposure use of antiretroviral therapy provides additional protection for persons at high risk of infection who are also offered standard prevention care, including HIV testing, counseling, condoms, and management of sexually transmitted infections. Trials are evaluating topical or oral use. Concerns have arisen with regard to optimal dosing strategies, costs, access, drug resistance, risk behavior, and the role of communities. Future implementation, if warranted, will be guided by the results of clinical trials in progress and engagement of communities exposed to HIV. PMID:20397962

  8. Evolving Strategies, Opportunistic Implementation: HIV Risk Reduction in Tanzania in the Context of an Incentive-Based HIV Prevention Intervention

    PubMed Central

    Packel, Laura; Keller, Ann; Dow, William H.; de Walque, Damien; Nathan, Rose; Mtenga, Sally

    2012-01-01

    Background Behavior change communication (BCC) interventions, while still a necessary component of HIV prevention, have not on their own been shown to be sufficient to stem the tide of the epidemic. The shortcomings of BCC interventions are partly due to barriers arising from structural or economic constraints. Arguments are being made for combination prevention packages that include behavior change, biomedical, and structural interventions to address the complex set of risk factors that may lead to HIV infection. Methods In 2009/2010 we conducted 216 in-depth interviews with a subset of study participants enrolled in the RESPECT study - an HIV prevention trial in Tanzania that used cash awards to incentivize safer sexual behaviors. We analyzed community diaries to understand how the study was perceived in the community. We drew on these data to enhance our understanding of how the intervention influenced strategies for risk reduction. Results We found that certain situations provide increased leverage for sexual negotiation, and these situations facilitated opportunistic implementation of risk reduction strategies. Opportunities enabled by the RESPECT intervention included leveraging conditional cash awards, but participants also emphasized the importance of exploiting new health status knowledge from regular STI testing. Risk reduction strategies included condom use within partnerships and/or with other partners, and an unexpected emphasis on temporary abstinence. Conclusions Our results highlight the importance of increasing opportunities for implementing risk reduction strategies. We found that an incentive-based intervention could be effective in part by creating such opportunities, particularly among groups such as women with limited sexual agency. The results provide new evidence that expanding regular testing of STIs is another important mechanism for providing opportunities for negotiating behavior change, beyond the direct benefits of testing. Exploiting

  9. Why blacks do not take part in HIV vaccine trials.

    PubMed Central

    Moutsiakis, Demetrius L.; Chin, P. Nancy

    2007-01-01

    BACKGROUND: AIDS is still a major cause of death. To combat this disease, researchers are developing a vaccine. Although blacks account for most new infections in the United States, they account for a low percent of experimental vaccine recipients. This study, conducted in a mid-sized U.S. city where vaccine trials are held, seeks to learn why. METHODS: We conducted 11 in-depth ethnographic interviews. Two groups were targeted: blacks who had not participated in HIV vaccine trials and blacks who had. RESULTS: Overall, three major causes of nonparticipation were identified: misinformation, fear/mistrust and stigma. Factors that favored participation included having close friends with HIV and being homosexual. CONCLUSIONS: HIV is considered by many blacks to be a gay, white disease. Steps to increase participation must include efforts to destigmatize the condition and disseminate accurate information. Efforts to address historical causes of mistrust through "education" alone are insufficient. Trust needs to be earned through long-term relationships with black communities. PMID:17393949

  10. Using HIV Networks to Inform Real Time Prevention Interventions

    PubMed Central

    Little, Susan J.; Kosakovsky Pond, Sergei L.; Anderson, Christy M.; Young, Jason A.; Wertheim, Joel O.; Mehta, Sanjay R.; May, Susanne; Smith, Davey M.

    2014-01-01

    Objective To reconstruct the local HIV-1 transmission network from 1996 to 2011 and use network data to evaluate and guide efforts to interrupt transmission. Design HIV-1 pol sequence data were analyzed to infer the local transmission network. Methods We analyzed HIV-1 pol sequence data to infer a partial local transmission network among 478 recently HIV-1 infected persons and 170 of their sexual and social contacts in San Diego, California. A transmission network score (TNS) was developed to estimate the risk of HIV transmission from a newly diagnosed individual to a new partner and target prevention interventions. Results HIV-1 pol sequences from 339 individuals (52.3%) were highly similar to sequences from at least one other participant (i.e., clustered). A high TNS (top 25%) was significantly correlated with baseline risk behaviors (number of unique sexual partners and insertive unprotected anal intercourse (p = 0.014 and p = 0.0455, respectively) and predicted risk of transmission (p<0.0001). Retrospective analysis of antiretroviral therapy (ART) use, and simulations of ART targeted to individuals with the highest TNS, showed significantly reduced network level HIV transmission (p<0.05). Conclusions Sequence data from an HIV-1 screening program focused on recently infected persons and their social and sexual contacts enabled the characterization of a highly connected transmission network. The network-based risk score (TNS) was highly correlated with transmission risk behaviors and outcomes, and can be used identify and target effective prevention interventions, like ART, to those at a greater risk for HIV-1 transmission. PMID:24901437

  11. Preventing HIV Transmission in Nigeria: Role of the Dentists

    PubMed Central

    Azodo, Clement Chinedu; Ehizele, Adebola Oluyemisi; Umoh, Agnes; Ogbebor, Gabriel

    2010-01-01

    Background: As healthcare providers, dentists are in a unique position to foster behavioural changes that are needed to stem the spread of HIV infection. This study was conducted to assess the role of dentists in the prevention of HIV transmission in Nigeria. Methods: This descriptive cross-sectional survey was conducted from June 2006 to January 2007. A multi-stage sampling technique was used to select 300 practising dentists from all parts of Nigeria. Data were collected through a self-administered questionnaire that focused on dentist demographic details, attitudes towards treating HIV-infected persons, involvement in public or clinic-based patient education on HIV and infection control. Results: Two hundred and fifty-seven questionnaires were returned completed, constituting an 86% response rate. The majority of respondents (77.8%) had their dental practice in the southern part of Nigeria, and 89% were in the age bracket of 21–40 years. HIV education by dentists was ranked as poor, as less than a quarter of respondents routinely educated patients on HIV in the clinic. Only a few dentists (33.3%) were involved in public enlightenment programme on HIV in the previous 12 months. Most of the respondents (93%) reported a willingness to treat HIV-infected patients while observing universal precautions. Good infection barrier practices were adopted by 89.9% of dentists, and disposable cartridges for local anaesthetic agents and dental needles were not reused by 93.4% of the respondents. Autoclaving was the most widely used sterilization method (73.2%), but less than half of the respondents knew how to ascertain whether sterilization was effective. Conclusion: This study revealed that efforts by Nigerian dentists to prevent HIV transmission are presently less than optimal. Therefore, there is a need for sensitisation and motivation through seminars, workshops and lectures. PMID:22135532

  12. Inhibition of Heat Shock Protein 90 Prevents HIV Rebound*

    PubMed Central

    Joshi, Pheroze; Maidji, Ekaterina; Stoddart, Cheryl A.

    2016-01-01

    HIV evades eradication because transcriptionally dormant proviral genomes persist in long-lived reservoirs of resting CD4+ T cells and myeloid cells, which are the source of viral rebound after cessation of antiretroviral therapy. Dormant HIV genomes readily produce infectious virus upon cellular activation because host transcription factors activated specifically by cell stress and heat shock mediate full-length HIV transcription. The molecular chaperone heat shock protein 90 (Hsp90) is overexpressed during heat shock and activates inducible cellular transcription factors. Here we show that heat shock accelerates HIV transcription through induction of Hsp90 activity, which activates essential HIV-specific cellular transcription factors (NF-κB, NFAT, and STAT5), and that inhibition of Hsp90 greatly reduces gene expression mediated by these factors. More importantly, we show that Hsp90 controls virus transcription in vivo by specific Hsp90 inhibitors in clinical development, tanespimycin (17-(allylamino)-17-demethoxygeldanamycin) and AUY922, which durably prevented viral rebound in HIV-infected humanized NOD scid IL-2Rγ−/− bone marrow-liver-thymus mice up to 11 weeks after treatment cessation. Despite the absence of rebound viremia, we were able to recover infectious HIV from PBMC with heat shock. Replication-competent virus was detected in spleen cells from these nonviremic Hsp90 inhibitor-treated mice, indicating the presence of a tissue reservoir of persistent infection. Our novel findings provide in vivo evidence that inhibition of Hsp90 activity prevents HIV gene expression in replication-competent cellular reservoirs that would typically cause rebound in plasma viremia after antiretroviral therapy cessation. Alternating or supplementing Hsp90 inhibitors with current antiretroviral therapy regimens could conceivably suppress rebound viremia from persistent HIV reservoirs. PMID:26957545

  13. Committed to the community: the Atlas HIV Prevention Program.

    PubMed

    Shepherd, Jennifer L; O'Caña, Frank

    2013-11-01

    Community-based organizations face multiple challenges in implementing preventive intervention programs that are both evidence based and sustainable under limited resources and staffing. This article describes the development and preliminary evaluation of the theory-based Atlas HIV prevention program, which includes a unique service-learning component and capitalizes on a committed core of volunteers. Supporting research is presented for the effectiveness among the volunteers of service learning and popular opinion leader approaches; the Atlas program was developed using these principles, in alignment with state and federal HIV prevention strategies. Nearly 40% of the Atlas volunteers were retained for more than 2 years, and 25% have served more than 3 years. During their tenure with Atlas, the volunteers demonstrated improved knowledge of HIV transmission and prevention and increased sexual efficacy, and nearly all had been tested for HIV. Community-based organizations are encouraged to incorporate service-learning when implementing prevention programs and develop committed volunteers in order to increase the effectiveness and sustainability of their prevention efforts.

  14. Components of Quality HIV/STD Prevention & Human Sexuality Education. Report of the HIV/STD Prevention & Human Sexuality Education Task Force.

    ERIC Educational Resources Information Center

    Florida State Dept. of Health and Rehabilitative Services, Tallahassee.

    This report sets forth the essential components of quality HIV/STD prevention and human sexuality education as determined by the HIV/STD Prevention and Human Sexuality Education Task Force. The first part of the report presents the purpose of the task force, background on Florida legislation on HIV/AIDS and sexuality education as part of…

  15. 'Getting to zero' in Asia and the Pacific through more strategic use of antiretrovirals for HIV prevention.

    PubMed

    Cassell, Michael M; Holtz, Timothy H; Wolfe, Mitchell I; Hahn, Michael; Prybylski, Dimitri

    2014-07-01

    Encouraged by experimental trials demonstrating the efficacy of antiretrovirals (ARVs) in preventing HIV infection, countries across the Asia-Pacific region have committed to the achievement of ambitious targets tantamount to ending AIDS. The available data suggest that some countries still can make progress through targeted condom promotion and the expansion of harm-reduction interventions, but that none may realise its vision of 'zero new HIV infections' without more strategic use of ARVs as part of a combination of HIV prevention efforts targeting key populations. Low rates of HIV testing among men who have sex with men, people who inject drugs, sex workers and other key populations evidence low treatment coverage where treatment could have the greatest impact on curbing local epidemics. Studies have demonstrated the promise of adding ARV treatment and pre-exposure prophylaxis to the existing HIV prevention toolkit, but achieving population-level impact will require service-delivery approaches that overcome traditional prevention, care and treatment program distinctions. Priorities include: (1) innovative strategies to reach, test, treat and retain in services the individuals most likely to acquire or transmit HIV; (2) task shifting and enhanced partnerships between the public sector and civil society; (3) improved 'cascade' data systems to assess and promote service uptake and retention; and (4) policy and financing reform to enhance HIV testing and treatment access among key populations.

  16. Depression Prevention Research: Design, Implementation, and Analysis of Randomized Trials.

    ERIC Educational Resources Information Center

    Munoz, Ricardo F.; And Others

    This document contains three papers concerned with prevention intervention research, a new area of depression research which has shown great promise for contributing new knowledge to the understanding of depression. The first paper, "Clinical Trials vs. Prevention Trials: Methodological Issues in Depression Research" (Ricardo F. Munoz), emphasizes…

  17. Training Manual for HIV/AIDS Prevention.

    ERIC Educational Resources Information Center

    Epps, Patricia H.; Vallenari, Allison

    This manual includes all necessary information for implementing the Champs program, which trains older elementary school students or middle/high school students to operate puppets to deliver an HIV/AIDS message to kindergarten through sixth graders. Relying on a peer approach, the Program provides scripted, prerecorded lessons intended to reach…

  18. Campus HIV Prevention Strategies: Planning for Success.

    ERIC Educational Resources Information Center

    Hoban, Mary T.; Ottenritter, Nan W.; Gascoigne, Jan L.; Kerr, Dianne L.

    This document presents the results of the National College Health Risk Behavior Survey (NCHRBS) conducted by the U.S. Centers for Disease Control (CDC) that pertain to HIV transmission. These results include sexual assault, alcohol and other drug use, and sexual behaviors. The survey was administered to a nationally representative random sample of…

  19. Paying for Prevention: Challenges to Health Insurance Coverage for Biomedical HIV Prevention in the United States

    PubMed Central

    Underhill, Kristen

    2014-01-01

    Reducing the incidence of HIV infection continues to be a crucial public health priority in the United States, especially among populations at elevated risk such as men who have sex with men, transgender women, people who inject drugs, and racial and ethnic minority communities. Although most HIV prevention efforts to date have focused on changing risky behaviors, the past decade has yielded efficacious new biomedical technologies designed to prevent infection, such as the prophylactic use of antiretroviral drugs and the first indications of an efficacious vaccine. Access to prevention technologies will be a significant part of the next decade’s response to HIV, and advocates are mobilizing to achieve more widespread use of these interventions. These breakthroughs, however, arrive at a time of escalating healthcare costs; health insurance coverage therefore raises pressing new questions about priority-setting and the allocation of responsibility for public health. The goals of this Article are to identify legal challenges and potential solutions for expanding access to biomedical HIV prevention through health insurance coverage. This Article discusses the public policy implications of HIV prevention coverage decisions, assesses possible legal grounds on which insurers may initially deny coverage for these technologies, and evaluates the extent to which these denials may survive external and judicial review. Because several of these legal grounds may be persuasive, particularly denials on the basis of medical necessity, this Article also explores alternative strategies for financing biomedical HIV prevention efforts. PMID:23356098

  20. Topical Microbicides and HIV Prevention in the Female Genital Tract

    PubMed Central

    Cottrell, Mackenzie L; Kashuba, Angela D. M.

    2014-01-01

    Worldwide, HIV disproportionately affects women who are often unable to negotiate traditional HIV preventive strategies such as condoms. In the absence of an effective vaccine or cure, chemoprophylaxis may be a valuable self-initiated alternative. Topical microbicides have been investigated as one such option. The first generation topical microbicides were non-specific, broad-spectrum antimicrobial agents, including surfactants, polyanions, and acid buffering gels, that generally exhibited contraceptive properties. After extensive clinical study, none prevented HIV infection, and their development was abandoned. Second generation topical microbicides include agents with selective mechanisms of antiviral activity. Most are currently being used for, or have previously been explored as, drugs for treatment of HIV. The most advanced of these is tenofovir 1% gel: the first topical agent shown to significantly reduce HIV infection by 39% compared to placebo. This review summarizes the evolution of topical microbicides for HIV chemoprophylaxis, highlights important concepts learned, and offers current and future considerations for this area of research. PMID:24664786

  1. HIV prevention for migrants in transit: developing and testing TRAIN.

    PubMed

    Bahromov, Mahbat; Weine, Stevan

    2011-06-01

    This study was a pilot investigation of the feasibility, acceptability, and effects of TRAIN (Transit to Russia AIDS Intervention with Newcomers) a three-session HIV preventive intervention for Tajik male labor migrants performed in transit. Sixty adult Tajik male labor migrants on the 5-day train ride from Dushanbe to Moscow were randomly assigned to either the intervention or a control condition. Each initially completed an in-person survey then another 3 days later (immediately postintervention), and participated in a cell phone survey three months later. All participants came to all intervention sessions, were satisfied with the program, and completed all postassessments. In comparison with the controls, the TRAIN group reported significant increases in condom use with sex workers and non-sex workers, condom knowledge, worry about HIV/AIDS, talking with persons about HIV/AIDS, talking with wife about HIV/AIDS, community activities, and religious activities. HIV/AIDS prevention performed in transit is feasible, accceptable, and potentially efficacious in diminishing HIV risk behaviors in labor migrants.

  2. Reducing HIV and partner violence risk among women with criminal justice system involvement: A randomized controlled trial of two Motivational Interviewing-based interventions

    PubMed Central

    Weir, Brian W.; O’Brien, Kerth; Bard, Ronda S.; Casciato, Carol J.; Maher, Julie E.; Dent, Clyde W.; Dougherty, John A.; Stark, Michael J.

    2010-01-01

    Women with histories of incarceration show high levels of risk for HIV and intimate partner violence (IPV). This randomized controlled trial with women at risk for HIV who had recent criminal justice system involvement (n=530) evaluated two interventions based on Motivational Interviewing to reduce either HIV risk or HIV and IPV risk. Baseline and 3, 6, and 9-month follow-up assessments measured unprotected intercourse, needle sharing, and IPV. Generalized estimating equations revealed that the intervention groups had significant decreases in unprotected intercourse and needle sharing, and significantly greater reductions in the odds and incidence rates of unprotected intercourse compared to the control group. No significant differences were found in changes in IPV over time between the HIV and IPV group and the control group. Motivational Interviewing-based HIV prevention interventions delivered by county health department staff appear helpful in reducing HIV risk behavior for this population. PMID:18636325

  3. A systematic review of income generation interventions, including microfinance and vocational skills training, for HIV prevention.

    PubMed

    Kennedy, Caitlin E; Fonner, Virginia A; O'Reilly, Kevin R; Sweat, Michael D

    2014-01-01

    Income generation interventions, such as microfinance or vocational skills training, address structural factors associated with HIV risk. However, the effectiveness of these interventions on HIV-related outcomes in low- and middle-income countries has not been synthesized. The authors conducted a systematic review by searching electronic databases from 1990 to 2012, examining secondary references, and hand-searching key journals. Peer-reviewed studies were included in the analysis if they evaluated income generation interventions in low- or middle-income countries and provided pre-post or multi-arm measures on behavioral, psychological, social, care, or biological outcomes related to HIV prevention. Standardized forms were used to abstract study data in duplicate and study rigor was assessed. Of the 5218 unique citations identified, 12 studies met criteria for inclusion. Studies were geographically diverse, with six conducted in sub-Saharan Africa, three in South or Southeast Asia, and three in Latin America and the Caribbean. Target populations included adult women (N = 6), female sex workers/bar workers (N = 3), and youth/orphans (N = 3). All studies targeted females except two among youth/orphans. Study rigor was moderate, with two group-randomized trials and two individual-randomized trials. All interventions except three included some form of microfinance. Only a minority of studies found significant intervention effects on condom use, number of sexual partners, or other HIV-related behavioral outcomes; most studies showed no significant change, although some may have had inadequate statistical power. One trial showed a 55% reduction in intimate partner violence (adjusted risk ratio 0.45, 95% confidence interval 0.23-0.91). No studies measured incidence/prevalence of HIV or sexually transmitted infections among intervention recipients. The evidence that income generation interventions influence HIV-related behaviors and outcomes is inconclusive. However, these

  4. A systematic review of income generation interventions, including microfinance and vocational skills training, for HIV prevention.

    PubMed

    Kennedy, Caitlin E; Fonner, Virginia A; O'Reilly, Kevin R; Sweat, Michael D

    2014-01-01

    Income generation interventions, such as microfinance or vocational skills training, address structural factors associated with HIV risk. However, the effectiveness of these interventions on HIV-related outcomes in low- and middle-income countries has not been synthesized. The authors conducted a systematic review by searching electronic databases from 1990 to 2012, examining secondary references, and hand-searching key journals. Peer-reviewed studies were included in the analysis if they evaluated income generation interventions in low- or middle-income countries and provided pre-post or multi-arm measures on behavioral, psychological, social, care, or biological outcomes related to HIV prevention. Standardized forms were used to abstract study data in duplicate and study rigor was assessed. Of the 5218 unique citations identified, 12 studies met criteria for inclusion. Studies were geographically diverse, with six conducted in sub-Saharan Africa, three in South or Southeast Asia, and three in Latin America and the Caribbean. Target populations included adult women (N = 6), female sex workers/bar workers (N = 3), and youth/orphans (N = 3). All studies targeted females except two among youth/orphans. Study rigor was moderate, with two group-randomized trials and two individual-randomized trials. All interventions except three included some form of microfinance. Only a minority of studies found significant intervention effects on condom use, number of sexual partners, or other HIV-related behavioral outcomes; most studies showed no significant change, although some may have had inadequate statistical power. One trial showed a 55% reduction in intimate partner violence (adjusted risk ratio 0.45, 95% confidence interval 0.23-0.91). No studies measured incidence/prevalence of HIV or sexually transmitted infections among intervention recipients. The evidence that income generation interventions influence HIV-related behaviors and outcomes is inconclusive. However, these

  5. 75 FR 70270 - Submission for OMB Review; Comment Request; Pretesting of NIAID's Biomedical HIV Prevention...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... NIAID's Biomedical HIV Prevention Research Communication Messages SUMMARY: In compliance with the... comment on proposed data collection projects, the National Institute of Allergy and Infectious Diseases... Collection: Title: Pretesting of NIAID's Biomedical HIV Prevention Research Communication Messages. Type...

  6. 76 FR 6484 - Submission for OMB Review; Comment Request; Pretesting of NIAID's Biomedical HIV Prevention...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-04

    ... NIAID's Biomedical HIV Prevention Research Communication Messages SUMMARY: Under the provisions of... Infectious Diseases (NIAID), the National Institutes of Health (NIH) has submitted to the Office of...: Title: Pretesting of NIAID's Biomedical HIV Prevention Research Communication Messages. Type...

  7. Global prevention, funding, accountability debated in fight against HIV / AIDS.

    PubMed

    1999-10-18

    World leaders, physicians, economists, governmental health organizations, and pharmaceutical manufacturers attended the Third International Conference on Healthcare Resource Allocation for HIV/AIDS and Other Life-threatening Illnesses in Vienna, Austria. The conference participants discussed the economic, ethical, and human rights issues underlying health care resource allocation. Some highlights of the meeting included: the prevention strategies in fighting AIDS virus; the use of high medical ethical standards; the affordability and accessibility of essential therapies; the economic aspects affecting the medical assistance mechanisms; the need to improve the pharmaceutical industry; the need to improve HIV/AIDS care access in developing countries; promoting the development of HIV/AIDS vaccines; and developing rapid diagnosis of HIV.

  8. Social and Structural HIV Prevention in Alcohol-Serving Establishments

    PubMed Central

    Kalichman, Seth C.

    2010-01-01

    Alcohol use is associated with risks for sexually transmitted infections (STIs), including HIV/AIDS. People meet new sex partners at bars and other places where alcohol is served, and drinking venues facilitate STI transmission through sexual relationships within closely knit sexual networks. This paper reviews HIV prevention interventions conducted in bars, taverns, and informal drinking venues. Interventions designed to reduce HIV risk by altering the social interactions within drinking environments have demonstrated mixed results. Specifically, venue-based social influence models have reduced community-level risk in U.S. gay bars, but these effects have not generalized to gay bars elsewhere or to other populations. Few interventions have sought to alter the structural and physical environments of drinking places for HIV prevention. Uncontrolled program evaluations have reported promising approaches to bar-based structural interventions with gay men and female sex workers. Finally, a small number of studies have examined multilevel approaches that simultaneously intervene at both social and structural levels with encouraging results. Multilevel interventions that take environmental factors into account are needed to guide future HIV prevention efforts delivered within alcohol-serving establishments. PMID:23584060

  9. Ethics of medical care and clinical research: a qualitative study of principal investigators in biomedical HIV prevention research.

    PubMed

    Haire, Bridget G

    2013-04-01

    In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must produce knowledge that may not have any immediate benefits for the research participant. This tension is exacerbated in HIV research in low and middle income countries, which frequently uncovers comorbidities other than the condition under study. Some bioethicists argue that as the goals of medicine and those of research are distinct, it is a mistake for researchers to assume therapeutic responsibilities while engaging in research. Others propose that there is a duty of care, but disagree as to how this is limited and specified. In this qualitative study, principal investigators from HIV prevention trials discuss their experience of providing medical benefits to participants within the context of conducting research into HIV biomedical prevention technologies. They describe the limitations imposed at times by funders and at times by infrastructure constraints, and canvass the importance of ancillary care provision and capacity building in trial communities. The views of the principal investigators are compatible with the perspective that there is a duty of care, limited by the nature of the research, the depth of the relationship between research and participant, and the capacity of the research site. The therapeutic orientation in HIV prevention trial appears to be indivisible from competent research practise by making concrete and appropriate benefits available to trial participants and their communities that support rather than compete with local infrastructure.

  10. Does message framing predict willingness to participate in a hypothetical HIV vaccine trial: an application of Prospect Theory.

    PubMed

    Evangeli, Michael; Kafaar, Zuhayr; Kagee, Ashraf; Swartz, Leslie; Bullemor-Day, Philippa

    2013-01-01

    It is vital that enough participants are willing to participate in clinical trials to test HIV vaccines adequately. It is, therefore, necessary to explore what affects peoples' willingness to participate (WTP) in such trials. Studies have only examined individual factors associated with WTP and not the effect of messages about trial participation on potential participants (e.g., whether losses or gains are emphasized, or whether the outcome is certain or uncertain). This study explores whether the effects of message framing on WTP in a hypothetical HIV vaccine trial are consistent with Prospect Theory. This theory suggests that people are fundamentally risk averse and that (1) under conditions of low risk and high certainty, gain-framed messages will be influential (2) under conditions of high risk and low certainty, loss-framed messages will be influential. This cross-sectional study recruited 283 HIV-negative students from a South African university who were given a questionnaire that contained matched certain gain-framed, certain loss-framed, uncertain gain-framed, and uncertain loss-framed statements based on common barriers and facilitators of WTP. Participants were asked to rate how likely each statement was to result in their participation in a hypothetical preventative HIV vaccine trial. Consistent with Prospect Theory predictions, for certain outcomes, gain-framed messages were more likely to result in WTP than loss-framed messages. Inconsistent with predictions, loss-framed message were not more likely to be related to WTP for uncertain outcomes than gain-framed messages. Older students were less likely to express their WTP across the different message frames. Recruitment for HIV vaccine trials should pay attention to how messages about the trial are presented to potential participants.

  11. Social media technologies for HIV prevention study retention among minority men who have sex with men (MSM).

    PubMed

    Young, Sean D

    2014-09-01

    This brief report describes results on study retention among minority men who have sex with men (MSM) from a 12-week, social networking-based, HIV prevention trial with 1-year follow-up. Participants, primarily minority MSM, were recruited using online and offline methods and randomly assigned to a Facebook (intervention or control) group. Participants completed a baseline survey and were asked to complete two follow-up surveys (12-week follow-up and 1-year post-intervention). 94 % of participants completed the first two surveys and over 82 % completed the baseline and both post-intervention surveys. Participants who spent a greater frequency of time online had almost twice the odds of completing all surveys. HIV negative participants, compared to those who were HIV positive, had over 25 times the odds of completing all surveys. HIV prevention studies on social networking sites can yield high participant retention rates. PMID:24062015

  12. Social media technologies for HIV prevention study retention among minority men who have sex with men (MSM).

    PubMed

    Young, Sean D

    2014-09-01

    This brief report describes results on study retention among minority men who have sex with men (MSM) from a 12-week, social networking-based, HIV prevention trial with 1-year follow-up. Participants, primarily minority MSM, were recruited using online and offline methods and randomly assigned to a Facebook (intervention or control) group. Participants completed a baseline survey and were asked to complete two follow-up surveys (12-week follow-up and 1-year post-intervention). 94 % of participants completed the first two surveys and over 82 % completed the baseline and both post-intervention surveys. Participants who spent a greater frequency of time online had almost twice the odds of completing all surveys. HIV negative participants, compared to those who were HIV positive, had over 25 times the odds of completing all surveys. HIV prevention studies on social networking sites can yield high participant retention rates.

  13. Young people and HIV prevention in Australian schools.

    PubMed

    Jones, Tiffany; Mitchell, Anne

    2014-06-01

    Australia has not seen a Human Immunodeficiency Virus (HIV) epidemic among young people. However, early research in the Australian context had indicated that the degree of unprotected sexual activity, partner change, and STI infection in this cohort would fuel a young people's epidemic if HIV ever reached a tipping point in the country. The difficulty of reaching young people outside school for HIV prevention has been no more successfully addressed in Australia than elsewhere. Therefore, the investment of Australian HIV prevention funds for youth has had an emphasis on school-based programs. This emphasis on formal schooling has led to a history of engagement with the ad hoc and unreliable nature of sexuality education in Australian schools. It has particularly been the catalyst for a struggle to construct young people as sexually active and as possessing a right to appropriate education, against tides of both secular and religiously-motivated resistance. The eight state and territory education sectors, along with the independent sectors, have had differing and sometimes troubled histories with HIV prevention. This paper discusses the differing HIV education policies and programs that have emerged in Australian schooling historically, and in some cases been abandoned altogether, amid strong public debates. It also considers current approaches, the new national curriculum, and future challenges. Additionally, the particular case of same sex attracted young men, who have a heightened level of vulnerability to HIV, is explored. Australian schools have struggled to address both the imperative for relevant sexuality education for same-sex-attracted young people and the broader issue of combating homophobia, which research has linked directly to this vulnerability. PMID:24846485

  14. Young people and HIV prevention in Australian schools.

    PubMed

    Jones, Tiffany; Mitchell, Anne

    2014-06-01

    Australia has not seen a Human Immunodeficiency Virus (HIV) epidemic among young people. However, early research in the Australian context had indicated that the degree of unprotected sexual activity, partner change, and STI infection in this cohort would fuel a young people's epidemic if HIV ever reached a tipping point in the country. The difficulty of reaching young people outside school for HIV prevention has been no more successfully addressed in Australia than elsewhere. Therefore, the investment of Australian HIV prevention funds for youth has had an emphasis on school-based programs. This emphasis on formal schooling has led to a history of engagement with the ad hoc and unreliable nature of sexuality education in Australian schools. It has particularly been the catalyst for a struggle to construct young people as sexually active and as possessing a right to appropriate education, against tides of both secular and religiously-motivated resistance. The eight state and territory education sectors, along with the independent sectors, have had differing and sometimes troubled histories with HIV prevention. This paper discusses the differing HIV education policies and programs that have emerged in Australian schooling historically, and in some cases been abandoned altogether, amid strong public debates. It also considers current approaches, the new national curriculum, and future challenges. Additionally, the particular case of same sex attracted young men, who have a heightened level of vulnerability to HIV, is explored. Australian schools have struggled to address both the imperative for relevant sexuality education for same-sex-attracted young people and the broader issue of combating homophobia, which research has linked directly to this vulnerability.

  15. Preventing perinatal transmission of HIV--costs and effectiveness of a recommended intervention.

    PubMed Central

    Gorsky, R D; Farnham, P G; Straus, W L; Caldwell, B; Holtgrave, D R; Simonds, R J; Rogers, M F; Guinan, M E

    1996-01-01

    OBJECTIVE. To calculate the national costs of reducing perinatal transmission of human immunodeficiency virus through counseling and voluntary testing of pregnant women and zidovudine treatment of infected women and their infants, as recommended by the Public Health Service, and to compare these costs with the savings from reducing the number of pediatric infections. METHOD. The authors analyzed the estimated costs of the intervention and the estimated cost savings from reducing the number of pediatric infections. The outcome measures are the number of infections prevented by the intervention and the net cost (cost of intervention minus the savings from a reduced number of pediatric HIV infections). The base model assumed that intervention participation and outcomes would resemble those found in the AIDS Clinical Trials Group Protocol 076. Assumptions were varied regarding maternal seroprevalence, participation by HIV-infected women, the proportion of infected women who accepted and completed the treatment, and the efficacy of zidovudine to illustrate the effect of these assumptions on infections prevented and net cost. RESULTS. Without the intervention, a perinatal HIV transmission rate of 25% would result in 1750 HIV-infected infants born annually in the United States, with lifetime medical-care costs estimated at $282 million. The cost of the intervention (counseling, testing, and zidovudine treatment) was estimated to be $ 67.6 million. In the base model, the intervention would prevent 656 pediatric HIV infections with a medical care cost saving of $105.6 million. The net cost saving of the intervention was $38.1 million. CONCLUSION. Voluntary HIV screening of pregnant women and ziovudine treatment for infected women and their infants resulted in cost savings under most of the assumptions used in this analysis. These results strongly support implementation of the Public Health Service recommendations for this intervention. PMID:8711101

  16. Preventing HIV: determinants of sexual behaviour.

    PubMed

    Donovan, B; Ross, M W

    2000-05-27

    AIDS has Invigorated and distorted the study of sexual behaviour. Because that study began so recently, there remain many unanswered questions about why we have sex at all, why we do sex one way rather than another, or even how we define sex. Yet in every instance in which well-designed and adequately resourced behavioural Interventions have been Implemented, these have netted success in the form of falling HIV incidences or prevalences. But, despite these successes, such interventions remain patchy and poorly supported. Perhaps humankind's traditional aversion for the public discussion of sexual matters underlies this reticence. Or maybe a new era of "creeping absolutism"--in which biomedical advances are given premature credit for what they can achieve in HIV control--has arrived.

  17. Preventing HIV: determinants of sexual behaviour.

    PubMed

    Donovan, B; Ross, M W

    2000-05-27

    AIDS has Invigorated and distorted the study of sexual behaviour. Because that study began so recently, there remain many unanswered questions about why we have sex at all, why we do sex one way rather than another, or even how we define sex. Yet in every instance in which well-designed and adequately resourced behavioural Interventions have been Implemented, these have netted success in the form of falling HIV incidences or prevalences. But, despite these successes, such interventions remain patchy and poorly supported. Perhaps humankind's traditional aversion for the public discussion of sexual matters underlies this reticence. Or maybe a new era of "creeping absolutism"--in which biomedical advances are given premature credit for what they can achieve in HIV control--has arrived. PMID:10866459

  18. HIV prevention cost-effectiveness: a systematic review

    PubMed Central

    2009-01-01

    Background After more than 25 years, public health programs have not been able to sufficiently reduce the number of new HIV infections. Over 7,000 people become infected with HIV every day. Lack of convincing evidence of cost-effectiveness (CE) may be one of the reasons why implementation of effective programs is not occurring at sufficient scale. This paper identifies, summarizes and critiques the CE literature related to HIV-prevention interventions in low- and middle-income countries during 2005-2008. Methods Systematic identification of publications was conducted through several methods: electronic databases, internet search of international organizations and major funding/implementing agencies, and journal browsing. Inclusion criteria included: HIV prevention intervention, year for publication (2005-2008), setting (low- and middle-income countries), and CE estimation (empirical or modeling) using outcomes in terms of cost per HIV infection averted and/or cost per disability-adjusted life year (DALY) or quality-adjusted life year (QALY). Results We found 21 distinct studies analyzing the CE of HIV-prevention interventions published in the past four years (2005-2008). Seventeen CE studies analyzed biomedical interventions; only a few dealt with behavioral and environmental/structural interventions. Sixteen studies focused on sub-Saharan Africa, and only a handful on Asia, Latin America and Eastern Europe. Many HIV-prevention interventions are very cost effective in absolute terms (using costs per DALY averted), and also in country-specific relative terms (in cost per DALY measured as percentage of GDP per capita). Conclusion There are several types of interventions for which CE studies are still not available or insufficient, including surveillance, abstinence, school-based education, universal precautions, prevention for positives and most structural interventions. The sparse CE evidence available is not easily comparable; thus, not very useful for decision

  19. Long-term follow-up of study participants from prophylactic HIV vaccine clinical trials in Africa.

    PubMed

    Schmidt, Claudia; Jaoko, Walter; Omosa-Manyonyi, Gloria; Kaleebu, Pontiano; Mpendo, Juliet; Nanvubya, Annet; Karita, Etienne; Bayingana, Roger; Bekker, Linda-Gail; Chomba, Elwyn; Kilembe, William; Nchabeleng, Maphoshane; Nyombayire, Julien; Stevens, Gwynn; Chetty, Paramesh; Lehrman, Jennifer; Cox, Josephine; Allen, Susan; Dally, Len; Smith, Carol; Fast, Patricia E

    2014-01-01

    Long-term safety is critical for the development and later use of a vaccine to prevent HIV/AIDS. Likewise, the persistence of vaccine-induced antibodies and their impact on HIV testing must be established. IAVI has sponsored several Phase I and IIA HIV vaccine trials enrolling healthy, HIV-seronegative African volunteers. Plasmid DNA and viral vector based vaccines were tested. No vaccine-related serious adverse events were reported. After completion of vaccine trials conducted between 2001-2007, both vaccine and placebo recipients were offered enrolment into an observational long-term follow-up study (LTFU) to monitor potential late health effects and persistence of immune responses. At scheduled 6-monthly clinic visits, a health questionnaire was administered; clinical events were recorded and graded for severity. Blood was drawn for HIV testing and cellular immune assays. 287 volunteers were enrolled; total follow-up after last vaccination was 1463 person years (median: 5.2 years). Ninety-three (93)% of volunteers reported good health at their last LTFU visit. Infectious diseases and injuries accounted for almost 50% of the 175 reported clinical events, of which over 95% were mild or moderate in severity. There were 30 six pregnancies, six incident HIV infections and 14 volunteers reported cases of social harm. Persistence of immune responses was rare. No safety signal was identified. No potentially vaccine-related medical condition, no immune mediated disease, or malignancy was reported. HIV vaccines studied in these trials had a low potential of induction of persisting HIV antibodies.

  20. Integrated Gender-Based Violence and HIV Risk Reduction Intervention for South African Men: Results of a Quasi-Experimental Field Trial

    PubMed Central

    Kalichman, Seth C.; Simbayi, Leickness C.; Cloete, Allanise; Clayford, Mario; Arnolds, Warda; Mxoli, Mpumi; Smith, Gino; Cherry, Chauncey; Shefer, Tammy; Crawford, Mary; Kalichman, Moira O.

    2010-01-01

    South Africa is in the midst of one of the world’s most devastating HIV/AIDS epidemics and there is a well documented association between violence against women and HIV transmission. Interventions that target men and integrate HIV prevention with gender-based violence prevention may demonstrate synergistic effects. A quasi-experimental field intervention trial was conducted with two communities randomly assigned to receive either: (a) a five session integrated intervention designed to simultaneously reduce gender-based violence (GBV) and HIV risk behaviors (N=242) or (b) a single 3-hour alcohol and HIV risk reduction session (N=233). Men were followed for 1, 3, and 6-months post intervention with 90% retention. Results indicated that the GBV/HIV intervention reduced negative attitudes toward women in the short term and reduced violence against women in longer term. Men in the GBV/HIV intervention also increased their talking with sex partners about condoms and were more likely to have been tested for HIV at the follow-ups. There were few differences between conditions on any HIV transmission risk reduction behavioral outcomes. Further research is needed to examine the potential synergistic effects of alcohol use, gender violence, and HIV prevention interventions. PMID:19353267

  1. Multipurpose prevention technologies: the future of HIV and STI protection

    PubMed Central

    2015-01-01

    Every day, more than 1 million people are newly infected with sexually transmitted infections (STIs) that can lead to morbidity, mortality, and an increased risk of human immunodeficiency virus (HIV) acquisition. Existing prevention and management strategies, including behavior change, condom promotion, and therapy have not reduced the global incidence and prevalence, pointing to the need for novel innovative strategies. This review summarizes important issues raised during a satellite session at the first HIV R4P conference, held in Cape Town, on October 31, 2014. We explore key STIs that are challenging public health today; new biomedical prevention approaches including multipurpose prevention technologies (MPTs); and the scientific and regulatory hurdles that must be overcome to make combination prevention tools a reality. PMID:25759332

  2. HIV Prevention in Schools: A Tool Kit for Education Leaders.

    ERIC Educational Resources Information Center

    Office of the Surgeon General (DHHS/PHS), Washington, DC.

    This packet of materials is Phase 1 of a toolkit designed to enlighten education leaders about the need for HIV prevention for youth, especially in communities of color. One element of the toolkit is a VHS videotape that features a brief message from former Surgeon General, Dr. David Satcher. The toolkit also includes a copy of a letter sent to…

  3. Adolescent Use of Two Types of HIV Prevention Agencies

    ERIC Educational Resources Information Center

    Hohman, Melinda; Shillington, Audrey M.; Min, Jong Won; Clapp, John D.; Mueller, Kristin; Hovell, Melbourne

    2008-01-01

    This study compared two groups of adolescents seeking help at HIV prevention drop-in agencies. The first group attended agencies in low-income Hispanic neighborhoods which recruited within the locale. The second group of youth attended agencies that recruited based upon a specific population--they targeted homeless and LGBQ youth. We explored the…

  4. Youth-Initiated HIV Risk and Substance Use Prevention Program.

    ERIC Educational Resources Information Center

    Goggin, K.; Metcalf, K.; Wise, D.; Kennedy, S.; Murray, T.; Burgess, D.; Reese-Smith, J.; Terhune, N.; Broadus, K.; Downes, A.; Buckendahl, H.

    This study evaluates the first year of a novel HIV and substance use prevention program for inner city youth (Offering New Youth eXperiences--ONYX). Baseline and follow-up measures of knowledge, attitudes, and risk behaviors were administered seven months apart to 441 youth participating in the ONYX program. Youth (n=71) who provided data at both…

  5. Nowhere to Run: HIV Prevention for Runaway and Homeless Youth.

    ERIC Educational Resources Information Center

    Posner, Marc

    This volume is a guide to providing effective Human Immunodeficiency Virus (HIV) and substance abuse prevention services to runaway and homeless youth. The guide is based on current research and the best programs in this field. Chapters 1 and 2 summarize what is known about runaway and homeless youth, the services these youth require if they are…

  6. Client Preferences for STD/HIV Prevention Programs.

    ERIC Educational Resources Information Center

    Hennessy, Michael; Mercier, Michele M.; Williams, Samantha P.; Arno, Janet N.

    2002-01-01

    Conducted a formative research study designed to elicit preferences for sexually transmitted disease (STD)/HIV prevention programs from clients at a midwestern STD clinic. Responses of 126 participants show preferences for mixed group or individual meetings with counselors, with extensive intervention less favored than single sessions. Discusses…

  7. Engaging Community Businesses in HIV Prevention: A Feasibility Study

    PubMed Central

    Rovniak, Liza S.; Hovell, Melbourne F.; Hofstetter, C. Richard; Blumberg, Elaine J.; Sipan, Carol L.; Batista, Marcia F.; Martinez-Donate, Ana P.; Mulvihill, Mary M.; Ayala, Guadalupe X.

    2009-01-01

    Purpose To explore the feasibility of engaging community businesses in HIV prevention. Design Randomly selected business owners/managers were asked to display discreetly wrapped condoms and brochures provided free-of-charge for 3 months. Assessments were conducted at baseline, mid-, and post-program. Customer feedback was obtained through an online survey. Setting San Diego, California neighborhood with a high rate of AIDS. Subjects Fifty-one business owners/managers representing 10 retail categories, and 52 customers. Measures Participation rates, descriptive characteristics, number of condoms and brochures distributed, customer feedback, business owners'/managers' program satisfaction and willingness to provide future support for HIV prevention. Analysis Kruskal-Wallis, Mann-Whitney U, Fisher's exact, and McNemar's tests were used to analyze data. Results The 20 business owners/managers (39%) who agreed to distribute condoms and brochures reported fewer years in business and more employees than those who agreed only to distribute brochures (20%) or refused to participate (41%), p <.05. Bars were the easiest of ten retail categories to recruit. Businesses with more employees and customers distributed more condoms and brochures, p < .05. More than 90% of customers supported distributing condoms and brochures in businesses and 96% of business owners/managers described their program experience as “positive.” Conclusion Businesses are willing to distribute condoms and brochures to prevent HIV. Policies to increase business participation in HIV prevention should be developed and tested. PMID:20465150

  8. Integrating HIV prevention into substance user treatment: current practices and challenges.

    PubMed

    Mitchell, Christopher G; Oltean, Anthony

    2007-01-01

    Despite well-organized prevention efforts, HIV continues to spread in the United States. Injection drug users (IDUs) and other substance users who engage in high-risk behaviors are at particularly high risk for contracting HIV. Substance abuse(dagger) counselors therefore are in a unique position to present HIV prevention messages to their clients. This article reports the results of a study that surveyed counselors in an urban setting (n = 116) to assess their knowledge of HIV, their current HIV prevention practices, and their attitudes about integrating HIV prevention more fully into their work. The article concludes with a discussion of the survey's limitations and its implications for training.

  9. Role of the pharmacist in pre-exposure chemoprophylaxis (PrEP) therapy for HIV prevention.

    PubMed

    Clauson, Kevin A; Polen, Hyla H; Joseph, Shine A; Zapantis, Antonia

    2009-01-01

    With a global estimate of 2.5 million new infections of HIV occurring yearly, discovering novel methods to help stem the spread of the virus is critical. The use of antiretroviral chemoprophylaxis for preventing HIV after accidental or occupational exposure and in maternal to fetal transmission has become a widely accepted method to combat HIV. Based on this success, pre-exposure chemoprophylaxis (PrEP) is being explored in at-risk patient populations such as injecting drug users, female sex workers and men who have sex with men. This off-label and unmonitored use has created a need for education and intervention by pharmacists and other healthcare professionals. Pharmacists should educate themselves on PrEP and be prepared to counsel patients about their means of obtaining it (e.g. borrowing or sharing medications and ordering from disreputable Internet pharmacies). They should also be proactive about medication therapy management in these patients due to clinically important drug interactions with PrEP medications. Only one trial exploring the safety and efficacy of tenofovir as PrEP has been completed thus far. However, five ongoing trials are in various stages and two additional studies are scheduled for the near future. Unfortunately, studies in this arena have met with many challenges that have threatened to derail progress. Ethical controversy surrounding post-trial care of participants who seroconvert during studies, as well as concerns over emerging viral resistance and logistical site problems, have already halted several PrEP trials. Information about these early trials has already filtered down to affected individuals who are experimenting with this unproven therapy as an "evening before pill". The potential for PrEP is promising; however, more extensive trials are necessary to establish its safety and efficacy. Pharmacists are well-positioned to play a key role in helping patients make choices about PrEP, managing their therapy, and developing policy

  10. Reduced HIV-stimulated T-helper cell reactivity in cord blood with short-course antiretroviral treatment for prevention of maternal–infant transmission

    PubMed Central

    Kuhn, L; Meddows-Taylor, S; Gray, G; Trabattoni, D; Clerici, M; Shearer, G M; Tiemessen, C

    2001-01-01

    T-helper cell responses to HIV have been associated with protection against maternal-infant HIV transmission in the absence of antiretroviral treatment, but the effects of antiretroviral treatment, now widely used for prevention, on development of these cell-mediated responses is unknown. We tested whether development of T-helper cell responses to HIV and other antigens would be affected by exposure to short-course regimens of zidovudine-lamivudine (ZDV-3TC) given to prevent maternal-infant HIV transmission. Cord blood samples were collected from 41 infants of HIV-infected mothers enrolled in a clinical trial in which they were treated with regimens of ZDV-3TC and from 29 infants whose HIV-infected mothers were not treated with any antiretroviral drugs. T-helper cell reactivity to HIV envelope peptides and other antigens was measured in vitro using a sensitive culture supernatant titration assay based on IL-2-dependent proliferation. Infants in the clinical trial were followed to 18 months to determine their HIV infection status, and venous blood samples were re-tested at 4·5 and 9 months for T-cell reactivity to HIV. HIV-stimulated T-helper cell reactivity in cord blood was detected 10-fold less frequently among those exposed to antiretroviral prophylaxis (2·4%) than among those unexposed (24·1%) (P = 0·007). Reductions in HIV-stimulated responses in cord blood occurred despite detectable HIV RNA (mean 3·38 standard deviation 0·76 log10 copies per ml) at delivery among treated women and occurred independent of treatment duration. Our results suggest that short-course antiretroviral treatment given to prevent maternal-infant HIV transmission may attenuate HIV-stimulated T-cell memory responses in the neonate. PMID:11298132

  11. Access for all: contextualising HIV treatment as prevention in Swaziland.

    PubMed

    Vernooij, Eva; Mehlo, Mandhla; Hardon, Anita; Reis, Ria

    2016-01-01

    This article explores how notions of the individual and population are evoked in two ongoing HIV treatment as prevention (TasP) implementation studies in Swaziland. By contrasting policy discourses with lived kinship experiences of people living with HIV, we seek to understand how TasP unfolds in the Swazi context. Data collection consisted of eight focus group discussions with people living with HIV who were members of support groups to examine their perspectives about TasP. In addition, 18 key informant interviews were conducted with study team members, national-level policy-makers and NGO representatives involved in the design of health communication messages about TasP in Swaziland. Thematic analysis was used to identify recurrent themes in transcripts and field notes. Policy-makers and people living with HIV actively resisted framing HIV treatment as a prevention technology but promoted it as (earlier) access to treatment for all. TasP was not conceptualised in terms of individual or societal benefits, which are characteristic of international public health debates; rather its locally situated meanings were embedded in kinship experiences, concerns about taking responsibility for one's own health and others, local biomedical knowledge about drug resistance, and secrecy. The findings from this study suggest that more attention is needed to understand how the global discourse of TasP becomes shaped in practice in different cultural contexts. PMID:27421047

  12. Are MSM willing to SMS for HIV prevention?

    PubMed

    Khosropour, Christine M; Lake, Jason G; Sullivan, Patrick S

    2014-01-01

    Text messaging is a potential HIV-prevention tool for men who have sex with men (MSM), specifically young MSM and MSM of color. To determine the willingness of MSM to receive text messages as part of an HIV-prevention intervention, we administered an online survey to MSM recruited from MySpace.com, which included questions about mobile phone ownership and willingness to participate in a future text message-based HIV research study. Of participants, 85% (n = 5,378) reported owning a mobile phone and 49% (n = 2,483) of mobile phone owners reported being willing to receive text messages in a future HIV research study. Black and Hispanic men were more willing than White non-Hispanic men to receive text messages. Men with a college degree were less willing to receive texts than men with a high school level of education, and men >22 years old were less likely to be willing to receive texts than those younger than 22 years of age. The authors' findings demonstrate that willingness to receive text messages as part of an HIV research study is moderate, and mirrors patterns of text message use in age and race. Variations in willingness should be taken into account when designing and implementing future interventions.

  13. Acceptability of male circumcision for prevention of HIV infection among men and women in Uganda.

    PubMed

    Albert, Lisa M; Akol, Angela; L'Engle, Kelly; Tolley, Elizabeth E; Ramirez, Catalina B; Opio, Alex; Tumwesigye, Nazarius M; Thomsen, Sarah; Neema, Stella; Baine, Sebastian O

    2011-12-01

    In the last decade, three randomized controlled trials in Kenya, South Africa, and Uganda have shown that medical male circumcision (MMC) reduces the sexual transmission of HIV from women to men. Objectives of this assessment were to measure acceptability of adult MMC and circumcision of children to inform policies regarding whether and how to promote MMC as an HIV prevention strategy. This mixed-method study, conducted across four Ugandan districts, included a two-stage household survey of 833 adult males and 842 adult females, focus group discussions, and a health provider survey. Respondents' acceptability of MMC was positive and substantial after being informed about the results of recent randomized trials. In uncircumcised men, between 40% and 62% across the districts would consider getting circumcised. Across the four districts between 60% and 86% of fathers and 49% and 95% of mothers were supportive of MMC for sons. Widespread support exists among men and women in this study for promoting MMC as part of Uganda's current 'ABC + ' HIV prevention strategy. PMID:21732902

  14. Pregnancy Incidence and Correlates during the HVTN 503 Phambili HIV Vaccine Trial Conducted among South African Women

    PubMed Central

    Latka, Mary H.; Fielding, Katherine; Gray, Glenda E.; Bekker, Linda-Gail; Nchabeleng, Maphoshane; Mlisana, Koleka; Nielson, Tanya; Roux, Surita; Mkhize, Baningi; Mathebula, Matsontso; Naicker, Nivashnee; de Bruyn, Guy; Kublin, James; Churchyard, Gavin J.

    2012-01-01

    Background HIV prevention trials are increasingly being conducted in sub-Saharan Africa. Women at risk for HIV are also at risk of pregnancy. To maximize safety, women agree to avoid pregnancy during trials, yet pregnancies occur. Using data from the HVTN 503/“Phambili” vaccine trial, we report pregnancy incidence during and after the vaccination period and identify factors, measured at screening, associated with incident pregnancy. Methods To enrol in the trial, women agreed and were supported to avoid pregnancy until 1 month after their third and final vaccination (“vaccination period”), corresponding to the first 7 months of follow-up. Unsterilized women, pooled across study arms, were analyzed. Poisson regression compared pregnancy rates during and after the vaccination period. Cox proportional hazards regression identified associations with first pregnancy. Results Among 352 women (median age 23 yrs; median follow-up 1.5 yrs), pregnancy incidence was 9.6/100 women-years overall and 6.8/100 w-yrs and 11.3/100 w-yrs during and after the vaccination period, respectively [Rate Ratio = 0.60 (0.32–1.14), p = 0.10]. In multivariable analysis, pregnancy was reduced among women who: enrolled at sites providing contraception on-site [HR = 0.43, 95% CI (0.22–0.86)]; entered the trial as injectable contraceptive users [HR = 0.37 (0.21–0.67)] or as consistent condom users (trend) [HR = 0.54 (0.28–1.04)]. Compared with women with a single partner of HIV-unknown status, pregnancy rates were increased among women with: a single partner whose status was HIV-negative [HR = 2.34(1.16–4.73)] and; 2 partners both of HIV-unknown status [HR = 4.42(1.59–12.29)]. Women with 2 more of these risk factors: marijuana use, heavy drinking, or use of either during sex, had increased pregnancy incidence [HR = 2.66 (1.24–5.72)]. Conclusions It is possible to screen South African women for pregnancy risk at trial entry. Providing injectable

  15. Technologies for HIV prevention and care: challenges for health services.

    PubMed

    Maksud, Ivia; Fernandes, Nilo Martinez; Filgueiras, Sandra Lucia

    2015-09-01

    This article aims to consider some relevant challenges to the provision of "new prevention technologies" in health services in a scenario where the "advances" in the global response to AIDS control are visible. We take as material for analysis the information currently available on the HIV post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP), treatment as prevention (TASP) and over the counter. The methodology consisted of the survey and analysis of the Biblioteca Virtual em Saúde (BVS: MEDLINE, LILACS, WHOLIS, PAHO, SciELO) articles that addressed the issue of HIV prevention and care in the context of so-called new prevention technologies. The results of the studies show that there is assistance on the ground of clinics for the treatment of disease responses, but there are several challenges related to the sphere of prevention. The articles list some challenges regarding to management, organization of services and the attention given by health professionals to users. The current context shows evidence of the effectiveness of antiretroviral therapy in reducing the risk of HIV transmission, but the challenges for the provision of preventive technologies in health services permeate health professionals and users in their individual dimensions and health services in organizational and structural dimension. Interventions should be made available in a context of community mobilization; there should be no pressure on people to make HIV testing, antiretroviral treatment or for prevention. In the management is responsible for the training of health professionals to inform, clarify and make available to users, partners and family information about the new antiretroviral use strategies.

  16. Heterologous Prime-Boost HIV-1 Vaccination Regimens in Pre-Clinical and Clinical Trials

    PubMed Central

    Brown, Scott A.; Surman, Sherri L.; Sealy, Robert; Jones, Bart G.; Slobod, Karen S.; Branum, Kristen; Lockey, Timothy D.; Howlett, Nanna; Freiden, Pamela; Flynn, Patricia; Hurwitz, Julia L.

    2010-01-01

    Currently, there are more than 30 million people infected with HIV-1 and thousands more are infected each day. Vaccination is the single most effective mechanism for prevention of viral disease, and after more than 25 years of research, one vaccine has shown somewhat encouraging results in an advanced clinical efficacy trial. A modified intent-to-treat analysis of trial results showed that infection was approximately 30% lower in the vaccine group compared to the placebo group. The vaccine was administered using a heterologous prime-boost regimen in which both target antigens and delivery vehicles were changed during the course of inoculations. Here we examine the complexity of heterologous prime-boost immunizations. We show that the use of different delivery vehicles in prime and boost inoculations can help to avert the inhibitory effects caused by vector-specific immune responses. We also show that the introduction of new antigens into boost inoculations can be advantageous, demonstrating that the effect of ‘original antigenic sin’ is not absolute. Pre-clinical and clinical studies are reviewed, including our own work with a three-vector vaccination regimen using recombinant DNA, virus (Sendai virus or vaccinia virus) and protein. Promising preliminary results suggest that the heterologous prime-boost strategy may possibly provide a foundation for the future prevention of HIV-1 infections in humans. PMID:20407589

  17. Incorporating couples-based approaches into HIV prevention for gay and bisexual men: opportunities and challenges.

    PubMed

    Purcell, David W; Mizuno, Yoko; Smith, Dawn K; Grabbe, Kristina; Courtenay-Quick, Cari; Tomlinson, Hank; Mermin, Jonathan

    2014-01-01

    Thirty years after the beginning of the HIV epidemic, gay, bisexual, and other men who have sex with men (collectively called MSM) bear a disproportionate burden of HIV in the United States and continue to acquire a distressingly high number and proportion of new infections. Historically, HIV prevention for MSM has been focused on individual-level behavior change, rarely intervening with MSM as part of a couple. Yet, an estimated 33–67% of HIV infections among MSM are acquired from primary sexual partners, suggesting that work with MSM as couples could be an important contributor to prevention. Given the emergence of high impact combination HIV prevention, it is timely to consider how work with the broad variety of male couples can improve both personal and community health. Couples HIV testing and counseling for MSM is an important advance for identifying men who are unaware that they are HIV-positive, identifying HIV-discordant couples, and supporting men who want to learn their HIV status with their partner. Once men know their HIV status, new advances in biomedical prevention, which can dramatically reduce risk of HIV transmission or acquisition, allow men to make prevention decisions that can protect themselves and their partners. This paper highlights the present-day challenges and benefits of using a couples-based approach with MSM in the era of combination prevention to increase knowledge of HIV status, increase identification of HIV discordant couples to improve targeting prevention services,and support mutual disclosure of HIV status.

  18. Structural drivers and social protection: mechanisms of HIV risk and HIV prevention for South African adolescents

    PubMed Central

    Cluver, Lucie Dale; Orkin, Frederick Mark; Meinck, Franziska; Boyes, Mark Edward; Sherr, Lorraine

    2016-01-01

    Introduction Social protection is high on the HIV-prevention agenda for youth in sub-Saharan Africa. However, questions remain: How do unconditional cash transfers work? What is the effect of augmenting cash provision with social care? And can “cash plus care” social protection reduce risks for adolescents most vulnerable to infection? This study tackles these questions by first identifying mediated pathways to adolescent HIV risks and then examining potential main and moderating effects of social protection in South Africa. Methods This study was a prospective observational study of 3515 10-to-17-year-olds (56.7% female; 96.8% one-year retention). Within randomly selected census areas in four rural and urban districts in two South African provinces, all homes with a resident adolescent were sampled between 2009/2010 and 2011/2012. Measures included 1) potential structural drivers of HIV infection such as poverty and community violence; 2) HIV risk behaviours; 3) hypothesized psychosocial mediating factors; and 4) types of social protection involving cash and care. Using gender-disaggregated analyses, longitudinal mediation models were tested for potential main and moderating effects of social protection. Results Structural drivers were associated with increased onset of adolescent HIV risk behaviour (p<0.001, B=0.06, SE=0.01), fully mediated by increased psychosocial problems. Both cash and care aspects of social protection were associated with reductions in HIV risk behaviour and psychosocial deprivations. In addition, cash social protection moderated risk pathways: for adolescent girls and boys experiencing more acute structural deprivation, social protection had the greatest associations with HIV risk prevention (e.g. moderation effects for girls: B=−0.08, p<0.002 between structural deprivation and psychosocial problems, and B=−0.07, p<0.001 between psychosocial problems and HIV risk behaviour). Conclusions Adolescents with the greatest structural

  19. HIV prevention research ethics: an introduction to the special issue.

    PubMed

    Fisher, Celia B

    2014-02-01

    This special issue of the Journal of Empirical Research on Human Research Ethics represents a sampling of projects fostered through the NIDA-funded Fordham University HIV Prevention Research Ethics Institute. The first three articles employ processes of co-learning to give voice to the experiences of individuals recovering from substance abuse and engaged in sex work who have participated in HIV prevention studies in the United States, India, and the Philippines. The fourth article describes a unique community-based approach to the development of research ethics training modules designed to increase participation of American Indian and Alaskan Native (AI/AN) tribal members as partners in research on health disparities. The last two articles focus a critical scholarly lens on two underexamined areas confronting IRB review of HIV research: The emerging and continuously changing ethical challenges of using social media sites for recruitment into HIV prevention research, and the handling of research-related complaints from participants involving perceived research harms or research experiences that do not accord with their initial expectations. Together, the articles in this special issue identify key ethical crossroads and provide suggestions for best practices that respect the values and merit the trust of research participants.

  20. Paying for prevention: challenges to health insurance coverage for biomedical HIV prevention in the United States.

    PubMed

    Underhill, Kristen

    2012-01-01

    Reducing the incidence of HIV infection continues to be a crucial public health priority in the United States, especially among populations at elevated risk such as men who have sex with men, transgender women, people who inject drugs, and racial and ethnic minority communities. Although most HIV prevention efforts to date have focused on changing risky behaviors, the past decade yielded efficacious new biomedical technologies designed to prevent infection, such as the prophylactic use of antiretroviral drugs and the first indications of an efficacious vaccine. Access to prevention technologies will be a significant part of the next decade's response to HIV and advocates are mobilizing to achieve more widespread use of these interventions. These breakthroughs, however, arrive at a time of escalating healthcare costs; health insurance coverage therefore raises pressing new questions about priority-setting and the allocation of responsibility for public health. The goals of this Article are to identify legal challenges and potential solutions for expanding access to biomedical HIV prevention through health insurance coverage. This Article discusses the public policy implications of HIVprevention coverage decisions, assesses possible legal grounds on which insurers may initially deny coverage for these technologies, and evaluates the extent to which these denials may survive external and judicial review. Because several of these legal grounds may be persuasive, particularly denials on the basis of medical necessity, this Article also explores alternative strategies for financing biomedical HIV prevention efforts.

  1. Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women

    PubMed Central

    Abdool Karim, Quarraisha; Abdool Karim, Salim S.; Frohlich, Janet A.; Grobler, Anneke C.; Baxter, Cheryl; Mansoor, Leila E.; Kharsany, Ayesha B.M.; Sibeko, Sengeziwe; Mlisana, Koleka P.; Omar, Zaheen; Gengiah, Tanuja N; Maarschalk, Silvia; Arulappan, Natasha; Mlotshwa, Mukelisiwe; Morris, Lynn; Taylor, Douglas

    2010-01-01

    The CAPRISA 004 trial assessed effectiveness and safety of a 1% vaginal gel formulation of tenofovir, a nucleotide reverse transcriptase inhibitor, for the prevention of HIV acquisition in women. A double-blind, randomized controlled trial was conducted comparing tenofovir gel (n=445) with placebo gel (n=444) in sexually active, HIV-uninfected 18-40 year-old women in urban and rural KwaZulu-Natal, South Africa HIV serostatus, safety, sexual behavior and gel and condom use were assessed at monthly follow-up visits for 30 months. HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years (wy), i.e. person time of study observation, (38/680.6wy) compared to 9.1 per 100 wy (60/660.7wy) in the placebo gel arm (Incidence Rate Ratio (IRR)=0.61; p=0.017).In high adherers (gel adherence >80%), HIV incidence was 54% lower (p=0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50-80%) and low adherers (gel adherence < 50%) the HIV incidence reduction was 38% and 28% respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall, and by 54% in women with high gel adherence. No increase in the overall adverse event rates was observed. There were no changes in viral load and no tenofovir resistance in HIV seroconvertors. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use. PMID:20643915

  2. HIV testing for HIV prevention: a comparative analysis of policies in Britain, Hungary and Sweden.

    PubMed

    Danziger, R

    1998-10-01

    This paper compares policies on named HIV testing in the context of HIV prevention in Britain, Hungary and Sweden, and considers the extent to which these policies are based on evidence of effectiveness or on other, more contextual, factors. In Britain, testing has not featured significantly as a prevention strategy, and named testing has generally been carried out only with the voluntary, informed consent of individuals. In Hungary, testing is central to HIV prevention, and is required by law of certain groups. HIV testing is carried out mainly on a voluntary basis in Sweden, but, unlike in Britain, it has been actively promoted by public health authorities. The paper contrasts the 'right not to know' one's HIV status which is widely respected in Britain, with the 'responsibility to find out' which is more pervasive in Hungary and Sweden. Although policy makers in all three countries appear convinced that their's is the right approach, there appears to be as yet a dearth of convincing evidence to support their arguments. PMID:9828953

  3. Community-based program to prevent HIV/STD infection among heterosexual black women.

    PubMed

    Painter, Thomas M; Herbst, Jeffrey H; Diallo, Dázon Dixon; White, Lisa Diane

    2014-04-18

    Heterosexual non-Hispanic black women in the United States are far more affected than women of other races or ethnicities by human immunodeficiency virus (HIV). SisterLove, Inc., a community-based organization in Atlanta, Georgia, responded to this disparity early in the epidemic by creating the Healthy Love HIV and sexually transmitted disease (STD) prevention intervention in 1989. Since then, SisterLove has been delivering the intervention to black women in metropolitan Atlanta. This report describes successful efforts by SisterLove, Inc., to develop, rigorously evaluate, and demonstrate the efficacy of Healthy Love, a 3-4-hour interactive, educational workshop, to reduce HIV- and sexually transmitted disease-related risk behaviors among heterosexual black women. On the basis of the evaluation findings, CDC packaged the intervention materials for use by service provider organizations in their efforts to reduce HIV disparities that affect black women in metropolitan Atlanta, the South, and the United States. This report also describes initiatives by SisterLove after the efficacy study to increase the potential effectiveness and reach of the Healthy Love intervention and further address HIV-related disparities that affect black women. CDC's Office of Minority Health and Health Equity selected the intervention analysis and discussion that follows to provide an example of a program that might be effective in reducing HIV-related disparities in the United States. The results of the randomized controlled efficacy trial highlight the potential of culturally tailored, interactive group intervention efforts to reduce health disparities. CDC's support for evaluating and packaging SisterLove's intervention materials, and making the materials available (www.effectiveinterventions.org) for use by service provider organizations, are important contributions toward efforts to address HIV-related disparities that affect black women.

  4. Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

    PubMed Central

    Grant, Robert M.; Lama, Javier R.; Anderson, Peter L.; McMahan, Vanessa; Liu, Albert Y.; Vargas, Lorena; Goicochea, Pedro; Casapía, Martín; Guanira-Carranza, Juan Vicente; Ramirez-Cardich, Maria E.; Montoya-Herrera, Orlando; Fernández, Telmo; Veloso, Valdilea G.; Buchbinder, Susan P.; Chariyalertsak, Suwat; Schechter, Mauro; Bekker, Linda-Gail; Mayer, Kenneth H.; Kallás, Esper Georges; Amico, K. Rivet; Mulligan, Kathleen; Bushman, Lane R.; Hance, Robert J.; Ganoza, Carmela; Defechereux, Patricia; Postle, Brian; Wang, Furong; McConnell, J. Jeff; Zheng, Jia-Hua; Lee, Jeanny; Rooney, James F.; Jaffe, Howard S.; Martinez, Ana I.; Burns, David N.; Glidden, David V.

    2011-01-01

    BACKGROUND Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. METHODS We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC–TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. RESULTS The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC–TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P = 0.005). In the FTC–TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC–TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P = 0.57). CONCLUSIONS Oral FTC–TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.) PMID:21091279

  5. Investigating combination HIV prevention: isolated interventions or complex system

    PubMed Central

    Brown, Graham; Reeders, Daniel; Dowsett, Gary W.; Ellard, Jeanne; Carman, Marina; Hendry, Natalie; Wallace, Jack

    2015-01-01

    Introduction Treatment as prevention has mobilized new opportunities in preventing HIV transmission and has led to bold new UNAIDS targets in testing, treatment coverage and transmission reduction. These will require not only an increase in investment but also a deeper understanding of the dynamics of combining behavioural, biomedical and structural HIV prevention interventions. High-income countries are making substantial investments in combination HIV prevention, but is this investment leading to a deeper understanding of how to combine interventions? The combining of interventions involves complexity, with many strategies interacting with non-linear and multiplying rather than additive effects. Discussion Drawing on a recent scoping study of the published research evidence in HIV prevention in high-income countries, this paper argues that there is a gap between the evidence currently available and the evidence needed to guide the achieving of these bold targets. The emphasis of HIV prevention intervention research continues to look at one intervention at a time in isolation from its interactions with other interventions, the community and the socio-political context of their implementation. To understand and evaluate the role of a combination of interventions, we need to understand not only what works, but in what circumstances, what role the parts need to play in their relationship with each other, when the combination needs to adapt and identify emergent effects of any resulting synergies. There is little development of evidence-based indicators on how interventions in combination should achieve that strategic advantage and synergy. This commentary discusses the implications of this ongoing situation for future research and the required investment in partnership. We suggest that systems science approaches, which are being increasingly applied in other areas of public health, could provide an expanded vocabulary and analytic tools for understanding these

  6. Quality of Care for HIV/AIDS and for Primary Prevention by HIV Specialists and Nonspecialists.

    PubMed

    Landovitz, Raphael J; Desmond, Katherine A; Gildner, Jennifer L; Leibowitz, Arleen A

    2016-09-01

    The role of HIV specialists in providing primary care to persons living with HIV/AIDS is evolving, given their increased incidence of comorbidities. Multivariate logit analysis compared compliance with sentinel preventive screening tests and interventions among publicly insured Californians with and without access to HIV specialists in 2010. Quality-of-care indicators [visit frequency, CD4 and viral load (VL) assessments, influenza vaccine, tuberculosis (TB) testing, lipid profile, glucose blood test, and Pap smears for women] were related to patient characteristics and provider HIV caseload. There were 9377 adult Medicare enrollees (71% also had Medicaid coverage) and 2076 enrollees with only Medicaid coverage. Adjusted for patient characteristics, patients seeing providers with greater HIV caseloads (>50 HIV patients) were more likely to meet visit frequency guidelines in both Medicare [98%; confidence interval (CI 97.5-98.2) and Medicaid (97%; CI 96.2-98.0), compared to 60% (CI 57.1-62.3) and 45% (CI 38.3-50.4), respectively, seeing providers without large HIV caseloads (p < 0.001). Patients seeing providers with larger caseloads were significantly more likely to have CD4 (p < 0.001), VL (p < 0.001), and TB testing (p < 0.05). A larger percentage of patients seeing large-volume Medicare providers received influenza vaccinations. Provider caseload was unrelated to lipid or glucose assessments or Pap Smears for women. Patients with access to large-volume providers were more likely to meet clinical guidelines for visits, CD4, VL, tuberculosis testing, and influenza vaccinations, and were not less likely to receive primary preventive care. Substantial insufficiencies remain in both monitoring to assess viral suppression and in preventive care. PMID:27610461

  7. Continued Follow-Up of Phambili Phase 2b Randomized HIV-1 Vaccine Trial Participants Supports Increased HIV-1 Acquisition among Vaccinated Men

    PubMed Central

    Moodie, Zoe; Metch, Barbara; Bekker, Linda-Gail; Churchyard, Gavin; Nchabeleng, Maphoshane; Mlisana, Koleka; Laher, Fatima; Roux, Surita; Mngadi, Kathryn; Innes, Craig; Mathebula, Matsontso; Allen, Mary; Bentley, Carter; Gilbert, Peter B.; Robertson, Michael; Kublin, James; Corey, Lawrence; Gray, Glenda E.

    2015-01-01

    Background The Phase 2b double-blinded, randomized Phambili/HVTN 503 trial evaluated safety and efficacy of the MRK Ad5 gag/pol/nef subtype B HIV-1 preventive vaccine vs placebo in sexually active HIV-1 seronegative participants in South Africa. Enrollment and vaccinations stopped and participants were unblinded but continued follow-up when the Step study evaluating the same vaccine in the Americas, Caribbean, and Australia was unblinded for non-efficacy. Final Phambili analyses found more HIV-1 infections amongst vaccine than placebo recipients, impelling the HVTN 503-S recall study. Methods HVTN 503-S sought to enroll all 695 HIV-1 uninfected Phambili participants, provide HIV testing, risk reduction counseling, physical examination, risk behavior assessment and treatment assignment recall. After adding HVTN 503-S data, HIV-1 infection hazard ratios (HR vaccine vs. placebo) were estimated by Cox models. Results Of the 695 eligible, 465 (67%) enrolled with 230 from the vaccine group and 235 from the placebo group. 38% of the 184 Phambili dropouts were enrolled. Enrollment did not differ by treatment group, gender, or baseline HSV-2. With the additional 1286 person years of 503-S follow-up, the estimated HR over Phambili and HVTN 503-S follow-up was 1.52 (95% CI 1.08–2.15, p = 0.02, 82 vaccine/54 placebo infections). The HR was significant for men (HR = 2.75, 95% CI 1.49, 5.06, p = 0.001) but not for women (HR = 1.12, 95% CI 0.73, 1.72, p = 0.62). Conclusion The additional follow-up from HVTN 503-S supported the Phambili finding of increased HIV-1 acquisition among vaccinated men and strengthened the evidence of lack of vaccine effect among women. Trial Registration clinicaltrials.gov NCT00413725 SA National Health Research Database DOH-27-0207-1539 PMID:26368824

  8. Information Vaccine: Using Graphic Novels as an HIV/AIDS Prevention Resource for Young Adults

    ERIC Educational Resources Information Center

    Albright, Kendra S.; Gavigan, Karen

    2014-01-01

    HIV/AIDS infections are growing at an alarming rate for young adults. In 2009, youth, ages 13-29, accounted for 39% of all new HIV infections in the U.S. (Division of HIV/ AIDS Prevention, Centers for Disease Control (CDC), 2011). South Carolina ranks eighth in the nation for new HIV cases, while the capital city of Columbia ranks seventh…

  9. Opportunities for HIV Combination Prevention to Reduce Racial and Ethnic Health Disparities

    ERIC Educational Resources Information Center

    Grossman, Cynthia I.; Purcell, David W.; Rotheram-Borus, Mary Jane; Veniegas, Rosemary

    2013-01-01

    Despite advances in HIV prevention and care, African Americans and Latino Americans remain at much higher risk of acquiring HIV, are more likely to be unaware of their HIV-positive status, are less likely to be linked to and retained in care, and are less likely to have suppressed viral load than are Whites. The first National HIV/AIDS Strategy…

  10. 77 FR 36550 - Office of Clinical and Preventive Services Funding Opportunity: National HIV Program for Enhanced...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-19

    ...: National HIV Program for Enhanced HIV/AIDS Screening and Engagement in Care Announcement Type: New. Funding Announcement Number: HHS-2012-IHS-OCPS-HIV-0001. Catalog of Federal Domestic Assistance Number: 93.933. DATES... applications for the Office of Clinical and Preventive Services: National HIV Program for Enhanced...

  11. 76 FR 66721 - CDC/HRSA Advisory Committee on HIV and STD Prevention and Treatment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-27

    ... HUMAN SERVICES Centers for Disease Control and Prevention CDC/HRSA Advisory Committee on HIV and STD... and control of HIV/AIDS and other STDs, the support of health care services to persons living with HIV/AIDS, and education of health professionals and the public about HIV/AIDS and other STDs. Matters To...

  12. Towards Combination HIV Prevention for Injection Drug Users: Addressing Addictophobia, Apathy and Inattention

    PubMed Central

    Strathdee, Steffanie A.; Shoptaw, Steven; Dyer, Typhanye Penniman; Quan, Vu Minh; Aramrattana, Apinun

    2013-01-01

    Purpose of the review Recent breakthroughs in HIV-prevention science led us to evaluate the current state of combination HIV-prevention for injection drug users (IDUs). We review the recent literature focusing on possible reasons why coverage of prevention interventions for HIV, HCV and tuberculosis among IDUs remains dismal. We make recommendations for future HIV research and policy. Recent findings IDUs disproportionately under-utilize VCT, primary care and ART, especially in countries that have the largest burden of HIV among IDUs. IDUs present later in the course of HIV infection and experience greater morbidity and mortality. Why are IDUs under-represented in HIV-prevention research, access to treatment for both HIV and addiction, and access to HIV combination prevention? Possible explanations include addictophobia, apathy, and inattention, which we describe in the context of recent literature and events. Summary This commentary discusses the current state of HIV-prevention interventions for IDUs including, VCT, NSP, OST, ART and PrEP, and discusses ways to work towards true combination HIV-prevention for IDU populations. Communities need to overcome tacit assumptions that IDUs can navigate through systems that are maintained as separate silos, and take a rights-based approach to HIV-prevention to ensure that IDUs have equitable access to life-saving prevention and treatments. PMID:22498479

  13. HIV transmission risk through anal intercourse: systematic review, meta-analysis and implications for HIV prevention

    PubMed Central

    Baggaley, Rebecca F; White, Richard G; Boily, Marie-Claude

    2010-01-01

    Background The human immunodeficiency virus (HIV) infectiousness of anal intercourse (AI) has not been systematically reviewed, despite its role driving HIV epidemics among men who have sex with men (MSM) and its potential contribution to heterosexual spread. We assessed the per-act and per-partner HIV transmission risk from AI exposure for heterosexuals and MSM and its implications for HIV prevention. Methods Systematic review and meta-analysis of the literature on HIV-1 infectiousness through AI was conducted. PubMed was searched to September 2008. A binomial model explored the individual risk of HIV infection with and without highly active antiretroviral therapy (HAART). Results A total of 62 643 titles were searched; four publications reporting per-act and 12 reporting per-partner transmission estimates were included. Overall, random effects model summary estimates were 1.4% [95% confidence interval (CI) 0.2–2.5)] and 40.4% (95% CI 6.0–74.9) for per-act and per-partner unprotected receptive AI (URAI), respectively. There was no significant difference between per-act risks of URAI for heterosexuals and MSM. Per-partner unprotected insertive AI (UIAI) and combined URAI–UIAI risk were 21.7% (95% CI 0.2–43.3) and 39.9% (95% CI 22.5–57.4), respectively, with no available per-act estimates. Per-partner combined URAI–UIAI summary estimates, which adjusted for additional exposures other than AI with a ‘main’ partner [7.9% (95% CI 1.2–14.5)], were lower than crude (unadjusted) estimates [48.1% (95% CI 35.3–60.8)]. Our modelling demonstrated that it would require unreasonably low numbers of AI HIV exposures per partnership to reconcile the summary per-act and per-partner estimates, suggesting considerable variability in AI infectiousness between and within partnerships over time. AI may substantially increase HIV transmission risk even if the infected partner is receiving HAART; however, predictions are highly sensitive to infectiousness assumptions

  14. HIV Treatment as Prevention: Issues in Economic Evaluation

    PubMed Central

    Bärnighausen, Till; Salomon, Joshua A.; Sangrujee, Nalinee

    2012-01-01

    Meyer-Rath and Over assert in another article in the July 2012 PLoS Medicine Collection, “Investigating the Impact of Treatment on New HIV Infections”, that economic evaluations of antiretroviral therapy (ART) in currently existing programs and in HIV treatment as prevention (TasP) programs should use cost functions that capture cost dependence on a number of factors, such as scale and scope of delivery, health states, ART regimens, health workers' experience, patients' time on treatment, and the distribution of delivery across public and private sectors. We argue that for particular evaluation purposes (e.g., to establish the social value of TasP) and from particular perspectives (e.g., national health policy makers) less detailed cost functions may be sufficient. We then extend the discussion of economic evaluation of TasP, describing why ART outcomes and costs assessed in currently existing programs are unlikely to be generalizable to TasP programs for several fundamental reasons. First, to achieve frequent, widespread HIV testing and high uptake of ART immediately following an HIV diagnosis, TasP programs will require components that are not present in current ART programs and whose costs are not included in current estimates. Second, the early initiation of ART under TasP will change not only patients' disease courses and treatment experiences—which can affect behaviors that determine clinical treatment success, such as ART adherence and retention—but also quality of life and economic outcomes for HIV-infected individuals. Third, the preventive effects of TasP are likely to alter the composition of the HIV-infected population over time, changing its biological and behavioral characteristics and leading to different costs and outcomes for ART. PMID:22802743

  15. HIV treatment as prevention: issues in economic evaluation.

    PubMed

    Bärnighausen, Till; Salomon, Joshua A; Sangrujee, Nalinee

    2012-01-01

    Meyer-Rath and Over assert in another article in the July 2012 PLoS Medicine Collection, "Investigating the Impact of Treatment on New HIV Infections", that economic evaluations of antiretroviral therapy (ART) in currently existing programs and in HIV treatment as prevention (TasP) programs should use cost functions that capture cost dependence on a number of factors, such as scale and scope of delivery, health states, ART regimens, health workers' experience, patients' time on treatment, and the distribution of delivery across public and private sectors. We argue that for particular evaluation purposes (e.g., to establish the social value of TasP) and from particular perspectives (e.g., national health policy makers) less detailed cost functions may be sufficient. We then extend the discussion of economic evaluation of TasP, describing why ART outcomes and costs assessed in currently existing programs are unlikely to be generalizable to TasP programs for several fundamental reasons. First, to achieve frequent, widespread HIV testing and high uptake of ART immediately following an HIV diagnosis, TasP programs will require components that are not present in current ART programs and whose costs are not included in current estimates. Second, the early initiation of ART under TasP will change not only patients' disease courses and treatment experiences--which can affect behaviors that determine clinical treatment success, such as ART adherence and retention--but also quality of life and economic outcomes for HIV-infected individuals. Third, the preventive effects of TasP are likely to alter the composition of the HIV-infected population over time, changing its biological and behavioral characteristics and leading to different costs and outcomes for ART.

  16. MTV's "Staying Alive" Global Campaign Promoted Interpersonal Communication about HIV and Positive Beliefs about HIV Prevention

    ERIC Educational Resources Information Center

    Geary, Cynthia Waszak; Burke; Holly McClain; Castelnau, Laure; Neupane; Shailes; Sall, Yacine Ba; Wong, Emily; Tucker, Heidi Toms

    2007-01-01

    In 2002 MTV launched a global multicomponent HIV prevention campaign, "Staying Alive," reaching over 166 countries worldwide. An evaluation of this campaign focused on three diverse sites: Kathmandu, Nepal; Sao Paulo, Brazil; and Dakar, Senegal. Data were collected before and after campaign implementation through population-based household…

  17. Planning ahead for implementation of long acting HIV prevention: challenges and opportunities

    PubMed Central

    Meyers, Kathrine

    2015-01-01

    Purpose of Review Broad-based access, uptake, and dissemination of daily oral HIV pre-exposure prophylaxis (PrEP) have been slow, despite strong evidence for efficacy. Effective and efficient implementation of long-acting (LA) HIV prevention products will require both analysis of the dynamics and determinants of daily oral PrEP implementation and identification of the distinct challenges and opportunities inherent in emerging technologies. Recent Findings Evidence suggests the importance of addressing implementation issues at three levels: patient, provider, and system. Patient-level factors include targeted education and messaging, tailored supports to enhance acceptability and uptake, and effective strategies for promoting adherence/persistence and retention in care. Provider-level factors include engaging a broad mix of providers, while ensuring adequate training and support for patient assessment, counseling, and follow-up. Systems-level factors include optimal delivery modalities, resource allocation, and ensuring access to populations most in need of new prevention options. Summary Formative social/behavioral research must be undertaken proactively in order to prepare for and address future implementation challenges and reduce the gap between proving efficacy in clinical trials and assuring real-world effectiveness. Conceptualizing new HIV prevention technologies as behavioral interventions at the level of the patient, provider, and system will be paramount to effective and efficient implementation. PMID:26049956

  18. Development of Topical Microbicides to Prevent the Sexual Transmission of HIV

    PubMed Central

    Buckheit, Robert W.; Watson, Karen M.; Morrow, Kathleen M.; Ham, Anthony S.

    2009-01-01

    Women comprise almost 50% of the population of people living with HIV and the majority of these women contracted the virus through sexual transmission in monogamous relationships in the developing world. In these environments, where women are not empowered to protect themselves through the negotiation of condom use, effective means of preventing HIV transmission are urgently needed. In the absence of an approved and effective vaccine, microbicides have become the strategy of choice to provide women with the ability to prevent HIV transmission from their infected partners. Topical microbicides are agents specifically developed and formulated for use in either the vaginal or rectal environment that prevent infection by sexually transmitted infectious organisms, including pathogenic viruses, bacteria and fungi. Although a microbicidal product will have many of the same properties as other anti-infective agents and would be similarly developed through human clinical trials, microbicide development bears its own challenges related to formulation and delivery and the unique environment in which the product must act, as well as the requirement to develop a product that is acceptable to the user. Herein, perspectives based on preclinical and clinical microbicide development experience, which have led to an evolving microbicide development algorithm, will be discussed. This article forms part of a special issue of Antiviral Research marking the 25th anniversary of antiretroviral drug discovery and development, Vol 85, issue 1, 2010”. PMID:19874851

  19. Configuring the users of new HIV-prevention technologies: the case of HIV pre-exposure prophylaxis.

    PubMed

    Holt, Martin

    2015-01-01

    HIV pre-exposure prophylaxis (PrEP) is a prevention technology that involves prescribing antiretroviral drugs to HIV-negative people to protect them from infection. This paper considers how the development of the technology has necessitated the parallel configuration of its users, and how this process has affected the perception and uptake of the technology. In designing a technology, potential users are typically defined, enabled and constrained, partly to create a target population (or market) for the technology, but also to reassure people that it can be used safely and effectively. This process may or may not be helpful for the uptake and use of the technology. Published research on PrEP indicates that while the technology was under trial, the primary focus was on the 'at-risk' subject in need of PrEP, with little or no consideration of the other qualities necessary for successful use. Post-trial accounts of PrEP have begun to outline desirable qualities of successful PrEP use, such as caution, compliance and being organised. It appears that the PrEP user was only partially configured during the technology's development, and the initial focus on risk has done little to counter fears of the technology, which may partially account for its slow uptake.

  20. Voluntary medical male circumcision: an HIV prevention priority for PEPFAR.

    PubMed

    Reed, Jason Bailey; Njeuhmeli, Emmanuel; Thomas, Anne Goldzier; Bacon, Melanie C; Bailey, Robert; Cherutich, Peter; Curran, Kelly; Dickson, Kim; Farley, Tim; Hankins, Catherine; Hatzold, Karin; Justman, Jessica; Mwandi, Zebedee; Nkinsi, Luke; Ridzon, Renee; Ryan, Caroline; Bock, Naomi

    2012-08-15

    As the science demonstrating strong evidence for voluntary medical male circumcision (VMMC) for HIV prevention has evolved, the President's Emergency Plan for AIDS Relief (PEPFAR) has collaborated with international agencies, donors, and partner country governments supporting VMMC programming. Mathematical models forecast that quickly reaching a large number of uncircumcised men with VMMC in strategically chosen populations may dramatically reduce community-level HIV incidence and save billions of dollars in HIV care and treatment costs. Because VMMC is a 1-time procedure that confers life-long partial protection against HIV, programs for adult men are vital short-term investments with long-term benefits. VMMC also provides a unique opportunity to reach boys and men with HIV testing and counseling services and referrals for other HIV services, including treatment. After formal recommendations by WHO in 2007, priority countries have pursued expansion of VMMC. More than 1 million males have received VMMC thus far, with the most notable successes coming from Kenya's Nyanza Province. However, a myriad of necessary cultural, political, and ethical considerations have moderated the pace of overall success. Because many millions more uncircumcised men would benefit from VMMC services now, US President Barack Obama committed PEPFAR to provide 4.7 million males with VMMC by 2014. Innovative circumcision methods-such as medical devices that remove the foreskin without injected anesthesia and/or sutures-are being rigorously evaluated. Incorporation of safe innovations into surgical VMMC programs may provide the opportunity to reach more men more quickly with services and dramatically reduce HIV incidence for all. PMID:22797745

  1. Voluntary medical male circumcision: an HIV prevention priority for PEPFAR.

    PubMed

    Reed, Jason Bailey; Njeuhmeli, Emmanuel; Thomas, Anne Goldzier; Bacon, Melanie C; Bailey, Robert; Cherutich, Peter; Curran, Kelly; Dickson, Kim; Farley, Tim; Hankins, Catherine; Hatzold, Karin; Justman, Jessica; Mwandi, Zebedee; Nkinsi, Luke; Ridzon, Renee; Ryan, Caroline; Bock, Naomi

    2012-08-15

    As the science demonstrating strong evidence for voluntary medical male circumcision (VMMC) for HIV prevention has evolved, the President's Emergency Plan for AIDS Relief (PEPFAR) has collaborated with international agencies, donors, and partner country governments supporting VMMC programming. Mathematical models forecast that quickly reaching a large number of uncircumcised men with VMMC in strategically chosen populations may dramatically reduce community-level HIV incidence and save billions of dollars in HIV care and treatment costs. Because VMMC is a 1-time procedure that confers life-long partial protection against HIV, programs for adult men are vital short-term investments with long-term benefits. VMMC also provides a unique opportunity to reach boys and men with HIV testing and counseling services and referrals for other HIV services, including treatment. After formal recommendations by WHO in 2007, priority countries have pursued expansion of VMMC. More than 1 million males have received VMMC thus far, with the most notable successes coming from Kenya's Nyanza Province. However, a myriad of necessary cultural, political, and ethical considerations have moderated the pace of overall success. Because many millions more uncircumcised men would benefit from VMMC services now, US President Barack Obama committed PEPFAR to provide 4.7 million males with VMMC by 2014. Innovative circumcision methods-such as medical devices that remove the foreskin without injected anesthesia and/or sutures-are being rigorously evaluated. Incorporation of safe innovations into surgical VMMC programs may provide the opportunity to reach more men more quickly with services and dramatically reduce HIV incidence for all.

  2. Voluntary Medical Male Circumcision: An HIV Prevention Priority for PEPFAR

    PubMed Central

    Reed, Jason Bailey; Njeuhmeli, Emmanuel; Thomas, Anne Goldzier; Bacon, Melanie C.; Bailey, Robert; Cherutich, Peter; Curran, Kelly; Dickson, Kim; Farley, Tim; Hankins, Catherine; Hatzold, Karin; Justman, Jessica; Mwandi, Zebedee; Nkinsi, Luke; Ridzon, Renee; Ryan, Caroline; Bock, Naomi

    2013-01-01

    As the science demonstrating strong evidence for voluntary medical male circumcision (VMMC) for HIV prevention has evolved, the President’s Emergency Plan for AIDS Relief (PEPFAR) has collaborated with international agencies, donors, and partner country governments supporting VMMC programming. Mathematical models forecast that quickly reaching a large number of uncircumcised men with VMMC in strategically chosen populations may dramatically reduce community-level HIV incidence and save billions of dollars in HIV care and treatment costs. Because VMMC is a 1-time procedure that confers life-long partial protection against HIV, programs for adult men are vital short-term investments with long-term benefits. VMMC also provides a unique opportunity to reach boys and men with HIV testing and counseling services and referrals for other HIV services, including treatment. After formal recommendations by WHO in 2007, priority countries have pursued expansion of VMMC. More than 1 million males have received VMMC thus far, with the most notable successes coming from Kenya’s Nyanza Province. However, a myriad of necessary cultural, political, and ethical considerations have moderated the pace of overall success. Because many millions more uncircumcised men would benefit from VMMC services now, US President Barack Obama committed PEPFAR to provide 4.7 million males with VMMC by 2014. Innovative circumcision methods—such as medical devices that remove the foreskin without injected anesthesia and/or sutures—are being rigorously evaluated. Incorporation of safe innovations into surgical VMMC programs may provide the opportunity to reach more men more quickly with services and dramatically reduce HIV incidence for all. PMID:22797745

  3. The costs of HIV prevention strategies in developing countries.

    PubMed Central

    Söderlund, N.; Lavis, J.; Broomberg, J.; Mills, A.

    1993-01-01

    Since many evaluations of HIV (human immunodeficiency virus) prevention programmes do not include data on costs, a preliminary analysis of the costs and outputs of a sample of HIV prevention projects was attempted. Case studies, representing six broad HIV prevention strategies in developing countries with differing levels of per capita gross domestic product, were sought on the basis of availability of data and potential generalizability. The six prevention strategies studied were mass media campaigns, peer education programmes, sexually transmitted disease treatment, condom social marketing, safe blood provision, and needle exchange/bleach provision programmes. Financial cost data were abstracted from published studies or were obtained directly from project coordinators. Although estimates of cost-effectiveness were not made, calculations of the relative cost per common process measure of output were compared. Condom distribution costs ranged from US$ 0.02 to 0.70 per condom distributed, and costs of strategies involving personal educational input ranged from US$ 0.15 to 12.59 per contact. PMID:8261563

  4. About the Community Oncology and Prevention Trials Research Group | Division of Cancer Prevention

    Cancer.gov

    The Community Oncology and Prevention Trials Research Group supports clinical oncology trials in cancer prevention and control in community settings. The group also supports investigator-initiated research projects in supportive, palliative and end-of-life care, and coordinates clinical oncology research projects with other NCI programs to be done in the community setting. |

  5. Biorepository for Selenium and Vitamin E Cancer Prevention Trial (SELECT) | Division of Cancer Prevention

    Cancer.gov

    As the largest prostate cancer prevention trial ever undertaken, the Selenium and Vitamin E Cancer Prevention Trial (SELECT) has assembled a substantial biorepository of specimens. To help make SELECT resources available to a wider research community, NCI and the Southwest Oncology Group are developing a plan for prostate cancer biology and nutritional science and micronutrient studies. |

  6. Traditional women's associations as channels for HIV / AIDS / STD prevention.

    PubMed

    Niang, C I

    1995-01-01

    Women of the Laobe ethnic group and the Dimba, a traditional women's association, provide advice about sexuality and reproductive health in southern Senegal. Research was initiated in October 1992 by the Cheikh Anta Diop University to determine whether these women could also help in HIV/AIDS and STD prevention activities. The study investigated men's and women's knowledge, attitudes, beliefs, and practices (KABP) related to sexuality and HIV/AIDS/STDs in the community of Kolda; practices potentially increasing women's risk of HIV/STD infection; and possibilities for integrating HIV/STD prevention messages into the interactions which take place between the Laobe and Dimba groups and the Kolda community. The KABP study was a questionnaire administered to 250 men and 250 women of reproductive age representing five ethnic groups residing in Kolda. 11 men and 14 women older than age 40 participated in in-depth sexual life history interviews. The survey and interviews indicate that people in Kolda do not generally see a link between sexual relations and STD transmission. Instead, STDs are attributed to behaviors such as urinating, walking barefoot on the urine of an already-infected person, encountering a "bad wind", and being cursed. Women may be at increased risk of HIV infection through practices designed to enhance sexual pleasure, including the insertion of organic and mineral product into the vagina, and the cutting of bumps and warts in and around the vagina. Sexual practices, knowledge, prevention through the Laobe and Dimba, and outcome and follow-up are discussed. PMID:12346870

  7. Conditional Cash Transfers and HIV/AIDS Prevention: Unconditionally Promising?

    PubMed

    Kohler, Hans-Peter; Thornton, Rebecca

    2012-06-01

    Conditional cash transfers (CCT) have recently received considerable attention as a potentially innovative and effective approach to the prevention of HIV/AIDS. We evaluate a conditional cash transfer program in rural Malawi which offered financial incentives to men and women to maintain their HIV status for approximately one year. The amounts of the reward ranged from zero to approximately 3-4 months wage. We find no effect of the offered incentives on HIV status or on reported sexual behavior. However, shortly after receiving the reward, men who received the cash transfer were 9 percentage points more likely and women were 6.7 percentage points less likely to engage in risky sex. Our analyses therefore question the "unconditional effectiveness" of CCT program for HIV prevention: CCT Programs that aim to motivate safe sexual behavior in Africa should take into account that money given in the present may have much stronger effects than rewards offered in the future, and any effect of these programs may be fairly sensitive to the specific design of the program, the local and/or cultural context, and the degree of agency an individual has with respect to sexual behaviors.

  8. Conditional Cash Transfers and HIV/AIDS Prevention: Unconditionally Promising?

    PubMed Central

    Kohler, Hans-Peter; Thornton, Rebecca

    2013-01-01

    Conditional cash transfers (CCT) have recently received considerable attention as a potentially innovative and effective approach to the prevention of HIV/AIDS. We evaluate a conditional cash transfer program in rural Malawi which offered financial incentives to men and women to maintain their HIV status for approximately one year. The amounts of the reward ranged from zero to approximately 3–4 months wage. We find no effect of the offered incentives on HIV status or on reported sexual behavior. However, shortly after receiving the reward, men who received the cash transfer were 9 percentage points more likely and women were 6.7 percentage points less likely to engage in risky sex. Our analyses therefore question the “unconditional effectiveness” of CCT program for HIV prevention: CCT Programs that aim to motivate safe sexual behavior in Africa should take into account that money given in the present may have much stronger effects than rewards offered in the future, and any effect of these programs may be fairly sensitive to the specific design of the program, the local and/or cultural context, and the degree of agency an individual has with respect to sexual behaviors. PMID:24319306

  9. Male circumcision and HIV prevention: a human rights and public health challenge.

    PubMed

    Csete, Joanne

    2007-05-01

    Three recent randomized clinical trials from Africa concluded that male circumcision can lead to a significant reduction in HIV risk for men. As a result, an exponential scale-up of services required to circumcise men is already figuring in the thinking of AIDS policy-makers at many levels. At this writing, the World Health Organization (WHO) is reviewing the three studies and other evidence, and is developing policy recommendations for making this HIV prevention intervention widely available. WHO says that this policy exercise"will need to take into account cultural and human rights considerations associated with promoting circumcision,"among other factors. In this article, Joanne Csete identifies some of the most important human rights questions that should be taken into account in the development of guidelines for national governments. The author argues that a scale-up of services to provide male circumcision provides an excellent opportunity to address issues concerning the subordination of women.

  10. HIV and family living. Preventing the spread of HIV and other diseases.

    PubMed

    Sax, P; Weinberger, H

    1995-10-01

    HIV is spread through direct contact with body fluids, such as blood, semen, vaginal fluids, and breast milk. HIV is not spread through everyday contact. People with HIV are not dangerous to the people they live with at home or in the community and with whom they have ordinary, non-sexual contact. Certain precautions should be taken, however, to minimize risk. First, personal items such as razors, toothbrushes or earrings, should not be shared. Latex gloves should be worn by uninfected family members when they may come into contact with bodily fluids, and the family members should always wash their hands with soap and water after touching blood and other fluids, even if gloves have been worn. The person with HIV can be protected by minimizing exposure to food-borne illnesses carried by raw or undercooked meat, eggs or unpasteurized milk; limiting contact with people who have colds, the flu or diarrhea; and avoiding contact with cages or litter boxes of pets. To help clarify sanitary measures, some frequently asked questions are answered. These questions address the safety of sharing food with HIV-infected people; chickenpox infection and emergence of shingles; prevention of CMV infection; toxoplasmosis and cats; spread of M. avium complex (MAC); and the safety of contact between HIV-infected people and infants.

  11. Improved Prevention Counseling by HIV Care Providers in a Multisite, Clinic-Based Intervention: Positive STEPs

    ERIC Educational Resources Information Center

    Thrun, Mark; Cook, Paul F.; Bradley-Springer, Lucy A.; Gardner, Lytt; Marks, Gary; Wright, Julie; Wilson, Tracey E.; Quinlivan, E. Byrd; O'Daniels, Christine; Raffanti, Stephen; Thompson, Melanie; Golin, Carol

    2009-01-01

    The Centers for Disease Control and Prevention have recommended that HIV care clinics incorporate prevention into clinical practice. This report summarizes HIV care providers' attitudes and counseling practices before and after they received training to deliver a counseling intervention to patients. Providers at seven HIV clinics received training…

  12. Sources of HIV-Prevention Information for Individuals at High Risk.

    ERIC Educational Resources Information Center

    Sagrestano, Lynda M.; Heiss-Wendt, Renate M.; Mizan, Ainon N.; Kittleson, Mark J.; Sarvela, Paul D.

    2001-01-01

    Identified the best methods of reaching people at high risk with HIV-prevention messages. Data from men who had sex with men, injection drug users, sex workers, HIV-positive people, heterosexuals, migrant workers, and perinatal women indicated that over 70 percent were exposed to HIV-prevention messages, though sources of exposure varied by risk…

  13. Associations between Social Capital and HIV Stigma in Chennai, India: Considerations for Prevention Intervention Design

    ERIC Educational Resources Information Center

    Sivaram, Sudha; Zelaya, Carla; Srikrishnan, A. K.; Latkin, Carl; Go, V. F.; Solomon, Suniti; Celentano, David

    2009-01-01

    Stigma against persons living with HIV/AIDS (PLHA) is a barrier to seeking prevention education, HIV testing, and care. Social capital has been reported as an important factor influencing HIV prevention and social support upon infection. In the study, we explored the associations between social capital and stigma among men and women who are…

  14. "It's Crazy Being a Black, Gay Youth." Getting Information about HIV Prevention: A Pilot Study

    ERIC Educational Resources Information Center

    Voisin, Dexter R.; Bird, Jason D. P.; Shiu, Chen-Shi; Krieger, Cathy

    2013-01-01

    Background: Access and adoption of HIV prevention information are important criteria for reducing HIV infection rates among men who have sex with men. Methods: Using focus group data, researchers sought to identify sources of HIV prevention information and barriers to adopting protective behaviors among young African American men who have sex with…

  15. 75 FR 39264 - CDC/HRSA Advisory Committee on HIV and STD Prevention and Treatment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-08

    ... CDC/HRSA Advisory Committee on HIV and STD Prevention and Treatment In accordance with section 10(a)(2..., CDC and the Administrator, HRSA, regarding activities related to prevention and control of HIV/AIDS and other STDs, the support of health care services to persons living with HIV/AIDS, and education...

  16. Combination HIV Prevention Interventions: The Potential of Integrated Behavioral and Biomedical Approaches

    PubMed Central

    Brown, Jennifer L.; Sales, Jessica M.; DiClemente, Ralph J.

    2014-01-01

    Background Combination HIV prevention interventions that integrate efficacious behavioral and biomedical strategies offer the potential to reduce new HIV infections. Purpose We overview the efficacy data for three biomedical HIV prevention approaches: microbicides, pre-exposure prophylaxis (PrEP), and an HIV vaccination, review factors associated with differential acceptability and uptake of these methods, and suggest strategies to optimize the effectiveness and dissemination of combination HIV prevention approaches. Methods A narrative review was conducted highlighting key efficacy data for microbicides, PrEP, and an HIV vaccination and summarizing acceptability data for each of the three biomedical HIV prevention approaches. Recommendations for the integration and dissemination of combined behavioral and biomedical HIV prevention approaches are provided. Results To date, microbicides and an HIV vaccination have demonstrated limited efficacy for the prevention of HIV. However, PrEP has demonstrated efficacy in reducing HIV incident infections. A diverse array of factors influences both hypothetical willingness and actual usage of each biomedical prevention method. Conclusions Strategies to effectively integrate and evaluate combination HIV prevention interventions are urgently needed. PMID:25216985

  17. Participation in Counseling Programs: High-Risk Participants are Reluctant to Accept HIV-Prevention Counseling

    ERIC Educational Resources Information Center

    Earl, Allison; Albarracin, Dolores; Durantini, Marta R.; Gunnoe, Joann B.; Leeper, Josh; Levitt, Justin H.

    2009-01-01

    HIV-prevention intervention effectiveness depends on understanding whether clients with highest need for HIV-prevention counseling accept it. With this objective, a field study with a high-risk community sample from the southeastern United States (N = 350) investigated whether initial knowledge about HIV, motivation to use condoms,…

  18. The importance of male partner involvement for women's acceptability and adherence to female-initiated HIV prevention methods in Zimbabwe.

    PubMed

    Montgomery, Elizabeth T; van der Straten, Ariane; Chidanyika, Agnes; Chipato, Tsungai; Jaffar, Shabbar; Padian, Nancy

    2011-07-01

    Enlisting male partner involvement is perceived as an important component of women's successful uptake of female-initiated HIV prevention methods. We conducted a longitudinal study among a cohort of 955 Zimbabwean women participating in a clinical trial of the effectiveness of a female-initiated HIV prevention method (the diaphragm and lubricant gel) to: (a) describe the extent to which women involved their male partners in the decision to use the study products, and (b) measure the effect perceived male partner support had on their acceptability and consistent use of these methods. Reported levels of male partner involvement in discussions and decisions regarding: joining the study, study activities, the outcome of HIV/STI test results, and product use were very high. In multivariate analyses, regular disclosure of study product use and partner approval for the diaphragm and gel were significantly associated with women's acceptability and consistent use of the products; an essential component for determining efficacy of investigational prevention methods. These results support the need for more sophisticated measurement of how couples interact to make decisions that impact study participation and investigational product use as well as more rigorous adaptations and evaluations of existing strategies to involve male partners in female-initiated HIV prevention trials.

  19. The importance of male partner involvement for women's acceptability and adherence to female-initiated HIV prevention methods in Zimbabwe.

    PubMed

    Montgomery, Elizabeth T; van der Straten, Ariane; Chidanyika, Agnes; Chipato, Tsungai; Jaffar, Shabbar; Padian, Nancy

    2011-07-01

    Enlisting male partner involvement is perceived as an important component of women's successful uptake of female-initiated HIV prevention methods. We conducted a longitudinal study among a cohort of 955 Zimbabwean women participating in a clinical trial of the effectiveness of a female-initiated HIV prevention method (the diaphragm and lubricant gel) to: (a) describe the extent to which women involved their male partners in the decision to use the study products, and (b) measure the effect perceived male partner support had on their acceptability and consistent use of these methods. Reported levels of male partner involvement in discussions and decisions regarding: joining the study, study activities, the outcome of HIV/STI test results, and product use were very high. In multivariate analyses, regular disclosure of study product use and partner approval for the diaphragm and gel were significantly associated with women's acceptability and consistent use of the products; an essential component for determining efficacy of investigational prevention methods. These results support the need for more sophisticated measurement of how couples interact to make decisions that impact study participation and investigational product use as well as more rigorous adaptations and evaluations of existing strategies to involve male partners in female-initiated HIV prevention trials. PMID:20844946

  20. A Pilot Trial of a Sexual Health Counseling Intervention for HIV-Positive Gay and Bisexual Men Who Report Anal Sex without Condoms

    PubMed Central

    Hart, Trevor A.; Stratton, Natalie; Coleman, Todd A.; Wilson, Holly A.; Simpson, Scott H.; Julien, Rick E.; Adam, Barry D.

    2016-01-01

    Background Even in the presence of promising biomedical treatment as prevention, HIV incidence among men who have sex with men has not always decreased. Counseling interventions, therefore, continue to play an important role in reducing HIV sexual transmission behaviors among gay and bisexual men and other men who have sex with men. The present study evaluated effects of a small-group counseling intervention on psychosocial outcomes and HIV sexual risk behavior. Method HIV-positive (HIV+) peer counselors administered seven 2-hour counseling sessions to groups of 5 to 8 HIV+ gay and bisexual men. The intervention employed information provision, motivational interviewing, and behavioral skills building to reduce sexual transmission risk behaviors. Results There was a significant reduction in condomless anal sex (CAS) with HIV-negative and unknown HIV-status partners, from 50.0% at baseline to 28.9% of the sample at 3-month follow-up. Findings were robust even when controlling for whether the participant had an undetectable viral load at baseline. Significant reductions were also found in the two secondary psychosocial outcomes, loneliness and sexual compulsivity. Conclusions The findings provide preliminary evidence that this intervention may offer an efficient way of concurrently reducing CAS and mental health problems, such as sexual compulsivity and loneliness, for HIV+ gay and bisexual men. Trial Registration ClinicalTrials.gov NCT02546271 PMID:27054341

  1. THE EFFECT OF A LOCAL CHANGE TEAM INTERVENTION ON STAFF ATTITUDES TOWARDS HIV SERVICE DELIVERY IN CORRECTIONAL SETTINGS:A RANDOMIZED TRIAL

    PubMed Central

    Visher, Christy A.; Hiller, Matthew; Belenko, Steven; Pankow, Jennifer; Dembo, Richard; Frisman, Linda K.; Pearson, Frank S.; Swan, Holly; Wiley, Tisha R. A.

    2015-01-01

    The National Criminal Justice Drug Abuse Treatment Studies research program conducted cluster randomized trials to test an organizational process improvement strategy for implementing evidence-based improvements in HIV services for preventing, detecting, and/or treating HIV for individuals under correctional supervision. Nine research centers conducted cluster randomized trials in which one correctional facility used a modified Network for Improvement of Addiction Treatment (NIATx) change team approach to implementing improved HIV services and the other facility used their own approach to implement the improved HIV services. This paper examines whether the intervention increased the perceived value of HIV services among staff of correctional and community HIV organizations. Baseline and follow-up measures of the perceived acceptability, feasibility, and organizational support for implementing HIV service improvements were collected from correctional, medical, and community HIV treatment staff. Results indicated that the perceived acceptability and feasibility of implementing HIV services improved among staff in the facilities using the modified NIATx change team approach as compared to staff in the comparison facilities. PMID:25299806

  2. Oral pre-exposure prophylaxis (PrEP) for prevention of HIV in serodiscordant heterosexual couples in the United States: opportunities and challenges.

    PubMed

    McMahon, James M; Myers, Julie E; Kurth, Ann E; Cohen, Stephanie E; Mannheimer, Sharon B; Simmons, Janie; Pouget, Enrique R; Trabold, Nicole; Haberer, Jessica E

    2014-09-01

    Oral HIV pre-exposure prophylaxis (PrEP) is a promising new biomedical prevention approach in which HIV-negative individuals are provided with daily oral antiretroviral medication for the primary prevention of HIV-1. Several clinical trials have demonstrated efficacy of oral PrEP for HIV prevention among groups at high risk for HIV, with adherence closely associated with level of risk reduction. In the United States (US), three groups have been prioritized for initial implementation of PrEP-injection drug users, men who have sex with men at substantial risk for HIV, and HIV-negative partners within serodiscordant heterosexual couples. Numerous demonstration projects involving PrEP implementation among MSM are underway, but relatively little research has been devoted to study PrEP implementation in HIV-serodiscordant heterosexual couples in the US. Such couples face a unique set of challenges to PrEP implementation at the individual, couple, and provider level with regard to PrEP uptake and maintenance, adherence, safety and toxicity, clinical monitoring, and sexual risk behavior. Oral PrEP also provides new opportunities for serodiscordant couples and healthcare providers for primary prevention and reproductive health. This article provides a review of the critical issues, challenges, and opportunities involved in the implementation of oral PrEP among HIV-serodiscordant heterosexual couples in the US.

  3. Oral Pre-Exposure Prophylaxis (PrEP) for Prevention of HIV in Serodiscordant Heterosexual Couples in the United States: Opportunities and Challenges

    PubMed Central

    Myers, Julie E.; Kurth, Ann E.; Cohen, Stephanie E.; Mannheimer, Sharon B.; Simmons, Janie; Pouget, Enrique R.; Trabold, Nicole; Haberer, Jessica E.

    2014-01-01

    Abstract Oral HIV pre-exposure prophylaxis (PrEP) is a promising new biomedical prevention approach in which HIV-negative individuals are provided with daily oral antiretroviral medication for the primary prevention of HIV-1. Several clinical trials have demonstrated efficacy of oral PrEP for HIV prevention among groups at high risk for HIV, with adherence closely associated with level of risk reduction. In the United States (US), three groups have been prioritized for initial implementation of PrEP—injection drug users, men who have sex with men at substantial risk for HIV, and HIV-negative partners within serodiscordant heterosexual couples. Numerous demonstration projects involving PrEP implementation among MSM are underway, but relatively little research has been devoted to study PrEP implementation in HIV-serodiscordant heterosexual couples in the US. Such couples face a unique set of challenges to PrEP implementation at the individual, couple, and provider level with regard to PrEP uptake and maintenance, adherence, safety and toxicity, clinical monitoring, and sexual risk behavior. Oral PrEP also provides new opportunities for serodiscordant couples and healthcare providers for primary prevention and reproductive health. This article provides a review of the critical issues, challenges, and opportunities involved in the implementation of oral PrEP among HIV-serodiscordant heterosexual couples in the US. PMID:25045996

  4. Pilot trial of an expressive writing intervention with HIV-positive methamphetamine-using men who have sex with men.

    PubMed

    Carrico, Adam W; Nation, Austin; Gómez, Walter; Sundberg, Jeffrey; Dilworth, Samantha E; Johnson, Mallory O; Moskowitz, Judith T; Rose, Carol Dawson

    2015-06-01

    Among men who have sex with men (MSM), the co-occurrence of trauma and stimulant use has negative implications for HIV/AIDS prevention. HIV-positive, methamphetamine-using MSM were recruited to pilot test a 7-session, multicomponent resilient affective processing (RAP) intervention that included expressive writing exercises targeting HIV-related traumatic stress. An open-phase pilot with 10 participants provided support for feasibility of intervention delivery such that 99% of the RAP sessions were completed in a 1-month period. Subsequently, 23 additional participants were enrolled in a pilot randomized controlled trial of the RAP intervention (n = 12) versus an attention-control condition that included writing exercises about neutral topics (n = 11). Acceptability was evidenced by participants randomized to RAP expressing significantly more negative emotions in their writing and reporting greater likelihood of recommending expressive writing exercises to a friend living with HIV. Over the 3-month follow-up period, attention-control participants reported significant decreases in HIV-related traumatic stress while RAP intervention participants reported no significant changes. Compared to attention-control participants, those in the RAP intervention reported significant reductions in the frequency of methamphetamine use immediately following the 1-month RAP intervention period. Thematic analyses of RAP expressive writing exercises revealed that multiple negative life events characterized by social stigma or loss contribute to the complex nature of HIV-related traumatic stress. Findings support the feasibility and acceptability of an exposure-based intervention targeting HIV-related traumatic stress. However, more intensive intervention approaches that simultaneously target trauma and stimulant use will likely be needed to optimize HIV/AIDS prevention efforts with this population. (PsycINFO Database Record

  5. Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa

    PubMed Central

    Kearns, Rachel; Siegler, Aaron J; Phaswana-Mafuya, Nancy; Bekker, Linda-Gail; Stephenson, Rob; Baral, Stefan D; Brookmeyer, Ron; Yah, Clarence S; Lambert, Andrew J; Brown, Benjamin; Rosenberg, Eli; Blalock Tharp, Mondie; de Voux, Alex; Beyrer, Chris; Sullivan, Patrick S

    2014-01-01

    coverage of PrEP for at-risk HIV-negative men. Formative qualitative research consisted of 79 in-depth interviews, and six focus group discussions in Cape Town and Port Elizabeth. Analysis of these data has informed pilot study protocol development and has been documented in peer-reviewed manuscripts. Qualitative work regarding stigma faced by South African MSM resulted in finalized scales for use in the pilot study questionnaire. A total of 37 health care providers completed training designed to facilitate clinically and culturally competent care for MSM in the Eastern Cape. Conclusions The design of a future, larger study of the HIV prevention package will be conducted at the end of the pilot study, powered to detect efficacy of the prevention package. Data from the updated mathematical model, results of the pilot study, acceptability data, and advancements in HIV prevention sciences will be considered in developing the final proposed package and study design. Trial Registration ClinicalTrials.gov NCT02043015; http://clinicaltrials.gov/show/NCT02043015 (Archived by WebCite at http://www.webcitation.org/6THvp7rAj). PMID:25325296

  6. HIV, sex, and social change: applying ESID principles to HIV prevention research.

    PubMed

    Fernández, M Isabel; Bowen, G Stephen; Gay, Caryl L; Mattson, Tiffany R; Bital, Evelyne; Kelly, Jeffrey A

    2003-12-01

    The HIV epidemic has been the most significant public health crisis of the last 2 decades. Although Experimental Social Innovation and Dissemination (ESID) principles have been used by many HIV prevention researchers, the clearest application is the series of model-building and replication experiments conducted by Kelly and colleagues. The model mobilized, trained, and engaged key opinion leaders to serve as behavior change and safe-sex endorsers in their social networks. This paper illustrates how ESID principles were used to develop, test, and disseminate an innovative social model and discusses the challenges of applying ESID methodology in the midst of a public health emergency. PMID:14703268

  7. Where are the young men in HIV prevention efforts? Comments on HIV prevention programs and research from young men who sex with men in Los Angeles county.

    PubMed

    Holloway, Ian W; Cederbaum, Julie A; Ajayi, Antonette; Shoptaw, Steven

    2012-12-01

    Despite increasing rates of HIV infection among young men who have sex with men (YMSM), only a minority participate in formal HIV prevention efforts. Semi-structured mixed-methods interviews were conducted with a diverse sample of YMSM (N = 100, M(age) = 25.0 years) in Los Angeles, California, to identify facilitators and barriers to participation in HIV prevention programs. Summative content analyses were used to evaluate transcribed field notes from these interviews. Results showed that 28.0 % of all participants had previously attended an HIV prevention program, and that 21.3 % of those who were also asked if they had ever participated in any research pertaining to HIV prevention had done so. A significantly higher percentage of those who had participated in HIV prevention programs had been tested for HIV in the past 6 months compared to those who had not (p < .05). The most frequently mentioned barriers to participation in such a program were being too busy to attend (12.0 %), not perceiving themselves to be at risk for HIV infection (14.0 %), and believing that they already knew everything they needed to know about HIV transmission (23.0 %). YMSM suggested that future interventions should use technology (e.g., the Internet, mobile devices), engage their social networks, and highlight HIV prevention as a means for community connection. Collectively, these results provide some explanations for why YMSM account for a minority of HIV prevention program participants and offer possible directions for future HIV prevention efforts that target YMSM. PMID:23132515

  8. AIDS and promiscuity: muddles in the models of HIV prevention.

    PubMed

    Bolton, R

    1992-05-01

    AIDS has been blamed on promiscuity and the promiscuous, and a major goal of many HIV-prevention programs has been to induce people to reduce the number of their sexual partners. Despite the salience of this concept in the AIDS discourse of scientists, policymakers, the media, religious leaders, and the gay community, critical analysis of the role of promiscuity in this epidemic has been lacking. Following a review of promiscuity in various genres of AIDS discourse, this article discusses promiscuity in American society and in HIV-prevention campaigns. The relative risks associated with monogamy, abstinence and promiscuity are examined, and the author concludes that the partner-reduction strategy, instead of contributing to a reduction in HIV transmission has been an impediment to AIDS prevention efforts, exacerbating the problem by undermining the sex-positive approaches to risk reduction that have proven effective. Responsibility for this misguided strategy is attributed to a moralistic approach to AIDS and to the misapplication of epidemiological concepts and inappropriate social science models to the task of promoting healthy forms of sexuality.

  9. 3 CFR 13649 - Executive Order 13649 of July 15, 2013. Accelerating Improvements in HIV Prevention and Care in...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Improvements in HIV Prevention and Care in the United States Through the HIV Care Continuum Initiative 13649... Accelerating Improvements in HIV Prevention and Care in the United States Through the HIV Care Continuum... respond to the ongoing domestic HIV epidemic, it is hereby ordered as follows: Section 1....

  10. Social network characteristics and HIV vulnerability among transgender persons in San Salvador: identifying opportunities for HIV prevention strategies.

    PubMed

    Barrington, Clare; Wejnert, Cyprian; Guardado, Maria Elena; Nieto, Ana Isabel; Bailey, Gabriela Paz

    2012-01-01

    The purpose of this study is to improve understanding of HIV vulnerability and opportunities for HIV prevention within the social networks of male-to-female transgender persons in San Salvador, El Salvador. We compare HIV prevalence and behavioral data from a sample of gay-identified men who have sex with men (MSM) (n = 279), heterosexual or bisexual identified MSM (n = 229) and transgender persons (n = 67) recruited using Respondent Driven Sampling. Transgender persons consistently reported higher rates of HIV risk behavior than the rest of the study population and were significantly more likely to be involved in sex work. While transgender persons reported the highest rates of exposure to HIV educational activities they had the lowest levels of HIV-related knowledge. Transgender respondents' social networks were homophilous and efficient at recruiting other transgender persons. Findings suggest that transgender social networks could provide an effective and culturally relevant opportunity for HIV prevention efforts in this vulnerable population.

  11. Thirty years of condom-based HIV prevention by gay men in New Zealand.

    PubMed

    Hughes, Anthony J; Saxton, Peter J

    2015-12-01

    Three decades after the first government-funded HIV prevention campaign in 1985, gay and bisexual men (GBM) remain the population most at risk of infection in New Zealand. We review the major determinants of the elevated HIV risk for GBM, describe New Zealand's prevention response over the first 30 years, and summarise the public health record. HIV incidence among GBM is driven by the heightened biological efficiency of HIV transmission during unprotected anal intercourse, dense sexual partnering networks, and endemic HIV prevalence. Responses in New Zealand have emphasised evidence-based primary prevention by condom use, which were implemented in communities and supported by comprehensive public health action. New Zealand has a good international HIV prevention record among GBM, however HIV diagnosis rates are now higher than they were during the epidemic nadir of the late 1990s. Lessons from the first three decades must underpin future HIV control efforts. PMID:26913905

  12. Assessment of topical microbicides to prevent HIV-1 transmission: concepts, testing, lessons learned.

    PubMed

    Friend, David R; Kiser, Patrick F

    2013-09-01

    The development of topically applied products capable of preventing vaginal and rectal transmission of HIV-1 has been on-going for nearly 20 years. Despite this, only one clinical trial has demonstrated protection against sexual transmission of HIV-1 in women. This review covers the development of microbicides, also referred to as topical pre-exposure prophylaxis (PrEP), through three stages. The first stage focused on nonspecific agents, including surfactants such as nonoxynol-9 (N-9), to prevent HIV-1 transmission. Unfortunately, N-9 enhanced susceptibility to sexual transmission of HIV-1 when evaluated for efficacy. Soon thereafter, other nonspecific agents (polyanions) were quickly moved into large efficacy trials. Due to a lack of coordination among investigators and funders, a large investment was made in a class of compounds shown ultimately to be ineffective, although poor adherence may have contributed to these findings. The second stage involved the assessment of the antiretroviral drug tenofovir, formulated as a vaginal gel, which was found to be modestly effective in a Phase IIb trial (CAPRISA-004) when dosed in a coitally-dependent manner. In another Phase IIb trial, VOICE (MTN-003), tenofovir gel was found to be ineffective when dosed once-daily in a coitally-independent manner. Based on pharmacokinetic data, it was concluded the participants were poorly adherent to this dosing regimen, leading to a lack of efficacy. Tenofovir gel is currently in a Phase III safety and efficacy trial in South Africa (FACTS-001), using the coitally-dependent dosing regimen employed in CAPRISA-004. We are now in the third stage of microbicide research. The antiretroviral drug dapivirine is currently in two Phase III safety and efficacy studies formulated as a vaginal ring. It is hoped that the once-monthly dosing regimen will lead to higher adherence than found in the VOICE study. It is now clear that product adherence could be the greatest challenge to demonstrating

  13. Developing a family-based HIV prevention intervention in rural Kenya: challenges in conducting community-based participatory research.

    PubMed

    Puffer, Eve S; Pian, Jessica; Sikkema, Kathleen J; Ogwang-Odhiambo, Rose A; Broverman, Sherryl A

    2013-04-01

    Community-Based Participatory research (CBPR) introduces new ethical challenges for HIV prevention studies in low-resource international settings. We describe a CBPR study in rural Kenya to develop and pilot a family-based HIV prevention and mental health promotion intervention. Academic partners (APs) worked with a community advisory committee (CAC) during formative research, intervention development, and a pilot trial. Ethical challenges emerged related to: negotiating power imbalances between APs and the CAC; CAC members' shifting roles as part of the CAC and wider community; and anticipated challenges in decision making about sustainability. Factors contributing to ethical dilemmas included low access to education, scarcity of financial resources, and the shortage of HIV-related services despite high prevalence.

  14. Sources of Racial/Ethnic Differences in Awareness of HIV Vaccine Trials

    PubMed Central

    Andrasik, Michele; Landers, Stewart; Karuna, Shelly; Mimiaga, Matthew J.; Wakefield, Steven; Mayer, Kenneth; Buchbinder, Susan; Koblin, Beryl A.

    2014-01-01

    Objectives. We explored the relative effects of 2 awareness components—exposure and attention—on racial/ethnic differences in HIV vaccine trial awareness among men who have sex with men (MSM). Methods. Surveys assessing awareness of and attitudes toward HIV vaccine trials were administered to 1723 MSM in 6 US cities. Proxy measures of exposure included use of HIV resources and other health care services, community involvement, income, and residence. Attention proxy measures included research attitudes, HIV susceptibility, and HIV message fatigue. Using logistic regression models, we assessed the extent to which these proxies accounted for racial/ethnic differences in vaccine trial awareness. Results. White MSM reported significantly (P < .01) higher rates of HIV vaccine trial awareness (22%) compared with Latino (17%), Black (13%) and “other” (13%) MSM. Venue-based exposure proxies and research-directed attitudinal attention proxies were significantly associated with awareness, but only accounted for the White-Latino disparity in awareness. No proxies accounted for the White-Black or White-“other” differentials in awareness. Conclusions. Sources of disparities in awareness of HIV vaccine trials remain to be explained. Future trials seeking to promote diverse participation should explore additional exposure and attention mediators. PMID:24922153

  15. Optimal Combinations of Broadly Neutralizing Antibodies for Prevention and Treatment of HIV-1 Clade C Infection

    PubMed Central

    Wagh, Kshitij; Bhattacharya, Tanmoy; Williamson, Carolyn; Robles, Alex; Bayne, Madeleine; Garrity, Jetta; Rist, Michael; Rademeyer, Cecilia; Yoon, Hyejin; Lapedes, Alan; Gao, Hongmei; Greene, Kelli; Louder, Mark K.; Kong, Rui; Karim, Salim Abdool; Burton, Dennis R.; Barouch, Dan H.; Nussenzweig, Michel C.; Mascola, John R.; Morris, Lynn; Montefiori, David C.; Korber, Bette; Seaman, Michael S.

    2016-01-01

    The identification of a new generation of potent broadly neutralizing HIV-1 antibodies (bnAbs) has generated substantial interest in their potential use for the prevention and/or treatment of HIV-1 infection. While combinations of bnAbs targeting distinct epitopes on the viral envelope (Env) will likely be required to overcome the extraordinary diversity of HIV-1, a key outstanding question is which bnAbs, and how many, will be needed to achieve optimal clinical benefit. We assessed the neutralizing activity of 15 bnAbs targeting four distinct epitopes of Env, including the CD4-binding site (CD4bs), the V1/V2-glycan region, the V3-glycan region, and the gp41 membrane proximal external region (MPER), against a panel of 200 acute/early clade C HIV-1 Env pseudoviruses. A mathematical model was developed that predicted neutralization by a subset of experimentally evaluated bnAb combinations with high accuracy. Using this model, we performed a comprehensive and systematic comparison of the predicted neutralizing activity of over 1,600 possible double, triple, and quadruple bnAb combinations. The most promising bnAb combinations were identified based not only on breadth and potency of neutralization, but also other relevant measures, such as the extent of complete neutralization and instantaneous inhibitory potential (IIP). By this set of criteria, triple and quadruple combinations of bnAbs were identified that were significantly more effective than the best double combinations, and further improved the probability of having multiple bnAbs simultaneously active against a given virus, a requirement that may be critical for countering escape in vivo. These results provide a rationale for advancing bnAb combinations with the best in vitro predictors of success into clinical trials for both the prevention and treatment of HIV-1 infection. PMID:27028935

  16. Optimal combinations of broadly neutralizing antibodies for prevention and treatments of HIV-1 clade C infection

    DOE PAGESBeta

    Wagh, Kshitij; Bhattacharya, Tanmoy; Williamson, Carolyn; Robles, Alex; Bayne, Madeleine; Garrity, Jetta; Rist, Michael; Rademeyer, Cecilia; Yoon, Hyejin; Lapedes, Alan Scott; et al

    2016-03-30

    In this study, the identification of a new generation of potent broadly neutralizing HIV-1 antibodies (bnAbs) has generated substantial interest in their potential use for the prevention and/or treatment of HIV-1 infection. While combinations of bnAbs targeting distinct epitopes on the viral envelope (Env) will likely be required to overcome the extraordinary diversity of HIV-1, a key outstanding question is which bnAbs, and how many, will be needed to achieve optimal clinical benefit. We assessed the neutralizing activity of 15 bnAbs targeting four distinct epitopes of Env, including the CD4-binding site (CD4bs), the V1/V2-glycan region, the V3-glycan region, and themore » gp41 membrane proximal external region (MPER), against a panel of 200 acute/early clade C HIV-1 Env pseudoviruses. A mathematical model was developed that predicted neutralization by a subset of experimentally evaluated bnAb combinations with high accuracy. Using this model, we performed a comprehensive and systematic comparison of the predicted neutralizing activity of over 1,600 possible double, triple, and quadruple bnAb combinations. The most promising bnAb combinations were identified based not only on breadth and potency of neutralization, but also other relevant measures, such as the extent of complete neutralization and instantaneous inhibitory potential (IIP). By this set of criteria, triple and quadruple combinations of bnAbs were identified that were significantly more effective than the best double combinations, and further improved the probability of having multiple bnAbs simultaneously active against a given virus, a requirement that may be critical for countering escape in vivo. These results provide a rationale for advancing bnAb combinations with the best in vitro predictors of success into clinical trials for both the prevention and treatment of HIV-1 infection.« less

  17. Effectiveness of HIV/STD Sexual Risk Reduction Groups for Women in Substance Abuse Treatment Programs: Results of a NIDA Clinical Trials Network Trial

    PubMed Central

    Tross, Susan; Campbell, Aimee N. C.; Cohen, Lisa R.; Calsyn, Donald; Pavlicova, Martina; Miele, Gloria; Hu, Mei-Chen; Haynes, Louise; Nugent, Nancy; Gan, Weijin; Hatch-Maillette, Mary; Mandler, Raul; McLaughlin, Paul; El-Bassel, Nabila; Crits-Christoph, Paul; Nunes, Edward V.

    2009-01-01

    Context Since drug-involved women are among the fastest growing groups with AIDS, sexual risk reduction intervention for them is a public health imperative. Objective Test effectiveness of HIV/STD safer sex skills building (SSB) groups for women in community drug treatment. Design Randomized trial of SSB versus standard HIV/STD Education (HE); assessments at baseline, 3- and 6- months Participants Women recruited from 12 methadone or psychosocial treatment programs in NIDA’s Clinical Trials Network. 515 women with ≥ one unprotected vaginal or anal sex occasion (USO) with a male partner in the past 6 months were randomized. Interventions In SSB, five 90-minute groups used problem-solving and skills rehearsal to increase HIV/STD risk awareness, condom use and partner negotiation skills. In HE, one 60-minute group covered HIV/STD disease, testing, treatment, and prevention information. Main Outcome Number of USOs at follow up. Results A significant difference in mean USOs was obtained between SSB and HE over time (F=67.2, p<.0001). At 3 months, significant decrements were observed in both conditions. At 6 months SSB maintained the decrease, HE returned to baseline (p<.0377). Women in SSB had 29% fewer USOs than those in HE. Conclusions Skills building interventions can produce ongoing sexual risk reduction in women in community drug treatment. PMID:18645513

  18. A Sequential Phase 2b Trial Design for Evaluating Vaccine Efficacy and Immune Correlates for Multiple HIV Vaccine Regimens

    PubMed Central

    Gilbert, Peter B.; Grove, Douglas; Gabriel, Erin; Huang, Ying; Gray, Glenda; Hammer, Scott M.; Buchbinder, Susan P.; Kublin, James; Corey, Lawrence; Self, Steven G.

    2012-01-01

    Five preventative HIV vaccine efficacy trials have been conducted over the last 12 years, all of which evaluated vaccine efficacy (VE) to prevent HIV infection for a single vaccine regimen versus placebo. Now that one of these trials has supported partial VE of a prime-boost vaccine regimen, there is interest in conducting efficacy trials that simultaneously evaluate multiple prime-boost vaccine regimens against a shared placebo group in the same geographic region, for accelerating the pace of vaccine development. This article proposes such a design, which has main objectives (1) to evaluate VE of each regimen versus placebo against HIV exposures occurring near the time of the immunizations; (2) to evaluate durability of VE for each vaccine regimen showing reliable evidence for positive VE; (3) to expeditiously evaluate the immune correlates of protection if any vaccine regimen shows reliable evidence for positive VE; and (4) to compare VE among the vaccine regimens. The design uses sequential monitoring for the events of vaccine harm, non-efficacy, and high efficacy, selected to weed out poor vaccines as rapidly as possible while guarding against prematurely weeding out a vaccine that does not confer efficacy until most of the immunizations are received. The evaluation of the design shows that testing multiple vaccine regimens is important for providing a well-powered assessment of the correlation of vaccine-induced immune responses with HIV infection, and is critically important for providing a reasonably powered assessment of the value of identified correlates as surrogate endpoints for HIV infection. PMID:23181167

  19. Phase 0/I/II Cancer Prevention Clinical Trials Program (Consortia) | Division of Cancer Prevention

    Cancer.gov

    Five cancer research centers lead multiple collaborative networks to assess potential cancer preventive agents and to conduct early clinical development of promising preventive agents. Also called the Consortia for Early Phase Prevention Trials, the studies require extensive biomarker analysis, investigation of the biologic effects of the cancer preventive agents on their intended molecular targets and on multiple endpoints associated with carcinogenesis, and correlation with clinically relevant endpoints.  | Systematic early clinical development of promising preventive agents through five major medical research centers.

  20. Implications of Mobility Patterns and HIV Risks for HIV Prevention Among Migrant Market Vendors in Kazakhstan

    PubMed Central

    Gilbert, Louisa; Terlikbayeva, Assel; West, Brooke; Bearman, Peter; Wu, Elwin; Zhussupov, Baurzhan; Platais, Ingrida; Brisson, Anne

    2011-01-01

    Objectives. We examined the relationships between mobility characteristics and sexual risk behaviors among male and female migrant market vendors in Almaty, Kazakhstan. Methods. Participants completed a structured interview covering sociodemographics, mobility characteristics, sexual behaviors, and biomarkers for HIV, HCV, and syphilis. We used multivariate analyses to examine associations between mobility patterns and HIV risks after adjusting for sociodemographics. Results. Longer duration of a participant's last trip outside Almaty increased the odds of reporting multiple sexual partners. More frequent travel to visit family or friends was associated with multiple sexual partners and unprotected sex with steady partners. More frequent travel to buy goods in the past year was associated with multiple sexual partners. Men who traveled more often to buy goods were more likely to have purchased sex within the previous 90 days. Conclusions. Relationships between mobility patterns and sexual risk behaviors underscore the need for HIV-prevention strategies targeting the specific transmission dynamics that migrant vendors are likely to present. PMID:21493929

  1. Selection of HIV vaccine candidates for concurrent testing in an efficacy trial.

    PubMed

    Huang, Ying; DiazGranados, Carlos; Janes, Holly; Huang, Yunda; deCamp, Allan C; Metch, Barbara; Grant, Shannon; Sanchez, Brittany; Phogat, Sanjay; Koutsoukos, Marguerite; Kanesa-Thasan, Niranjan; Bourguignon, Patricia; Collard, Alix; Buchbinder, Susan; Tomaras, Georgia D; McElrath, Julie; Gray, Glenda; Kublin, James G; Corey, Lawrence; Gilbert, Peter B

    2016-04-01

    Phase IIb or III HIV-1 vaccine efficacy trials are generally large and operationally challenging. To mitigate this challenge, the HIV Vaccine Trials Network is designing a Phase IIb efficacy trial accommodating the evaluation of multiple vaccine regimens concurrently. As this efficacy trial would evaluate a limited number of vaccine regimens, there is a need to develop a framework for optimizing the strategic selection of regimens from the large number of vaccine candidates tested in Phase I/IIa trials. In this paper we describe the approaches for the selection process, including the choice of immune response endpoints and the statistical criteria and algorithms. We illustrate the selection approaches using data from HIV-1 vaccine trials.

  2. Prevention literacy: community-based advocacy for access and ownership of the HIV prevention toolkit

    PubMed Central

    Parker, Richard G; Perez-Brumer, Amaya; Garcia, Jonathan; Gavigan, Kelly; Ramirez, Ana; Milnor, Jack; Terto, Veriano

    2016-01-01

    Introduction Critical technological advances have yielded a toolkit of HIV prevention strategies. This literature review sought to provide contextual and historical reflection needed to bridge the conceptual gap between clinical efficacy and community effectiveness (i.e. knowledge and usage) of existing HIV prevention options, especially in resource-poor settings. Methods Between January 2015 and October 2015, we reviewed scholarly and grey literatures to define treatment literacy and health literacy and assess the current need for literacy related to HIV prevention. The review included searches in electronic databases including MEDLINE, PsycINFO, PubMed, and Google Scholar. Permutations of the following search terms were used: “treatment literacy,” “treatment education,” “health literacy,” and “prevention literacy.” Through an iterative process of analyses and searches, titles and/or abstracts and reference lists of retrieved articles were reviewed for additional articles, and historical content analyses of grey literature and websites were additionally conducted. Results and discussion Treatment literacy was a well-established concept developed in the global South, which was later partially adopted by international agencies such as the World Health Organization. Treatment literacy emerged as more effective antiretroviral therapies became available. Developed from popular pedagogy and grassroots efforts during an intense struggle for treatment access, treatment literacy addressed the need to extend access to underserved communities and low-income settings that might otherwise be excluded from access. In contrast, prevention literacy is absent in the recent surge of new biomedical prevention strategies; prevention literacy was scarcely referenced and undertheorized in the available literature. Prevention efforts today include multimodal techniques, which jointly comprise a toolkit of biomedical, behavioural, and structural/environmental approaches

  3. Prevention literacy: community-based advocacy for access and ownership of the HIV prevention toolkit

    PubMed Central

    Parker, Richard G; Perez-Brumer, Amaya; Garcia, Jonathan; Gavigan, Kelly; Ramirez, Ana; Milnor, Jack; Terto, Veriano

    2016-01-01

    Introduction Critical technological advances have yielded a toolkit of HIV prevention strategies. This literature review sought to provide contextual and historical reflection needed to bridge the conceptual gap between clinical efficacy and community effectiveness (i.e. knowledge and usage) of existing HIV prevention options, especially in resource-poor settings. Methods Between January 2015 and October 2015, we reviewed scholarly and grey literatures to define treatment literacy and health literacy and assess the current need for literacy related to HIV prevention. The review included searches in electronic databases including MEDLINE, PsycINFO, PubMed, and Google Scholar. Permutations of the following search terms were used: “treatment literacy,” “treatment education,” “health literacy,” and “prevention literacy.” Through an iterative process of analyses and searches, titles and/or abstracts and reference lists of retrieved articles were reviewed for additional articles, and historical content analyses of grey literature and websites were additionally conducted. Results and discussion Treatment literacy was a well-established concept developed in the global South, which was later partially adopted by international agencies such as the World Health Organization. Treatment literacy emerged as more effective antiretroviral therapies became available. Developed from popular pedagogy and grassroots efforts during an intense struggle for treatment access, treatment literacy addressed the need to extend access to underserved communities and low-income settings that might otherwise be excluded from access. In contrast, prevention literacy is absent in the recent surge of new biomedical prevention strategies; prevention literacy was scarcely referenced and undertheorized in the available literature. Prevention efforts today include multimodal techniques, which jointly comprise a toolkit of biomedical, behavioural, and structural/environmental approaches

  4. Effect of social cognitive theory-based HIV education prevention program among high school students in Nanjing, China.

    PubMed

    Li, Xiaoming; Zhang, Liying; Mao, Rong; Zhao, Qun; Stanton, Bonita

    2011-06-01

    This study was designed to evaluate potential preventive effects of a cultural adaption of the Focus on Kids (FOK) program among Chinese adolescents through a quasi-experimental intervention trial in Nanjing, China. High school students were assigned to either experimental groups (n = 140) or control groups (n = 164) by schools (with three schools in each condition). The participants completed a confidential questionnaire at baseline and 6-month post-intervention with a follow-up rate of 94.4% (287 of 304). The outcome measures included HIV knowledge, HIV-related perceptions based on the protection motivation theory, stigmatizing attitude toward people living with HIV/AIDS (PLWHA), intentions of health-related risk behaviors and sexual intercourse in the previous 6 months. Results showed a significant intervention effect at 6-month post-intervention in increasing HIV knowledge, decreasing perceptions of response cost associated with abstinence and reducing stigmatizing attitudes toward PLWHA, after controlling for key demographic characteristics and relevant baseline measures. Further mediation analysis suggested that HIV knowledge mediated the effect of intervention on stigma reduction. Findings from this study support the feasibility and initial efficacy of the cultural adaptation of FOK HIV prevention program among high school students in China.

  5. Expanding the partnership. The private sector's role in HIV / AIDS prevention.

    PubMed

    Lamptey, P

    1996-07-01

    The public sector supports most HIV/AIDS prevention and care activities in developing countries, with significant funding provided by the US Agency for International Development, the Overseas Development Authority, the European Community, and international banking institutions such as the World Bank. Local nongovernmental organizations (NGOs) and international private voluntary organizations (PVOs) implement many of the grassroots prevention and care efforts in developing countries, but often require support from donor agencies. While the private commercial sector has played a minor role in supporting HIV/AIDS prevention and care efforts, a number of local and multinational companies are beginning to recognize the importance of protecting their workers from HIV infection. These companies are motivated by a sense of moral obligation and/or view HIV/AIDS prevention as a cost-effective investment. Mainly affecting the most economically productive age groups, the HIV/AIDS epidemic will have a significant impact upon private industry. Workplace-based prevention programs and policies, private sector resources for HIV/AIDS prevention and care, how HIV/AIDS programs can benefit from the private sector's experience in commercial service delivery, research and development, and corporate direct cash and in-kind contributions to government and NGO HIV/AIDS prevention activities are discussed. The AIDS Control and Prevention (AIDSCAP) Project's Businesses Managing AIDS Project helps owners and managers understand the potential impact of HIV/AIDS upon their businesses and the benefits of HIV/AIDS prevention. PMID:12347592

  6. Recently Opened Trials | Division of Cancer Prevention

    Cancer.gov

    MRI and Gene Expression in Diagnosing Patients with Ductal Breast Cancer In SituThis clinical trial studies magnetic resonance imaging (MRI) and gene expression in diagnosing patients with abnormal cells in the breast duct that have not spread outside the duct. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. MRI may help find and diagnose patients with breast cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment. | Important new studies, actively accruing participants.

  7. Reducing risky relationships: a multisite randomized trial of a prison-based intervention for reducing HIV sexual risk behaviors among women with a history of drug use.

    PubMed

    Knudsen, Hannah K; Staton-Tindall, Michele; Oser, Carrie B; Havens, Jennifer R; Leukefeld, Carl G

    2014-01-01

    Women involved in the criminal justice system, particularly those with a history of drug use, are at elevated risk of HIV infection, yet few HIV prevention interventions have been tailored for delivery to incarcerated women. Drawing on the Relational Model, the Reducing Risky Relationships for HIV (RRR-HIV) intervention was developed and evaluated in a multisite randomized clinical trial. Women with weekly drug use prior to incarceration (n = 444) who were incarcerated within correctional institutions in four states were randomized to (1) the RRR-HIV intervention consisting of an HIV educational video, five group sessions, and one postrelease booster session or (2) a control condition consisting of the HIV educational video. The RRR-HIV intervention combined didactic and interactive content regarding seven "thinking myths" about intimate relationships that may result in decisions to engage in risky sexual behaviors. Data were collected while women were still incarcerated and approximately 90 days following release from prison by trained interviewers. A negative binomial regression (NBR) model of unprotected sexual behaviors at the 90-day follow-up indicated that RRR-HIV participants reported fewer unprotected sexual behaviors than women in the control condition once the analysis was adjusted for study site. Future studies should examine the sustainability of the RRR-HIV intervention's effect on risk reduction. Implementation research is needed to determine whether delivery of this intervention by correctional staff or peers, rather than research staff, yields similar reductions in unprotected sexual behaviors. PMID:24410251

  8. Does participation in an HIV vaccine efficacy trial affect risk behaviour in South Africa?

    PubMed Central

    Gray, GE; Metch, B; Churchyard, G; Mlisana, K; Nchabeleng, M; Allen, M; Moodie, Z; Kublin, J; Bekker, L-G

    2014-01-01

    Background Increased sexual risk behaviour in participants enrolled in HIV prevention trials has been a concern. The HVTN 503/Phambili study, a phase 2B study of the Merck Ad-5 multiclade HIV vaccine in South Africa, suspended enrollment and vaccinations following the results of the Step study. Participants were notified of their treatment allocation and continue to be followed. We investigated changes in risk behaviour over time and assessed the impact of study unblinding. Methods 801 participants were enrolled. Risk behaviors were assessed with an interviewer-administered questionnaire at 6-month intervals. We assessed change from enrolment to the first 6-month assessment pre-unblinding and between enrolment and at least 6 months post-unblinding on all participants with comparable data. A one-time unblinding risk perception questionnaire was administered post-unblinding. Results A decrease in participants reporting unprotected sex was observed in both measured time periods for men and women, with no differences by treatment arm. At 6 months (pre-unblinding), 29.6% of men and 35.8% of women reported changing from unprotected to protected sex (p <0.0001 for each).Men (22%) were more likely than women (14%) to report behavior change after unblinding (p=0.009). Post-enrolment, 142 (45%) of 313 previously uncircumcised men underwent medical circumcision. 663 participants completed the unblinding questionnaire. More vaccine (24.6%) as compared to placebo recipients (12.0%) agreed that they were more likely to get HIV than most people (p<0.0001), and attributed this to receiving the vaccine. Conclusion We did not find evidence of risk compensation during this clinical trial. Some risk behaviour reductions including male circumcision were noted irrespective of treatment allocation. PMID:23370155

  9. Trial NCT01950403 | Division of Cancer Prevention

    Cancer.gov

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  10. Trial NCT01968798 | Division of Cancer Prevention

    Cancer.gov

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  11. Trial NCT01824836 | Division of Cancer Prevention

    Cancer.gov

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  12. Trial NCT02314156 | Division of Cancer Prevention

    Cancer.gov

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  13. Trial NCT01594502 | Division of Cancer Prevention

    Cancer.gov

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  14. Trial NCT00917735 | Division of Cancer Prevention

    Cancer.gov

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic chang