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Sample records for hiv prevention trials

  1. Preventive Misconception and Adolescents’ Knowledge about HIV Vaccine Trials

    PubMed Central

    Ott, Mary A.; Alexander, Andreia B.; Lally, Michelle; Steever, John B.; Zimet, Gregory D.

    2013-01-01

    Objective Adolescents have had very limited access to research on biomedical prevention interventions despite high rates of HIV acquisition. One concern is that adolescents are a vulnerable population, and trials carry a possibility of harm, requiring investigators to take additional precautions. Of particular concern is preventive misconception, or the overestimation of personal protection that is afforded by enrollment in a prevention intervention trial. Methods As part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16–19 year olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semi-structured interview about their understanding and opinions related to enrollment in a HIV vaccine trial. A grounded theory analysis looked for shared concepts, and focused on the content and process of adolescent participants’ understanding HIV vaccination and the components of preventive misconception, including experiment, placebo and randomisation. Results Across interviews, adolescents demonstrated active processing of information, in which they questioned the interviewer, verbally worked out their answers based upon information provided, and corrected themselves. We observed a wide variety of understanding of research concepts. While most understood experiment and placebo, fewer understood randomisation. All understood the need for safer sex even if they did not understand the more basic concepts. Conclusions Education about basic concepts related to clinical trials, time to absorb materials and assessment of understanding may be necessary in future biomedical prevention trials. PMID:23355050

  2. Treatment as Prevention: Characterization of Partner Infections in the HIV Prevention Trials Network 052 Trial.

    PubMed

    Eshleman, Susan H; Hudelson, Sarah E; Redd, Andrew D; Swanstrom, Ronald; Ou, San-San; Zhang, Xinyi Cindy; Ping, Li-Hua; Piwowar-Manning, Estelle; Porcella, Stephen F; Sievers, Matthew F; Martens, Craig A; Bruno, Daniel; Dukhovlinova, Elena; McCauley, Marybeth; Gamble, Theresa; Fogel, Jessica M; Sabin, Devin; Quinn, Thomas C; Gunde, Laurence; Maliwichi, Madalitso; Nhando, Nehemiah; Akelo, Victor; Moyo, Sikhulile; Panchia, Ravindre; Kumarasamy, Nagalingeswaran; Chotirosniramit, Nuntisa; Melo, Marineide Gonçalves de; Pilotto, Jose; Grinsztejn, Beatriz; Mayer, Kenneth; Chen, Ying Q; Hughes, James P; Cohen, Myron S

    2017-01-01

    HIV Prevention Trials Network 052 demonstrated that antiretroviral therapy (ART) prevents HIV transmission in serodiscordant couples. HIV from index-partner pairs was analyzed to determine the genetic linkage status of partner infections. Forty-six infections were classified as linked, indicating that the index was the likely source of the partner's infection. Lack of viral suppression and higher index viral load were associated with linked infection. Eight linked infections were diagnosed after the index started ART: 4 near the time of ART initiation and 4 after ART failure. Linked infections were not observed when the index participant was stably suppressed on ART.

  3. Partnering for Care in HIV Prevention Trials

    PubMed Central

    MacQueen, Kathleen M.; McLoughlin, Kerry; Alleman, Patty; Burke, Holly McClain; Mack, Natasha

    2015-01-01

    Qualitative Case Studies Were conducted at seven international sites conducting HIV prevention research in Africa, Asia, and the Americas to identify strategies for ensuring that health needs of research participants identified in the course of research are adequately addressed. Key factors were identified that contribute to the balance between direct care and healthcare referrals at a research site, as well as the overall quality of the healthcare made available to research participants. The case studies exemplify the concept of “moral negotiation” in research (Weijer & LeBlanc, 2006), that is, a process where researchers and sponsors negotiate with increasingly empowered local communities and host countries to achieve meaningful and substantive benefits from biomedical research for all stakeholders. PMID:19385753

  4. 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

  5. Creating an African HIV clinical research and prevention trials network: HIV prevalence, incidence and transmission.

    PubMed

    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.

  6. 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

  7. HIV Epidemic in Asia: Implications for HIV Vaccine and Other Prevention Trials.

    PubMed

    Phanuphak, Nittaya; Lo, Ying-Ru; Shao, Yiming; Solomon, Sunil Suhas; O'Connell, Robert J; Tovanabutra, Sodsai; Chang, David; Kim, Jerome H; Excler, Jean Louis

    2015-11-01

    An overall decrease of HIV prevalence is now observed in several key Asian countries due to effective prevention programs. The decrease in HIV prevalence and incidence may further improve with the scale-up of combination prevention interventions. The implementation of future prevention trials then faces important challenges. The opportunity to identify heterosexual populations at high risk such as female sex workers may rapidly wane. With unabating HIV epidemics among men who have sex with men (MSM) and transgender (TG) populations, an effective vaccine would likely be the only option to turn the epidemic. It is more likely that efficacy trials will occur among MSM and TG because their higher HIV incidence permits smaller and less costly trials. The constantly evolving patterns of HIV-1 diversity in the region suggest close monitoring of the molecular HIV epidemic in potential target populations for HIV vaccine efficacy trials. CRF01_AE remains predominant in southeast Asian countries and MSM populations in China. This relatively steady pattern is conducive to regional efficacy trials, and as efficacy warrants, to regional licensure. While vaccines inducing nonneutralizing antibodies have promise against HIV acquisition, vaccines designed to induce broadly neutralizing antibodies and cell-mediated immune responses of greater breadth and depth in the mucosal compartments should be considered for testing in MSM and TG. The rationale and design of efficacy trials of combination prevention modalities such as HIV vaccine and preexposure prophylaxis (PrEP) remain hypothetical, require high adherence to PrEP, are more costly, and present new regulatory challenges. The prioritization of prevention interventions should be driven by the HIV epidemic and decided by the country-specific health and regulatory authorities. Modeling the impact and cost-benefit may help this decision process.

  8. HIV Epidemic in Asia: Implications for HIV Vaccine and Other Prevention Trials

    PubMed Central

    Phanuphak, Nittaya; Lo, Ying-Ru; Shao, Yiming; Solomon, Sunil Suhas; O'Connell, Robert J.; Tovanabutra, Sodsai; Chang, David; Kim, Jerome H.

    2015-01-01

    Abstract An overall decrease of HIV prevalence is now observed in several key Asian countries due to effective prevention programs. The decrease in HIV prevalence and incidence may further improve with the scale-up of combination prevention interventions. The implementation of future prevention trials then faces important challenges. The opportunity to identify heterosexual populations at high risk such as female sex workers may rapidly wane. With unabating HIV epidemics among men who have sex with men (MSM) and transgender (TG) populations, an effective vaccine would likely be the only option to turn the epidemic. It is more likely that efficacy trials will occur among MSM and TG because their higher HIV incidence permits smaller and less costly trials. The constantly evolving patterns of HIV-1 diversity in the region suggest close monitoring of the molecular HIV epidemic in potential target populations for HIV vaccine efficacy trials. CRF01_AE remains predominant in southeast Asian countries and MSM populations in China. This relatively steady pattern is conducive to regional efficacy trials, and as efficacy warrants, to regional licensure. While vaccines inducing nonneutralizing antibodies have promise against HIV acquisition, vaccines designed to induce broadly neutralizing antibodies and cell-mediated immune responses of greater breadth and depth in the mucosal compartments should be considered for testing in MSM and TG. The rationale and design of efficacy trials of combination prevention modalities such as HIV vaccine and preexposure prophylaxis (PrEP) remain hypothetical, require high adherence to PrEP, are more costly, and present new regulatory challenges. The prioritization of prevention interventions should be driven by the HIV epidemic and decided by the country-specific health and regulatory authorities. Modeling the impact and cost–benefit may help this decision process. PMID:26107771

  9. 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.

  10. 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

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

    PubMed

    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.

  12. Viral linkage in HIV-1 seroconverters and their partners in an HIV-1 prevention clinical trial.

    PubMed

    Campbell, Mary S; Mullins, James I; Hughes, James P; Celum, Connie; Wong, Kim G; Raugi, Dana N; Sorensen, Stefanie; Stoddard, Julia N; Zhao, Hong; Deng, Wenjie; Kahle, Erin; Panteleeff, Dana; Baeten, Jared M; McCutchan, Francine E; Albert, Jan; Leitner, Thomas; Wald, Anna; Corey, Lawrence; Lingappa, Jairam R

    2011-03-02

    Characterization of viruses in HIV-1 transmission pairs will help identify biological determinants of infectiousness and evaluate candidate interventions to reduce transmission. Although HIV-1 sequencing is frequently used to substantiate linkage between newly HIV-1 infected individuals and their sexual partners in epidemiologic and forensic studies, viral sequencing is seldom applied in HIV-1 prevention trials. The Partners in Prevention HSV/HIV Transmission Study (ClinicalTrials.gov #NCT00194519) was a prospective randomized placebo-controlled trial that enrolled serodiscordant heterosexual couples to determine the efficacy of genital herpes suppression in reducing HIV-1 transmission; as part of the study analysis, HIV-1 sequences were examined for genetic linkage between seroconverters and their enrolled partners. We obtained partial consensus HIV-1 env and gag sequences from blood plasma for 151 transmission pairs and performed deep sequencing of env in some cases. We analyzed sequences with phylogenetic techniques and developed a Bayesian algorithm to evaluate the probability of linkage. For linkage, we required monophyletic clustering between enrolled partners' sequences and a Bayesian posterior probability of ≥ 50%. Adjudicators classified each seroconversion, finding 108 (71.5%) linked, 40 (26.5%) unlinked, and 3 (2.0%) indeterminate transmissions, with linkage determined by consensus env sequencing in 91 (84%). Male seroconverters had a higher frequency of unlinked transmissions than female seroconverters. The likelihood of transmission from the enrolled partner was related to time on study, with increasing numbers of unlinked transmissions occurring after longer observation periods. Finally, baseline viral load was found to be significantly higher among linked transmitters. 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

  13. 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. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

  14. Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial.

    PubMed

    Fogel, Jessica M; Hudelson, Sarah E; Ou, San-San; Hart, Stephen; Wallis, Carole; Morgado, Mariza G; Saravanan, Shanmugam; Tripathy, Srikanth; Hovind, Laura; Piwowar-Manning, Estelle; Sabin, Devin; McCauley, Marybeth; Gamble, Theresa; Zhang, Xinyi C; Eron, Joseph J; Gallant, Joel E; Kumwenda, Johnstone; Makhema, Joseph; Kumarasamy, Nagalingeswaran; Chariyalertsak, Suwat; Hakim, James; Badal-Faesen, Sharlaa; Akelo, Victor; Hosseinipour, Mina C; Santos, Breno R; Godbole, Sheela V; Pilotto, Jose H; Grinsztejn, Beatriz; Panchia, Ravindre; Mayer, Kenneth H; Chen, Ying Q; Cohen, Myron S; Eshleman, Susan H

    2016-07-01

    Early initiation of antiretroviral treatment (ART) reduces HIV transmission and has health benefits. HIV drug resistance can limit treatment options and compromise use of ART for HIV prevention. We evaluated drug resistance in 85 participants in the HIV Prevention Trials Network 052 trial who started ART at CD4 counts of 350-550 cells per cubic millimeter and failed ART by May 2011; 8.2% had baseline resistance and 35.3% had resistance at ART failure. High baseline viral load and less education were associated with emergence of resistance at ART failure. Resistance at ART failure was observed in 7 of 8 (87.5%) participants who started ART at lower CD4 cell counts.

  15. 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. © 2013 John Wiley & Sons Ltd.

  16. 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…

  17. 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…

  18. Apples and oranges? Interpreting success in HIV prevention trials

    PubMed Central

    Heise, Lori L.; Watts, Charlotte; Foss, Anna; Trussell, James; Vickerman, Peter; Hayes, Richard; McCormack, Sheena

    2013-01-01

    Background In the last decade, several large-scale, clinical trials evaluating the efficacy of novel HIV prevention products have been completed, and 8 are currently underway or about to be reported. Little attention has been given in the literature to the level of protection sufficient to warrant introduction, and there is concern that using the term “efficacy” to describe the effect of user-controlled methods such as microbicides may mislead policymakers. Design We review how the fields of family planning, vaccine science, and mathematical modelling understand and use the terms efficacy and effectiveness and explore with simple mathematical models, how trial results of user-controlled products relate to common understandings of these terms. Results Each field brings different assumptions, a different evidence base, and different expectations to interpretations of efficacy and effectiveness—a reality that could cloud informed assessment of emerging data. Conclusion When making judgments on the utility of new health technologies, it is important to use standards that yield appropriate comparisons for the innovation and that take into account the local epidemic and available alternatives. PMID:21134498

  19. US Black Women and HIV Prevention: Time for New Approaches to Clinical Trials.

    PubMed

    Adaora A, Adimora; Cole, Stephen R; Eron, Joseph J

    2017-04-05

    Black women bear the highest burden of HIV infection among US women. Tenofovir/emtricitabine HIV prevention trials among women in Africa have yielded varying results. Ideally, a randomized controlled trial (RCT) among US women would provide data for guidelines for US women's HIV pre-exposure prophylaxis use. However, even among US Black women at high risk for HIV infection, sample size requirements for an RCT with HIV incidence as its outcome are prohibitively high. We propose to circumvent this large sample size requirement by evaluating relationships between HIV incidence and drug concentrations measured among participants in traditional phase 3 trials in high incidence settings - and then applying these observations to drug concentrations measured among at risk individuals in lower incidence settings, such as US Black women. This strategy could strengthen the evidence base to enable Black women to fully benefit from prevention research advances and decrease racial disparities in HIV rates.

  20. Ethical issues for late-stage trials of multipurpose prevention technologies for HIV and pregnancy.

    PubMed

    Cohen, Jessica A; Mastroianni, Anna C; Macklin, Ruth

    2014-11-01

    Multipurpose prevention technologies (MPTs) designed to simultaneously prevent pregnancy and HIV could provide urgently needed tools to address unmet sexual and reproductive health needs of women worldwide. Late-stage clinical trials will be complex given the need to demonstrate efficacy for HIV and contraceptive indications simultaneously from a single product. Currently, HIV and pregnancy prevention trials have distinctive design features that will need to be reconciled in MPT trials. This article identifies several ethical issues uniquely associated with this research that will benefit from future deliberation and guidance to ensure that this globally important research can proceed efficiently and expeditiously. Copyright © 2014. Published by Elsevier Ireland Ltd.

  1. 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

  2. Improving ethical and participatory practice for marginalized populations in biomedical HIV prevention trials: lessons from Thailand.

    PubMed

    Allman, Dan; Ditmore, Melissa Hope; Kaplan, Karyn

    2014-01-01

    This paper presents findings from a qualitative investigation of ethical and participatory issues related to the conduct of biomedical HIV prevention trials among marginalized populations in Thailand. This research was deemed important to conduct, as several large-scale biomedical HIV prevention trials among marginalized populations had closed prematurely in other countries, and a better understanding of how to prevent similar trial closures from occurring in the future was desired. In-depth key informant interviews were held in Bangkok and Chiang Mai, Thailand. Interviews were audio recorded, transcribed, translated and thematically analyzed. The Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP) guided this work. Fourteen interviews were conducted: 10 with policymakers, academic and community-based researchers and trial staff and four with representatives of non-governmental organizations (NGOs). Suggested ways to improve ethical and participatory practice centered on standards of HIV prevention, informed consent, communication and human rights. In particular, the need to overcome language and literacy differences was identified. Key informants felt communication was the basis of ethical understanding and trust within biomedical HIV prevention trial contexts, and thus fundamental to trial participants' ability to exercise free will. Biomedical HIV prevention trials present opportunities for inclusive and productive ethical and participatory practice. Key informants suggested that efforts to improve practice could result in better relationships between research stakeholders and research investigative teams and by extension, better, more ethical participatory trials. This research took place in Thailand and its findings apply primarily to Thailand. However, given the universality of many ethical considerations, the results of this study can inform the improvement of ethical and participatory practice in other parts of the world where

  3. Retaining Hard-to-Reach Women in HIV Prevention and Vaccine Trials: Project ACHIEVE

    PubMed Central

    Brown-Peterside, Pamela; Rivera, Evelyn; Lucy, Debbie; Slaughter, Izzie; Ren, Leigh; Chiasson, Mary Ann; Koblin, Beryl A.

    2001-01-01

    Project ACHIEVE, which conducts HIV prevention research studies, maintains a women's site in the South Bronx in New York City. Owing to a focused retention effort at the South Bronx site, high retention rates were achieved in a vaccine preparedness study for women at high risk of HIV infection. Comparable retention rates have been achieved in HIV vaccine trials with similar cohorts of women at this site. These results suggest that concerns about retaining hard-to-reach populations should not cause these populations to be excluded from HIV vaccine and prevention trials. PMID:11527761

  4. HIV Prevention

    MedlinePlus

    ... Abroad Treatment Basic Statistics Get Tested Find an HIV testing site near you. Enter ZIP code or city Follow HIV/AIDS CDC HIV CDC HIV/AIDS See RSS | ... Collapse All Is abstinence the only 100% effective HIV prevention option? Yes. Abstinence means not having oral, ...

  5. HIV drug resistance in adults failing early antiretroviral treatment: results from the HIV Prevention Trials Network 052 trial

    PubMed Central

    Fogel, Jessica M.; Hudelson, Sarah E.; Ou, San-San; Hart, Stephen; Wallis, Carole; Morgado, Mariza G.; Saravanan, Shanmugam; Tripathy, Srikanth; Hovind, Laura; Piwowar-Manning, Estelle; Sabin, Devin; McCauley, Marybeth; Gamble, Theresa; Zhang, Xinyi Cindy; Eron, Joseph J.; Gallant, Joel E.; Kumwenda, Johnstone; Makhema, Joseph; Kumarasamy, Nagalingeswaran; Chariyalertsak, Suwat; Hakim, James; Badal-Faesen, Sharlaa; Akelo, Victor; Hosseinipour, Mina C.; Santos, Breno Riegel; Godbole, Sheela V.; Pilotto, Jose Henrique; Grinsztejn, Beatriz; Panchia, Ravindre; Mayer, Kenneth H.; Chen, Ying Q.; Cohen, Myron S.; Eshleman, Susan H.

    2016-01-01

    Early initiation of antiretroviral therapy (ART) reduces HIV transmission and has health benefits. HIV drug resistance can limit treatment options and compromise use of ART for HIV prevention. We evaluated drug resistance in 85 participants in the HPTN 052 trial who started ART at CD4 counts of 350–550 cells/mm3 and failed ART by May 2011; 8.2% had baseline resistance and 35.3% had resistance at ART failure. High baseline viral load and less education were associated with emergence of resistance at ART failure. Resistance at ART failure was observed in 7/8 (87.5%) participants who started ART at lower CD4 cell counts. PMID:26859828

  6. Reaping the prevention benefits of highly active antiretroviral treatment: policy implications of HIV Prevention Trials Network 052.

    PubMed

    Forsyth, Andrew D; Valdiserri, Ronald O

    2012-03-01

    This review explores the policy implications of findings from the HIV Prevention Trials Network (HPTN 052) treatment as prevention (TasP) study. To date, the potential of antiretrovirals to prevent sexual transmission of HIV by infected persons has been grounded in observational cohort, ecological, mathematical modeling, and meta-analytic studies. HPTN 052 represents the first randomized controlled trial to test the secondary prevention benefit of HIV transmission using antiretroviral treatment in largely asymptomatic persons with high CD4 cell counts. The US National HIV/AIDS Strategy has among its key goals the reduction of incident HIV infections, improved access to quality care and associated outcomes, and the reduction in HIV-associated health disparities and inequities. HPTN 052 demonstrates that providing TasP, in combination with other effective prevention strategies offers the promise of achieving these life-saving goals. But HPTN 052 also highlights the need for cautious optimism and underscores the importance of addressing current gaps in the HIV prevention, treatment, and care continuum in order for 'TasP' strategies to achieve their full potential. Among these are necessary improvements in the capacity to expand HIV testing, facilitate effective linkage and retention in care, and improve treatment initiation, maintenance, and virus suppression.

  7. HIV/AIDS Clinical Trials

    MedlinePlus

    ... Contact Us | En Español OFFERING INFORMATION ON HIV/AIDS TREATMENT, PREVENTION, AND RESEARCH Search Search Search Search Search Menu Home Guidelines Understanding HIV/AIDS Drugs Clinical Trials Apps Home Guidelines Understanding HIV/ ...

  8. Estimation of HIV Incidence in a Large, Community-Based, Randomized Clinical Trial: NIMH Project Accept (HIV Prevention Trials Network 043)

    PubMed Central

    Fiamma, Agnes; Kulich, Michal; Donnell, Deborah; Bassuk, Deb; Mullis, Caroline E.; Chin, Craig; Swanson, Priscilla; Hackett, John; Clarke, William; Marzinke, Mark; Szekeres, Greg; Gray, Glenda; Richter, Linda; Alexandre, Michel W.; Chariyalertsak, Suwat; Chingono, Alfred; Celentano, David D.; Morin, Stephen F.; Sweat, Michael; Coates, Thomas; Eshleman, Susan H.

    2013-01-01

    Background National Institute of Mental Health Project Accept (HIV Prevention Trials Network [HPTN] 043) is a large, Phase III, community-randomized, HIV prevention trial conducted in 48 matched communities in Africa and Thailand. The study intervention included enhanced community-based voluntary counseling and testing. The primary endpoint was HIV incidence, assessed in a single, cross-sectional, post-intervention survey of >50,000 participants. Methods HIV rapid tests were performed in-country. HIV status was confirmed at a central laboratory in the United States. HIV incidence was estimated using a multi-assay algorithm (MAA) that included the BED capture immunoassay, an avidity assay, CD4 cell count, and HIV viral load. Results Data from Thailand was not used in the endpoint analysis because HIV prevalence was low. Overall, 7,361 HIV infections were identified (4 acute, 3 early, and 7,354 established infections). Samples from established infections were analyzed using the MAA; 467 MAA positive samples were identified; 29 of those samples were excluded because they contained antiretroviral drugs. HIV prevalence was 16.5% (range at study sites: 5.93% to 30.8%). HIV incidence was 1.60% (range at study sites: 0.78% to 3.90%). Conclusions In this community-randomized trial, a MAA was used to estimate HIV incidence in a single, cross-sectional post-intervention survey. Results from this analysis were subsequently used to compare HIV incidence in the control and intervention communities. Trial Registration ClinicalTrials.gov NCT00203749 PMID:23874597

  9. Estimating effectiveness in HIV prevention trials with a Bayesian hierarchical compound Poisson frailty model.

    PubMed

    Coley, Rebecca Yates; Brown, Elizabeth R

    2016-07-10

    Inconsistent results in recent HIV prevention trials of pre-exposure prophylactic interventions may be due to heterogeneity in risk among study participants. Intervention effectiveness is most commonly estimated with the Cox model, which compares event times between populations. When heterogeneity is present, this population-level measure underestimates intervention effectiveness for individuals who are at risk. We propose a likelihood-based Bayesian hierarchical model that estimates the individual-level effectiveness of candidate interventions by accounting for heterogeneity in risk with a compound Poisson-distributed frailty term. This model reflects the mechanisms of HIV risk and allows that some participants are not exposed to HIV and, therefore, have no risk of seroconversion during the study. We assess model performance via simulation and apply the model to data from an HIV prevention trial. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  10. 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.

  11. Cost-effectiveness of interventions to prevent HIV and STDs among women: a randomized controlled trial.

    PubMed

    Ruger, Jennifer Prah; Abdallah, Arbi Ben; Ng, Nora Y; Luekens, Craig; Cottler, Linda

    2014-10-01

    Injection drug use is a leading transmission route of HIV and STDs, and disease prevention among drug users is an important public health concern. This study assesses cost-effectiveness of behavioral interventions for reducing HIV and STDs infections among injection drug-using women. Cost-effectiveness analysis was conducted from societal and provider perspectives for randomized trial data and Bernoullian model estimates of infections averted for three increasingly intensive interventions: (1) NIDA's standard intervention (SI); (2) SI plus a well woman exam (WWE); and (3) SI, WWE, plus four educational sessions (4ES). Trial results indicate that 4ES was cost-effective relative to WWE, which was dominated by SI, for most diseases. Model estimates, however, suggest that WWE was cost-effective relative to SI and dominated 4ES for all diseases. Trial and model results agree that WWE is cost-effective relative to SI per hepatitis C infection averted ($109 308 for in trial, $6 016 in model) and per gonorrhea infection averted ($9 461 in trial, $14 044 in model). In sensitivity analysis, trial results are sensitive to 5 % change in WWE effectiveness relative to SI for hepatitis C and HIV. In the model, WWE remained cost-effective or cost-saving relative to SI for HIV prevention across a range of assumptions. WWE is cost-effective relative to SI for preventing hepatitis C and gonorrhea. WWE may have similar effects as the costlier 4ES.

  12. A qualitative study of obstacles to diaphragm and condom use in an HIV prevention trial in sub-Saharan Africa.

    PubMed

    Kacanek, Deborah; Dennis, Amanda; Sahin-Hodoglugil, Nuriye Nalan; Montgomery, Elizabeth T; Morar, Neetha; Mtetwa, Sibongile; Nkala, Busi; Phillip, Jessica; Watadzaushe, Connie; van der Straten, Ariane

    2012-02-01

    Consistent condom use and the substitution of condoms with potential HIV prevention methods of lower or unknown effectiveness are important concerns in the development of new prevention technologies. This qualitative study explored obstacles to consistent condom use with the diaphragm in MIRA, an HIV prevention trial in South Africa and Zimbabwe. We conducted 26 focus group discussions (FGDs) with 206 women and 7 FGDs and 10 in-depth interviews with 41 male partners of intervention-arm women. The belief that the diaphragm/gel prevented HIV, women's difficulties negotiating condom use, and men's unawareness that using the products together was recommended were obstacles to consistent condom use with the diaphragm/gel. Concerns about protection from HIV and pregnancy, recognition that the diaphragm was not yet proven to prevent HIV or sexually transmitted infections, and the trial context were facilitators. Understanding selective study product use in HIV prevention trials may inform improved adherence counseling and male involvement strategies.

  13. Methodological Overview of an African American Couple-Based HIV/STD Prevention Trial

    PubMed Central

    2010-01-01

    Objective To provide an overview of the NIMH Multisite HIV/STD Prevention Trial for African American Couples conducted in four urban areas: Atlanta, Los Angeles, New York, and Philadelphia. The rationale, study design methods, proposed data analyses, and study management are described. Design This is a two arm randomized Trial, implementing a modified randomized block design, to evaluate the efficacy of a couples based intervention designed for HIV serodiscordant African American couples. Methods The study phases consisted of formative work, pilot studies, and a randomized clinical trial. The sample is 535 HIV serodiscordant heterosexual African American couples. There are two theoretically derived behavioral interventions with eight group and individual sessions: the Eban HIV/STD Risk Reduction Intervention (treatment) versus the Eban Health Promotion Intervention (control). The treatment intervention was couples based and focused on HIV/STD risk reduction while the control was individual based and focused on health promotion. The two study conditions were structurally similar in length and types of activities. At baseline, participants completed an Audio Computer-assisted Self Interview (ACASI) interview as well as interviewer-administered questionnaire, and provided biological specimens to assess for STDs. Similar follow-up assessments were conducted immediately after the intervention, at 6 months, and at 12 months. Results The Trial results will be analyzed across the four sites by randomization assignment. Generalized estimating equations (GEE) and mixed effects modeling (MEM) are planned to test: (1) the effects of the intervention on STD incidence and condom use as well as on mediator variables of these outcomes, and (2) whether the effects of the intervention differ depending on key moderator variables (e.g., gender of the HIV-seropositive partners, length of relationship, psychological distress, sexual abuse history, and substance abuse history

  14. Venue-based recruitment of women at elevated risk for HIV: an HIV Prevention Trials Network study.

    PubMed

    Haley, Danielle F; 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

    2014-06-01

    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. 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. 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. 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.

  15. A pilot study on willingness to participate in future preventive HIV vaccine trials.

    PubMed

    Suhadev, Mohanarani; Nyamathi, Adeline M; Swaminathan, Soumya; Venkatesan, P; Raja Sakthivel, M; Shenbagavalli, R; Suresh, Anitha; Fahey, John L

    2006-12-01

    In India, phase-I human clinical trials for a preventive HIV vaccine are being conducted at Pune and Chennai Centres. In order to find out the willingness of populations at risk to participate in future preventive HIV vaccine trials (HIVVTs) and to assess the factors that enhance or deter them from participation, a study was conducted at Chennai and Madurai in Tamil Nadu. This cross-sectional study was conducted among transport workers, people attending sexually transmitted infection clinics, injection drug users, men having sex with men, women in sex industry and a representative sample of monogamous married women, by employing measurement scales. A structured questionnaire on knowledge and attitudes about the HIV vaccine was used to measure the participants' knowledge and attitudes about HIV vaccine and HIVVTs. Of the 112 participants, 67 (60%) were men. Mean age of the respondents was 32 yr; 68 per cent were high school educated. Majority of respondents were willing to participate in a future HIVVT and the reasons were altruism, protection from HIV, and support for the researchers. Major concerns were vaccine efficacy, side effects of the vaccine and the impact of a HIV vaccine on the participants' lives. Majority (85%) agreed that sex without condom would not be safe despite the availability of an HIV vaccine. It is likely that high-risk volunteers will be willing to enroll in HIVVTs. Barriers and concerns should be dealt with carefully by providing correct information. Also there is a need for more education to ensure participants' understanding of key concepts of HIV vaccine trial.

  16. The HOPE social media intervention for global HIV prevention in Peru: a cluster randomised controlled trial.

    PubMed

    Young, Sean D; Cumberland, William G; Nianogo, Roch; Menacho, Luis A; Galea, Jerome T; Coates, Thomas

    2015-01-01

    Social media technologies offer new approaches to HIV prevention and promotion of testing. We examined the efficacy of the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. In this cluster randomised controlled trial, Peruvian MSM from Greater Lima (including Callao) who had sex with a man in the past 12 months, were 18 years of age or older, were HIV negative or serostatus unknown, and had a Facebook account or were willing to create one (N=556) were randomly assigned (1:1) by concealed allocation to join intervention or control groups on Facebook for 12 weeks. For the intervention, Peruvian MSM were trained and assigned to be HIV prevention mentors (peer-leaders) to participants in Facebook groups. The interventions period lasted 12 weeks. Participants in control groups received an enhanced standard of care, including standard offline HIV prevention available in Peru and participation in Facebook groups (without peer leaders) that provided study updates and HIV testing information. After accepting a request to join the groups, continued participation was voluntary. Participants also completed questionnaires on HIV risk behaviours and social media use at baseline and 12 week follow-up. The primary outcome was the number of participants who received a free HIV test at a local community clinic. The facebook groups were analysed as clusters to account for intracluster correlations. This trial is registered with ClinicalTrials.gov, number NCT01701206. Of 49 peer-leaders recruited, 34 completed training and were assigned at random to the intervention Facebook groups. Between March 19, 2012, and June 11, 2012, and Sept 26, 2012, and Dec 19, 2012, 556 participants were randomly assigned to intervention groups (N=278) or control groups (N=278); we analyse data for 252 and 246. 43 participants (17%) in the intervention group and 16 (7%) in the control groups got tested for HIV (adjusted

  17. Randomised trials of STD treatment for HIV prevention: report of an international workshop. HIV/STD Trials Workshop Group.

    PubMed Central

    Hayes, R; Wawer, M; Gray, R; Whitworth, J; Grosskurth, H; Mabey, D

    1997-01-01

    Three community trials of the impact of STD treatment interventions on HIV incidence in rural populations have been completed or are in progress in Uganda and Tanzania. Investigators from these trials met for a joint technical workshop in Baltimore in May 1996. This report summarises the consensus of the workshop, with the aim of providing useful input to research on HIV intervention strategies. Issues discussed include: (i) the role of community randomised trials; (ii) strategies for STD management; (iii) epidemiological and statistical issues in the design and analysis of community randomised trials; (iv) diagnostic methods for STDs in population surveys; (v) treatment regimens for STDs in rural Africa; and (vi) ethical issues in community trials. PMID:9582456

  18. Quality assurance of HIV prevention counseling in a multi-center randomized controlled trial. Project RESPECT Study Group.

    PubMed Central

    Kamb, M L; Dillon, B A; Fishbein, M; Willis, K L

    1996-01-01

    Current HIV prevention counseling strategies rely largely on interventions aimed at changing behaviors. Among these is HIV prevention counseling and testing, which has been a prominent component in the federally supported strategies for HIV/AIDS prevention in the United States. To assess the efficacy of HIV counseling in reducing risk behaviors and preventing HIV infection and other sexually transmitted diseases, a multicenter, randomized controlled trial is being conducted among sexually transmitted disease clinic patients (Project RESPECT). The trial compares three separate HIV prevention strategies on increasing condom use and decreasing new cases of sexually transmitted diseases. The strategies are (a) Enhanced HIV Prevention Counseling, a 4-session individual counseling intervention based on behavioral and social science theory; (b) HIV Prevention Counseling, a 2-session individual pre- and post test counseling strategy that attempts to increase perception of risk and reduce risk behaviors using small, achievable steps; and (c) HIV Education, a brief 2-session pre- and post-test strategy that is purely informational. One difficulty in conducting randomized trials of behavioral interventions is assuring that the interventions are being conducted both as conceptualized and in a consistent manner by different counselors and, for multicenter studies, at different study sites. This article describes the quality assurance measures that have been used for Project RESPECT. These have included development of standard tools, standard training, frequent observation and feedback to study personnel, and process evaluation. PMID:8862164

  19. Selection of populations represented in the NIMH Collaborative HIV/STD Prevention Trial.

    PubMed

    2007-04-01

    To identify venues with vulnerable populations suitable for testing the community popular opinion leader intervention in each of the five countries (China, India, Peru, Russia, and Zimbabwe) participating in the National Institute of Mental Health (NIMH) Collaborative HIV/STD Prevention Trial. HIV epidemiology and vulnerable populations differ considerably across the countries. Therefore, different community populations were targeted in the five countries. Venues and populations were chosen on the basis of specific selection criteria (investigated during the Trial's ethnographic research phase): the willingness of stakeholders and gatekeepers of the venues to cooperate; geographical boundaries defining each venue; population stability within venues; the independence of venues and non-overlap of population members across multiple venues; population size within each venue; social interaction opportunities; and either a high level of sexual risk behavior or a high prevalence of sexually transmitted diseases (STDs) or HIV. Venues and populations selected were food market stall owners and workers in China, male patrons of wine shops and at-risk women congregating near the shops in India, young men and women in social gathering points in neighborhoods in Peru, trade and vocational school dormitory residents in Russia, and people congregating in growth points in Zimbabwe. Although the target populations differed across countries, they shared in common high behavioral or biological risk at baseline and suitability for a randomized trial of a community-level HIV/STD prevention behavioral intervention.

  20. Recruitment of minority women and their main sexual partners in an HIV/STI prevention trial.

    PubMed

    Witte, Susan S; El-Bassel, Nabila; Gilbert, Louisa; Wu, Elwin; Chang, Mingway; Steinglass, Peter

    2004-12-01

    Recruiting heterosexual couples into randomized clinical trials (RCTs) to test the efficacy of HIV/sexually transmitted infection (STI) prevention interventions is a challenge that requires innovative strategies and consideration of ethical issues, including participant safety and confidentiality. This paper provides a brief review of the literature on minority and couple RCT recruitment and describes the development (preparation phase and protocol development) and implementation (strategies employed and barriers) of a recruitment protocol that safely enrolled 217 predominantly African American and Latino heterosexual couples into a relationship-based, HIV/STI prevention study. The success of this recruitment protocol with no reported adverse events demonstrates the feasibility of engaging urban minority women and men in RCTs. This study builds on a small literature base articulating specific couple recruitment strategies. More research delineating and testing specific strategies for recruiting defined populations into clinical trials is needed to advance the science of study recruitment and improve generalizability of research findings.

  1. Successful increase in contraceptive uptake among Kenyan HIV-1-serodiscordant couples enrolled in an HIV-1 prevention trial.

    PubMed

    Ngure, Kenneth; Heffron, Renee; Mugo, Nelly; Irungu, Elizabeth; Celum, Connie; Baeten, Jared M

    2009-11-01

    To evaluate a multipronged approach to promote dual contraceptive use by women within heterosexual HIV-1-serodiscordant partnerships. For 213 HIV-1-serodiscordant couples in Thika, Kenya, participating in an HIV-1 prevention clinical trial, contraceptive promotion was initiated through a multipronged intervention that included staff training, couples family planning sessions, and free provision of hormonal contraception on-site. Contraceptive use and pregnancy incidence were compared between two time periods (before versus after June 2007, when the intervention was initiated) and between Thika and other Kenyan trial sites (Eldoret, Kisumu, and Nairobi). Generalized estimating equations and Andersen-Gill proportional hazards modeling were used. Nonbarrier contraceptive use increased after implementation of the intervention: from 31.5 to 64.7% of visits among HIV-1-seropositive women [odds ratio 4.0, 95% confidence interval (CI) 3.0-5.3] and from 28.6 to 46.7% of visits among HIV-1-seronegative women (odds ratio 2.2, 95% CI 1.4-3.5). In comparison, at the other Kenyan sites, where the intervention was not implemented, contraceptive use changed minimally, from 15.6 to 22.3% of visits for HIV-1-seropositive women and from 13.6 to 12.7% among HIV-1-seronegative women. Self-reported condom use remained high during follow-up. Pregnancy incidence at the Thika was significantly lower after compared with before June 2007 (hazard ratio 0.2, 95% CI 0.1-0.6) and was approximately half that at other Kenyan sites during the intervention period (hazard ratio 0.5, 95% CI 0.3-0.8). A multipronged family planning intervention can lead to high nonbarrier contraceptive uptake and reduced pregnancy incidence among women in HIV-1-serodiscordant partnerships.

  2. Successful increase in contraceptive uptake among Kenyan HIV-1 serodiscordant couples enrolled in an HIV-1 prevention trial

    PubMed Central

    Ngure, Kenneth; Heffron, Renee; Mugo, Nelly; Irungu, Elizabeth; Celum, Connie; Baeten, Jared

    2016-01-01

    Objective To evaluate a multi-pronged approach to promote dual contraceptive use by women within heterosexual HIV-1 serodiscordant partnerships. Methods For 213 HIV-1 serodiscordant couples in Thika, Kenya participating in an HIV-1 prevention clinical trial, contraceptive promotion was initiated through a multi-pronged intervention that included staff training, couples family planning sessions, and free provision of hormonal contraception on-site. Contraceptive use and pregnancy incidence were compared between two time periods (before versus after June 2007, when the intervention was initiated) and between Thika and other Kenyan trial sites (Eldoret, Kisumu, and Nairobi). Generalized estimating equations and Andersen-Gill proportional hazards modeling were used. Results Non-barrier contraceptive use increased after implementation of the intervention: from 31.5% to 64.7% of visits among HIV-1 seropositive women (odds ratio [OR] 4.0, 95% confidence interval [CI] 3.0–5.3) and from 28.6% to 46.7% of visits among HIV-1 seronegative women (OR 2.2, 95% CI 1.4–3.5). In comparison, at the other Kenyan sites, where the intervention was not implemented, contraceptive use changed minimally, from 15.6% to 22.3% of visits for HIV-1 seropositive women and from 13.6% to 12.7% among HIV-1 seronegative women. Self-reported condom use remained high during follow-up. Pregnancy incidence at the Thika was significantly lower after compared with before June 2007 (hazard ratio [HR] 0.2, 95% CI 0.1–0.6), and was approximately half that at other Kenyan sites during the intervention period (HR 0.5, 95% CI 0.3–0.8). Conclusions A multi-pronged family planning intervention can lead to high non-barrier contraceptive uptake and reduced pregnancy incidence among women in HIV-1 serodiscordant partnerships. PMID:20081393

  3. Phase I/II trial of HIV-1 hyperimmune globulin for the prevention of HIV-1 vertical transmission in Uganda.

    PubMed

    Guay, Laura A; Musoke, Philippa; Hom, David L; Nakabiito, Clemensia; Bagenda, Danstan; Fletcher, Courtney V; Marum, Lawrence H; Fowler, Mary Glenn; Falksveden, Lars G; Wahren, Britta; Kataaha, Peter; Wigzell, Hans; Mmiro, Francis A; Jackson, J Brooks

    2002-07-05

    To assess the safety, tolerance, pharmacokinetics, and virologic and immunologic changes associated with the use of Ugandan HIV hyperimmune globulin (HIVIGLOB) in HIV infected pregnant Ugandan women and their infants. A prospective, phase I/II, three-arm dose escalation trial of HIVIGLOB. HIVIGLOB was prepared from discarded HIV infected units of blood collected from the National Blood Bank in Kampala. From June 1996 to April 1997, 31 HIV positive pregnant women were enrolled with HIVIGLOB infusions given at 37 weeks gestation and within 16 h of birth for infants. The first 10 mother-infant pairs were infused at a dose of 50 mg/kg, followed by 11 pairs at 200 mg/kg, and 10 pairs at 400 mg/kg. Study participants were followed for 30 months. Thirty-one women and 29 infants were infused with HIVIGLOB. The infusions were safe and well tolerated by the women and their infants at all doses. There were no significant changes in virologic or immunologic parameters after HIVIGLOB infusion. Pharmacokinetic properties of this product were similar to other immune globulin products with a median half-life of 28 days in women and 30 days in infants. An HIV immune globulin product derived from HIV infected Ugandan donors is safe, well tolerated, and has pharmacokinetic properties consistent with other immunoglobulin products. Data suggest that a 400 mg/kg dose of HIVIGLOB would be the most appropriate dose for a subsequent efficacy trial of HIVIGLOB for the prevention of mother to child HIV transmission.

  4. The HOPE Social Media Intervention for Global HIV Prevention: A Cluster Randomized Controlled Trial in Peru

    PubMed Central

    Young, Sean D.; Cumberland, William G.; Nianogo, Roch; Menacho, Luis A.; Galea, Jerome T.; Coates, Thomas

    2015-01-01

    Background Social media technologies are newly emerging tools that can be used for HIV prevention and testing in low- and middle-income countries, such as Peru. This study examined the efficacy of using the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. Methods In a cluster randomized controlled trial with concealed allocation, Peruvian MSM from Greater Lima/Callao (N = 556) were randomly assigned to join private intervention or control groups on Facebook for 12 weeks. In the intervention condition, forty-nine Peruvian MSM were trained and randomly assigned to be HIV prevention mentors to participants via Facebook groups over 12 weeks. Control participants received an enhanced standard of care, including standard offline HIV prevention available in Peru as well as participation in Facebook groups (without peer leaders) that provided study updates and HIV testing information. After accepting a request to join the groups, continued participation was voluntary. Participants could request a free HIV test at a local community clinic, and completed questionnaires on HIV risk behaviors and social media use at baseline and 12-week follow-up. Findings Between March 19, 2012, and June 11, 2012, and Sept 26, 2012, and Dec 19, 2012, 556 participants were randomly assigned to intervention groups (N=278) or control groups (N=278); we analyse data for 252 and 246. 43 participants (17%) in the intervention group and 16 (7%) in the control groups got tested for HIV (adjusted odds ratio 2.61, 95% CI 1.55–4.38). No adverse events were reported. Retention at 12-week follow-up was 90%. Across conditions, 7 (87.5%) of the 8 participants who tested positive were linked to care at a local clinic. Interpretation Development of peer-mentored social media communities seemed to be an effective method to increase HIV testing among high-risk populations in Peru.: Results suggest that the HOPE social

  5. 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

  6. Screening for genital and anorectal sexually transmitted infections in HIV prevention trials in Africa

    PubMed Central

    Grijsen, ML; Graham, SM; Mwangome, M; Githua, P; Mutimba, S; Wamuyu, L; Okuku, H; Price, MA; McClelland, RS; Smith, AD; Sanders, EJ

    2014-01-01

    Objectives To demonstrate the value of routine, basic sexually transmitted infection (STI) screening at enrolment into an HIV-1 vaccine feasibility cohort study and to highlight the importance of soliciting a history of receptive anal intercourse (RAI) in adults identified as ‘high risk’. Methods Routine STI screening was offered to adults at high risk for HIV-1 upon enrolment into a cohort study in preparation for HIV-1 vaccine trials. Risk behaviors and STI prevalence were summarized, and the value of microscopy assessed. Associations between prevalent HIV-1 infection and RAI or prevalent STIs were evaluated with multiple logistic regression. Results Participants had a high burden of untreated STIs. Symptom-directed management would have missed 67% of urethritis cases in men and 59% of cervicitis cases in women. RAI was reported by 36% of male and 18% of female participants. RAI was strongly associated with HIV-1 in men (adjusted odds ratio [aOR] = 3.8, 95% CI 2.0 – 6.9), and independently associated with syphilis in women (aOR 12.9, 95% CI 3.4 – 48.7). Conclusions High-risk adults recruited for HIV-1 prevention trials carry a high STI burden. Symptom-directed treatment may miss many cases, and simple laboratory-based screening can be done with little cost. Risk assessment should include questions about anal intercourse and whether condoms were used. STI screening, including specific assessment for anorectal disease, should be offered in African research settings recruiting participants at high risk for HIV-1 acquisition. PMID:18375645

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

    PubMed Central

    2011-01-01

    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. PMID:21968079

  8. A post-trial assessment of factors influencing study drug adherence in a randomized biomedical HIV-1 prevention trial

    PubMed Central

    Jacob, Shevin T.; Baeten, Jared M.; Hughes, James P.; Peinado, Jesús; Wang, Jing; Sanchez, Jorge; Reid, Stewart E.; Delany-Moretlwe, Sinead; Cowan, Frances; Fuchs, Jonathan; Koblin, Beryl; Griffith, Sam; Wald, Anna; Celum, Connie

    2010-01-01

    High adherence and maintenance of blinding are critical for placebo-controlled efficacy trials of HIV-1 biomedical prevention strategies. We assessed adherence to study drug and factors affecting adherence, including perceived randomization group, in a post-trial questionnaire of participants who completed HPTN 039, a randomized, placebo-controlled trial of HSV-2 suppression with twice-daily acyclovir to reduce HIV-1 acquisition. Of the 3172 trial participants, 2003 (63%) completed the post-trial questionnaire. Of these 2003, 72% reported missing a dose of study drug less than twice a week. Study drug adherence was not compromised by perceived randomization or genital ulcer symptoms during the study. Alcohol use was cited as an adherence barrier in some populations. Assessment of study drug adherence during and at the end of trials can evaluate perceptions of randomization and adherence by randomization arm, help to better understand barriers to and motivations for adherence, and develop interventions to increase adherence for future trials. PMID:21104007

  9. In pursuit of an HIV vaccine: designing efficacy trials in the context of partially effective nonvaccine prevention modalities.

    PubMed

    Janes, Holly; Gilbert, Peter; Buchbinder, Susan; Kublin, James; Sobieszczyk, Magdalena E; Hammer, Scott M

    2013-11-01

    The HIV prevention landscape is evolving rapidly, and future efficacy trials of candidate vaccines, which remain the best long-term option for stemming the HIV epidemic, will be conducted in the context of partially effective nonvaccine prevention modalities. It is essential that these trials provide for valid and efficient evaluation of vaccine efficacy and immune correlates. The availability of partially effective prevention modalities presents opportunities to study their interactions with vaccines to maximally reduce HIV incidence. This article proposes an approach for conducting future vaccine efficacy trials in the context of background use of partially effective nonvaccine prevention modalities, and for conducting future vaccine efficacy trials that provide nonvaccine prevention modalities in one or more of the randomized study groups. Strategies are discussed for responding to emerging evidence on nonvaccine prevention modalities during ongoing vaccine trials. Next-generation HIV vaccine efficacy trials will almost certainly be more complex in their design and implementation but may become more relevant to at-risk populations and better suited to the ultimate goal of reducing HIV incidence at the population level.

  10. 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.

  11. 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

  12. Representation of Latinos and Blacks in screening for and enrollment into preventive HIV vaccine trials in New York City.

    PubMed

    Ellman, Tanya M; Hawkins, Kellie; Benitez, Jorge; Negron, Ramon; Chang, Steven; Palmer, Steven; Robertson, Verna; Chiasson, Mary Ann; Sobieszczyk, Magdalena E

    2015-11-27

    In the United States, Latinos and Blacks are disproportionately affected by HIV/AIDS, but have been underrepresented in HIV vaccine trials. We assessed screening and enrollment of Blacks and Latinos for preventive HIV vaccine trials conducted in New York City, 2009-2012. A retrospective analysis was conducted among 18-50 year old men and transgender women screening for four preventive phase 1 and 2 HIV vaccine trials. Demographic, recruitment, and behavioral/medical eligibility data and outcome of screening were examined. To determine factors associated with enrollment, a multivariable logistic regression analysis was performed. Among 6077 individuals who provided contact information, 2536 completed a phone pre-screen. 96 (1.6% of recruitment contacts) enrolled. Latinos were 35.7% of recruitment contacts, but 17.7% of those enrolled, whereas Blacks were 22.5% and 32.3%, respectively. Among all Latinos, nearly one third were excluded for being uncircumcised, an eligibility criterion for several studies. In multivariable analysis among potentially eligible potential participants, controlling for age and recruitment method, Latinos were less likely than Whites to enroll in a preventive HIV vaccine trial (aOR 0.52, 95% CI 0.28-0.95) whereas Blacks were as likely as Whites (aOR 0.99, 95% CI 0.59-1.67). Individuals recruited through print advertisements, social media/internet, referral, and other modes were more likely to enroll compared to those recruited through in-person outreach, controlling for age and race/ethnicity. Targeted outreach has led to substantial inclusion of Latinos and Blacks, with Blacks comprising almost a third of those enrolled in these preventive HIV vaccine trials. Latinos, however, were less likely to enroll compared to Whites. Circumcision status as an eligibility criterion partly accounts for this, but further studies are warranted to address the reasons Latinos decide not to participate in preventive HIV vaccine trials. Copyright © 2015

  13. What is a Preventive HIV Vaccine?

    MedlinePlus

    ... AIDS Drugs Clinical Trials Apps skip to content HIV Overview Home Understanding HIV/AIDS Fact Sheets What ... Send us an email What is a Preventive HIV Vaccine? Last Reviewed: August 16, 2017 Key Points ...

  14. Facebook Advertising to Recruit Young, Urban Women into an HIV Prevention Clinical Trial.

    PubMed

    Jones, Rachel; Lacroix, Lorraine J; Porcher, Eloni

    2017-05-20

    Advertising via Facebook to elicit involvement in clinical trials has demonstrated promise in expanding geographic reach while maintaining confidentiality. The purpose of this study is to evaluate Facebook advertising to reach at-risk, predominately African American or Black women in higher HIV prevalence communities for an HIV prevention clinical trial, and to compare baseline characteristics to those recruited on-the-ground. Maintaining confidentiality and the practical aspects of creating and posting ads on Facebook are described. The advertising strategy targeted multicultural affinities, gender, age, interest terms, and zip codes. We report on results during 205 days. A total of 516,498 Facebook users viewed the ads an average of four times, resulting in 37,133 clicks to the study website. Compared to 495 screened on-the-ground, 940 were screened via Facebook ads, of these, half (n = 477, 50.74%) were high risk, and of those at risk, 154 were randomized into the 6-month clinical trial. Black women comprised 71.60% (n = 673) of the total screened online. Roughly twice as many Black women screened via Facebook compared to on-the-ground, yet, the percentage at high risk was similar. Preliminary data suggest that the extent to which ad headlines and photos tap into authentic social experience, advertising on Facebook can extend geographic reach and provide a comparative sample to women recruited on-the-ground.

  15. Expanding substance use treatment options for HIV prevention with Buprenorphine-Naloxone: HIV Prevention Trials Network 058 (HPTN 058)

    PubMed Central

    Metzger, David S.; Donnell, Deborah; Celentano, David D.; Jackson, J. Brooks; Shao, Yiming; Aramrattana, Apinun; Wei, Liu; Fu, Liping; Ma, Jun; Lucas, Gregory M.; Chawarski, Marek; Ruan, Yuhua; Richardson, Paul; Shin, Katherine; Chen, Ray Y.; Sugarman, Jeremy; Dye, Bonnie J.; Rose, Scott M.; Beauchamp, Geetha; Burns, David N.

    2015-01-01

    Background Injection opioid use plays a significant role in the transmission of HIV infection in many communities and several regions of the world. Access to evidence-based treatments for opioid use disorders is extremely limited. Methods HPTN 058 was a randomized controlled trial designed to compare the impact of two medication assisted treatment (MAT) strategies on HIV incidence or death among opioid dependent people who inject drugs (PWID). HIV-negative opiate dependent PWID were recruited from four communities in Thailand and China with historically high prevalence of HIV among PWID. 1251 participants were randomly assigned to either; 1) a one year intervention consisting of two opportunities for a 15 day detoxification with buprenorphine/naloxone (BUP/NX) combined with up to 21 sessions of behavioral drug and risk counseling (Short Term Medication Assisted Treatment: ST-MAT) or, 2) thrice weekly dosing for 48 weeks with BUP/NX and up to 21 counseling sessions (Long Term Medication Assisted Treatment: LT-MAT) followed by dose tapering. All participants were followed for 52 weeks after treatment completion to assess durability of impact. Results While the study was stopped early due to lower than expected occurrence of the primary endpoints, sufficient data were available to assess the impact of the interventions on drug use and injection related risk behavior. At weeks 26, 22% of ST-MAT participants had negative urinalyses for opioids compared to 57% in the LT-MAT (p<0.001). Differences disappeared in the year following treatment: at week 78, 35% in ST-MAT and 32% in the LT-MAT had negative urinalyses. Injection related risk behaviors were significantly reduced in both groups following randomization. Conclusions Participants receiving BUP/NX three times weekly were more likely to reduce opioid injection while on active treatment. Both treatment strategies were considered safe and associated with reductions in injection related risk behavior. These data support

  16. Contraceptive Use and Pregnancy Incidence Among Women Participating in an HIV Prevention Trial.

    PubMed

    Akello, Carolyne A; Bunge, Katherine E; Nakabiito, Clemensia; Mirembe, Brenda G; Fowler, Mary Glenn; Mishra, Anupam; Marrazzo, Jeanne; Chirenje, Zvavahera M; Celum, Connie; Balkus, Jennifer E

    2017-06-01

    Recent HIV prevention trials required use of effective contraceptive methods to fulfill eligibility for enrollment. We compared pregnancy rates in a subset of participants enrolled in the Microbicide Trials Network protocol (MTN-003), a randomized trial of chemoprophylaxis to prevent HIV acquisition among women aged 18-45 years who initiated depot medroxyprogesterone acetate (DMPA) or combined oral contraceptives (COCs) at enrollment, relative to those already using DMPA or COCs. Data were analyzed from MTN-003 participants from Uganda. Before enrollment, information on contraceptive type and initiation date was obtained. Urine pregnancy tests were performed at monthly follow-up visits. Cox proportional hazards models were used to compare pregnancy incidence among new users (initiated ≤60 days before enrollment) and established users (initiated >60 days before enrollment). Of 322 women enrolled, 296 were COC or DMPA users, 82 (28%) were new users, and 214 (72%) were established users. Pregnancy incidence was higher among new contraceptive users compared to established users (20.70% vs. 10.55%; adjusted hazard ratio [HR] = 1.66; 95% confidence interval [95% CI] 0.93-2.96). Among DMPA users, pregnancy incidence was 10.20% in new users versus 3.48% in established users (HR = 2.56; 95% CI 0.86-7.65). Among new COC users, pregnancy incidence was 42.67% in new users versus 23.67% in established COC users (adjusted HR = 1.74; 95% CI 0.87-3.48). New contraceptive users, regardless of method, at the Uganda MTN-003 site had an increased pregnancy risk compared to established users, which may be due to contraceptive initiation primarily for trial eligibility. New users may benefit from intensive contraceptive counseling and additional contraceptive options, including longer acting reversible contraceptives.

  17. Pregnancy incidence and outcomes among women receiving preexposure prophylaxis for HIV prevention: a randomized clinical trial.

    PubMed

    Mugo, Nelly R; Hong, Ting; Celum, Connie; Donnell, Deborah; Bukusi, Elizabeth A; John-Stewart, Grace; Wangisi, Jonathan; Were, Edwin; Heffron, Renee; Matthews, Lynn T; Morrison, Susan; Ngure, Kenneth; Baeten, Jared M

    Antiretroviral preexposure prophylaxis (PrEP), using tenofovir disoproxil fumarate (TDF) and combination emtricitabine/tenofovir disoproxil fumarate (FTC+TDF), is efficacious for prevention of human immunodeficiency virus (HIV) acquisition. PrEP could reduce periconception HIV risk, but the effect on pregnancy outcomes is not well defined. To assess pregnancy incidence and outcomes among women using PrEP during the periconception period. Randomized trial among 1785 HIV-serodiscordant heterosexual couples (the Partners PrEP Study) in which the female partner was HIV uninfected that demonstrated that PrEP was efficacious for HIV prevention, conducted between July 2008 and June 2013 at 9 sites in Kenya and Uganda. Daily oral TDF (n = 598), combination FTC+TDF (n = 566), or placebo (n = 621) through July 2011, when PrEP demonstrated efficacy for HIV prevention. Thereafter, participants continued receiving active PrEP without placebo. Pregnancy testing occurred monthly and study medication was discontinued when pregnancy was detected. Pregnancy incidence, birth outcomes (live births, pregnancy loss, preterm birth, congenital anomalies), and infant growth. A total of 431 pregnancies occurred. Pregnancy incidence was 10.0 per 100 person-years among women assigned placebo, 11.9 among those assigned TDF (incidence difference, 1.9; 95% CI, -1.1 to 4.9 [P = .22 vs placebo]), and 8.8 among those assigned FTC+TDF (incidence difference, -1.3; 95% CI, -4.1 to 1.5 [P = .39 vs placebo]). Before discontinuation of the placebo treatment group in July 2011, the occurrence of pregnancy loss (96 of 288 pregnancies) was 42.5% for women receiving FTC+TDF compared with 32.3% for those receiving placebo (difference for FTC+TDF vs placebo, 10.2%; 95% CI, -5.3% to 25.7%; P = .16) and was 27.7% for those receiving TDF alone (difference vs placebo, -4.6%; 95% CI, -18.1% to 8.9%; P = .46). After July 2011, the frequency of pregnancy loss (52 of 143 pregnancies) was 37

  18. Use of placebos in Phase 1 preventive HIV vaccine clinical trials.

    PubMed

    Huang, Yunda; Karuna, Shelly T; Janes, Holly; Frahm, Nicole; Nason, Martha; Edlefsen, Paul T; Kublin, James G; Corey, Lawrence; McElrath, M Juliana; Gilbert, Peter B

    2015-02-04

    Phase 1 preventive HIV vaccine trials are often designed as randomized, double-blind studies with the inclusion of placebo recipients. Careful consideration is needed to determine when the inclusion of placebo recipients is highly advantageous and when it is optional for achieving the study objectives of assessing vaccine safety, tolerability and immunogenicity. The inclusion of placebo recipients is generally important to form a reference group that ensures fair evaluation and interpretation of subjective study endpoints, or endpoints whose levels may change due to exposures besides vaccination. In some settings, however, placebo recipients are less important because other data sources and tools are available to achieve the study objectives. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Use of antiretrovirals in HIV-infected children in a tuberculosis prevention trial: IMPAACT P1041.

    PubMed

    Zeldow, B; Kim, S; McSherry, G; Cotton, M F; Jean-Philippe, P; Violari, A; Bobat, R; Nachman, S; Mofenson, L M; Madhi, S A; Mitchell, C

    2017-01-01

    International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1041, a tuberculosis (TB) prevention trial conducted among children enrolled from 2004 to 2008 during South Africa's roll-out of combination antiretroviral therapy (ART). To estimate TB incidence and mortality and the effect of ART. Children were pre-screened to exclude TB disease and exposure, actively screened 3-monthly for TB exposure and symptoms, and provided post-exposure isoniazid prophylaxis therapy (IPT). TB diagnoses were definite, probable, or possible, and mortality all-cause. Testing was at the 5% significance level. In 539 children (aged 3-4 months) followed up for a median of 74 weeks (interquartile range [IQR] 48-116), incidence/100 person-years (py) was 10.67 (95%CI 8.47-13.26) for any TB and 2.89 (95%CI 1.85-4.31) for definite/probable TB. Any TB incidence was respectively 9.39, 13.59, and 9.83/100 py before, <180 days after, and 180 days after ART initiation. Adjusted analysis showed a non-significant increase in any TB (HR 1.32, 95%CI 0.71-2.52, P = 0.38) and a significant reduction in mortality (HR 0.39, 95%CI 0.17-0.82, P = 0.017) following ART initiation. ART reduced mortality but not TB incidence in human immunodeficiency virus (HIV) infected children in IMPAACT P1041, possibly attributable to active screening for TB exposure and symptoms with post-exposure IPT. Research into this as a strategy for TB prevention in high HIV-TB burden settings may be warranted.

  20. 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

  1. Access to treatment in HIV prevention trials: perspectives from a South African community.

    PubMed

    Barsdorf, Nicola; Maman, Suzanne; Kass, Nancy; Slack, Catherine

    2010-08-01

    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.

  2. Project Enhance: A Randomized Controlled Trial of an Individualized HIV Prevention Intervention for HIV-Infected Men Who Have Sex With Men Conducted in a Primary Care Setting

    PubMed Central

    Safren, Steven A.; O’Cleirigh, Conall M.; Skeer, Margie; Elsesser, Steven A.; Mayer, Kenneth H.

    2013-01-01

    Objective Men who have sex with men (MSM) are the largest group of individuals in the U.S. living with HIV and have the greatest number of new infections. This study was designed to test a brief, culturally relevant prevention intervention for HIV-infected MSM, which could be integrated into HIV care. Method HIV-infected MSM who received HIV care in a community health center (N = 201), and who reported HIV sexual transmission-risk behavior (TRB) in the prior 6 months, were randomized to receive the intervention or treatment as usual. The intervention, provided by a medical social worker, included proactive case management for psychosocial problems, counseling about living with HIV, and HIV TRB risk reduction. Participants were followed every 3 months for one year. Results Participants, regardless of study condition, reported reductions in HIV TRB, with no significant differential effect by condition in primary intent-to-treat analyses. When examining moderators, the intervention was differentially effective in reducing HIV TRB for those who screened in for baseline depression, but this was not the case for those who did not screen in for depression. Conclusions The similar level of reduction in HIV TRB in the intervention and control groups, consistent with other recent secondary prevention interventions, speaks to the need for new, creative designs, or more potent interventions in secondary HIV prevention trials, as the control group seemed to benefit from risk assessment, study contact, and referrals provided by study staff. The differential finding for those with depression may suggest that those without depression could reap benefits from limited interventions, but those with a comorbid psychiatric diagnosis may require additional interventions to modify their sexual risk behaviors. PMID:22746262

  3. Intention to use condom, cusp modeling, and evaluation of an HIV prevention intervention trial.

    PubMed

    Chen, Xinguang; Stanton, Bonita; Chen, Din; Li, Xiaoming

    2013-07-01

    Adolescents are at particularly high risk to acquire HIV infection; increasing the likelihood of condom use is an effective measure to reduce the risk of such infections. Challenges in assessing actual condom use behavior among early adolescents render the precursor measure, intention to use condoms, an appealing alternative. While analyzing data from a randomized controlled trial to evaluate a theory-based intervention program to promote condom use among early adolescents, we observed a modest effect with regard to condom use intention when the linear analytical approach was used. If intention, as a measure of the readiness to perform a behavior, also contains a nonlinear discrete component, it would be more appropriately modeled using a nonlinear approach. In this study, data from a randomized controlled trial (N=1360) were analyzed using the cusp catastrophe method with HIV knowledge and condom skills as the asymmetry variables and condom use self-efficacy as the bifurcation variables. Findings from concurrent and longitudinal modeling analyses indicated a much better fit of the cusp model (R2 = 0.85); AIC and BIC were one-fourth that of than the linear (R2 lt; 0.10) or the logistic model (R2 lt; 0.15). Receipt of the intervention as an asymmetry variable was significantly predicted condom use intention but did not as a bifurcation variable. In conclusion, adolescent intentions to use a condom contain both a continuous process and a discrete process and can better be modeled with cusp catastrophe methods. A much greater program effect is likely from the same prevention intervention if additional measures are taken to foster sudden changes in condom intention.

  4. INTENTION TO USE CONDOM, CUSP MODELING, AND EVALUATION OF AN HIV PREVENTION INTERVNETION TRIAL

    PubMed Central

    Chen, Xinguang; Stanton, Bonita; Chen, Ding-Geng; Li, Xiaoming

    2014-01-01

    Adolescents are at particularly high risk to acquire HIV infection; increasing the likelihood of condom use is an effective measure to reduce the risk of such infections. Challenges in assessing actual condom use behavior among early adolescents render the precursor measure, intention to use condoms, an appealing alternative. While analyzing data from a randomized controlled trial to evaluate a theory-based intervention program to promote condom use among early adolescents, we observed a modest effect with regard to condom use intention when the linear analytical approach was used. If intention, as a measure of the readiness to perform a behavior, also contains a nonlinear discrete component, it would be more appropriately modeled using a non-linear approach. In this study, data from a randomized controlled trial (N=1360) were analyzed using the cusp catastrophe method with HIV knowledge and condom skills as the asymmetry variables and condom use self-efficacy as the bifurcation variables. Findings from concurrent and longitudinal modeling analyses indicated a much better fit of the cusp model (R2 = 0.85 and 4+ times smaller AIC and BIC) than the linear (R2 <=0.10 and 4+ times larger AIC and BIC) or the logistic model (R2<0.15, also 4+ times larger AIC and BIC). Receipt of the intervention as an asymmetry variable was significantly predicted condom use intention but did not as a bifurcation variable. In conclusion, adolescent intentions to use a condom contain both a continuous process and a discrete process and can better be modeled with cusp methods. A much greater program effect is likely from the same prevention intervention if additional measures are taken to foster sudden changes in condom intention. PMID:23735493

  5. 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

  6. 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,…

  7. 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,…

  8. 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

  9. Comparative Effectiveness of Web-Based vs. Educator-Delivered HIV Prevention for Adolescent Substance Users: A Randomized, Controlled Trial

    PubMed Central

    Marsch, Lisa A.; Guarino, Honoria; Grabinski, Michael J.; Syckes, Cassandra; Dillingham, Elaine T.; Xie, Haiyi; Crosier, Benjamin S.

    2015-01-01

    Background Young people who engage in substance use are at risk for becoming infected with HIV and diseases with similar transmission dynamics. Effective disease prevention programs delivered by prevention specialists exist but are rarely provided in systems of care due to staffing/resource constraints and operational barriers - and are thus of limited reach. Web-based prevention interventions could possibly offer an effective alternative to prevention specialist-delivered interventions and may enable widespread, cost-effective access to evidence-based prevention programming. Previous research has shown the HIV/disease prevention program within the web-based Therapeutic Education System (TES) to be an effective adjunct to a prevention specialist-delivered intervention. The present study was the first randomized, clinical trial to evaluate the comparative effectiveness of this web-based intervention as a standalone intervention relative to a traditional, prevention specialist-delivered intervention. Methods Adolescents entering outpatient treatment for substance use participated in this multi-site trial. Participants were randomly assigned to either a traditional intervention delivered by a prevention specialist (n = 72) or the web-delivered TES intervention (n = 69). Intervention effectiveness was assessed by evaluating changes in participants’ knowledge about HIV, hepatitis, and sexually transmitted infections, intentions to engage in safer sex, sex-related risk behavior, self-efficacy to use condoms, and condom use skills. Findings Participants in the TES intervention achieved significant and comparable increases in HIV/disease-related knowledge, condom use self-efficacy, and condom use skills and comparable decreases in HIV risk behavior relative to participants who received the intervention delivered by a prevention specialist. Participants rated TES as easier to understand. Conclusion This study indicates that TES is as effective as HIV/disease prevention

  10. 'I heard about this study on the radio': using community radio to strengthen Good Participatory Practice in HIV prevention trials.

    PubMed

    Medeossi, Bonnie-Jeanne; Stadler, Jonathan; Delany-Moretlwe, Sinead

    2014-08-26

    During the Microbicides Development Program (MDP) 301, a clinical trial of a candidate microbicide amongst women in Johannesburg, South Africa, we used community radio to promote awareness of the trial, to inform community members about specific medical research procedures and terminologies, and to stimulate dialogue between researchers and local citizens. We used mixed methods to undertake a retrospective analysis of the social responses to the radio shows, focusing specifically on recruitment and participation in the MDP301 trial. We collected quantitative data that describes the themes and listener responses, the costs per broadcast, and the impact of the radio broadcasts on trial recruitment. Qualitative data on local reactions to the shows was gleaned from in-depth interviews with trial participants. Over a seven-year period, 205 individual broadcasts were made on two separate community radio stations. Show themes were either specifically related to medical research issues (36%), or focused on general health issues (46%), and sexual and reproductive health, including HIV prevention (18%). 403 listeners made telephone calls to the radio station, and 12% of women enrolled as participants in MDP301 (n = 9, 385) reported that they had first heard about the trial from the radio. Qualitative interviews (n = 401) with female MDP301 participants highlighted the effects of the radio shows in making women aware of the trial, impressing them with the importance of health screening and knowledge, legitimizing trial participation, and stimulating dialogue between trial participants and their male partners. Community radio is a potent tool for raising awareness and local knowledge about medical research and, in addition to other methodologies, can be used to promote recruitment into clinical trials. We suggest that future HIV prevention trials consider an investment in community radio beyond recruitment advertisements that incorporates this into the broader community

  11. HIV prevention for juvenile drug court offenders: a randomized controlled trial focusing on affect management.

    PubMed

    Tolou-Shams, Marina; Houck, Christopher; Conrad, Selby M; Tarantino, Nicholas; Stein, L A R; Brown, Larry K

    2011-07-01

    Juvenile drug court (JDC) offenders have benefited from evidence-based interventions addressing antisocial behavior, mental health, and substance use; however, interventions addressing HIV risk behavior are lacking. This study presents pilot findings and lessons learned from a group-based HIV prevention intervention delivered to JDC offenders. Participants were randomized to a five-session HIV prevention (n = 29) or health promotion (n = 28) condition and completed measures of sexual risk taking and substance use at baseline and 3 months postintervention. No between-group differences by time emerged on measures of sexual risk taking or other HIV-related behaviors and attitudes. Both groups improved their rates of HIV testing and decreased their substance use during sex over time. Delivering an HIV prevention intervention to drug court offenders is feasible; however, more intensive interventions that incorporate multiple systems and address co-occurring mental health difficulties may be needed to effect sexual behavioral change among these high-risk court-involved youth.

  12. HIV Prevention for Juvenile Drug Court Offenders: A Randomized Controlled Trial Focusing on Affect Management

    PubMed Central

    Tolou-Shams, Marina; Houck, Christopher D.; Conrad, Selby M.; Tarantino, Nicholas; Stein, L.A.R.; Brown, Larry K.

    2011-01-01

    Background Juvenile drug court offenders have benefited from evidence-based interventions addressing antisocial behavior, mental health and/or substance use; however, interventions addressing HIV risk behavior are lacking. This study presents pilot findings and lessons learned from a group-based HIV prevention intervention delivered to juvenile drug court offenders. Methods Participants were randomized to a 5-session HIV Prevention (n =29) or Health Promotion (n=28) condition and completed measures of sexual risk taking and substance use at baseline and 3 month post-intervention. Results No between-group differences by time emerged on measures of sexual risk-taking or other HIV-related behaviors and attitudes. Both groups improved their rates of HIV testing and decreased their substance use during sex over time. Conclusions Delivering an HIV prevention intervention to drug court offenders is feasible; however, more intensive interventions that incorporate multiple systems and address co-occurring mental health difficulties may be needed to affect sexual behavioral change among these high-risk court-involved youth. PMID:21474529

  13. 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

  14. Intentions to use preexposure prophylaxis among current phase 2B preventive HIV-1 vaccine efficacy trial participants.

    PubMed

    Fuchs, Jonathan D; Sobieszczyk, Magdalena E; Madenwald, Tamra; Grove, Doug; Karuna, Shelly T; Andrasik, Michele; Sherwat, Adam; Broder, Gail; Mayer, Kenneth; Koblin, Beryl; Hammer, Scott

    2013-07-01

    In November 2010, the iPrEx study reported that preexposure prophylaxis (PrEP) with daily tenofovir disoproxil fumarate/emtricitabine reduced HIV infections by 44% among men who have sex with men and subsequent trials corroborated efficacy among heterosexual men and women. During regularly scheduled follow-up visits from January to March 2011, participants in an ongoing phase 2b vaccine efficacy trial completed an anonymous Web survey about PrEP. Among 376 respondents, 17% reported they were very likely to use PrEP in the next year. Nonwhite participants were more likely to use PrEP. Among those with some level of interest, intent to use PrEP was greatest if the drug were available through the clinical trial or health insurance. Most (91%) believed taking PrEP would not change their willingness to stay in the vaccine trial and few thought it would affect recruitment. As key stakeholders, currently enrolled trial participants can offer vital input about emerging prevention technologies that may affect the design of future HIV vaccine and nonvaccine prevention trials.

  15. Intentions to use pre-exposure prophylaxis among current phase 2B preventive HIV-1 vaccine efficacy trial participants

    PubMed Central

    Fuchs, Jonathan D.; Sobieszczyk, Magdalena E.; Madenwald, Tamra; Grove, Doug; Karuna, Shelly T.; Andrasik, Michele; Sherwat, Adam; Broder, Gail; Mayer, Kenneth; Koblin, Beryl; Hammer, Scott

    2013-01-01

    In November 2010, the iPrEx study reported that pre-exposure prophylaxis (PrEP) with daily tenofovir disoproxil fumarate/emtricitabine reduced HIV infections by 44% among men who have sex with men and subsequent trials corroborated efficacy among heterosexual men and women. During regularly scheduled follow-up visits from January-March 2011, participants in an ongoing phase 2b vaccine efficacy trial completed an anonymous web survey about PrEP. Among 376 respondents, 17% reported they were very likely to use PrEP in the next year. Non-white participants were more likely to use PrEP. Among those with some level of interest, intent to use PrEP was greatest if the drug were available through the clinical trial or health insurance. Most (91%) believed taking PrEP would not change their willingness to stay in the vaccine trial and few thought it would affect recruitment. As key stakeholders, currently enrolled trial participants can offer vital input about emerging prevention technologies that may affect the design of future HIV vaccine and non-vaccine prevention trials. PMID:23614998

  16. Contraception use and impact on pregnancy prevention in women participating in an HIV prevention trial in South Africa.

    PubMed

    Moodley, Jayajothi; Naidoo, Sarita; Wand, Handan; Ramjee, Gita

    2016-01-01

    Unplanned pregnancy rates in South Africa are high. Effective use of contraception is therefore an essential public health intervention to prevent unplanned pregnancies. This study describes contraception use and its impact on pregnancy in women participating in HIV prevention research and its implications for public health practice. A secondary analysis of sociodemographic, behavioural, contraception use, and pregnancy incidence data was conducted amongst women participating in the Microbicides Development Programme (MDP) 301 trial conducted in Durban, South Africa. Log-rank tests were carried out to compare the pregnancy incidence between women who reported use of injectable contraceptive methods compared to women using oral contraceptive pills, using condoms and other methods (intrauterine device, traditional methods and natural methods). The effect of types of contraceptives on pregnancy incidence was assessed using Cox proportional hazards regression models. Of the 2018 women enrolled, injectable contraception was the most commonly used method (52%) compared to pills, condoms for pregnancy prevention and other methods. Injectable contraception use was associated with lower crude pregnancy incidence of 4.4 per 100 woman-years [95% confidence interval (95% CI 3.3-5.9)] compared to women using pills [19.3 per 100 woman-years (95% CI 13.3-28.0)], condoms [19.7 per 100 woman-years (95% CI 16.3-23.6)] and other methods [11.5 per 100 woman-years (95% CI 7.5-17.6)]. This effect remained significant when adjusted for age, level of education, condom use at last sex act [hazard ratio 0.27, (95% CI 0.16-0.47, p<0.001)]. Injectable contraception offered a high level of protection against pregnancies among women in Durban. ISRCTN64716212. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  17. Engaging members of African American and Latino communities in preventive HIV vaccine trials.

    PubMed

    Sobieszczyk, Magdalena E; Xu, Guozhen; Goodman, Krista; Lucy, Debbie; Koblin, Beryl A

    2009-06-01

    African Americans (AAs) and Latinos in United States bear a disproportionate burden of HIV infection, yet remain underrepresented in HIV vaccine trials. The success in engaging and enrolling AAs and Latinos in phase 1 and phase 2 vaccine trials at 2 research sites in New York City is described. A retrospective analysis of 1683 HIV-uninfected individuals who completed > or = 1 stage of the screening process from 2002 to 2006. Data on sociodemographic, behavioral characteristics, medical eligibility, and enrollment in National Institutes of Health-sponsored vaccine trials were collected. 7.5% of screening participants completed enrollment; 33% were AAs, 24% Latinos. The proportion of enrollees did not differ significantly by race/ethnicity. Low-risk vs. high-risk AAs (49% vs. 23%, P = 0.006) and high-risk vs. low-risk Latinos (31% vs. 13%, P = 0.006) were more likely to enroll. Among them, loss to follow-up was the most common reason for not completing screening. In multivariate analysis, older participants, high-risk men, and high-risk women were more likely to complete enrollment. Once potential minority participants are identified and engaged in the screening process, it is possible to enroll them at rates comparable to white participants. Experience at these sites suggests that the challenge in achieving high rates of minority participation is in increasing the initial pool of candidates prescreening for HIV vaccine studies.

  18. Pregnancy and contraceptive use among women participating in an HIV prevention trial in Tanzania

    PubMed Central

    Odutola, Aderonke; Baisley, Kathy; Hayes, Richard J; Rusizoka, Mary; Tanton, Clare; Weiss, Helen A; Changalucha, John; Ross, David A

    2012-01-01

    Objectives Information on pregnancy rates and factors associated with pregnancy and contraceptive use is important for clinical trials in women in sub-Saharan Africa where withdrawal of investigational products may be required in the event of pregnancy with a consequent effect on sample size and trial power. Methods A prospective cohort analysis of pregnancy and contraceptive use was conducted in Tanzanian women enrolled in a randomised placebo-controlled trial of herpes simplex virus-suppressive therapy with acyclovir to measure the effect on HIV incidence in HIV-negative women and on genital and plasma HIV viral load in HIV-positive women. The cohort was followed every 3 months for 12–30 months. Women at each visit were categorised into users or non-users of contraception. Pregnancy rates and factors associated with pregnancy incidence and contraceptive use were measured. Results Overall 254 of 1305 enrolled women became pregnant at least once during follow-up (pregnancy rate: 12.0/100 person-years). Younger age, being unmarried, higher baseline parity and changes in contraceptive method during follow-up were independently associated with pregnancy. Having paid sex and being HIV positive were associated with lower risk of pregnancy. Uptake of contraception was associated with young age, being unmarried, occupation, parity and the number and type of sexual partners. Conclusions Data on use of contraceptive methods and risk factors for pregnancy can help to guide decisions on trial eligibility and the need for additional counselling. Mandatory reliable contraceptive use in study participants may be required to reduce pregnancy rates in studies where pregnancy is contraindicated. PMID:22436198

  19. 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

  20. Change in condom and other barrier method use during and after an HIV prevention trial in Zimbabwe

    PubMed Central

    2010-01-01

    Background We examined the use of male condoms and the diaphragm following completion of a clinical trial of the diaphragm's HIV prevention effectiveness. In the trial, called Methods for Improving Reproductive Health in Africa (MIRA), women were randomized to a diaphragm group (diaphragm, gel and condoms) or a condom-only control group. At trial exit, all women were offered the diaphragm and condoms. Methods Our sample consisted of 801 Zimbabwean MIRA participants who completed one post-trial visit (median lapse: nine months; range two to 20 months). We assessed condom, diaphragm and any barrier method use at last sex act at enrolment, final MIRA and post-trial visits. We used multivariable random effects logistic regression to examine changes in method use between these three time points. Results and discussion In the condom group, condom use decreased from 86% at the final trial visit to 67% post trial (AOR = 0.20; 95% CI: 0.12 to 0.33). In the diaphragm group, condom use was 61% at the final trial visit, and did not decrease significantly post trial (AOR = 0.77; 95% CI: 0.55 to 1.09), while diaphragm use decreased from 79% to 50% post trial (AOR = 0.18; 95% CI: 0.12 to 0.28). Condom use significantly decreased between the enrolment and post-trial visits in both groups. Use of any barrier method was similar in both groups: it significantly decreased between the final trial and the post-trial visits, but did not change between enrolment and the post-trial visits. Conclusions High condom use levels achieved during the trial were not sustained post trial in the condom group. Post-trial diaphragm use remained relatively high in the diaphragm group (given its unknown effectiveness), but was very low in the condom group. Introducing "new" methods for HIV prevention may require time and user skills before they get adopted. Our findings underscore the potential benefit of providing a mix of methods to women as it may encourage more protected acts. PMID:20955629

  1. 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

  2. Results of the NIMH collaborative HIV/sexually transmitted disease prevention trial of a community popular opinion leader intervention.

    PubMed

    2010-06-01

    To determine whether community populations in community popular opinion leader intervention venues showed greater reductions in sexual risk practices and lower HIV/sexually transmitted disease (STD) incidence than those in comparison venues. 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 community popular opinion leader 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 2 years. Both intervention and comparison conditions showed declines of approximately 33% in risk behavior prevalence and had comparable diseases incidence within and across countries. 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.

  3. Microbicide trials for preventing HIV/AIDS in South Africa: phase II trial partricipants' experiences and psychological needs.

    PubMed

    Pistorius, A G; van de Wijgert, J H H M; Sebola, M; Friedland, B; Nagel, E; Bokaba, C; Hoosen, A A

    2004-08-01

    The Microbicide Division of the Department of Medical Microbiology at MEDUNSA, South Africa, recently completed a phase II expanded safety trial of the candidate microbicide Carraguard. A microbicide is a vaginal product that women might use, if proven safe and effective, to protect themselves from HIV and possibly other sexually transmitted infections (STIs). The study participants were from Ga-Rankuwa and its neighbouring areas, an historically disadvantaged residential township near Pretoria. We conducted six focus group discussions with phase II trial participants to evaluate their experiences with trial participation and their psychological needs. Participants spontaneously talked about their experiences with the study gel and speculum examinations. They felt that they had received high quality medical care. They indicated that their personal hygiene and knowledge of the female reproductive system, HIV and other STIs had improved, which helped their familie and empowered them as women. Participants valued being able to discuss their anxiety about HIV/AIDS wit study staff. They felt that the study provided them with a supportive environment in which their personal problems (not necessarily restricted to HIV/AIDS) could be addressed. Some recommended that the study staf improve their professionalism and punctuality. They suggested the formation of participant support groups, an expressed a preference to remain involved in the trial. Some participants appeared to have become dependent o services provided during the trial. We have taken the results of these focus group discussions into account during planning for a phase III efficacy trial of Carraguard to be conducted in the same and other similar communities.

  4. "It is better to die": experiences of traditional health practitioners within the HIV treatment as prevention trial communities in rural South Africa (ANRS 12249 TasP trial).

    PubMed

    Moshabela, Mosa; Zuma, Thembelihle; Orne-Gliemann, Joanna; Iwuji, Collins; Larmarange, Joseph; McGrath, Nuala

    2016-01-01

    The ANRS 12249 Treatment-as-Prevention (TasP) cluster-randomized trial in rural South Africa uses a "test and treat" approach. Home-based testing services and antiretroviral treatment initiation satellite clinics were implemented in every cluster as part of the trial. A social science research agenda was nested within TasP with the aim of understanding the social, economic and contextual factors that affect individuals, households, communities and health systems with respect to TasP. Considering the rural nature of the trial setting, we sought to understand community perceptions and experiences of the TasP Trial interventions as seen through the eyes of traditional health practitioners (THPs). A qualitative study design was adopted using four repeat focus group discussions conducted with nine THPs, combined with community walks and photo-voice techniques, over a period of 18 months. A descriptive, interpretive and explanatory approach to analysis was adopted. Findings indicate that THPs engaged with the home-based testing services and HIV clinics established for TasP. Specifically, home-based testing services were perceived as relatively successful in increasing access to HIV testing. A major gap observed by THPs was linkage to HIV clinics. Most of their clients, and some of the THPs themselves, found it difficult to use HIV clinics due to fear of labelling, stigma and discrimination, and the ensuing personal implications of unsolicited disclosure. On the one hand, a growing number of patients diagnosed with HIV have found sanctuary with THPs as alternatives to clinics. On the other hand, THPs in turn have been struggling to channel patients suspected of HIV into clinics through referrals. Therefore, acceptability of the TasP test and treat approach by THPs is a major boost to the intervention, but further success can be achieved through strengthened ties with communities to combat stigma and effectively link patients into HIV care, including partnerships with THPs

  5. 'It looks like you just want them when things get rough': civil society perspectives on negative trial results and stakeholder engagement in HIV prevention trials.

    PubMed

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

    2013-12-01

    Civil society organizations (CSOs) have significantly impacted on the politics of health research and the field of bioethics. In the global HIV epidemic, CSOs have served a pivotal stakeholder role. The dire need for development of new prevention technologies has raised critical challenges for the ethical engagement of community stakeholders in HIV research. This study explored the perspectives of CSO representatives involved in HIV prevention trials (HPTs) on the impact of premature trial closures on stakeholder engagement. Fourteen respondents from South African and international CSOs representing activist and advocacy groups, community mobilisation initiatives, and human and legal rights groups were purposively sampled based on involvement in HPTs. Interviews were conducted from February-May 2010. Descriptive analysis was undertaken across interviews and key themes were developed inductively. CSO representatives largely described positive outcomes of recent microbicide and HIV vaccine trial terminations, particularly in South Africa, which they attributed to improvements in stakeholder engagement. Ongoing challenges to community engagement included the need for principled justifications for selective stakeholder engagement at strategic time-points, as well as the need for legitimate alternatives to CABs as mechanisms for engagement. Key issues for CSOs in relation to research were also raised. © 2012 John Wiley & Sons Ltd.

  6. Motivation, recruitment, and screening of volunteers for a phase I/II HIV preventive vaccine trial in Thailand.

    PubMed

    Jenkins, R A; Chinaworapong, S; Morgan, P A; Ruangyuttikarn, C; Sontirat, A; Chiu, J; Michael, R A; Nitayaphan, S; Khamboonruang, C

    1998-06-01

    Data from recruitment and screening for a phase I/II preventive HIV-1 vaccine trial in Thailand were evaluated with respect to correlates of participation at each phase. Correlates included demographic variables, motivation for interest in the trial, and factors related to communication and contact. Participants were recruited at two sites through varied methods. The majority of prescreenees reported altruistic motives for interest in the trial and blood donors emerged as a group that may have been particularly altruistic. Findings indicated site differences in attrition during recruitment and screening, but not in enrollment into the vaccine trial. Blood donation and willingness to be contacted by phone at home were significantly related to making and keeping screening appointments.

  7. Early Weaning of HIV-Exposed Uninfected Infants and Risk of Serious Gastroenteritis: Findings from Two Perinatal HIV Prevention Trials in Kampala, Uganda

    PubMed Central

    Onyango-Makumbi, Carolyne; Bagenda, Danstan; Mwatha, Antony; Omer, Saad B.; Musoke, Philippa; Mmiro, Francis; Zwerski, Sheryl L.; Kateera, Brenda Asiimwe; Musisi, Maria; Fowler, Mary Glenn; Jackson, J. Brooks; Guay, Laura A.

    2009-01-01

    Objective To assess serious gastroenteritis risk and mortality associated with early cessation of breastfeeding in infants enrolled in two prevention-of-maternal-to-child-HIV-transmission trials in Uganda. Methods We used hazard rates to evaluate serious gastroenteritis events by month of age and mortality among HIV-exposed uninfected infants enrolled in the HIVNET 012 (1997-2001) and HIVIGLOB/NVP (2004-2007) trials. HIV-infected mothers were counseled using local infant feeding guidelines current at the time. Results Breastfeeding cessation occurred earlier in HIVIGLOB/NVP compared to HIVNET 012 (median 4.0 vs. 9.3 months, p<0.001). Rates of serious gastroenteritis were higher in HIVIGLOB/NVP (8.0/1000 child-months) compared to HIVNET 012 (3.1/1000 child-months; p < 0.001). Serious gastroenteritis events also peaked earlier at 3-4 and 7-8 months (16.2/1000 and 15.0/1000 child-months, respectively) compared to HIVNET 012 at 9 to10 months (20.8/1000 child-months). All cause-infant mortality did not statistically differ between the HIVIGLOB/NVP and the HIVNET 012 trials [3.2/1000 versus 2.0/1000 child-months respectively, (p=0.10)] Conclusion Early breastfeeding cessation seen in the HIVIGLOB/NVP trial was associated with increased risk of serious gastroenteritis among HIV-exposed uninfected infants when compared to later breastfeeding cessation in the HIVNET 012 trial. Testing interventions which could decrease HIV transmission through breastfeeding and allow safe breastfeeding into the second year of life are urgently needed. PMID:19779355

  8. A phase I trial of preventive HIV vaccination with heterologous poxviral-vectors containing matching HIV-1 inserts in healthy HIV-uninfected subjects

    PubMed Central

    Keefer, Michael C.; Frey, Sharon E.; Elizaga, Marnie; Metch, Barbara; De Rosa, Stephen C.; Barroso, Paulo F.; Tomaras, Georgia; Cardinali, Massimo; Goepfert, Paul; Kalichman, Artur; Philippon, Valérie; McElrath, M. Juliana; Jin, Xia; Ferrari, Guido; Defawe, Olivier D.; Mazzara, Gail P.; Montefiori, David; Pensiero, Michael; Panicali, Dennis L.; Corey, Lawrence

    2011-01-01

    We evaluated replication-defective poxvirus vectors (modified vaccinia Ankara [MVA] and fowlpox [FPV]) in a homologous and heterologous vector prime-boost vaccination regimen containing matching HIV inserts (MVA-HIV and FPV-HIV) given at months 0, 1, 3, 5 and 7 in 150 healthy HIV-negative vaccinia-naïve participants. FPV-HIV alone was poorly immunogenic, while the high dose (109 pfu/2ml) of MVA-HIV alone elicited maximal responses after two injections: CD4+ and CD8+ T-cell responses in 26/55 (47.3%) and 5/60 (8.3%) of participants, respectively and IFN-γ ELISpot responses in 28/62 (45.2%). The infrequent CD8+ T-cell responses following MVA-HIV priming were boosted only by the heterologous (FPV-HIV) construct in 14/27 [51.9%] of participants post-4th vaccination. Alternatively, HIV envelope-specific binding antibodies were demonstrated in approximately two-thirds of recipients of the homologous boosting regimen, but in less than 20% of subjects after the heterologous vector boost. Thus, a heterologous poxvirus vector prime-boost regimen can induce an HIV-specific CD8+ T-cell and CD4+ T-cell responses, which may be an important feature of an optimal regimen for preventive HIV vaccination. PMID:21216311

  9. 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.

  10. 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

  11. Efficacy of theory-based HIV behavioral prevention among rural-to-urban migrants in China: a randomized controlled trial.

    PubMed

    Li, Xiaoming; Lin, Danhua; Wang, Bo; Du, Hongfei; Tam, Cheuk Chi; Stanton, Bonita

    2014-08-01

    Our objective was to evaluate the efficacy of a cultural adaptation of a social cognitive theory-based HIV behavioral prevention program among young rural-to-urban migrants in China. The intervention design and assessment were guided by the Protection Motivation Theory (PMT). The intervention was evaluated through a randomized controlled trial with 6-month and 12-month follow-ups. The primary behavioral outcome was the use of condoms. Other outcome measures include HIV knowledge, condom use knowledge, HIV-related perceptions (PMT constructs), and intention to use condom. The mixed-effects regression models for condom use with regular partners indicated that overall frequency of condom use, condom use in last three sexual acts and proper condom use increased over time for the participants but the increases were significantly greater among the intervention group than the control group at 6-month and 12-month follow-ups. The mixed-effects models for HIV-related perceptions indicated that extrinsic rewards, intrinsic rewards, and response costs decreased while vulnerability, severity, response efficacy, and self-efficacy increased over time for the intervention group. The increases in HIV knowledge, condom use knowledge, and intention to use condom were also significantly greater among the intervention group than the control group. The data in the current study suggested efficacy of a social cognitive theory-based behavioral intervention in increasing condom use among young migrants in China. The intervention also increased protective perceptions and decreased risk perception posited by the theory (i.e., PMT).

  12. The exploitation of "Exploitation" in the tenofovir prep trial in Cameroon: Lessons learned from media coverage of an HIV prevention trial.

    PubMed

    Mack, Natasha; Robinson, Elizabeth T; MacQueen, Kathleen M; Moffett, Jill; Johnson, Laura M

    2010-06-01

    media coverage influences how clinical trials are perceived internationally and in communities where trials occur, affecting recruitment, retention, and political support for research. We conducted a discourse analysis of news coverage from 2004-2005 of a trial in Cameroon on oral PrEP for HIV prevention, to identify messages, communication techniques, and sources of messages that were amplified via media. We identified two parallel discourses: one on ethical concerns about the Cameroon trial, and a second, more general "science exploitation" discourse concerned with the potential for trials with vulnerable participant populations to be conducted unethically, benefiting only wealthy populations. Researchers should overtly address exploitation as an integral, ongoing component of research, particularly where historical or cultural conditions set the stage for controversy to emerge.

  13. Enhanced retention strategies and willingness to participate among hard-to-reach female sex workers in Barcelona for HIV prevention and vaccine trials

    PubMed Central

    Etcheverry, M. Florencia; Evans, Jennifer L.; Sanchez, Emilia; Mendez-Arancibia, Eva; Meroño, Mercé; Gatell, José M.; Page, Kimberly; Joseph, Joan

    2013-01-01

    The potential for implementation of HIV vaccine trials in hard-to-reach female sex workers in an inner city area of Barcelona, Spain was assessed via a study of HIV risk, willingness to participate and the success of retention strategies. In 130 women, serological HIV status, behavioral risk exposures and willingness to participate in future HIV vaccine trials were recorded every six months using a confidential questionnaire. An enhanced retention (ER) strategy was compared with a control retention (CR) strategy comprising the recording of data on appointment cards. HIV seroincidence and retention rates were estimated. Retention rates after 6 and 12 mo of follow-up in the ER group were 76% and 69% respectively compared with 16% and 13% in the CR group. Among the ER group 97% were willing to participate in HIV vaccine trials at baseline and, after 12 mo of follow-up. Willingness was significantly associated with higher HIV risk exposure, and higher education level. Successfully retaining these cohorts over time in settings with a high HIV seroincidence rate is an ongoing challenge that will need to be addressed to ensure participation in future trials. Furthermore, as we have demonstrated, the fact that retaining hard-to-reach populations is difficult should not exclude this target population for HIV vaccine and prevention trials. PMID:23291931

  14. Effects of a social network HIV/STD prevention intervention for MSM in Russia and Hungary: a randomized controlled trial.

    PubMed

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

    2015-03-13

    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. A two-arm trial with 18 sociocentric networks of MSM randomized to the social network intervention or standard HIV/STD testing/counseling. St. Petersburg, Russia and Budapest, Hungary. Eighteen '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 three-ring sociocentric networks (mean size = 35 members, n = 626) were recruited. Empirically identified network leaders were trained and guided to convey HIV prevention advice to other network members. Changes in sexual behavior from baseline to 3-month and 12-month follow-up, with composite HIV/STD incidence, measured at 12 months to corroborate behavior changes. There were significant reductions between baseline, first follow-up, and second follow-up in the intervention versus comparison arm for proportion of men engaging in any unprotected anal intercourse (UAI) (P = 0.04); UAI with a nonmain partner (P = 0.04); and UAI with multiple partners (P = 0.002). The mean percentage of unprotected anal intercourse acts significantly declined (P = 0.001), as well as the mean number of UAI acts among men who initially had multiple partners (P = 0.05). Biological HIV/STD incidence was 15% in comparison condition networks and 9% in intervention condition networks. Even where same-sex behavior is stigmatized, it is possible to reach MSM and deliver HIV prevention through their social networks.

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

    PubMed

    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

    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. 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. 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 vaccine-increased risk was concentrated in

  16. 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

  17. Preventing Mother-to-Child Transmission of HIV

    MedlinePlus

    ... AIDS Drugs Clinical Trials Apps skip to content HIV and Pregnancy Home Understanding HIV/AIDS Fact Sheets ... an email Preventing Mother-to-Child Transmission of HIV Last Reviewed: May 16, 2017 Key Points Mother- ...

  18. 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

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

    PubMed

    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

    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. 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. 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. This multiple case study revealed common themes underlying community stakeholder engagement across four country settings that largely mirror GPP goals and the GPP Blueprint, as well as highlighting

  20. 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.

  1. HIV-related stigma and universal testing and treatment for HIV prevention and care: design of an implementation science evaluation nested in the HPTN 071 (PopART) cluster-randomized trial in Zambia and South Africa.

    PubMed

    Hargreaves, James R; Stangl, Anne; Bond, Virginia; Hoddinott, Graeme; Krishnaratne, Shari; Mathema, Hlengani; Moyo, Maureen; Viljoen, Lario; Brady, Laura; Sievwright, Kirsty; Horn, Lyn; Sabapathy, Kalpana; Ayles, Helen; Beyers, Nulda; Bock, Peter; Fidler, Sarah; Griffith, Sam; Seeley, Janet; Hayes, Richard

    2016-12-01

    Stigma and discrimination related to HIV and key populations at high risk of HIV have the potential to impede the implementation of effective HIV prevention and treatment programmes at scale. Studies measuring the impact of stigma on these programmes are rare. We are conducting an implementation science study of HIV-related stigma in communities and health settings within a large, pragmatic cluster-randomized trial of a universal testing and treatment intervention for HIV prevention in Zambia and South Africa and will assess how stigma affects, and is affected by, implementation of this intervention. A mixed-method evaluation will be nested within HIV prevention trials network (HPTN) 071/PopART (Clinical Trials registration number NCT01900977), a three-arm trial comparing universal door-to-door delivery of HIV testing and referral to prevention and treatment services, accompanied by either an immediate offer of anti-retroviral treatment to people living with HIV regardless of clinical status, or an offer of treatment in-line with national guidelines, with a standard-of-care control arm. The primary outcome of HPTN 071/PopART is HIV incidence measured among a cohort of 52 500 individuals in 21 study clusters. Our evaluation will include integrated quantitative and qualitative data collection and analysis in all trial sites. We will collect quantitative data on indicators of HIV-related stigma over 3 years from large probability samples of community members, health workers and people living with HIV. We will collect qualitative data, including in-depth interviews and observations from members of these same groups sampled purposively. In analysis, we will: (1) compare HIV-related stigma measures between study arms, (2) link data on stigma to measures of the success of implementation of the PopART intervention and (3) explore changes in the dominant drivers and manifestations of stigma in study communities and the health system. HIV-related stigma may impede the

  2. A qualitative study of participant adherence in a randomized controlled trial of herpes suppressive therapy for HIV prevention in Tanzania.

    PubMed

    Plummer, Mary L; Watson-Jones, Deborah; Lees, Shelley; Baisley, Kathy; Matari, Salma; Changalucha, John; Clayton, Tim; Mugeye, Kokugonza; Tanton, Clare; Weiss, Helen A; Ross, David A; Hayes, Richard J

    2010-04-01

    Poor participant adherence to treatment may contribute to lack of impact in some biomedical HIV prevention trials. This qualitative study explored adherence in a randomized controlled trial of herpes suppressive therapy to reduce HIV acquisition and infectivity among 1305 Tanzanian women. The trial found participants completed 72% of visits on treatment; 52-56% of women on treatment had > or = 90% adherence by pill count estimate; and between six and nine months 30/86 (35%) of urine samples from acyclovir recipients tested acyclovir negative, and 7/86 (8%) from placebo recipients tested acyclovir positive. Twenty in-depth interviews (IDIs) were conducted after 30 months with respondents randomly selected from "acyclovir negative" acyclovir recipients and "acyclovir positive" placebo recipients, or by preliminary pill count adherence categories ("under users," "good users," and "over users"). Almost all respondents reported appropriate adherence and positive trial attitudes, e.g., trusting staff, appreciating services, perceiving pills as beneficial. Fourteen understood placebo use, and six understood the trial purpose. Notably, 5/9 acyclovir recipients and 1/11 placebo recipients believed their pills had treated pre-existing sexually transmitted infections. Limited understanding did not negatively affect reported adherence. Reported adherence problems usually related to illness, travel, and/or family obligations (e.g., husband's disapproval). "Acyclovir positive" placebo recipients denied taking other participants' pills. The IDIs also did not resolve discrepant reports of pill loss or theft. Biomedical HIV interventions often have strong behavioral components that require close attention during intervention development, trial design, and process and impact evaluation. This study identified topics which warrant further consideration, including: information reinforcement and comprehension assessment throughout a trial for long-term participant understanding

  3. Predictors of Early and Late Mother-to-Child Transmission of HIV in a Breastfeeding Population: HIV Network for Prevention Trials 012 Experience, Kampala, Uganda

    PubMed Central

    Mmiro, Francis A.; Aizire, Jim; Mwatha, Anthony K.; Eshleman, Susan H.; Donnell, Deborah; Fowler, Mary Glenn; Nakabiito, Clemensia; Musoke, Philippa M.; Jackson, J. Brooks; Guay, Laura A.

    2009-01-01

    Objective: To determine the predictors for early versus later (breastfeeding) transmission of HIV-1. Methods: Secondary data analysis was performed on HIV Network for Prevention Trials 012, a completed randomized clinical trial assessing the relative efficacy of nevirapine (NVP) versus zidovudine in reducing mother-to-child transmission (MTCT) of HIV-1. We used Cox regression analysis to assess risk factors for MTCT. The ViroSeq HIV genotyping and a sensitive point mutation assay were used to detect NVP resistance mutations. Results: In this subset analyses, 122 of 610 infants were HIV infected, of whom 99 (81.1%) were infected early (first positive polymerase chain reaction ≤56 days). Incidence of MTCT after 56 days was low [0.7% per month (95% confidence interval, CI: 0.4 to 1.0)], but continued through 18 months. In multivariate analyses, early MTCT “factors” included NVP versus zidovudine (hazard ratio (HR) = 0.57, 95% CI: 0.38 to 0.86), pre-entry maternal viral load (VL, HR = 1.76, 95% CI: 1.28 to 2.41), and CD4 cell count (HR = 1.16, 95% CI: 1.05 to 1.28). Maternal VL (6–8 weeks) was associated with late MTCT (HR = 3.66, 95% CI: 1.78 to 7.50), whereas maternal NVP resistance (6–8 weeks) was not. Conclusions: Maternal VL was the best predictor of both early and late transmission. Maternal NVP resistance at 6–8 weeks did not predict late transmission. PMID:19617849

  4. The participation of minors in preventive HIV research trials in South Africa: legal and human rights considerations.

    PubMed

    van Wyk, Christa

    2003-01-01

    The constitutional prohibition of experimentation/research without the individual subject's (own) consent is investigated. A distinction is drawn between therapeutic and non-therapeutic research. A minor of 14 is competent to consent independently to medical treatment (which would include therapeutic research), but not to non-therapeutic research. A minor must be at least 18 years to be able to do so. Proxy consent can be secured for the participation of minors under 18 in non-therapeutic research only if they assent, if their participation in the research is indispensable and the research carries no more than negligible risk. Since the risks inherent in HIV preventive vaccine trials may carry more than negligible risk, these trials may not be carried out on children under 18. The limitation of rights and the consideration of foreign and international law in the interpretation of the South African Bill of Rights are investigated.

  5. A Review of HIV Prevention Studies that Use Social Networking Sites: Implications for Recruitment, Health Promotion Campaigns, and Efficacy Trials.

    PubMed

    Jones, Jamal; Salazar, Laura F

    2016-11-01

    This review describes the use of social networking sites (SNS) in the context of primary prevention of HIV. A review was conducted to assess the published literature for HIV interventions using SNS. Sixteen articles describing twelve interventions were included. SNS were instrumental in recruiting hard-to-reach populations within a short amount of time; were able to reach wide audiences beyond the targeted population for HIV prevention campaigns; and helped to significantly reduce sexual risk behaviors and increase HIV testing. SNS are a viable option to recruit hidden populations, engage the target audience, and disseminate HIV prevention messages. Researchers should use SNS to generate sampling frames that can be used to select participants. Practitioners should use SNS to post images of preventive behavior within health promotion campaigns. Researchers should use multiple SNS platforms to engage participants. As more studies are published using SNS for HIV prevention, meta-analyses will be needed.

  6. Behavioural intervention trials for HIV/STD prevention in schools: are they feasible?

    PubMed

    Stephenson, J M; Oakley, A; Charleston, S; Brodala, A; Fenton, K; Petruckevitch, A; Johnson, A M

    1998-12-01

    To assess the feasibility of conducting a large randomised controlled trial (RCT) of peer led intervention in schools to reduce the risk of HIV/STD and promote sexual health. Four secondary schools in Greater London were randomly assigned to receive peer led intervention (two experimental schools) or to act as control schools. In the experimental schools, trained volunteers aged 16-17 years (year 12) delivered the peer led intervention to 13-14 year old pupils (year 9). In the control schools, year 9 pupils received the usual teacher led sex education. Questionnaire data collected from year 9 pupils at baseline included views on the quality of sex education/intervention received, and knowledge and attitudes about HIV/AIDS and other sexual matters. Focus groups were also conducted with peer educators and year 9 pupils. Data on the process of delivering sex education/intervention and on attitudes to the RCT were collected for each of the schools. Analysis focused on the acceptability of a randomised trial to schools, parents, and pupils. Nearly 500 parents were informed about the research and invited to examine the study questionnaire; only nine raised questions and only one pupil was withdrawn from the study. Questionnaire completion rates were around 90% in all schools. At baseline, the majority of year 9 pupils wanted more information about a wide range of sexual matters. Focus group work indicated considerable enthusiasm for peer led education, among peer educators and year 9 pupils. Class discipline was the most frequently noted problem with the delivery of the peer led intervention. Evaluation of a peer led behavioural intervention through an RCT can be acceptable to schools, pupils, and parents and is feasible in practice. In general, pupils who received the peer led intervention responded more positively than those in control schools. A large RCT of the long term (5-7 year) effects of this novel intervention on sexual health outcomes is now under way.

  7. Impact of targeted counseling on reported vaginal hygiene practices and bacterial vaginosis: the HIV Prevention Trials Network 035 study.

    PubMed

    Kasaro, Margaret P; Husnik, Marla J; Chi, Benjamin H; Reid, Cheri; Magure, Tsitsi; Makanani, Bonus; Tembo, Tchangani; Ramjee, Gita; Maslankowski, Lisa; Rabe, Lorna; Brad Guffey, M

    2017-04-01

    The objective of this study was to describe the impact of intense counseling to reduce vaginal hygiene practices and its effect on bacterial vaginosis. A secondary data analysis of the HIV Prevention Trials Network 035 study was undertaken, focusing on HIV-negative, nonpregnant women who were at least 18 years old, in seven African sites and one US site. At enrollment and during follow-up quarterly visits, vaginal hygiene practices were determined by face-to-face administration of a behavioral assessment questionnaire. Vaginal hygiene practices were categorized as insertion into the vagina of (1) nothing, (2) water only, and (3) other substances with or without water. Each practice was quantified by frequency and type/combination of inserted substances. At quarterly visits, diagnosis of bacterial vaginosis was made using the Nugent score. Trends for vaginal hygiene practices and bacterial vaginosis were evaluated using generalized estimating equation models. A total of 3087 participants from the HIV Prevention Trials Network 035 study were eligible for this analysis. At enrollment, 1859 (60%) reported recent vaginal hygiene practices. By one year, this figure had decreased to 1019 (33%) with counseling. However, bacterial vaginosis prevalence remained consistent across the study observation period, with 36%-38% of women testing positive for the condition ( p for trend = 0.27). Overall, those who reported douching with water only (AOR = 1.03, 95%CI: 0.94-1.13) and those who reported inserting other substances (AOR= 0.98, 95%CI: 0.88-1.09) in the past quarter were not more likely to have bacterial vaginosis compared to those who reported no insertions. However, in South Africa, an increase in bacterial vaginosis was seen among those who reported inserting other substances (AOR: 1.48, 95%CI: 1.17, 1.88). In conclusion, targeted counseling against vaginal hygiene practices resulted in change in self-reported behavior but did not have an impact on bacterial vaginosis

  8. Effect of Seasonal Variation on Adult Clinical Laboratory Parameters in Rwanda, Zambia, and Uganda: Implications for HIV Biomedical Prevention Trials

    PubMed Central

    Ruzagira, Eugene; Abaasa, Andrew; Karita, Etienne; Mulenga, Joseph; Kilembe, William; Allen, Susan; Bahemuka, Ubaldo; Bwanika, Agnes N.; Levin, Jonathan; Price, Matthew A.; Kamali, Anatoli

    2014-01-01

    Objectives To investigate the effect of seasonal variation on adult clinical laboratory parameters in Rwanda, Zambia, and Uganda and determine its implications for HIV prevention and other clinical trials. Methods Volunteers in a cross-sectional study to establish laboratory reference intervals were asked to return for a seasonal visit after the local season had changed from dry to rainy or vice versa. Volunteers had to be clinically healthy, not pregnant and negative for HIV, Hepatitis B and C, and syphilis infection at both visits. At each visit, blood was taken for measurement of hemoglobin, haematocrit, mean corpuscular volume, red blood cells, platelets, total white blood cells (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, CD4/CD8 T cells, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, direct bilirubin, total bilirubin, total immunoglobulin gamma, total protein, creatinine, total amylase, creatine phosphokinase and lactate dehydrogenase (LDH). Consensus dry season reference intervals were applied to rainy season values (and vice versa) and the proportion of ‘out-of-range’ values determined. Percentage differences between dry and rainy season parameter mean values were estimated. Results In this cohort of 903 volunteers, less than 10.0% of consensus parameter (except LDH) values in one season were “out-of-range” in the other. Twenty-two (22) percent of rainy season LDH values fell outside of the consensus dry season interval with the higher values observed in the rainy season. Variability between consensus seasonal means ranged from 0.0% (total WBC, neutrophils, monocytes, basophils, and direct bilirubin) to 40.0% (eosinophils). Within sites, the largest seasonal variations were observed for monocytes (Masaka, 11.5%), LDH (Lusaka, 21.7%), and basophils (Kigali, 22.2%). Conclusions Seasonality had minimal impact on adult clinical laboratory parameter values in Rwanda, Zambia, and Uganda. Seasonal

  9. The Promise of Antiretrovirals for HIV Prevention

    PubMed Central

    Flash, Charlene; Krakower, Douglas; Mayer, Kenneth H.

    2013-01-01

    With an estimated 2.6 million new HIV infections diagnosed annually, the world needs new prevention strategies to partner with condom use, harm reduction approaches for injection drug users, and male circumcision. Antiretrovirals can reduce the risk of mother-to-child HIV transmission and limit HIV acquisition after occupational exposure. Macaque models and clinical trials demonstrate efficacy of oral or topical antiretrovirals used prior to HIV exposure to prevent HIV transmission, ie pre-exposure prophylaxis (PrEP). Early initiation of effective HIV treatment in serodiscordant couples results in a 96% decrease in HIV transmission. HIV testing to determine serostatus and identify undiagnosed persons is foundational to these approaches. The relative efficacy of different approaches, adherence, cost and long-term safety will affect uptake and impact of these strategies. Ongoing research will help characterize the role for oral and topical formulations and help quantify potential benefits in sub-populations at risk for HIV acquisition. PMID:22351302

  10. Keeping Adolescent Orphans in School as HIV Prevention: Evidence from a Randomized Controlled Trial in Kenya

    PubMed Central

    Cho, Hyunsan; Hallfors, Denise D.; Mbai, Isabella I.; Itindi, Janet; Milimo, Benson W.; Halpern, Carolyn T.; Iritani, Bonita J.

    2010-01-01

    Purpose We report findings from a pilot study in western Kenya, using an experimental design to test whether comprehensive support to keep adolescent orphans in school can reduce HIV risk factors. Methods Adolescent orphans age 12–14 years (N=105) in Nyanza Province were randomized to condition, after stratifying by household, gender, and baseline survey report of sexual behavior. The intervention comprised school fees, uniforms, and a “community visitor” who monitored school attendance and helped to resolve problems that would lead to absence or dropout. Data were analyzed using Generalized Estimating Equations over two time points, controlling for gender and age. Results Compared with controls, intervention students were less likely to drop out of school, commence sexual intercourse, or report attitudes supporting early sex. School support also increased pro-social bonding and gender equity attitudes. Conclusions After one year of exposure to the intervention, we found evidence suggesting that comprehensive school support can prevent school dropout, delay sexual debut, and reduce HIV risk factors. More research, with much larger samples, is needed to better understand factors that mediate the association between educational support and delayed sexual debut, and how gender might moderate these relationships. PMID:21501814

  11. Undue inducement, or unfair exclusion: considering a case study of pregnancy in an HIV prevention trial.

    PubMed

    Haire, Bridget G; Folayan, Morenike Oluwatoyin

    2017-07-24

    In their recent paper' Undue inducement: a case study in CAPRISA 008', Mngadi et al conclude that a participant in an HIV prevention study who deliberately concealed her pregnancy was not'unduly induced' to participate by the offer of an experimental product. This paper argues that while the authors' conclusion is sound, the framing of this case study is consistent with the preoccupation in research ethics with the concept of undue inducement, coupled with a highly risk-averse attitude to pregnancy (regardless of whether those risks may be willingly assumed by pregnant women themselves). We suggest that the critical research ethics question raised by Mngadi et al's case study is not 'undue inducement', but the exclusion of pregnant women from research studies where the risks are acceptable to the potential participant, and benefits likely. We also suggest that current regulatory paradigms regarding pregnancy are both overly paternalistic and value the fetus over the mother. In order to ensure timely provision of new HIV prevention agents, we argue that there is a need for expeditious testing of proven effective agents in pregnancy, with due consideration given to situations where preliminary efficacy data exist but fall short of licensure standards. This requires a paradigm shift from researchers, funders, regulators and ethical review bodies towards practices that critically examine the legitimacy of the exclusion of pregnant women on a study-by-study basis. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. Project Shikamana: Baseline Findings From a Community Empowerment–Based Combination HIV Prevention Trial Among Female Sex Workers in Iringa, Tanzania

    PubMed Central

    Mbwambo, Jessie; Likindikoki, Samuel; Beckham, Sarah; Mwampashi, Ard; Shembilu, Catherine; Mantsios, Andrea; Leddy, Anna; Davis, Wendy; Galai, Noya

    2017-01-01

    Background: Community empowerment approaches have been found to be effective in responding to HIV among female sex workers (FSWs) in South Asia and Latin America. To date, limited rigorous evaluations of these approaches have been conducted in sub-Saharan Africa. Methods: A phase II community randomized controlled trial is being conducted in Iringa, Tanzania, to evaluate the effectiveness of a community empowerment–based combination HIV prevention model (Project Shikamana) among a stratified sample of HIV-infected and HIV-uninfected FSWs. Cohort members were recruited from entertainment venues across 2 communities in the region using time-location sampling. All study participants gave consent, and were surveyed and screened for HIV at baseline. Primary biological study outcomes are viral suppression among the HIV-infected and remaining free of HIV among HIV-uninfected women. Results: A cohort of 496 FSWs was established and is currently under follow-up. Baseline HIV prevalence was 40.9% (203/496). Among HIV-infected FSWs, 30.5% (62/203) were previously aware of their HIV status; among those who were aware, 69.4% were on antiretroviral therapy (43/62); and for those on antiretroviral therapy, 69.8% (30/43) were virally suppressed. Factors associated with both HIV infection and viral suppression at baseline included community, age, number of clients, and substance use. Amount of money charged per client and having tested for sexually transmitted infection in the past 6 months were protective for HIV infection. Social cohesion among FSWs was protective for viral suppression. Conclusions: Significant gaps exist in HIV service coverage and progress toward reaching the 90-90-90 goals among FSWs in Iringa, Tanzania. Community empowerment approaches hold promise given the high HIV prevalence, limited services and stigma, discrimination, and violence. PMID:27930613

  13. 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.

    PubMed

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

    2013-06-01

    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, identified as African American/Black race, reported having at least two sex partners in the prior 90 days (at least one of whom must be a male partner), unprotected anal sex with male partner in the prior 90 days, and willing to test for HIV. Retention exceeded 95% at 3-month follow-up. Results of multivariate logistic regression analysis adjusting for baseline risk, HIV status, and health insurance indicate intervention efficacy in decreasing the number of male sex partners and marginal effects on condom use with male partners and HIV-negative/unknown partners. Specifically, intervention condition was associated with increased odds of zero male sex partners (adjusted odds ratio [AOR] = 3.03, 95% confidence interval [CI] = 1.26-7.28), condom use with male partners (AOR = 2.64, 95% CI = 0.95-7.36), and HIV-negative/unknown status partners (AOR = 3.19, 95% CI = 0.98-10.38) at follow-up. These results contribute to the limited number of culturally appropriate models of HIV prevention intervention that are urgently needed for African American men who have sex with men to address their persistently high rates of HIV.

  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. Fostering community understanding of sufficient benefit and early stopping for a phase 2B HIV prevention clinical trial in Africa.

    PubMed

    White, Rhonda; Chileshe, Modesta; Dawson, Liza; Donnell, Deborah; Hillier, Sharon; Morar, Neetha; Noguchi, Lisa; Dixon, Dennis

    2011-02-01

    Most trials of interventions are designed to address the traditional null hypothesis of no benefit. VOICE, a phase 2B HIV prevention trial funded by NIH and conducted in Africa, is designed to assess if the intervention will prevent a substantial fraction of infections. Planned interim analysis may provide conclusive evidence against the traditional null hypothesis without establishing substantial benefit. At this interim point, the Data and Safety Monitoring Board would then face the dilemma of knowing the product has some positive effect, but perhaps not as great an effect as the protocol has declared necessary. In March 2008, NIH program staff recommended that the VOICE protocol team discuss the stopping rules with stakeholders prior to initiating the protocol. The goals of the workshop were to inform community representatives about the potential ethical dilemma associated with stopping rules and engage in dialogue about these issues. We describe the resulting community consultation and summarize the outcomes. A 2-day workshop was convened with the goal of having a clear and transparent consultation with the stakeholders around the question, 'Given emerging evidence that a product could prevent some infections, would the community support a decision to continue accruing to the trial?' Participants included research staff and community stakeholders. Lectures with visual aids, discussions, and exercises using interactive learning tasks were used, with a focus on statistics and interpreting data from trials, particularly interim data. Results of oral and written evaluations by participants were reviewed. The feedback was mostly positive, with some residual confusion regarding statistical concepts. However, discussions with attendees later revealed that not all felt prepared to engage fully in the workshop. This was the presenters' first experience facilitating a formal discussion with an audience that had no advanced science, research, or mathematics training

  16. Fostering Community Understanding of Sufficient Benefit and Early Stopping for a Phase 2B HIV Prevention Clinical Trial in Africa

    PubMed Central

    White, Rhonda; Chileshe, Modesta; Dawson, Liza; Donnell, Deborah; Hillier, Sharon; Morar, Neetha; Noguchi, Lisa; Dixon, Dennis

    2012-01-01

    Background Most trials of interventions are designed to address the traditional null hypothesis of no benefit. VOICE, a phase 2B HIV prevention trial funded by NIH and conducted in Africa, is designed to assess if the intervention will prevent a substantial fraction of infections. Planned interim analysis may provide conclusive evidence against the traditional null hypothesis without establishing substantial benefit. At this interim point, the Data and Safety Monitoring Board would then face the dilemma of knowing the product has some positive effect, but perhaps not as great an effect as the protocol has declared necessary. Purpose In March 2008, NIH program staff recommended that the VOICE protocol team discuss the stopping rules with stakeholders prior to initiating the protocol. The goals of the workshop were to inform community representatives about the potential ethical dilemma associated with stopping rules and engage in dialogue about these issues. We describe the resulting community consultation and summarize the outcomes. Methods A 2-day workshop was convened with the goal of having a clear and transparent consultation with the stakeholders around the question, ‘Given emerging evidence that a product could prevent some infections, would the community support a decision to continue accruing to the trial?’ Participants included research staff and community stakeholders. Lectures with visual aids, discussions, and exercises using interactive learning tasks were used, with a focus on statistics and interpreting data from trials, particularly interim data. Results Results of oral and written evaluations by participants were reviewed. The feedback was mostly positive, with some residual confusion regarding statistical concepts. However, discussions with attendees later revealed that not all felt prepared to engage fully in the workshop. Limitations This was the presenters’ first experience facilitating a formal discussion with an audience that had no

  17. HIV/AIDS Clinical Trials Fact Sheet

    MedlinePlus

    ... and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help researchers ... to HIV Can anyone participate in an HIV/AIDS clinical trial? It depends on the study. Some ...

  18. Incentivising safe sex: a randomised trial of conditional cash transfers for HIV and sexually transmitted infection prevention in rural Tanzania

    PubMed Central

    Dow, William H; Nathan, Rose; Abdul, Ramadhani; Abilahi, Faraji; Gong, Erick; Isdahl, Zachary; Jamison, Julian; Jullu, Boniphace; Krishnan, Suneeta; Majura, Albert; Miguel, Edward; Moncada, Jeanne; Mtenga, Sally; Mwanyangala, Mathew Alexander; Packel, Laura; Schachter, Julius; Shirima, Kizito; Medlin, Carol A

    2012-01-01

    Objective The authors evaluated the use of conditional cash transfers as an HIV and sexually transmitted infection prevention strategy to incentivise safe sex. Design An unblinded, individually randomised and controlled trial. Setting 10 villages within the Kilombero/Ulanga districts of the Ifakara Health and Demographic Surveillance System in rural south-west Tanzania. Participants The authors enrolled 2399 participants, aged 18–30 years, including adult spouses. Interventions Participants were randomly assigned to either a control arm (n=1124) or one of two intervention arms: low-value conditional cash transfer (eligible for $10 per testing round, n=660) and high-value conditional cash transfer (eligible for $20 per testing round, n=615). The authors tested participants every 4 months over a 12-month period for the presence of common sexually transmitted infections. In the intervention arms, conditional cash transfer payments were tied to negative sexually transmitted infection test results. Anyone testing positive for a sexually transmitted infection was offered free treatment, and all received counselling. Main outcome measures The primary study end point was combined prevalence of the four sexually transmitted infections, which were tested and reported to subjects every 4 months: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium. The authors also tested for HIV, herpes simplex virus 2 and syphilis at baseline and month 12. Results At the end of the 12-month period, for the combined prevalence of any of the four sexually transmitted infections, which were tested and reported every 4 months (C trachomatis, N gonorrhoeae, T vaginalis and M genitalium), unadjusted RR for the high-value conditional cash transfer arm compared to controls was 0.80 (95% CI 0.54 to 1.06) and the adjusted RR was 0.73 (95% CI 0.47 to 0.99). Unadjusted RR for the high-value conditional cash transfer arm compared to the low

  19. 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.

  20. Implementation of a couple-based HIV prevention program: a cluster randomized trial comparing manual versus Web-based approaches.

    PubMed

    Witte, Susan S; Wu, Elwin; El-Bassel, Nabila; Hunt, Timothy; Gilbert, Louisa; Medina, Katie Potocnik; Chang, Mingway; Kelsey, Ryan; Rowe, Jessica; Remien, Robert

    2014-09-11

    Despite great need, the number of HIV prevention implementation studies remains limited. The challenge for researchers, in this time of limited HIV services agency resources, is to conceptualize and test how to disseminate efficacious, practical, and sustainable prevention programs more rapidly, and to understand how to do so in the absence of additional agency resources. We tested whether training and technical assistance (TA) in a couple-based HIV prevention program using a Web-based modality would yield greater program adoption of the program compared to training and TA in the same program in a manual-based modality among facilitators who delivered the interventions at 80 agencies in New York State. This study used a cluster randomized controlled design. Participants were HIV services agencies (N = 80) and up to 6 staff members at each agency (N = 253). Agencies were recruited, matched on key variables, and randomly assigned to two conditions. Staff members participated in a four-day, face-to-face training session, followed by TA calls at two and four months, and follow-up assessments at 6, 12, and 18 months post- training and TA. The primary outcomes examined number of couples with whom staff implemented the program, mean number of sessions implemented, whether staff implemented at least one session or whether staff implemented a complete intervention (all six sessions) of the program. Outcomes were measured at both the agency and participant level. Over 18 months following training and TA, at least one participant from 13 (33%) Web-based assigned agencies and 19 (48%) traditional agencies reported program use. Longitudinal multilevel analysis found no differences between groups on any outcomes at the agency or participant level with one exception: Web-based agencies implemented the program with 35% fewer couples compared with staff at manual-based agencies (IRR 0.35, CI, 0.13-0.94). Greater implementation of a Web-based program may require more

  1. 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

  2. Human rights and maternal-fetal HIV transmission prevention trials in Africa.

    PubMed

    Annas, G J; Grodin, M A

    1998-04-01

    The human rights issues raised by the conduct of maternal-fetal human immunodeficiency virus transmission trials in Africa are not unique to either acquired immunodeficiency syndrome or Africa, but public discussion of these trials presents an opportunity for the United States and other wealthy nations to take the rights and welfare of impoverished populations seriously. The central issue at stake when developed countries perform research on subjects in developing countries is exploitation. The only way to prevent exploitation of a research population is to insist not only that informed consent be obtained but also that, should an intervention be proven beneficial, the intervention will be delivered to the impoverished population. Human rights are universal and cannot be compromised solely on the basis of beliefs or practices of any one country or group. The challenge to the developed countries is to implement programs to improve the health of the people in developing countries both by improving public health infrastructure and by delivering effective drugs and vaccines to the people.

  3. Human rights and maternal-fetal HIV transmission prevention trials in Africa.

    PubMed Central

    Annas, G J; Grodin, M A

    1998-01-01

    The human rights issues raised by the conduct of maternal-fetal human immunodeficiency virus transmission trials in Africa are not unique to either acquired immunodeficiency syndrome or Africa, but public discussion of these trials presents an opportunity for the United States and other wealthy nations to take the rights and welfare of impoverished populations seriously. The central issue at stake when developed countries perform research on subjects in developing countries is exploitation. The only way to prevent exploitation of a research population is to insist not only that informed consent be obtained but also that, should an intervention be proven beneficial, the intervention will be delivered to the impoverished population. Human rights are universal and cannot be compromised solely on the basis of beliefs or practices of any one country or group. The challenge to the developed countries is to implement programs to improve the health of the people in developing countries both by improving public health infrastructure and by delivering effective drugs and vaccines to the people. PMID:9550993

  4. 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

  5. Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants' Explanations for Dishonesty.

    PubMed

    Montgomery, Elizabeth T; Mensch, B; Musara, P; Hartmann, M; Woeber, K; Etima, J; van der Straten, A

    2017-02-01

    Consistent over-reporting of product use limits researchers' ability to accurately measure adherence and estimate product efficacy in HIV prevention trials. While lying is a universal characteristic of the human condition, growing evidence of a stark discrepancy between self-reported product use and biologic or pharmacokinetic evidence demands examination of the reasons research participants frequently misrepresent product use in order to mitigate this challenge in future research. This study (VOICE-D) was an ancillary post-trial study of the vaginal and oral interventions to control the epidemic (VOICE) phase IIb trial (MTN 003). It was conducted in three African countries to elicit candid accounts from former VOICE trial participants about why actual product use was lower than reported. In total 171 participants were enrolled between December 2012 and March 2014 in South Africa (n = 47), Uganda (n = 59) and Zimbabwe (n = 65). Data suggested that participants understood the importance of daily product use and honest reporting, yet acknowledged that research participants typically lie. Participants cited multiple reasons for misreporting adherence, including human nature, self-presentation with study staff, fear of repercussions (study termination resulting in loss of benefits and experience of HIV-related stigma), a permissive environment in which it was easy to get away with misreporting, and avoiding inconvenient additional counseling. Some participants also reported mistrust of the staff and reciprocal dishonesty about the study products. Many suggested real-time blood-monitoring during trials would encourage greater fidelity to product use and honesty in reporting. Participants at all sites understood the importance of daily product use and honesty, while also acknowledging widespread misreporting of product use. Narratives of dishonesty may suggest a wider social context of hiding products from partners and distrust about research, influenced by rumors

  6. High prevalence of obesity among women who enrolled in HIV prevention trials in KwaZulu-Natal, South Africa: healthy diet and life style messages should be integrated into HIV prevention programs.

    PubMed

    Wand, Handan; Ramjee, Gita

    2013-02-21

    In South Africa, poverty and the dual epidemics of HIV and tuberculosis underscore the need for prevention efforts for obesity. The aim of this study was to describe the prevalence of obesity in a cohort of South African women and discuss the implications for public health practices. A total of 5,495 HIV-negative women from KwaZulu-Natal, South Africa enrolled in three microbicide trials during the period of 2002-2008 were categorised as normal weight (body mass index (BMI: 18.6-<25), overweight (BMI: 25-<30) or obese (BMI: 30+). Incidence of HIV and other sexually transmitted infections such as Chlamydia and gonorrhoea were also estimated and compared by BMI groups. Combined data was analysed using STATA 10.0. Approximately 70% of the sample population was classified as being overweight or obese. Older age and lack of education were determined to be significant predictors of obesity. Women who were 35 years or older were more than three times as likely to be overweight and more than 12 times as likely to be obese compared to the youngest group. The highest HIV and STI incidence rates were observed among those with BMI <25 kg/m(2) (normal weight) compared to women with BMI more than 25 kg/m2 (8.1 and 19.8 per 100 person-year respectively, P<0.001, both). Effective obesity prevention strategies are needed to re-formulate HIV prevention programmes by incorporating healthy diet and life style messages to target those who are at highest risk not just for HIV infection but also for non-communicable diseases.

  7. High prevalence of obesity among women who enrolled in HIV prevention trials in KwaZulu-Natal, South Africa: healthy diet and life style messages should be integrated into HIV prevention programs

    PubMed Central

    2013-01-01

    Background In South Africa, poverty and the dual epidemics of HIV and tuberculosis underscore the need for prevention efforts for obesity. The aim of this study was to describe the prevalence of obesity in a cohort of South African women and discuss the implications for public health practices. Methods A total of 5,495 HIV-negative women from KwaZulu-Natal, South Africa enrolled in three microbicide trials during the period of 2002–2008 were categorised as normal weight (body mass index (BMI: 18.6-<25), overweight (BMI: 25-<30) or obese (BMI: 30+). Incidence of HIV and other sexually transmitted infections such as Chlamydia and gonorrhoea were also estimated and compared by BMI groups. Combined data was analysed using STATA 10.0. Results Approximately 70% of the sample population was classified as being overweight or obese. Older age and lack of education were determined to be significant predictors of obesity. Women who were 35 years or older were more than three times as likely to be overweight and more than 12 times as likely to be obese compared to the youngest group. The highest HIV and STI incidence rates were observed among those with BMI <25 kg/m2 (normal weight) compared to women with BMI more than 25 kg/m2 (8.1 and 19.8 per 100 person-year respectively, P<0.001, both). Conclusion Effective obesity prevention strategies are needed to re-formulate HIV prevention programmes by incorporating healthy diet and life style messages to target those who are at highest risk not just for HIV infection but also for non-communicable diseases. PMID:23432964

  8. Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058.

    PubMed

    Lucas, Gregory M; Beauchamp, Geetha; Aramrattana, Apinun; Shao, Yiming; Liu, Wei; Fu, Liping; Jackson, J Brooks; Celentano, David D; Richardson, Paul; Metzger, David

    2012-03-01

    Buprenorphine/naloxone (BUP/NX) is not licenced for use in China or Thailand and there was little clinical experience with this drug combination in these countries at the inception of HIV Prevention Trial Network (HPTN) 058, a randomized trial comparing risk reduction counselling combined with either short-term or long-term medication assisted treatment with BUP/NX to prevent HIV infection and death amongst opioid-dependent injectors. We conducted a safety phase that included the first 50 subjects enrolled at each of the three initial study sites (N=150). Clinical and laboratory assessments were conducted at baseline and weekly for the first 4 weeks. Changes in laboratory parameters were estimated with random effects models. BUP/NX was well tolerated by study subjects and opioid withdrawal scores decreased substantially during the 3-day induction. Two participants experienced grade 3 clinical adverse events, which were categorized as probably not related to the study drug. Grade 2 or 3 increases in alanine aminotransferase (ALT) occurred in 25 (17%) subjects. The magnitude of ALT increase over 4-week follow-up was strongly associated with baseline ALT elevation. In Chinese and Thai opioid-dependent injectors, we found BUP/NX to be effective in reducing opioid withdrawal symptoms and safe during short-term use. ALT increases were observed over 4-week-follow-up, which are consistent with reports from Western populations. Long-term safety and efficacy evaluations are indicated. Copyright © 2011 Elsevier B.V. All rights reserved.

  9. Follow YOUR Heart: development of an evidence-based campaign empowering older women with HIV to participate in a large-scale cardiovascular disease prevention trial.

    PubMed

    Zanni, Markella V; Fitch, Kathleen; Rivard, Corinne; Sanchez, Laura; Douglas, Pamela S; Grinspoon, Steven; Smeaton, Laura; Currier, Judith S; Looby, Sara E

    2017-03-01

    Women's under-representation in HIV and cardiovascular disease (CVD) research suggests a need for novel strategies to ensure robust representation of women in HIV-associated CVD research. To elicit perspectives on CVD research participation among a community-sample of women with or at risk for HIV, and to apply acquired insights toward the development of an evidence-based campaign empowering older women with HIV to participate in a large-scale CVD prevention trial. In a community-based setting, we surveyed 40 women with or at risk for HIV about factors which might facilitate or impede engagement in CVD research. We applied insights derived from these surveys into the development of the Follow YOUR Heart campaign, educating women about HIV-associated CVD and empowering them to learn more about a multi-site HIV-associated CVD prevention trial: REPRIEVE. Endorsed best methods for learning about a CVD research study included peer-to-peer communication (54%), provider communication (46%) and video-based communication (39%). Top endorsed non-monetary reasons for participating in research related to gaining information (63%) and helping others (47%). Top endorsed reasons for not participating related to lack of knowledge about studies (29%) and lack of request to participate (29%). Based on survey results, the REPRIEVE Follow YOUR Heart campaign was developed. Interwoven campaign components (print materials, video, web presence) offer provider-based information/knowledge, peer-to-peer communication, and empowerment to learn more. Campaign components reflect women's self-identified motivations for research participation - education and altruism. Investigation of factors influencing women's participation in HIV-associated CVD research may be usefully applied to develop evidence-based strategies for enhancing women's enrollment in disease-specific large-scale trials. If proven efficacious, such strategies may enhance conduct of large-scale research studies across disciplines.

  10. Sexual risk behaviour of Canadian participants in the first efficacy trial of a preventive HIV-1 vaccine

    PubMed Central

    Lampinen, Thomas M.; Chan, Keith; Remis, Robert S.; Fikre Merid, Maraki; Rusch, Melanie; Vincelette, Jean; Logue, Ken; Popovic, Vladimir; Alary, Michel; Schechter, Martin T.; Hogg, Robert S.

    2005-01-01

    Background Phase I and phase II HIV-1 vaccine trials have revealed increases in risky sexual activity among study subjects during the trials, perhaps because the subjects believe that the vaccine being tested is efficacious; subjects may thus suffer harm from their participation. We evaluated the sexual behaviour of Canadian men who have sex with men (MSM) who participated in the phase III Vax004 trial of an HIV-1 vaccine. Methods Using self-reports of sexual behaviours during the 6 months before trial entry as a baseline, we determined changes in reported sexual behaviour after 6, 12 and 18 months of participation in the trial. Results Of 291 HIV-seronegative MSM enrolled from July to October 1999, 260 (89%) completed 18 months of follow-up, 19 (7%) experienced seroconversion, and 12 (4%) did not complete follow-up. Unprotected receptive anal intercourse during the previous 6 months with partners whose HIV-1 serostatus was positive or unknown was reported by 21% of men at enrolment and by 27% at any point during 18 months of follow-up. No increase in this behaviour from baseline was reported by participants, including among men who were motivated to enrol because of expected protection from HIV-1 infection, men who believed they had received the vaccine, men who believed that the vaccine had greater than 50% efficacy, or men who believed that they had received the vaccine and that vaccine efficacy was greater than 50%. Interpretation MSM can be successfully enrolled in HIV-1 vaccine efficacy trials without evident increases in those sexual behaviours most associated with HIV-1 risk. PMID:15710939

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

    PubMed

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

    2015-08-01

    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 intraclass correlation coefficient (ICC)-the degree to which outcomes of individuals clustered within groups (e.g., schools) are correlated. ICC estimates vary widely depending on outcome, population, and setting, and small changes in ICCs can have large effects on the sample size needed to estimate intervention effects. This study addresses a gap in the literature by providing estimates of ICCs for adolescent sexual risk-taking outcomes under a range of study conditions. Multilevel regression analyses were applied to existing data from four federally funded GRTs of school-based HIV/STI/pregnancy prevention programs to obtain a variety of ICC estimates. ICCs ranged from 0 to 0.15, with adjustment for covariates and repeated measurements reducing the ICC in the majority of cases. Minimum detectable effect sizes with 80% power and 0.05 significance levels ranged from small to medium Cohen's d (0.13 to 0.53) assuming 20 schools of 100 students each. This study provides the first known set of ICC estimates for investigators to use when planning studies of school-based programs to prevent sexual risk behaviors in youth. The results provide further evidence of the importance of using the appropriate adjusted ICC estimate at the design stage to maximize resources in costly GRTs. © 2015 Society for Public Health Education.

  12. The Cedar Project WelTel mHealth intervention for HIV prevention in young Indigenous people who use illicit drugs: study protocol for a randomized controlled trial.

    PubMed

    Jongbloed, Kate; Friedman, Anton J; Pearce, Margo E; Van Der Kop, Mia L; Thomas, Vicky; Demerais, Lou; Pooyak, Sherri; Schechter, Martin T; Lester, Richard T; Spittal, Patricia M

    2016-03-09

    Despite successes in preventing and treating HIV, Indigenous people in Canada continue to face disproportionately high rates of HIV infection. Programs that support healing from lifetime trauma, support connection to culture, and reduce drug-related harms are critical to preventing HIV among young Indigenous people who use drugs. The Cedar Project WelTel mHealth intervention proposed here is a structured mobile-phone initiative to connect young Indigenous people who use drugs with Cedar Case Managers in a community-based setting. The intervention consists of a package of supports, including a mobile phone and cellular plan, weekly two-way text messaging, and support from Cedar Case Managers. The Cedar Project WelTel mHealth study is a multi-site Zelen pre-randomized trial to measure the effect of a two-way supportive text-message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in two Canadian cities. The trial is nested within the Cedar Project, an ongoing cohort study addressing HIV and hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia. The Cedar Project Partnership, an independent body of Indigenous Elders, leaders, and health/social service experts, governs all aspects of the study. Two hundred participants will be followed over a 16-month period, with HIV propensity score at 6 months as the primary outcome. Secondary outcomes include HIV propensity at 1 year, HIV risk, resilience, psychological distress, access to drug-related services, and connection to culture measured at 6 months and 1 year. Primary analysis is by intention to treat. Culturally safe interventions that address barriers to HIV prevention while supporting the strength of young Indigenous people who use drugs are urgently needed. Despite presenting a tremendous opportunity to connect young, highly transient Indigenous people who use drugs to prevention services, supportive two-way m

  13. 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

  14. 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

  15. Randomized community-level HIV prevention intervention trial for men who drink in South African alcohol-serving venues

    PubMed Central

    Simbayi, Leickness C.; Cain, Demetria; Carey, Kate B.; Carey, Michael P.; Eaton, Lisa; Harel, Ofer; Mehlomakhulu, Vuyelwa; Mwaba, Kelvin

    2014-01-01

    Background: South African alcohol-serving establishments (i.e., shebeens) offer unique opportunities to reduce HIV risks among men who drink. Purpose: To test an individual- and a social structural-level HIV prevention intervention for men who drink in shebeens. Methods: Twelve matched pairs of township neighbourhoods were randomized to receive either (i) an HIV prevention intervention (guided by Social Action Theory) to reduce sexual risk and increase risk reduction communication in social networks, or (ii) an attention-matched control intervention that focused on the prevention of relationship violence. At the individual level, the interventions delivered skills building workshops focused on sexual risk reduction. At the social structural level, the intervention aimed to increase conversations about safer sex among men in the shebeens, distributed small media and implemented community educational events. Individual-level outcomes were assessed by following the workshop cohorts for 1 year (N = 984), and community-level outcomes were examined through cross-sectional community surveys conducted for 1 year in the shebeens (N = 9,678). Results: Men in the HIV prevention workshops demonstrated greater condom use, more HIV prevention-oriented conversations and greater perceptions of safer sex norms than men in the comparison workshops. Changes at the community level demonstrated significant differences in condom use, although the pattern was not consistent over time. Conclusions: Multi-level interventions that target men who drink in South African shebeens may help reduce risks for HIV and other sexually transmitted infections. PMID:24248803

  16. 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

  17. 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

    Hayes, Richard; Ayles, Helen; Beyers, Nulda; Sabapathy, Kalpana; Floyd, Sian; Shanaube, Kwame; Bock, Peter; Griffith, Sam; Moore, Ayana; Watson-Jones, Deborah; Fraser, Christophe; Vermund, Sten H; Fidler, Sarah

    2014-02-13

    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. 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. 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 optimal delivery of current policies and

  18. All4You! A Randomized Trial of an HIV, Other STDs, and Pregnancy Prevention Intervention for Alternative School Students

    ERIC Educational Resources Information Center

    Coyle, Karin K.; Kirby, Douglas B.; Robin, Leah E.; Banspach, Stephen W.; Baumler, Elizabeth; Glassman, Jill R.

    2006-01-01

    This study evaluated All4You!, a theoretically based curriculum designed to reduce sexual risk behaviors associated with HIV, other STDs, and unintended pregnancy among students in alternative schools. The study featured a randomized controlled trial involving 24 community day schools in northern California. A cohort of 988 students was assessed…

  19. Unity in Diversity: Results of a randomized clinical culturally tailored pilot HIV prevention intervention trial for African American men who have sex with men; Baltimore, Maryland

    PubMed Central

    Tobin, K; Kuramoto, SJ; German, D; Fields, E; Spikes, PS; Patterson, J; Latkin, C

    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 (AA MSM). 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, identified as African American/black race, reported having at least two sex partners in the prior 90 days (at least one of whom must be a male partner), unprotected anal sex with male partner in the prior 90 days and willing to test for HIV. Retention exceeded 95% at 3 month follow-up. Results of multivariate logistic regression analysis adjusting for baseline risk, HIV status and health insurance indicate intervention efficacy in decreasing the number of male sex partners and marginal effects on condom use with male partners and HIV negative/unknown partners. Specifically, intervention condition was associated with increased odds of zero male sex partners (AOR=3.03, 95%CI=1.26–7.28), condom use with male partners (AOR=2.64, 95%CI=0.95–7.36) and HIV negative/unknown status partners (AOR=3.19, 95%CI=0.98–10.38) at follow-up. These results contribute to the limited number of culturally appropriate models of HIV prevention intervention that are urgently needed for African American men who have sex with men to address their persistently high rates of HIV. PMID:22984216

  20. Combining biomedical preventions for HIV: Vaccines with pre-exposure prophylaxis, microbicides or other HIV preventions

    PubMed Central

    McNicholl, Janet M.

    2016-01-01

    ABSTRACT Biomedical preventions for HIV, such as vaccines, microbicides or pre-exposure prophylaxis (PrEP) with antiretroviral drugs, can each only partially prevent HIV-1 infection in most human trials. Oral PrEP is now FDA approved for HIV-prevention in high risk groups, but partial adherence reduces efficacy. If combined as biomedical preventions (CBP) an HIV vaccine could provide protection when PrEP adherence is low and PrEP could prevent vaccine breakthroughs. Other types of PrEP or microbicides may also be partially protective. When licensed, first generation HIV vaccines are likely to be partially effective. Individuals at risk for HIV may receive an HIV vaccine combined with other biomedical preventions, in series or in parallel, in clinical trials or as part of standard of care, with the goal of maximally increasing HIV prevention. In human studies, it is challenging to determine which preventions are best combined, how they interact and how effective they are. Animal models can determine CBP efficacy, whether additive or synergistic, the efficacy of different products and combinations, dose, timing and mechanisms. CBP studies in macaques have shown that partially or minimally effective candidate HIV vaccines combined with partially effective oral PrEP, vaginal PrEP or microbicide generally provided greater protection than either prevention alone against SIV or SHIV challenges. Since human CBP trials will be complex, animal models can guide their design, sample size, endpoints, correlates and surrogates of protection. This review focuses on animal studies and human models of CBP and discusses implications for HIV prevention. PMID:27679928

  1. What is a Preventive HIV Vaccine?

    MedlinePlus

    ... Mental Health How to Find HIV Treatment Services HIV Overview What is a Preventive HIV Vaccine? (Last updated 2/20/2017; last reviewed ... a preventive HIV vaccine. What is a preventive HIV vaccine? A preventive HIV vaccine is given to ...

  2. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial

    PubMed Central

    2013-01-01

    Background A total of 22 priority countries have been identified by the WHO that account for 90% of pregnant women living with HIV. Nigeria is one of only 4 countries among the 22 with an HIV testing rate for pregnant women of less than 20%. Currently, most pregnant women must access a healthcare facility (HF) to be screened and receive available prevention of mother-to-child HIV transmission (PMTCT) interventions. Finding new approaches to increase HIV testing among pregnant women is necessary to realize the WHO/ President's Emergency Plan for AIDS Relief (PEPFAR) goal of eliminating new pediatric infections by 2015. Methods This cluster randomized trial tests the comparative effectiveness of a congregation-based Healthy Beginning Initiative (HBI) versus a clinic-based approach on the rates of HIV testing and PMTCT completion among a cohort of church attending pregnant women. Recruitment occurs at the level of the churches and participants (in that order), while randomization occurs only at the church level. The trial is unblinded, and the churches are informed of their randomization group. Eligible participants, pregnant women attending study churches, are recruited during prayer sessions. HBI is delivered by trained community health nurses and church-based health advisors and provides free, integrated on-site laboratory tests (HIV plus hemoglobin, malaria, hepatitis B, sickle cell gene, syphilis) during a church-organized ‘baby shower.’ The baby shower includes refreshments, gifts exchange, and an educational game show testing participants’ knowledge of healthy pregnancy habits in addition to HIV acquisition modes, and effective PMTCT interventions. Baby receptions provide a contact point for follow-up after delivery. This approach was designed to reduce barriers to screening including knowledge, access, cost and stigma. The primary aim is to evaluate the effect of HBI on the HIV testing rate among pregnant women. The secondary aims are to evaluate the

  3. Characteristics Associated with HIV Drug Resistance Among Women Screening for an HIV Prevention Trial in KwaZulu-Natal, South Africa.

    PubMed

    Mensch, Barbara S; Gorbach, Pamina M; Kelly, Cliff; Kiepiela, Photini; Gomez, Kailazarid; Ramjee, Gita; Ganesh, Shayhana; Morar, Neetha; Soto-Torres, Lydia; Parikh, Urvi M

    2015-11-01

    While the expansion of antiretroviral therapy (ART) in sub-Saharan Africa has reduced morbidity and mortality from HIV/AIDS, it has increased concern about drug resistance. The Microbicide Trials Network 009 study assessed the prevalence of drug-resistance mutations among women at clinical sites in Durban, South Africa who tested seropositive for HIV-1 at screening for the VOICE trial. The objective of this paper was to identify characteristics and behaviors associated with drug resistance. Factors found to be significantly associated with increased resistance were high perceived risk of getting HIV and prior participation in a microbicide trial, a likely proxy for familiarity with the health care system. Two factors were found to be significantly associated with reduced resistance: having a primary sex partner and testing negative for HIV in the past year. Other variables hypothesized to be important in identifying women with resistant virus, including partner or friend on ART who shared with the participant and being given antiretrovirals during pregnancy or labor, or the proxy variable-number of times given birth in a health facility-were not significantly associated. The small number of participants with resistant virus and the probable underreporting of sensitive behaviors likely affected our ability to construct a comprehensive profile of the type of HIV-positive women at greatest risk of developing resistance mutations.

  4. 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. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  5. Approaches to Preventative and Therapeutic HIV vaccines

    PubMed Central

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

    2016-01-01

    Novel strategies are being researched to discover vaccines to prevent and treat HIV-1. Nonefficacious 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. PMID:26985884

  6. Do clinical decision-support reminders for medical providers improve isoniazid preventative therapy prescription rates among HIV-positive adults? Study protocol for a randomized controlled trial.

    PubMed

    Green, Eric P; Catalani, Caricia; Diero, Lameck; Carter, E Jane; Gardner, Adrian; Ndwiga, Charity; Keny, Aggrey; Owiti, Philip; Israelski, Dennis; Biondich, Paul

    2015-04-09

    This document describes a research protocol for a study designed to estimate the impact of implementing a reminder system for medical providers on the use of isoniazid preventative therapy (IPT) for adults living with HIV in western Kenya. People living with HIV have a 5% to 10% annual risk of developing active tuberculosis (TB) once infected with TB bacilli, compared to a 5% lifetime risk in HIV-negative people with latent TB infection. Moreover, people living with HIV have a 20-fold higher risk of dying from TB. A growing body of literature suggests that IPT reduces overall TB incidence and is therefore of considerable benefit to patients and the larger community. However, in 2009, of the estimated 33 million people living with HIV, only 1.7 million (5%) were screened for TB, and about 85,000 (0.2%) were offered IPT. This study will examine the use of clinical decision-support reminders to improve rates of initiation of preventative treatment in a TB/HIV co-morbid population living in a TB endemic area. This will be a pragmatic, parallel-group, cluster-randomized superiority trial with a 1:1 allocation to treatment ratio. For the trial, 20 public medical facilities that use clinical summary sheets generated from an electronic medical records system will participate as clusters. All HIV-positive adult patients who complete an initial encounter at a study cluster and at least one return encounter during the study period will be included in the study cohort. The primary endpoint will be IPT prescription at 3 months post the initial encounter. We will conduct both individual-level and cluster-level analyses. Due to the nature of the intervention, the trial will not be blinded. This study will contribute to the growing evidence base for the use of electronic health interventions in low-resource settings to promote high-quality clinical care, health system optimization and positive patient outcomes. Trial registration ClinicalTrials.gov NCT01934309, registered 29

  7. 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

  8. Lessons from HIV-1 vaccine efficacy trials.

    PubMed

    Excler, Jean-Louis; Michael, Nelson L

    2016-11-01

    Only four HIV-1 vaccine concepts have been tested in six efficacy trials with no product licensed to date. Several scientific and programmatic lessons can be learned from these studies generating new hypotheses and guiding future steps. RV144 [ALVAC-HIV (canarypox vector) and AIDSVAX B/E (bivalent gp120 HIV-1 subtype B and CRF01_AE)] remains the only efficacy trial that demonstrated a modest vaccine efficacy, which led to the identification of immune correlates of risk. Progress on subtype-specific, ALVAC (canarypox vector) and gp120 vaccine prime-boost approaches has been slow, but we are finally close to the launch of an efficacy study in Africa in 2016. The quest of a globally effective HIV-1 vaccine has led to the development of new approaches. Efficacy studies of combinations of Adenovirus type 26 (Ad26)/Modified Vaccinia Ankara (MVA)/gp140 vaccines with mosaic designs will enter efficacy studies mid-2017 and cytomegalovirus (CMV)-vectored vaccines begin Phase I studies at the same time. Future HIV-1 vaccine efficacy trials face practical challenges as effective nonvaccine prevention programs are projected to decrease HIV-1 incidence. An HIV-1 vaccine is urgently needed. Increased industry involvement, mobilization of resources, expansion of a robust pipeline of new concepts, and robust preclinical challenge studies will be essential to accelerate efficacy testing of next generation HIV-1 vaccine candidates.

  9. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial.

    PubMed

    Ezeanolue, Echezona E; Obiefune, Michael C; Yang, Wei; Obaro, Stephen K; Ezeanolue, Chinenye O; Ogedegbe, Gbenga G

    2013-06-08

    A total of 22 priority countries have been identified by the WHO that account for 90% of pregnant women living with HIV. Nigeria is one of only 4 countries among the 22 with an HIV testing rate for pregnant women of less than 20%. Currently, most pregnant women must access a healthcare facility (HF) to be screened and receive available prevention of mother-to-child HIV transmission (PMTCT) interventions. Finding new approaches to increase HIV testing among pregnant women is necessary to realize the WHO/ President's Emergency Plan for AIDS Relief (PEPFAR) goal of eliminating new pediatric infections by 2015. This cluster randomized trial tests the comparative effectiveness of a congregation-based Healthy Beginning Initiative (HBI) versus a clinic-based approach on the rates of HIV testing and PMTCT completion among a cohort of church attending pregnant women. Recruitment occurs at the level of the churches and participants (in that order), while randomization occurs only at the church level. The trial is unblinded, and the churches are informed of their randomization group. Eligible participants, pregnant women attending study churches, are recruited during prayer sessions. HBI is delivered by trained community health nurses and church-based health advisors and provides free, integrated on-site laboratory tests (HIV plus hemoglobin, malaria, hepatitis B, sickle cell gene, syphilis) during a church-organized 'baby shower.' The baby shower includes refreshments, gifts exchange, and an educational game show testing participants' knowledge of healthy pregnancy habits in addition to HIV acquisition modes, and effective PMTCT interventions. Baby receptions provide a contact point for follow-up after delivery. This approach was designed to reduce barriers to screening including knowledge, access, cost and stigma. The primary aim is to evaluate the effect of HBI on the HIV testing rate among pregnant women. The secondary aims are to evaluate the effect of HBI on the rate of

  10. 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

  11. High prevalence of drug resistance amongst HIV-exposed and -infected children in a tuberculosis prevention trial.

    PubMed

    Hesseling, A C; Kim, S; Madhi, S; Nachman, S; Schaaf, H S; Violari, A; Victor, T C; McSherry, G; Mitchell, C; Cotton, M F

    2012-02-01

    An emergence of drug-resistant tuberculosis (DR-TB) in settings affected by human immunodeficiency virus (HIV) and tuberculosis (TB) has been observed. We investigated the prevalence of DR-TB in P1041, a multicentered, randomised, double-blind trial which compared the administration of isoniazid (INH) to placebo, in HIV-exposed, non-infected and -infected African infants in the absence of any documented TB exposure. The prevalence of multidrug-resistant TB (MDR-TB) was 22.2% (95%CI 8.5-45.8) and INH monoresistance 5.6% (95%CI 0.1-27.6) among culture-confirmed cases, with all MDR-TB occurring in a single site. There was no association between INH treatment or placebo group, or between HIV infection status, and DR-TB prevalence. There was a high prevalence of DR-TB among HIV-exposed and -infected children. Surveillance of DR-TB among children in high-burden TB-HIV settings should be routine.

  12. Efficacy of a single-session HIV prevention intervention for black women: a group randomized controlled trial.

    PubMed

    Diallo, Dázon Dixon; Moore, Trent Wade; Ngalame, Paulyne M; White, Lisa Diane; Herbst, Jeffrey H; Painter, Thomas M

    2010-06-01

    SisterLove Inc., a community-based organization (CBO) in Atlanta, Georgia, evaluated the efficacy of its highly interactive, single-session HIV prevention intervention for black women, the Healthy Love Workshop (HLW). HLW is delivered to pre-existing groups of women (e.g., friends, sororities) in settings of their choosing. Eligible groups of women were randomly assigned to receive the intervention (15 groups; 161 women) or a comparison workshop (15 groups; 152 women). Behavioral assessments were conducted at baseline and at 3- and 6-month follow-ups. Among sexually active women at the 3-month follow-up, HLW participants were more likely than comparison participants to report having used condoms during vaginal sex with any male partner or with a primary male partner, and to have used condoms at last vaginal, anal or oral sex with any male partner. At the 6-month follow-up, HLW participants were more likely to report condom use at last vaginal, anal or oral sex with any male partner, and having an HIV test and receiving their test results. The study findings suggest that a single-session intervention delivered to pre-existing groups of black women is an efficacious approach to HIV prevention. This study also demonstrates that a CBO can develop and deliver a culturally appropriate, effective HIV prevention intervention for the population it serves and, with adequate resources and technical assistance, rigorously evaluate its intervention.

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

    PubMed Central

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

    2015-01-01

    Sexual risk-taking is influenced by individual, interpersonal and social factors. This paper presents findings from a qualitative followup 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. PMID:26223703

  14. 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…

  15. 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…

  16. 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

  17. 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

  18. A Non-Inferiority Trial of an Evidence-Based Secondary HIV Prevention Behavioral Intervention Compared to an Adapted, Abbreviated Version: Rationale and Intervention Description

    PubMed Central

    Shrestha, Roman; Krishnan, Archana; Altice, Frederick L.; Copenhaver, Michael

    2015-01-01

    Background Real-world clinical settings like addiction treatment programs are ill-equipped to deploy and sustain the existing-resource-demanding evidence-based interventions (EBIs) that target HIV-infected people who use drugs (PWUDs), and this has left a critical void in current HIV prevention efforts. In response to this unmet need, we have conducted formative research in addiction treatment settings that has resulted in Holistic Health for HIV (3H+) – an empirically adapted, substantially abbreviated version of Holistic Health Recovery Program (HHRP+), a CDC-recommended EBI targeting HIV-infected PWUDs. Methods Using a non-inferiority randomized controlled trial design, we will determine whether the abbreviated 3H+ intervention is comparable (i.e., within a 10% margin) and cost-effective relative to the original HHRP+ intervention in terms of reducing HIV risk behaviors and improving antiretroviral therapy (ART) adherence among HIV-infected PWUDs in addiction treatment who report drug- or sex-related HIV risk behaviors. Conclusions This article provides a description of the development and adaptation of the 3H+ intervention, the innovative non-inferiority comparative experimental design for testing the 3H+ to the HHRP+. Furthermore, it provides empirical evidence from a formal cost-effectiveness analysis justifying the cost-effectiveness of the 3H+ intervention when compared to the HHRP+ intervention. If confirmed to be comparable and more cost-effective, as hypothesized, the 3H+ intervention has the potential to be readily and immediately integrated within common clinical settings where large numbers of HIV-infected PWUDs receive clinical services. PMID:26253181

  19. A non-inferiority trial of an evidence-based secondary HIV prevention behavioral intervention compared to an adapted, abbreviated version: Rationale and intervention description.

    PubMed

    Shrestha, Roman; Krishnan, Archana; Altice, Frederick L; Copenhaver, Michael

    2015-09-01

    Real-world clinical settings like addiction treatment programs are ill-equipped to deploy and sustain the existing resource-demanding evidence-based interventions (EBIs) that target HIV-infected people who use drugs (PWUDs), and this has left a critical void in current HIV prevention efforts. In response to this unmet need, we have conducted formative research in addiction treatment settings that has resulted in Holistic Health for HIV (3H+) - an empirically adapted, substantially abbreviated version of Holistic Health Recovery Program (HHRP+), a CDC-recommended EBI targeting HIV-infected PWUDs. Using a non-inferiority randomized controlled trial design, we will determine whether the abbreviated 3H+ intervention is comparable (i.e., within a 10% margin) and cost-effective relative to the original HHRP+ intervention in terms of reducing HIV risk behaviors and improving antiretroviral therapy (ART) adherence among HIV-infected PWUDs in addiction treatment who report drug- or sex-related HIV risk behaviors. This article provides a description of the development and adaptation of the 3H+ intervention, the innovative non-inferiority comparative experimental design for testing the 3H+ to the HHRP+. Furthermore, it provides empirical evidence from a formal cost-effectiveness analysis justifying the cost-effectiveness of the 3H+ intervention when compared to the HHRP+ intervention. If confirmed to be comparable and more cost-effective, as hypothesized, the 3H+ intervention has the potential to be readily and immediately integrated within common clinical settings where large numbers of HIV-infected PWUDs receive clinical services. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. 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

  1. Gender-based violence and HIV: relevance for HIV prevention in hyperendemic countries of southern Africa.

    PubMed

    Andersson, Neil; Cockcroft, Anne; Shea, Bev

    2008-12-01

    Gender-based violence (GBV) is common in southern Africa. Here we use GBV to include sexual and non-sexual physical violence, emotional abuse, and forms of child sexual abuse. A sizeable literature now links GBV and HIV infection.Sexual violence can lead to HIV infection directly, as trauma increases the risk of transmission. More importantly, GBV increases HIV risk indirectly. Victims of childhood sexual abuse are more likely to be HIV positive, and to have high risk behaviours.GBV perpetrators are at risk of HIV infection, as their victims have often been victimised before and have a high risk of infection. Including perpetrators and victims, perhaps one third of the southern African population is involved in the GBV-HIV dynamic.A randomised controlled trial of income enhancement and gender training reduced GBV and HIV risk behaviours, and a trial of a learning programme reported a non-significant reduction in HIV incidence and reduction of male risk behaviours (primary prevention). Interventions among survivors of GBV can reduce their HIV risk (secondary prevention). Various strategies can reduce spread of HIV from infected GBV survivors (tertiary prevention). Dealing with GBV could have an important effect on the HIV epidemic.A policy shift is necessary. HIV prevention policy should recognise the direct and indirect implications of GBV for HIV prevention, the importance of perpetrator dynamics, and that reduction of GBV should be part of HIV prevention programmes. Effective interventions are likely to include a structural component, and a GBV awareness component.

  2. “It is better to die”: experiences of traditional health practitioners within the HIV treatment as prevention trial communities in rural South Africa (ANRS 12249 TasP trial)

    PubMed Central

    Zuma, Thembelihle; Orne-Gliemann, Joanna; Iwuji, Collins; Larmarange, Joseph; McGrath, Nuala

    2016-01-01

    The ANRS 12249 Treatment-as-Prevention (TasP) cluster-randomized trial in rural South Africa uses a “test and treat” approach. Home-based testing services and antiretroviral treatment initiation satellite clinics were implemented in every cluster as part of the trial. A social science research agenda was nested within TasP with the aim of understanding the social, economic and contextual factors that affect individuals, households, communities and health systems with respect to TasP. Considering the rural nature of the trial setting, we sought to understand community perceptions and experiences of the TasP Trial interventions as seen through the eyes of traditional health practitioners (THPs). A qualitative study design was adopted using four repeat focus group discussions conducted with nine THPs, combined with community walks and photo-voice techniques, over a period of 18 months. A descriptive, interpretive and explanatory approach to analysis was adopted. Findings indicate that THPs engaged with the home-based testing services and HIV clinics established for TasP. Specifically, home-based testing services were perceived as relatively successful in increasing access to HIV testing. A major gap observed by THPs was linkage to HIV clinics. Most of their clients, and some of the THPs themselves, found it difficult to use HIV clinics due to fear of labelling, stigma and discrimination, and the ensuing personal implications of unsolicited disclosure. On the one hand, a growing number of patients diagnosed with HIV have found sanctuary with THPs as alternatives to clinics. On the other hand, THPs in turn have been struggling to channel patients suspected of HIV into clinics through referrals. Therefore, acceptability of the TasP test and treat approach by THPs is a major boost to the intervention, but further success can be achieved through strengthened ties with communities to combat stigma and effectively link patients into HIV care, including partnerships with

  3. 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

  4. Future of phylogeny in HIV prevention.

    PubMed

    Brenner, Bluma G; Wainberg, Mark A

    2013-07-01

    The success of the HIV Prevention Trials Network 052 trial has led to revisions in HIV-1 treatment guidelines. Antiretroviral therapy may reduce the risk of HIV-1 transmissions at the population level. The design of successful treatment as prevention interventions will be predicated on a comprehensive understanding of the spatial, temporal, and biological dynamics of heterosexual men who have sex with men and intravenous drug user epidemics. Viral phylogenetics can capture the underlying structure of transmission networks based on the genetic interrelatedness of viral sequences and cluster networks that could not be otherwise identified. This article describes the phylogenetic expansion of the Montreal men who have sex with men epidemic over the last decade. High rates of coclustering of primary infections are associated with 1 infection leading to 13 onward transmissions. Phylogeny substantiates the role of primary and recent stage infection in transmission dynamics, underlying the importance of timely diagnosis and immediate antiretroviral therapy initiation to avert transmission cascades.

  5. HIV Prevention Counseling Intervention Delivered During Routine Clinical Care Reduces HIV Risk Behavior in HIV-Infected South Africans Receiving Antiretroviral Therapy: The Izindlela Zokuphila/Options for Health Randomized Trial

    PubMed Central

    Fisher, Jeffrey D.; Cornman, Deborah H.; Shuper, Paul A.; Christie, Sarah; Pillay, Sandy; Macdonald, Susan; Ngcobo, Ntombenhle; Amico, K. Rivet; Lalloo, Umesh; Friedland, Gerald; Fisher, William A.

    2014-01-01

    Context Sustainable interventions are needed to minimize HIV risk behavior among people living with HIV (PLWH) in South Africa on antiretroviral therapy (ART), a significant proportion of whom do not achieve viral suppression. Objective To determine whether a brief lay counselor delivered intervention implemented during routine care can reduce risky sex among PLWH on ART. Design Cluster randomized 16 HIV clinical care sites in KwaZulu Natal, South Africa, to intervention or standard-of-care. Setting Publicly funded HIV clinical care sites. Patients 1891 PLWH on ART received the HIV prevention counseling intervention (n = 967) or standard-of-care counseling (n = 924). Intervention Lay counselors delivered a brief intervention using motivational interviewing strategies based on the Information—Motivation—Behavioral Skills (IMB) model during routine clinical care. Main Outcome Measures Number of sexual events without a condom in the past four weeks with partners of any HIV status, and with partners perceived to be HIV-negative or HIV-status unknown, assessed at baseline, 6, 12, and 18 months. Results Intervention participants reported significantly greater reductions in HIV risk behavior on both primary outcomes, compared to standard-of-care participants. Differences in STI incidence between arms were not observed. Conclusion Effective behavioral interventions, delivered by lay counselors within the clinical care setting, are consistent with the strategy of linking HIV care and HIV prevention and integrating biomedical and behavioral approaches to stemming the HIV epidemic. PMID:25230288

  6. Assessment of the Safety and Immunogenicity of 2 Novel Vaccine Platforms for HIV-1 Prevention: A Randomized Trial.

    PubMed

    Baden, Lindsey R; Karita, Etienne; Mutua, Gaudensia; Bekker, Linda-Gail; Gray, Glenda; Page-Shipp, Liesl; Walsh, Stephen R; Nyombayire, Julien; Anzala, Omu; Roux, Surita; Laher, Fatima; Innes, Craig; Seaman, Michael S; Cohen, Yehuda Z; Peter, Lauren; Frahm, Nicole; McElrath, M Juliana; Hayes, Peter; Swann, Edith; Grunenberg, Nicole; Grazia-Pau, Maria; Weijtens, Mo; Sadoff, Jerry; Dally, Len; Lombardo, Angela; Gilmour, Jill; Cox, Josephine; Dolin, Raphael; Fast, Patricia; Barouch, Dan H; Laufer, Dagna S

    2016-03-01

    A prophylactic HIV-1 vaccine is a global health priority. To assess a novel vaccine platform as a prophylactic HIV-1 regimen. Randomized, double-blind, placebo-controlled trial. Both participants and study personnel were blinded to treatment allocation. (ClinicalTrials.gov: NCT01215149). United States, East Africa, and South Africa. Healthy adults without HIV infection. 2 HIV-1 vaccines (adenovirus serotype 26 with an HIV-1 envelope A insert [Ad26.EnvA] and adenovirus serotype 35 with an HIV-1 envelope A insert [Ad35.Env], both administered at a dose of 5 × 1010 viral particles) in homologous and heterologous combinations. Safety and immunogenicity and the effect of baseline vector immunity. 217 participants received at least 1 vaccination, and 210 (>96%) completed follow-up. No vaccine-associated serious adverse events occurred. All regimens were generally well-tolerated. All regimens elicited humoral and cellular immune responses in nearly all participants. Preexisting Ad26- or Ad35-neutralizing antibody titers had no effect on vaccine safety and little effect on immunogenicity. In both homologous and heterologous regimens, the second vaccination significantly increased EnvA antibody titers (approximately 20-fold from the median enzyme-linked immunosorbent assay titers of 30-300 to 3000). The heterologous regimen of Ad26-Ad35 elicited significantly higher EnvA antibody titers than Ad35-Ad26. T-cell responses were modest and lower in East Africa than in South Africa and the United States. Because the 2 envelope inserts were not identical, the boosting responses were complex to interpret. Durability of the immune responses elicited beyond 1 year is unknown. Both vaccines elicited significant immune responses in all populations. Baseline vector immunity did not significantly affect responses. Second vaccinations in all regimens significantly boosted EnvA antibody titers, although vaccine order in the heterologous regimen had a modest effect on the immune response

  7. Microbicides: a new hope for HIV prevention

    PubMed Central

    Nutan; Gupta, Satish K.

    2011-01-01

    Human immunodeficiency virus (HIV), causative agent of acquired immunodeficiency syndrome (AIDS), is a global health concern. To control its transmission, safe sex has been proposed as one of the strategies. Microbicides- intravaginal/intrarectal topical formulations of anti-HIV agents have also been proposed to prevent HIV transmission. Microbicides would provide protection by directly inactivating HIV or preventing the attachment, entry or replication of HIV in susceptible target cells as well as their dissemination from target cells present in semen or the host cells lining the vaginal/rectal wall to other migratory cells. Microbicides must be safe, effective following vaginal or rectal administration, and should cause minimal or no genital symptoms or inflammations following long-term repeated usage. However, a safe and efficacious anti-HIV microbicide is not yet available despite the fact that more than 60 candidate agents have been identified to have in vitro activity against HIV, several of which have advanced to clinical testing. Nonetheless, proof-of-concept of microbicides has been established based on the results of recent CAPRISA 004 clinical trials. In this article, the trends and challenges in the development of effective and safe microbicides to combat HIV transmission are reviewed. PMID:22310826

  8. 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.

  9. 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

  10. Lessons Learned from HIV Vaccine Clinical Efficacy Trials

    PubMed Central

    Day, Tracey A.; Kublin, James G.

    2014-01-01

    The past few years have witnessed many promising advances in HIV prevention strategies involving pre-exposure prophylaxis approaches. Some may now wonder whether an HIV vaccine is still needed, and whether developing one is even possible. The partial efficacy reported in the RV144 trial and the encouraging results of the accompanying immune correlates analysis suggest that an effective HIV vaccine is achievable. These successes have provided a large impetus and guidance for conducting more HIV vaccine trials. A key lesson learned from RV144 is that assessment of HIV acquisition is now a feasible and valuable primary objective for HIV preventive vaccine trials. In this article we review how RV144 and other HIV vaccine efficacy trials have instructed the field and highlight some of the HIV vaccine concepts in clinical development. After a long and significant investment, HIV vaccine clinical research is paying off in the form of valuable lessons that, if applied effectively, will accelerate the path toward a safe and effective vaccine. Together with other HIV prevention approaches, preventive and therapeutic HIV vaccines will be invaluable tools in bringing the epidemic to an end. PMID:24033299

  11. Lost in Translation: Language, Terminology, and Understanding of Penile-Anal Intercourse in an HIV Prevention Trial in South Africa, Uganda, and Zimbabwe.

    PubMed

    Duby, Zoe; Hartmann, Miriam; Mahaka, Imelda; Munaiwa, Otillia; Nabukeera, Josephine; Vilakazi, Nozipho; Mthembu, Funeka; Colvin, Christopher J; Mensch, Barbara; van der Straten, Ariane

    2016-01-01

    Despite efforts to use culturally appropriate, understandable terms for sexual behavior in HIV prevention trials, the way in which participants interpret questions is underinvestigated and not well understood. We present findings from qualitative interviews with 88 women in South Africa, Uganda, and Zimbabwe who had previously participated in an HIV prevention trial. Findings suggested that participants may have misinterpreted questions pertaining to penile-anal intercourse (PAI) to refer to vaginal sex from behind and subsequently misreported the behavior. Three key issues emerge from these findings: first, the underreporting of socially stigmatized sexual behaviors due to social desirability bias; second, the inaccurate reporting of sexual behaviors due to miscomprehension of research terms; and third, the ambiguity in vernacular terms for sexual behavior and lack of acceptable terms for PAI in some languages. These findings highlight methodological challenges around developing clear and unambiguous definitions for sexual behaviors, with implications not only for clinical trials but also for clinical practice and sexual risk assessment. We discuss the challenges in collecting accurate and reliable data on heterosexual PAI in Africa and make recommendations for improved data collection on sensitive behaviors.

  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. HIV-1 drug resistance emergence among breastfeeding infants born to HIV-infected mothers during a single-arm trial of triple-antiretroviral prophylaxis for prevention of mother-to-child transmission: a secondary analysis.

    PubMed

    Zeh, Clement; Weidle, Paul J; Nafisa, Lillian; Lwamba, Humphrey M; Okonji, Jully; Anyango, Emily; Bondo, Philip; Masaba, Rose; Fowler, Mary Glenn; Nkengasong, John N; Thigpen, Michael C; Thomas, Timothy

    2011-03-01

    Nevirapine and lamivudine given to mothers are transmitted to infants via breastfeeding in quantities sufficient to have biologic effects on the virus; this may lead to an increased risk of a breastfed infant's development of resistance to maternal antiretrovirals. The Kisumu Breastfeeding Study (KiBS), a single-arm open-label prevention of mother-to-child HIV transmission (PMTCT) trial, assessed the safety and efficacy of zidovudine, lamivudine, and either nevirapine or nelfinavir given to HIV-infected women from 34 wk gestation through 6 mo of breastfeeding. Here, we present findings from a KiBS trial secondary analysis that evaluated the emergence of maternal ARV-associated resistance among 32 HIV-infected breastfed infants. All infants in the cohort were tested for HIV infection using DNA PCR at multiple study visits during the 24 mo of the study, and plasma RNA viral load for all HIV-PCR-positive infants was evaluated retrospectively. Specimens from mothers and infants with viral load >1,000 copies/ml were tested for HIV drug resistance mutations. Overall, 32 infants were HIV infected by 24 mo of age, and of this group, 24 (75%) infants were HIV infected by 6 mo of age. Of the 24 infants infected by 6 mo, nine were born to mothers on a nelfinavir-based regimen, whereas the remaining 15 were born to mothers on a nevirapine-based regimen. All infants were also given single-dose nevirapine within 48 hours of birth. We detected genotypic resistance mutations in none of eight infants who were HIV-PCR positive by 2 wk of age (specimens from six infants were not amplifiable), for 30% (6/20) at 6 wk, 63% (14/22) positive at 14 wk, and 67% (16/24) at 6 mo post partum. Among the 16 infants with resistance mutations by 6 mo post partum, the common mutations were M184V and K103N, conferring resistance to lamivudine and nevirapine, respectively. Genotypic resistance was detected among 9/9 (100%) and 7/15 (47%) infected infants whose mothers were on nelfinavir and

  14. 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

  15. Adherence to Early Antiretroviral Therapy: Results From HPTN 052, a Phase III, Multinational Randomized Trial of ART to Prevent HIV-1 Sexual Transmission in Serodiscordant Couples.

    PubMed

    Safren, Steven A; Mayer, Kenneth H; Ou, San-San; McCauley, Marybeth; Grinsztejn, Beatriz; Hosseinipour, Mina C; Kumarasamy, Nagalingeswaran; Gamble, Theresa; Hoffman, Irving; Celentano, David; Chen, Ying Qing; Cohen, Myron S

    2015-06-01

    Combination antiretroviral therapy (ART) for HIV-1-infected individuals prevents sexual transmission if viral load is suppressed. Participants were HIV-1-infected partners randomized to early ART (CD4 350-550) in HPTN052 (n = 886, median follow-up = 2.1 years), a clinical trial of early ART to prevent sexual transmission of HIV-1 in serodiscordant couples at 13 sites in 9 countries. Adherence was assessed through pill count (dichotomized at <95%) and through self-report items. Predictors of adherence were mental health and general health perceptions, substance use, binge drinking, social support, sexual behaviors, and demographics. Viral suppression was defined as HIV plasma viral load <400 copies per milliliter. Adherence counseling and couples' counseling about safer sex were provided. Logistic and linear regression models using generalized estimating equation for repeated measurements were used. Through pill count, 82% of participants were adherent at 1 month and 83.3% at 1 year. Mental health was the only psychosocial variable associated with adherence [pill count, odds ratios (OR) = 1.05, 95% confidence intervals (CIs): 1.00 to 1.11; self-report parameter estimate, OR = 0.02, 95% CI: 0.01 to 0.04], although regional differences emerged. Pill count (OR = 1.19, 95% CI: 1.10 to 1.30) and self-report (OR = 1.42, 95% CI: 1.14 to 1.77) adherence were associated with viral suppression. Although adherence was high among individuals in stable relationships taking ART for prevention, mental health and adherence covaried. Assessing and intervening on mental health in the context of promoting adherence to ART as prevention should be explored. Adherence and couples' counseling, feedback about viral suppression, and/or altruism may also help explain the magnitude of adherence observed.

  16. Adherence to Early Antiretroviral Therapy: Results from HPTN 052, A Phase III, Multinational Randomized Trial of ART to Prevent HIV-1 Sexual Transmission in Serodiscordant Couples

    PubMed Central

    Safren, Steven A.; Mayer, Kenneth H.; Ou, San-San; McCauley, Marybeth; Grinsztejn, Beatriz; Hosseinipour, Mina C.; Kumarasamy, Nagalingeswaran; Gamble, Theresa; Hoffman, Irving; Celentano, David; Chen, Ying Qing; Cohen, Myron S.

    2015-01-01

    Background Combination antiretroviral therapy (ART) for HIV-1 infected individuals prevents sexual transmission if viral load is suppressed. Methods Participants were HIV-1 infected partners randomized to early ART (CD4 350-550) in HPTN052 (n=886, median follow-up = 2.1 years), a clinical trial of early ART to prevent sexual transmission of HIV-1 in serodiscordant couples at 13 sites in 9 countries. Adherence was assessed via pill-count (dichotomized at <95%) and via self-report items. Predictors of adherence were mental health and general health perceptions, substance use, binge drinking, social support, sexual behaviors, and demographics. Viral suppression was defined as HIV plasma viral load <400 copies/ml. Adherence counseling and couples counseling about safer sex was provided. Logistic and linear regression models using generalized estimating equation for repeated measurements were employed. Findings Via pill-count, 82% of participants were adherent at 1 month and 83.3% at 1 year. Mental health was the only psychosocial variable associated with adherence (pill-count OR=1.05: 95% CI: 1.00 – 1.11; self-report parameter estimate (b)=0.02, 95% CI: 0.01 –0.04), though regional differences emerged. Pill-count (OR=1.19, 95% CI: 1.10-1.30) and self-report (OR=1.42, 95% CI: 1.14-1.77) adherence were associated with viral suppression. Interpretation While adherence was high among individuals in stable relationships taking ART for prevention, mental health and adherence co-varied. Assessing and intervening on mental health in the context of promoting adherence to ART as prevention should be explored. Adherence and couples counseling, feedback about viral suppression, and/or altruism may also help explain the magnitude of adherence observed. PMID:26009832

  17. Supporting Adolescent Orphan Girls to Stay in School as HIV Risk Prevention: Evidence From a Randomized Controlled Trial in Zimbabwe

    PubMed Central

    Cho, Hyunsan; Rusakaniko, Simbarashe; Iritani, Bonita; Mapfumo, John; Halpern, Carolyn

    2011-01-01

    Objectives. Using a randomized controlled trial in rural eastern Zimbabwe, we tested whether comprehensive support to keep orphan adolescent girls in school could reduce HIV risk. Methods. All orphan girls in grade 6 in 25 primary schools were invited to participate in the study in fall 2007 (n = 329). Primary schools were randomized to condition. All primary schools received a universal daily feeding program; intervention participants received fees, uniforms, and a school-based helper to monitor attendance and resolve problems. We conducted annual surveys and collected additional information on school dropout, marriage, and pregnancy rates. We analyzed data using generalized estimating equations over 3 time points, controlling for school and age at baseline. Results. The intervention reduced school dropout by 82% and marriage by 63% after 2 years. Compared with control participants, the intervention group reported greater school bonding, better future expectations, more equitable gender attitudes, and more concerns about the consequences of sex. Conclusions. We found promising evidence that comprehensive school support may reduce HIV risk for orphan girls. Further study, including assessment of dose response, cost benefit, and HIV and herpes simplex virus 2 biomarker measurement, is warranted. PMID:21493943

  18. HIV-1 Prevention for HIV-1 Serodiscordant Couples

    PubMed Central

    Curran, Kathryn; Baeten, Jared M.; Coates, Thomas J.; Kurth, Ann; Mugo, Nelly R.

    2013-01-01

    A substantial proportion of HIV-1-infected individuals in sub-Saharan Africa are in stable relationships with HIV-1-uninfected partners, and HIV-1 serodiscordant couples thus represent an important target population for HIV-1 prevention. Couple-based HIV-1 testing and counseling facilitates identification of HIV-1 serodiscordant couples, counseling about risk reduction, and referrals to HIV-1 treatment, reproductive health services, and support services. Maximizing HIV-1 prevention for HIV-1 serodiscordant couples requires a combination of strategies, including counseling about condoms, sexual risk, fertility, contraception, and the clinical and prevention benefits of antiretroviral therapy (ART) for the HIV-1-infected partner; provision of clinical care and ART for the HIV-1-infected partner; antenatal care and services to prevent mother to child transmission for HIV-1- infected pregnant women; male circumcision for HIV-1-uninfected men; and, pending guidelines and demonstration projects, oral pre-exposure prophylaxis (PrEP) for HIV-1-uninfected partners. PMID:22415473

  19. Tenofovir Disoproxil Fumarate for Prevention of HIV Infection in Women: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Trial

    PubMed Central

    Peterson, Leigh; Taylor, Doug; Roddy, Ronald; Belai, Ghiorghis; Phillips, Pamela; Nanda, Kavita; Grant, Robert; Clarke, Edith Essie Kekawo; Doh, Anderson Sama; Ridzon, Renee; Jaffe, Howard S; Cates, Willard

    2007-01-01

    Objectives: The objective of this trial was to investigate the safety and preliminary effectiveness of a daily dose of 300 mg of tenofovir disoproxil fumarate (TDF) versus placebo in preventing HIV infection in women. Design: This was a phase 2, randomized, double-blind, placebo-controlled trial. Setting: The study was conducted between June 2004 and March 2006 in Tema, Ghana; Douala, Cameroon; and Ibadan, Nigeria. Participants: We enrolled 936 HIV-negative women at high risk of HIV infection into this study. Intervention: Participants were randomized 1:1 to once daily use of 300 mg of TDF or placebo. Outcome measures: The primary safety endpoints were grade 2 or higher serum creatinine elevations (>2.0 mg/dl) for renal function, grade 3 or 4 aspartate aminotransferase or alanine aminotransferase elevations (>170 U/l) for hepatic function, and grade 3 or 4 phosphorus abnormalities (<1.5 mg/dl). The effectiveness endpoint was infection with HIV-1 or HIV-2. Results: Study participants contributed 428 person-years of laboratory testing to the primary safety analysis. No significant differences emerged between treatment groups in clinical or laboratory safety outcomes. Study participants contributed 476 person-years of HIV testing to the primary effectiveness analysis, during which time eight seroconversions occurred. Two were diagnosed in participants randomized to TDF (0.86 per 100 person-years) and six in participants receiving placebo (2.48 per 100 person-years), yielding a rate ratio of 0.35 (95% confidence interval = 0.03–1.93), which did not achieve statistical significance. Owing to premature closures of the Cameroon and Nigeria study sites, the planned person-years of follow-up and study power could not be achieved. Conclusion: Daily oral use of TDF in HIV-uninfected women was not associated with increased clinical or laboratory adverse events. Effectiveness could not be conclusively evaluated because of the small number of HIV infections observed during the

  20. Elective caesarean-section versus vaginal delivery in prevention of vertical HIV-1 transmission: a randomised clinical trial.

    PubMed

    1999-03-27

    Results from observational studies suggest that caesarean-section delivery may reduce the risk of mother-to-child transmission of HIV-1 infection in comparison with vaginal delivery. We carried out a randomised clinical trial to address this issue and to assess the extent of postdelivery complications. Eligible women were between 34 and 36 weeks of pregnancy, with a confirmed diagnosis of HIV-1 infection, and without an indication for caesarean-section delivery or a contraindication to this mode of delivery. Women were randomly assigned elective caesarean-section delivery at 38 weeks of pregnancy or vaginal delivery. An infant was classified as uninfected if he or she became negative for antibody to HIV-1 by age 18 months or was negative for virus by PCR or culture on at least two occasions, with no clinical, immunological, or viral evidence of infection. From 1993, to March, 1998, 436 women were randomised. We present the results of an analysis updated to November, 1998, with data on the infection status of 370 infants. Three (1.8%) of 170 infants born to women assigned caesarean-section delivery were infected, compared with 21 (10.5%) of 200 born to women assigned vaginal delivery (p<0.001). Seven (3.4%) of 203 infants of women who actually gave birth by caesarean section were infected compared with 15 (10.2%) of 167 born vaginally (p=0.009). There were few postpartum complications and no serious adverse events in either group. Our findings provide evidence that elective caesarean-section delivery significantly lowers the risk of mother-to-child transmission of HIV-1 infection without a significantly increased risk of complications for the mother.

  1. Assessment of the Safety and Immunogenicity of 2 Novel Vaccine Platforms for HIV-1 Prevention: A Randomized Trial

    PubMed Central

    Baden, Lindsey R; Karita, Etienne; Mutua, Gaudensia; Bekker, Linda-Gail; Gray, Glenda; Page-Shipp, Liesl; Walsh, Stephen R; Nyombayire, Julien; Anzala, Omu; Roux, Surita; Laher, Fatima; Innes, Craig; Seaman, Michael; Cohen, Yehuda Z; Peter, Lauren; Frahm, Nicole; McElrath, M Juliana; Hayes, Peter; Swann, Edith; Grunenberg, Nicole; Grazia-Pau, Maria; Weijtens, Mo; Sadoff, Jerry; Dally, Len; Lombardo, Angela; Gilmour, Jill; Cox, Josephine; Dolin, Raphael; Fast, Patricia; Barouch, Dan H; Laufer, Dagna S; Johnson, Jennifer; Kleinjan, Jane; Ingabire, Rosine; Nyasani, Delvin; Crida, Danielle; Mangeya, Nicholas; Mamba, Musawenkosi; Mngadi, Kathy; Dominguez, David J; Yanosick, Katherine E; Cormier, Emmanuel; Hural, John; Stevens, Gwynn; Adams, Elizabeth; Kublin, James; Hendriks, Jenny; Sayeed, Eddy; Ackland, James; Anas, Kamaal; Zackariah, Devika; Vooijs, Dani; Chinyenze, Kundai; Matsoso, Mabela; Park, Harriet; Welsh, Sabrina

    2016-01-01

    Background A prophylactic HIV-1 vaccine is a global health priority. Objective To assess a novel vaccine platform as a prophylactic HIV-1 vaccine regimen. Design/Setting This randomized, double-blind, placebo-controlled trial assessed two candidate HIV-1 vaccines (Ad26.EnvA and Ad35-Env both at 5×1010 vp) in homologous and heterologous combinations in three geographic regions (US, East and South Africa). Both subjects and study personnel were blinded to treatment allocation. (NCT 01215149). Patients Healthy HIV uninfected adults. Measurements Safety and immunogenicity were assessed and the impact of baseline vector immunity was analyzed. Results 217 subjects received at least 1 vaccination and 210 (>96%) completed follow-up, No vaccine-associated serious adverse events occurred. All regimens were generally well tolerated though more vaccine recipients had transient moderate or severe systemic reactions (36.5%) compared to placebo recipients (20.5%). All regimens elicited humoral and cellular immune responses in nearly all volunteers. There was no impact of pre-existing Ad26 or Ad35 neutralizing antibody titers on vaccine safety and little on immunogenicity. In both homologous and heterologous regimens the second vaccination significantly increased EnvA antibody titers (~20 fold from median ELISA titers of 30–300 to 3000). The heterologous regimen Ad26-Ad35 elicited significantly higher EnvA antibody titers than Ad35-Ad26. T cell responses were modest and lower in East Africa than in South Africa and the United States. Conclusions Both vaccines elicited significant immune responses in all populations. Baseline vector immunity did not have a significant impact on immune responses. Second vaccinations in all regimens significantly boosted EnvA titers though vaccine order in the heterologous regimen had a modest effect on the immune response. Primary Funding IAVI, NIAID/NIH, and the Ragon Institute in collaboration with Crucell Holland BV. PMID:26833336

  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. 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

    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

    2016-01-02

    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. 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. MRC Clinical Trials Unit at UCL, Public Health England, and Gilead Sciences. Copyright © 2016 McCormack et al. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.

  4. Texting improves testing: a randomized trial of two-way SMS to increase postpartum prevention of mother-to-child transmission retention and infant HIV testing.

    PubMed

    Odeny, Thomas A; Bukusi, Elizabeth A; Cohen, Craig R; Yuhas, Krista; Camlin, Carol S; McClelland, R Scott

    2014-09-24

    Many sub-Saharan African countries report high postpartum loss to follow-up of mother-baby pairs. We aimed to determine whether interactive text messages improved rates of clinic attendance and early infant HIV testing in the Nyanza region of Kenya. Parallel-group, unblinded, randomized controlled trial. HIV-positive pregnant women at least 18 years old and enrolled in the prevention of mother-to-child transmission of HIV programme were randomized to receive either text messages (SMS group, n = 195) or usual care (n = 193). Messages were developed using formative focus group research informed by constructs of the Health Belief Model. The SMS group received up to eight text messages before delivery (depending on gestational age), and six messages postpartum. Primary outcomes included maternal postpartum clinic attendance and virological infant HIV testing by 8 weeks postpartum. The primary analyses were intention-to-treat. Of the 388 enrolled women, 381 (98.2%) had final outcome information. In the SMS group, 38 of 194 (19.6%) women attended a maternal postpartum clinic compared to 22 of 187 (11.8%) in the control group (relative risk 1.66, 95% confidence interval 1.02-2.70). HIV testing within 8 weeks was performed in 172 of 187 (92.0%) infants in the SMS group compared to 154 of 181 (85.1%) in the control group (relative risk 1.08, 95% confidence interval 1.00-1.16). Text messaging significantly improved maternal postpartum visit attendance, but overall return rates for these visits remained low. In contrast, high rates of early infant HIV testing were achieved in both arms, with significantly higher testing rates in the SMS compared to the control infants.

  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. 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.

  7. 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

  8. 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

  9. Adherence and acceptability in MTN 001: A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women

    PubMed Central

    Minnis, Alexandra M.; Gandham, Sharavi; Richardson, Barbra A.; Guddera, Vijayanand; Chen, Beatrice A.; Salata, Robert; Nakabiito, Clemensia; Hoesley, Craig; Justman, Jessica; Soto-Torres, Lydia; Patterson, Karen; Gomez, Kailazarid; Hendrix, Craig

    2012-01-01

    We compared adherence to and acceptability of daily topical and oral formulations of tenofovir (TFV) used as pre-exposure prophylaxis (PrEP) for HIV prevention among women in South Africa, Uganda and the United States. 144 sexually active, HIV-uninfected women participated in a cross-over study of three regimens: oral tablet, vaginal gel, or both. We tested for differences in adherence and evaluated product acceptability. Self-reported adherence for all regimens was high (94%), but serum TFV concentrations indicated only 64% of participants used tablets consistently. Most women in the U.S. (72%) favored tablets over gel; while preferences varied at the African sites (42% preferred gel and 40% tablets). Findings indicate a role for oral and vaginal PrEP formulations and highlight the importance of integrating pharmacokinetics-based adherence assessment in future trials. Biomedical HIV prevention interventions should consider geographic and cultural experience with product formulations, partner involvement, and sexual health benefits that ultimately influence use. PMID:23065145

  10. Integrating Behavioral HIV Interventions into Biomedical Prevention Trials with Youth: Lessons from Chicago’s Project PrEPare

    PubMed Central

    Hosek, Sybil G.; Green, Keith R.; Siberry, George; Lally, Michelle; Balthazar, Christopher; Serrano, Pedro A.; Kapogiannis, Bill

    2013-01-01

    On the heels of several trials demonstrating the efficacy of pre-exposure prophylaxis (PrEP) and the recent approval by the FDA of the supplemental indication for Truvada as PrEP, researchers, advocates, and community providers are calling for the investigation of implementation strategies that combine behavioral interventions with biomedical prevention. This paper describes the modification and integration of an evidence-based group-level intervention into a small PrEP pilot trial with young men who have sex with men (YMSM). The behavioral intervention as well as ongoing risk reduction counseling sessions were found to be highly acceptable among a sample of racially diverse YMSM. PMID:24223514

  11. Reducing lost to follow-up in a large clinical trial of prevention of mother-to-child transmission of HIV: the Breastfeeding, Antiretrovirals and Nutrition study experience.

    PubMed

    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

    2015-04-01

    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 rates have been reported. In this article, we describe the effectiveness of methods used to encourage retention in the Breastfeeding, Antiretrovirals, and Nutrition study and analyze factors associated with lost to follow-up in the study. The Breastfeeding, Antiretrovirals, and Nutrition clinical trial was designed to evaluate the efficacy of three different mother-to-child HIV transmission prevention strategies. Lower than expected participant retention prompted enhanced efforts to reduce lost to follow-up during the conduct of the trial. Following study completion, we employed regression modeling to determine predictors of perfect attendance and variables associated with being lost to follow-up. During the study, intensive tracing efforts were initiated after the first 1686 mother-infant pairs had been enrolled, and 327 pairs were missing. Of these pairs, 60 were located and had complete data obtained. Among the 683 participants enrolling after initiation of intensive tracing efforts, the lost to follow-up rate was 3.4%. At study's end, 290 (12.2%) of the 2369 mother-infant pairs were lost to follow-up. 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 lost to follow-up. In this large HIV prevention trial, intensive tracing efforts centered on reaching study participants at their homes succeeded in finding a substantial proportion of lost to follow-up participants and were very effective in preventing further lost to follow-up during the remainder of the trial. The association between food insecurity and lower rates of lost to

  12. 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

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

    PubMed

    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

    2010-10-16

    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. 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. 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 vs 4·3 [3·6-5·2] for placebo, hazard

  14. 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

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

    PubMed

    Yuen, Winnie Wing-Yan; Wong, William Chi-Wai; Tang, Catherine So-Kum; Holroyd, Eleanor; Tiwari, Agnes Fung-Yee; Fong, Daniel Yee-Tak; Chin, Weng Yee

    2013-07-26

    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. 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. 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-being and safe sex for this high

  16. Overview of the landscape of HIV prevention.

    PubMed

    Haase, Ashley T

    2014-06-01

    In this introductory essay on the landscape of HIV prevention, my intent is to provide context for the subsequent topics discussed at the Symposium on Hormone Regulation of the Mucosal Environment in the female reproductive tract (FRT) and the Prevention of HIV infection: FRT immunity, mucosal microenvironment and HIV prevention, and the risk and impact of hormonal contraceptives on HIV transmission.

  17. Efficacy of a Health Educator–Delivered HIV Prevention Intervention for Latina Women: A Randomized Controlled Trial

    PubMed Central

    DiClemente, Ralph J.; Villamizar, Kira; Er, Deja L.; DeVarona, Martina; Taveras, Janelle; Painter, Thomas M.; Lang, Delia L.; Hardin, James W.; Ullah, Evelyn; Stallworth, JoAna; Purcell, David W.; Jean, Reynald

    2011-01-01

    Objectives. We developed and assessed AMIGAS (Amigas, Mujeres Latinas, Inform andonos, Gui andonos, y Apoy andonos contra el SIDA [friends, Latina women, informing each other, guiding each other, and supporting each other against AIDS]), a culturally congruent HIV prevention intervention for Latina women adapted from SiSTA (Sistas Informing Sistas about Topics on AIDS), an intervention for African American women. Methods. We recruited 252 Latina women aged 18 to 35 years in Miami, Florida, in 2008 to 2009 and randomized them to the 4-session AMIGAS intervention or a 1-session health intervention. Participants completed audio computer-assisted self-interviews at baseline and follow-up. Results. Over the 6-month follow-up, AMIGAS participants reported more consistent condom use during the past 90 (adjusted odds ratio [AOR] = 4.81; P < .001) and 30 (AOR = 3.14; P < .001) days and at last sexual encounter (AOR = 2.76; P < .001), and a higher mean percentage condom use during the past 90 (relative change = 55.7%; P < .001) and 30 (relative change = 43.8%; P < .001) days than did comparison participants. AMIGAS participants reported fewer traditional views of gender roles (P = .008), greater self-efficacy for negotiating safer sex (P < .001), greater feelings of power in relationships (P = .02), greater self-efficacy for using condoms (P < .001), and greater HIV knowledge (P = .009) and perceived fewer barriers to using condoms (P < .001). Conclusions. Our results support the efficacy of this linguistically and culturally adapted HIV intervention among ethnically diverse, predominantly foreign-born Latina women. PMID:22021297

  18. Uptake of biomedical interventions for prevention of sexually transmitted HIV.

    PubMed

    Abbas, Ume L

    2011-03-01

    To examine the population-level effects of introducing and/or expanding biomedical interventions for prevention of human immunodeficiency virus (HIV) sexually transmitted infections through mathematical modeling. Successes of several ground-breaking clinical trials have invigorated the field of HIV prevention with new enthusiasm and opportunities for research into and application of biomedical HIV prevention. Mathematical modeling has advanced in tandem with valuable contributions to both investigative science and public health. New models provide qualitative and quantitative insights regarding the epidemiological impact of the uptake of biomedical interventions, singly and/or in combination including treatment of sexually transmitted infections, condom use, male circumcision, antiretroviral treatment and pre-exposure prophylaxis and vaccine for HIV prevention. Biomedical interventions are critical for reversing the HIV pandemic. Mathematical modeling is invaluable for informed biomedical HIV prevention research, policy and practice.

  19. 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, ...

  20. Willingness of Kenyan HIV-1 serodiscordant couples to use antiretroviral based HIV-1 prevention strategies

    PubMed Central

    Heffron, Renee; Ngure, Kenneth; Mugo, Nelly; Celum, Connie; Kurth, Ann; Curran, Kathryn; Baeten, Jared M.

    2012-01-01

    Introduction Antiretroviral treatment (ART) and pre-exposure prophylaxis (PrEP) have demonstrated efficacy as new HIV-1 prevention approaches for HIV-1 serodiscordant couples. Methods Among Kenyan HIV-1 serodiscordant heterosexual couples participating in a clinical trial of PrEP, we conducted a cross-sectional study and used descriptive statistical methods to explore couples' willingness to use antiretrovirals for HIV-1 prevention. The study was conducted prior to July 2011, when studies among heterosexual populations reported that ART and PrEP reduced HIV-1 risk. Results For 181 couples in which the HIV-1 infected partner had a CD4 count ≥350 cells/μL and had not yet initiated ART (and thus did not qualify for ART under Kenyan guidelines), 60.2% of HIV-1 infected partners (69.4% of men and 57.9% of women) were willing to use early ART (at CD4 ≥350 cells/μL) for HIV-1 prevention. Among HIV-1 uninfected partners, 92.7% (93.8% of men and 86.1% of women) reported willingness to use PrEP. When given a hypothetical choice of early ART or PrEP for HIV-1 prevention, 52.5% of HIV-1 infected participants would prefer to initiate ART early and 56.9% of HIV-1 uninfected participants would prefer to use PrEP. Conclusions Nearly 40% of Kenyan HIV-1 infected individuals in known HIV-1 serodiscordant partnerships reported reservations about early ART initiation for HIV-1 prevention. PrEP interest in this PrEP-experienced population was high. Strategies to achieve high uptake and sustained adherence to ART and PrEP for HIV-1 prevention in HIV-1 serodiscordant couples will require responding to couples' preferences for prevention strategies. PMID:22595872

  1. Bone Age and Mineral Density Assessments Using Plain Roentgenograms in Tenofovir-exposed Infants in Malawi and Brazil Enrolled in HIV Prevention Trials Network 057.

    PubMed

    Osorio, Luiz Eduardo; Boechat, Maria Ines; Mirochnick, Mark; Kumwenda, Newton; Kreitchmann, Regis; Emel, Lynda; Pinto, Jorge; Joao, Esau; Santos, Breno; Swenson, Molly; George, Kathleen; Sato, Paul; Mofenson, Lynne; Nielsen-Saines, Karin

    2017-02-01

    Tenofovir disoproxil fumarate (TDF) use during pregnancy has been increasing, and studies linking bone toxicity with exposure to TDF have raised concern for its use in infants. Hand/wrist and spine radiographs were obtained at 3 days and 12 weeks of age in infants born to HIV-infected pregnant women enrolled in the HIV Prevention Trials Network 057 pharmacokinetic study of TDF conducted in Malawi and Brazil assigned to 3 TDF dosing cohorts. In cohort 1, mothers received 600 mg of TDF during labor. In cohort 2, infants received 4 mg/kg dose on days 0, 3 and 5. In cohort 3, a 900 mg maternal dose was given during labor, followed by a 6 mg/kg infant dose on days 0, 3 and 5 of life. Across all 3 cohorts, 89 infants had radiographs performed at either time point, and 85 had radiographs performed at both time points. Metaphyseal lucency was present in 1 case in Brazil and 2 in Malawi. Fifteen percent of infants from Brazil and 9% of infants from Malawi presented bone age discrepancies. No other abnormalities were identified in Brazil, whereas in Malawi, there were 7 more cases of wrist osteopenia, 2 of spine osteopenia and 3 other abnormalities. Bone abnormalities were not uncommon in the overall cohort of HIV-exposed infants. Because of very limited study drug exposure at the time of birth, it is unlikely that TDF was associated with these findings. Untreated maternal HIV disease and/or maternal nutritional status could potentially be related to fetal bone development. This association should be explored in future cohort studies.

  2. Effectiveness of co-trimoxazole to prevent Plasmodium falciparum malaria in HIV-positive pregnant women in sub-Saharan Africa: an open-label, randomized controlled trial.

    PubMed

    Klement, Elise; Pitché, Palokinam; Kendjo, Eric; Singo, Assétina; D'Almeida, Stéphane; Akouete, Folly; Akpaloo, Yawo; Tossa, Kokou; Prince-Agbodjan, Serge; Patassi, Akouda; Caumes, Eric

    2014-03-01

    Human immunodeficiency virus (HIV) and malaria during pregnancy cause substantial perinatal mortality. As co-trimoxazole (CMX) protects children and HIV-positive adults against malaria, we compared the effectiveness of daily CMX with sulfadoxine-pyrimethamine intermittent preventive treatment (IPT-SP) on malaria risk in HIV-positive pregnant women in a Plasmodium falciparum-endemic African area.  From January 2009 to April 2011, we included in a randomized noninferiority trial all HIV type 1-infected pregnant women (≤28 weeks' gestation, CD4 count ≥200 cells/µL, hemoglobin level ≥7 g/L) in 19 health centers in Togo. Women were randomly assigned to daily 800 mg/160 mg CMX, or IPT-SP. The primary outcome was the proportion of malaria-free pregnancies. Other outcomes included malaria incidence, parasitemia, placental malaria, anemia, and infants' birth weight. Of 264 women randomly assigned to the CMX or IPT-SP group, 126 of 132 and 124 of 132, respectively, were included in the analysis. There were 33 confirmed cases of clinical malaria among 31 women in the CMX group, and 19 among 19 women in the IPT-SP group. Ninety-five of 126 (75.4%) women in the CMX group and 105 of 124 (84.7%) in the IPT-SP group remained malaria-free during their pregnancy (difference, 9.3%; 95% confidence interval [CI], -.53 to 19.1, not meeting the predefined noninferiority criterion). The incidence rate in intention-to-treat analysis was 108.8 malaria episodes per 100 person-years in CMX (95% CI, 105.4-112.2) and 90.1 in IPT-SP (95% CI, 86.8-93.4) (not significant). Prevalence of parasitemia was 16.7% in the CMX group vs 28% in the IPT-SP group (P = .02). Histology revealed 20.3% placental malaria in the CMX group vs. 24.6% in the IPT-SP group (not significant). Grade 3-4 anemia was more frequent in the CMX group (10% vs 4%; P = .008). No pregnant women died. Median birth weight was similar.  Daily CMX was not noninferior to IPT-SP for preventing maternal malaria but safe and at

  3. Actor-partner effects associated with experiencing intimate partner violence or coercion among male couples enrolled in an HIV prevention trial

    PubMed Central

    2014-01-01

    Background Intimate partner violence (IPV) and coercion have been associated with negative health outcomes, including increased HIV risk behaviors, among men who have sex with men (MSM). This is the first study to describe the prevalence and factors associated with experiencing IPV or coercion among US MSM dyads using the actor-partner interdependence model (APIM), an analytic framework to describe interdependent outcomes within dyads. Methods Among MSM couples enrolled as dyads in an HIV prevention randomized controlled trial (RCT), two outcomes are examined in this cross-sectional analysis: 1) the actor experiencing physical or sexual IPV from the study partner in the past 3-months and 2) the actor feeling coerced to participate in the RCT by the study partner. Two multilevel APIM logistic regression models evaluated the association between each outcome and actor, partner, and dyad-level factors. Results Of 190 individuals (95 MSM couples), 14 reported experiencing physical or sexual IPV from their study partner in the past 3 months (7.3%) and 12 reported feeling coerced to participate in the RCT by their study partner (6.3%). Results of multivariate APIM analyses indicated that reporting experienced IPV was associated (p < 0.1) with non-Black/African American actor race, lower actor education, and lower partner education. Reporting experienced coercion was associated (p < 0.1) with younger actor age and lower partner education. Conclusions These findings from an HIV prevention RCT for MSM show considerable levels of IPV experienced in the past 3-months and coercion to participate in the research study, indicating the need for screening tools and support services for these behaviors. The identification of factors associated with IPV and coercion demonstrate the importance of considering actor and partner effects, as well as dyadic-level effects, to improve development of screening tools and support services for these outcomes. PMID:24580732

  4. Efficacy of a Six-Month versus a 36-Month Regimen for Prevention of Tuberculosis in HIV-Infected Persons in India: A Randomized Clinical Trial

    PubMed Central

    Swaminathan, Soumya; Menon, Pradeep Aravindan; Gopalan, Narendran; Perumal, Venkatesan; Santhanakrishnan, Ramesh Kumar; Ramachandran, Ranjani; Chinnaiyan, Ponnuraja; Iliayas, Sheik; Chandrasekaran, Padmapriyadarsini; Navaneethapandian, Pooranaganga Devi; Elangovan, Thiruvalluvan; Pho, Mai Tuyet; Wares, Fraser; Paranji RamaIyengar, Narayanan

    2012-01-01

    Background The optimal duration of preventive therapy for tuberculosis (TB) among HIV-infected persons in TB-endemic countries is unknown. Methods An open-label randomized clinical trial was performed and analyzed for equivalence. Seven hundred and twelve HIV-infected, ART-naïve patients without active TB were randomized to receive either ethambutol 800 mg and isoniazid 300 mg daily for six-months (6EH) or isoniazid 300 mg daily for 36-months (36H). Drugs were dispensed fortnightly and adherence checked by home visits. Patients had chest radiograph, sputum smear and culture performed every six months, in addition to investigations if they developed symptoms. The primary endpoint was incident TB while secondary endpoints were all-cause mortality and adverse events. Survival analysis was performed on the modified intent to treat population (m-ITT) and rates compared. Findings Tuberculosis developed in 22 (6.4%) of 344 subjects in the 6EH arm and 13 (3.8%) of 339 subjects in the 36H arm with incidence rates of 2.4/100py (95%CI- 1.4–3.5) and 1.6/100py (95% CI-0.8–3.0) with an adjusted rate ratio (aIRR) of 1.6 (0.8–3.2). Among TST-positive subjects, the aIRR of 6EH was 1.7 (0.6–4.3) compared to 36H, p = 0.8. All-cause mortality and toxicity were similar in the two arms. Among 15 patients with confirmed TB, 4 isolates were resistant to isoniazid and 2 were multidrug-resistant. Interpretation Both regimens were similarly effective in preventing TB, when compared to historical incidence rates. However, there was a trend to lower TB incidence with 36H. There was no increase in isoniazid resistance compared to the expected rate in HIV-infected patients. The trial is registered at ClinicalTrials.gov, NCT00351702. PMID:23251327

  5. 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.

  6. Impact of targeted counseling on reported vaginal hygiene practices and bacterial vaginosis: the HIV Prevention Trials Network 035 study

    PubMed Central

    Kasaro, Margaret P; Husnik, Marla J; Chi, Benjamin H; Reid, Cheri; Magure, Tsitsi; Makanani, Bonus; Tembo, Tchangani; Ramjee, Gita; Maslankowski, Lisa; Rabe, Lorna; Guffey, M Brad

    2016-01-01

    Objective We describe the impact of intense counseling to reduce vaginal hygiene practices and its effect on bacterial vaginosis (BV). Design Secondary data analysis of HPTN 035 trial Setting Seven African and one U.S. site Population HIV negative, non-pregnant women at least 18years old Methods At enrollment and during follow-up quarterly visits, vaginal hygiene practices were determined by face-to-face administration of a behavioral assessment questionnaire. Vaginal hygiene practices were categorized as insertion into the vagina of: (1) nothing; (2) water only; and (3) other substances with or without water. Each practice was quantified by frequency and type/combination of inserted substances. At quarterly visits, diagnosis of BV was made using the Nugent score. Trends for vaginal hygiene practices and BV were evaluated using generalized estimating equation models. Results 3087 participants from the HPTN 035 study were eligible for this analysis. At enrollment, 1859 (60%) reported recent vaginal hygiene practices. By one year, this figure had decreased to 1019 (33%) with counseling. However, BV prevalence remained consistent across the study observation period, with 36–38% of women testing positive for the condition (p for trend= 0.27). Overall, those who reported douching with water only (AOR= 1.03, 95%CI: 0.94 – 1.13) and those who reported inserting other substances (AOR= 0.98, 95%CI: 0.88 – 1.09) in the past quarter were not more likely to have BV compared to those who reported no insertions. However, in South Africa, an increase in BV was seen among those who reported inserting other substances (AOR: 1.48, 95%CI: 1.17, 1.88). Conclusions Targeted counseling against vaginal hygiene practices resulted in change in self-reported behavior, but did not have an impact on BV diagnosis in all but one site. PMID:27277555

  7. Condoms, Lubricants and Rectal Cleansing: Practices Associated with Heterosexual Penile-Anal Intercourse Amongst Participants in an HIV Prevention Trial in South Africa, Uganda and Zimbabwe

    PubMed Central

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

    2015-01-01

    We investigated condom and lubricant use, rectal cleansing and rectal gel use for penile-anal intercourse (PAI), during in-depth interviews with women from South Africa, Uganda and Zimbabwe who formerly participated in VOICE, a five-arm HIV prevention trial of two antiretroviral tablets and a vaginal gel. Few studies have addressed practices related to PAI among women; existing data from Africa on condom and lubricant use for PAI, as well as preparatory practices of PAI such as rectal cleansing, are limited to men who have sex with men. Women demonstrated a lack of awareness of HIV transmission risks of PAI and none of the participants reported using condom-compatible lubricants for PAI. Participants described a variety of preparatory rectal cleansing practices. Some participants disclosed rectal use of the vaginal study gel. Understanding practices related to PAI in Africa is critical to microbicide development, as these practices are likely to influence the acceptability, feasibility, and use of both vaginal and rectal microbicide products. PMID:26126586

  8. Lost in Translation: Assessing Effectiveness of Focus Group Questioning Techniques to Develop Improved Translation of Terminology Used in HIV Prevention Clinical Trials

    PubMed Central

    Mack, Natasha; Ramirez, Catalina B.; Friedland, Barbara; Nnko, Soori

    2013-01-01

    Introduction Achieving participant comprehension has proven to be one of the most difficult, practical, and ethical challenges of HIV prevention clinical trials. It becomes even more challenging when local languages do not have equivalent scientific and technical vocabularies, rendering communication of scientific concepts in translated documents extremely difficult. Even when bilingual lexicons are developed, there is no guarantee that participants understand the terminology as translated. Methods We conducted twelve focus groups with women of reproductive age in Mwanza, Tanzania to explore the effectiveness of four questioning techniques for: (1) assessing participants' familiarity with existing technical terms and concepts, (2) generating a list of acceptable technical and non-technical terms, (3) testing our definitions of technical terms, and (4) verifying participants' preferences for terms. Focus groups were transcribed, translated, and qualitatively analyzed. Results and Discussion A translation process that uses all four questioning techniques in a step-wise approach is an effective way to establish a baseline understanding of participants' familiarity with research terms, to develop and test translatable definitions, and to identify participants' preferred terminology for international HIV clinical research. This may help to ensure that important concepts are not “lost in translation.” The results emphasize the importance of using a variety of techniques depending on the level of participant familiarity with research concepts, the existence of colloquial or technical terms in the target language, and the inherent complexity of the terms. PMID:24040075

  9. Condoms, Lubricants and Rectal Cleansing: Practices Associated with 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

    2016-04-01

    We investigated condom and lubricant use, rectal cleansing and rectal gel use for penile-anal intercourse (PAI), during in-depth interviews with women from South Africa, Uganda and Zimbabwe who formerly participated in VOICE, a five-arm HIV prevention trial of two antiretroviral tablets and a vaginal gel. Few studies have addressed practices related to PAI among women; existing data from Africa on condom and lubricant use for PAI, as well as preparatory practices of PAI such as rectal cleansing, are limited to men who have sex with men. Women demonstrated a lack of awareness of HIV transmission risks of PAI and none of the participants reported using condom-compatible lubricants for PAI. Participants described a variety of preparatory rectal cleansing practices. Some participants disclosed rectal use of the vaginal study gel. Understanding practices related to PAI in Africa is critical to microbicide development, as these practices are likely to influence the acceptability, feasibility, and use of both vaginal and rectal microbicide products.

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

    PubMed

    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

    2012-06-30

    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. 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. 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-antiretroviral, 13 in infant

  11. 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

  12. Willingness to participate in HIV vaccine trials: The impact of trial attributes

    PubMed Central

    Newman, Peter A.; Duan, Naihua; Lee, Sung-Jae; Rudy, Ellen; Seiden, Danielle; Kakinami, Lisa; Cunningham, William

    2010-01-01

    Objectives To assess willingness to participate (WTP) in hypothetical Phase III preventive HIV vaccine trials, and the impact of trial attributes on WTP, among low socioeconomic, ethnically diverse adults from communities at elevated risk for HIV infection. Method Participants (n=123; median age=38; 69% male; 37% Latino; 14% African-American) were recruited in Los Angeles in 2003 using multi-site, venue-based sampling. WTP was assessed for eight hypothetical HIV vaccine trials that varied across seven dichotomous attributes, using a 27-4 fractional factorial experimental design. Individual-specific impact of vaccine trial attributes on WTP was estimated using within-individual ANOVA and then meta-analyzed across individuals. Results Mean WTP for eight hypothetical vaccine trials ranged from 1.74 to 3.81 (1=highly unlikely, 5=highly likely). Lower WTP was associated with vaccine-induced infection risk (impact=0.88, p<0.0001), false HIV-positives (0.53, p<0.0001), no provision of free HIV medications (0.52, p<0.0001), and longer trial duration (0.27; p=0.0002). Conclusion HIV vaccine trial attributes may strongly influence WTP. Although existing candidate vaccines cannot cause HIV infection, perceptions of risk may impede WTP. Eliciting trial preferences and concerns prior to trial implementation may enable accommodation of participant preferences and support tailored interventions to address concerns and misconceptions to facilitate enrollment in safe and ethical trials among vulnerable communities. PMID:17275895

  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. “If It’s Not Working, Why Would They Be Testing It?”: mental models of HIV vaccine trials and preventive misconception among men who have sex with men in India

    PubMed Central

    2013-01-01

    Background Informed consent based on comprehension of potential risks and benefits is fundamental to the ethical conduct of clinical research. We explored mental models of candidate HIV vaccines and clinical trials that may impact on the feasibility and ethics of biomedical HIV prevention trials among men who have sex with men (MSM) in India. Methods A community-based research project was designed and implemented in partnership with community-based organizations serving MSM in Chennai and Mumbai. We conducted 12 focus groups (n = 68) with diverse MSM and 14 key informant interviews with MSM community leaders/service providers using a semi-structured interview guide to explore knowledge and beliefs about HIV vaccines and clinical trials. Focus groups (60–90 minutes) and interviews (45–60 minutes) were conducted in participants’ native language (Tamil in Chennai; Marathi or Hindi in Mumbai), audio-taped, transcribed and translated into English. We explored focus group and interview data using thematic analysis and a constant comparative method, with a focus on mental models of HIV vaccines and clinical trials. Results A mental model of HIV vaccine-induced seropositivity as “having HIV” resulted in fears of vaccine-induced infection and HIV stigma. Some participants feared inactivated vaccines might “drink blood” and “come alive”. Pervasive preventive misconception was based on a mental model of prevention trials as interventions, overestimation of likely efficacy of candidate vaccines and likelihood of being assigned to the experimental group, with expectations of protective benefits and decreased condom use. Widespread misunderstanding and lack of acceptance of placebo and random assignment supported perceptions of clinical trials as “cheating”. Key informants expressed concerns that volunteers from vulnerable Indian communities were being used as “experimental rats” to benefit high-income countries. Conclusions Evidence

  15. What can HIV vaccine trials teach us about future HIV vaccine dissemination?

    PubMed Central

    Newman, Peter A.; Duan, Naihua; Kakinami, Lisa; Roberts, Kathleen

    2008-01-01

    Summary This investigation explored commonalities and differences in barriers and motivators to HIV vaccine trial participation and acceptability of future U.S. Food and Drug Administration (FDA)-approved HIV vaccines in order to identify implications of clinical trials for future HIV vaccine dissemination. Fifteen focus groups were conducted with 157 predominately ethnic minority and low income participants recruited using venue-based sampling in Los Angeles. Data were analyzed using narrative thematic analysis. Barriers and motivators in common across willingness to participate (WTP) in HIV vaccine trials and future HIV vaccine acceptability (e.g., concerns about vaccine-induced infection, false-positives, side effects, efficacy, mistrust and stigma) suggest clinical trials present significant opportunities to develop and evaluate empirically based interventions to support future HIV vaccine dissemination. Barriers specific to HIV vaccine acceptability (e.g., concerns about duration of protection, cross-clade protection, cost and access) also indicate the need for formative research focused specifically on future dissemination. Protection motivation, common to WTP and acceptability, highlights the need to provide and evaluate prevention counseling and education in clinical trials, which may form the basis of evidence-informed preventive interventions to be launched in tandem with dissemination of partial efficacy HIV vaccines. PMID:18420313

  16. 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

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

    2014-09-01

    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. 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. 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. 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.

  17. 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

  18. 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).

  19. 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

  20. 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

  1. 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

  2. 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

  3. Participant retention in clinical trials of candidate HIV vaccines.

    PubMed

    de Bruyn, Guy; Hudgens, Michael G; Sullivan, Patrick S; Duerr, Ann C

    2005-08-01

    : To determine predictors of loss to follow-up (LTFU) in trials of candidate HIV vaccines. : Data were obtained from trials of candidate preventive HIV vaccines conducted by the AIDS Vaccine Evaluation Group (AVEG) and HIV Network for Prevention Trials (HIVNET) that enrolled HIV-negative volunteers. Analytic models included multiple logistic regression and generalized estimating equations. : Of 3033 volunteers enrolled in 48 trials, 282 (9.3%) persons did not complete follow-up. In univariate analyses, age, trial duration, and number of immunizations were associated with LTFU. In a multivariate logistic model, age (per year) (adjusted odds ratio [AOR] = 0.96, 95% confidence interval [CI]: 0.95, 0.98) and study duration (per month) (AOR = 1.04, 95% CI: 1.01, 1.08) remained significantly associated with LTFU. : Younger age and increasing trial duration predicted LTFU. Limiting enrollment in trials of novel products to those less than 40 years of age may exclude participants shown to have improved retention. Trials should be designed to last only as long as required to address the scientific question. Retention efforts in future trials should especially address younger persons.

  4. 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…

  5. 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…

  6. HIV prevention advice for people with serious mental illness.

    PubMed

    Wright, Nicola; Akhtar, Athfah; Tosh, Graeme E; Clifton, Andrew V

    2016-09-09

    People with serious mental illness have rates of Human Immuno-deficiency Virus (HIV) infection higher than expected in the general population for the same demographic area. Despite this elevated prevalence, UK national strategies around sexual health and HIV prevention do not state that people with serious mental illness are a high risk group. However, a significant proportion in this group are sexually active and engage in HIV-risk behaviours including having multiple sexual partners, infrequent use of condoms and trading sex for money or drugs. Therefore we propose the provision of HIV prevention advice could enhance the physical and social well being of this population. To assess the effects of HIV prevention advice in reducing morbidity, mortality and preserving the quality of life in people with serious mental illness. We searched the Cochrane Schizophrenia Group's Trials Register (24 January 2012; 4 July 2016). We planned to include all randomised controlled trials focusing on HIV prevention advice versus standard care or comparing HIV prevention advice with other more focused methods of delivering care or information for people with serious mental illness. Review authors (NW, AC, AA, GT) independently screened search results and did not identify any studies that fulfilled the review's criteria. We did not identify any randomised studies that evaluated advice regarding HIV for people with serious mental illness. The excluded studies illustrate that randomisation of packages of care relevant to both people with serious mental illness and HIV risk are possible. Policy makers, clinicians, researchers and service users need to collaborate to produce guidance on how best to provide advice for people with serious mental illness in preventing the spread of HIV infection. It is entirely feasible that this could be within the context of a well-designed simple large randomised study.

  7. Vaginal microbicides and the prevention of HIV transmission

    PubMed Central

    Cutler, Blayne; Justman, Jessica

    2009-01-01

    Worldwide, nearly half of all individuals living with HIV are now women, who acquire the virus largely by heterosexual exposure. With an HIV vaccine likely to be years away, topical microbicide formulations applied vaginally or rectally are being investigated as another strategy for HIV prevention. A review of preclinical and clinical research on the development of microbicides formulated to prevent vaginal HIV transmission yielded 118 studies: 73 preclinical and 45 clinical. Preclinical research included in-vitro assays and cervical explant models, as well as animal models. Clinical research included phase I and II/IIb safety studies, and phase III efficacy studies. Whereas most phase I and phase II clinical trials have found microbicide compounds to be safe and well tolerated, phase III trials completed to date have not demonstrated efficacy in preventing HIV transmission. Topical microbicides are grouped into five classes of agents, based on where they disrupt the pathway of sexual transmission of HIV. These classes include surfactants/membrane disruptors, vaginal milieu protectors, viral entry inhibitors, reverse transcriptase inhibitors, and a fifth group whose mechanism is unknown. The trajectory of microbicide development has been toward agents that block more specific virus—host cell interactions. Microbicide clinical trials face scientifically and ethically complex issues, such as the choice of placebo gel, the potential for viral resistance, and the inclusion of HIV-infected participants. Assessment of combination agents will most likely advance this field of research. PMID:18992405

  8. 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

  9. Estimating Efficacy in a Randomized Trial With Product Nonadherence: Application of Multiple Methods to a Trial of Preexposure Prophylaxis for HIV Prevention

    PubMed Central

    Murnane, Pamela M.; Brown, Elizabeth R.; Donnell, Deborah; Coley, R. Yates; Mugo, Nelly; Mujugira, Andrew; Celum, Connie; Baeten, Jared M.

    2015-01-01

    Antiretroviral preexposure prophylaxis (PrEP) for persons at high risk of human immunodeficiency virus infection is a promising new prevention strategy. Six randomized trials of oral PrEP were recently conducted and demonstrated efficacy estimates ranging from 75% to no effect, with nonadherence likely resulting in attenuated estimates of the protective effect of PrEP. In 1 of these trials, the Partners PrEP Study (Kenya and Uganda, 2008–2011), participants (4,747 serodiscordant heterosexual couples) were randomized to receipt of tenofovir (TDF), coformulated TDF/emtricitabine (FTC), or placebo. Intention-to-treat analyses found efficacy estimates of 67% for TDF and 75% for TDF/FTC. We applied multiple methods to data from that trial to estimate the efficacy of PrEP with high adherence, including principal stratification and inverse-probability-of-censoring (IPC) weights. Results were further from the null when correcting for nonadherence: 1) among the strata with an estimated 100% probability of high adherence (TDF hazard ratio (HR) = 0.19, 95% confidence interval (CI): 0.07, 0.56; TDF/FTC HR = 0.12, 95% CI: 0.03, 0.52); 2) with IPC weights used to approximate a continuously adherent population (TDF HR = 0.18, 95% CI: 0.06, 0.53; TDF/FTC HR = 0.15, 95% CI: 0.04, 0.52); and 3) in per-protocol analysis (TDF HR = 0.18, 95% CI: 0.06, 0.53; TDF/FTC HR = 0.16, 95% CI: 0.05, 0.53). Our results suggest that the efficacy of PrEP with high adherence is over 80%. PMID:26487343

  10. Estimating efficacy in a randomized trial with product nonadherence: application of multiple methods to a trial of preexposure prophylaxis for HIV prevention.

    PubMed

    Murnane, Pamela M; Brown, Elizabeth R; Donnell, Deborah; Coley, R Yates; Mugo, Nelly; Mujugira, Andrew; Celum, Connie; Baeten, Jared M

    2015-11-15

    Antiretroviral preexposure prophylaxis (PrEP) for persons at high risk of human immunodeficiency virus infection is a promising new prevention strategy. Six randomized trials of oral PrEP were recently conducted and demonstrated efficacy estimates ranging from 75% to no effect, with nonadherence likely resulting in attenuated estimates of the protective effect of PrEP. In 1 of these trials, the Partners PrEP Study (Kenya and Uganda, 2008-2011), participants (4,747 serodiscordant heterosexual couples) were randomized to receipt of tenofovir (TDF), coformulated TDF/emtricitabine (FTC), or placebo. Intention-to-treat analyses found efficacy estimates of 67% for TDF and 75% for TDF/FTC. We applied multiple methods to data from that trial to estimate the efficacy of PrEP with high adherence, including principal stratification and inverse-probability-of-censoring (IPC) weights. Results were further from the null when correcting for nonadherence: 1) among the strata with an estimated 100% probability of high adherence (TDF hazard ratio (HR) = 0.19, 95% confidence interval (CI): 0.07, 0.56; TDF/FTC HR = 0.12, 95% CI: 0.03, 0.52); 2) with IPC weights used to approximate a continuously adherent population (TDF HR = 0.18, 95% CI: 0.06, 0.53; TDF/FTC HR = 0.15, 95% CI: 0.04, 0.52); and 3) in per-protocol analysis (TDF HR = 0.18, 95% CI: 0.06, 0.53; TDF/FTC HR = 0.16, 95% CI: 0.05, 0.53). Our results suggest that the efficacy of PrEP with high adherence is over 80%.

  11. Internet-Based HIV Prevention With At-Home Sexually Transmitted Infection Testing for Young Men Having Sex With Men: Study Protocol of a Randomized Controlled Trial of Keep It Up! 2.0

    PubMed Central

    Madkins, Krystal; Greene, George J; Parsons, Jeffrey T; Johnson, Brent A; Sullivan, Patrick; Bass, Michael; Abel, Rebekah

    2017-01-01

    Background Human immunodeficiency virus (HIV) infections are increasing among young men who have sex with men (YMSM), yet few HIV prevention programs have studied this population. Keep It Up! (KIU!), an online HIV prevention program tailored to diverse YMSM, was developed to fill this gap. The KIU! 2.0 randomized controlled trial (RCT) was launched to establish intervention efficacy. Objective The objective of the KIU! study is to advance scientific knowledge of technology-based behavioral HIV prevention, as well as improve public health by establishing the efficacy of an innovative electronic health (eHealth) prevention program for ethnically and racially diverse YMSM. The intervention is initiated upon receipt of a negative HIV test result, based on the theory that testing negative is a teachable moment for future prevention behaviors. Methods This is a two-group, active-control RCT of the online KIU! intervention. The intervention condition includes modules that use videos, animation, games, and interactive exercises to address HIV knowledge, motivation for safer behaviors, self-efficacy, and behavioral skills. The control condition reflects HIV information that is readily available on many websites, with the aim to understand how the KIU! intervention improves upon information that is currently available online. Follow-up assessments are administered at 3, 6, and 12 months for each arm. Testing for urethral and rectal sexually transmitted infections (STIs) is completed at baseline and at 12-month follow-up for all participants, and at 3- and 6-month follow-ups for participants who test positive at baseline. The primary behavioral outcome is unprotected anal sex at all follow-up points, and the primary biomedical outcome is incident STIs at 12-month follow-up. Results Consistent with study aims, the KIU! technology has been successfully integrated into a widely-used health technology platform. Baseline enrollment for the RCT was completed on December 30, 2015 (N

  12. 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

  13. 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

  14. Screening and evaluation of potential volunteers for a phase III trial in Thailand of a candidate preventive HIV vaccine (RV148).

    PubMed

    2011-06-06

    Screening for the community-based, phase III, prime-boost HIV vaccine trial conducted in Thailand (also referred to as "RV144") began in September 2003 and concluded in December 2005 in Rayong and Chon Buri provinces. During this period 26,676 persons were consented and screened for vaccine trial eligibility in a separate protocol ("RV148") at 47 screening sites, of which 26,548 were tested for HIV, and 16,402 were ultimately enrolled in RV144 and received at least one vaccination or corresponding placebo injection. Fifty-eight percent of those enrolled in RV148 were men and roughly half of the men and women were married. A slight majority was born in the provinces in which the study was conducted. The median age was 23 (IQR 20-26) and most had achieved a level of education that was higher than grade 9, which is compulsory for Thai citizens. The prevalence of confirmed HIV infection was 1.6%; among persons who did not return for confirmatory testing, it was 2.0%. Eighty-three percent were infected with CRF01_AE strains (formerly subtype E) as determined by serological typing. The estimated incidence of HIV infection using a capture EIA assay was 0.19 per 100 person-years. Female sex, older age, single marital status, and lower educational attainment were associated with HIV infection. Persons who reported working in the fishing or sex-work industries were more frequently infected (2.4% and 4.1%, respectively), but accounted for a small percent of the tested population in RV148 (0.7% and 0.6%, respectively), reflecting the overall low-risk of HIV in this study. Those screened for eligibility but did not participate in the vaccine trial were not substantially different from enrolled vaccine trial subjects.

  15. Text messaging to improve attendance at post-operative clinic visits after adult male circumcision for HIV prevention: a randomized controlled trial.

    PubMed

    Odeny, Thomas A; Bailey, Robert C; Bukusi, Elizabeth A; Simoni, Jane M; Tapia, Kenneth A; Yuhas, Krista; Holmes, King K; McClelland, R Scott

    2012-01-01

    Following male circumcision for HIV prevention, a high proportion of men fail to return for their scheduled seven-day post-operative visit. We evaluated the effect of short message service (SMS) text messages on attendance at this important visit. We enrolled 1200 participants >18 years old in a two-arm, parallel, randomized controlled trial at 12 sites in Nyanza province, Kenya. Participants received daily SMS text messages for seven days (n = 600) or usual care (n = 600). The primary outcome was attendance at the scheduled seven-day post-operative visit. The primary analysis was by intention-to-treat. Of participants receiving SMS, 387/592 (65.4%) returned, compared to 356/596 (59.7%) in the control group (relative risk [RR] = 1.09, 95% confidence interval [CI] 1.00-1.20; p = 0.04). Men who paid more than US$1.25 to travel to clinic were at higher risk for failure to return compared to those who spent ≤ US$1.25 (adjusted relative risk [aRR] 1.35, 95% CI 1.15-1.58; p<0.001). Men with secondary or higher education had a lower risk of failure to return compared to those with primary or less education (aRR 0.87, 95% CI 0.74-1.01; p = 0.07). Text messaging resulted in a modest improvement in attendance at the 7-day post-operative clinic visit following adult male circumcision. Factors associated with failure to return were mainly structural, and included transportation costs and low educational level. ClinicalTrials.govNCT01186575.

  16. Comparison of Closed-Ended, Open-Ended, and Perceived Informed Consent Comprehension Measures for a Mock HIV Prevention Trial among Women in Tanzania

    PubMed Central

    MacQueen, Kathleen M.; Chen, Mario; Ramirez, Catalina; Nnko, Soori E. A.; Earp, Kelly M.

    2014-01-01

    Verifying participant comprehension continues to be a difficult ethical and regulatory challenge for clinical research. An increasing number of articles assessing methods to improve comprehension have been published, but they use a wide range of outcome measures including open-ended, closed-ended, and self-perceived measures of comprehension. Systematic comparisons of different measures have rarely been reported. This study evaluated the likely direction of bias observed when using open-ended, closed-ended, and perceived ease of comprehension measures among women administered a mock informed consent process in Mwanza, Tanzania. Participants were randomized to either a closed-ended or an open-ended assessment of comprehension, administered the consent process for a hypothetical HIV prevention trial in Kiswahili, and then administered a comprehension assessment, per their randomization. They were then asked how easy or hard it was to understand each of the informed consent components measured in the comprehension assessment. Women in the closed-ended arm had significantly higher overall comprehension scores than in the open-ended arm. Perceived scores were significantly higher when compared to both open-ended and close-ended scores within arms but were similar between arms. Findings highlight the importance of comprehension assessments in complex clinical trials that go beyond asking participants if they understand or have any questions. They also indicate the need for continued exploration of objective measures of comprehension in international clinical research settings, so that points in need of clarification can be efficiently and effectively identified and addressed. Such measures would reduce burdens on both staff and participants that result from well-intentioned but potentially unnecessary time spent explaining in unwarranted detail things already understood. PMID:25157899

  17. HealthMap: a cluster randomised trial of interactive health plans and self-management support to prevent coronary heart disease in people with HIV.

    PubMed

    Dodson, Sarity; Klassen, Karen M; McDonald, Karalyn; Millard, Tanya; Osborne, Richard H; Battersby, Malcolm W; Fairley, Christopher K; Simpson, Julie A; Lorgelly, Paula; Tonkin, Andrew; Roney, Janine; Slavin, Sean; Sterjovski, Jasminka; Brereton, Margot; Lewin, Sharon R; Crooks, Levinia; Watson, Jo; Kidd, Michael R; Williams, Irith; Elliott, Julian H

    2016-03-05

    The leading causes of morbidity and mortality for people in high-income countries living with HIV are now non-AIDS malignancies, cardiovascular disease and other non-communicable diseases associated with ageing. This protocol describes the trial of HealthMap, a model of care for people with HIV (PWHIV) that includes use of an interactive shared health record and self-management support. The aims of the HealthMap trial are to evaluate engagement of PWHIV and healthcare providers with the model, and its effectiveness for reducing coronary heart disease risk, enhancing self-management, and improving mental health and quality of life of PWHIV. The study is a two-arm cluster randomised trial involving HIV clinical sites in several states in Australia. Doctors will be randomised to the HealthMap model (immediate arm) or to proceed with usual care (deferred arm). People with HIV whose doctors are randomised to the immediate arm receive 1) new opportunities to discuss their health status and goals with their HIV doctor using a HealthMap shared health record; 2) access to their own health record from home; 3) access to health coaching delivered by telephone and online; and 4) access to a peer moderated online group chat programme. Data will be collected from participating PWHIV (n = 710) at baseline, 6 months, and 12 months and from participating doctors (n = 60) at baseline and 12 months. The control arm will be offered the HealthMap intervention at the end of the trial. The primary study outcomes, measured at 12 months, are 1) 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by a Framingham Heart Study risk equation; and 2) Positive and Active Engagement in Life Scale from the Health Education Impact Questionnaire (heiQ). The study will determine the viability and utility of a novel technology-supported model of care for maintaining the health and wellbeing of people with HIV. If shown to be effective, the HealthMap model

  18. eHealth interventions for HIV prevention.

    PubMed

    Noar, Seth M; Willoughby, Jessica Fitts

    2012-01-01

    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.

  19. 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

  20. Comprehensive HIV Prevention for Transgender Persons.

    PubMed

    Neumann, Mary Spink; Finlayson, Teresa J; Pitts, Nicole L; Keatley, JoAnne

    2017-02-01

    Transgender persons are at high risk for HIV infection, but prevention efforts specifically targeting these people have been minimal. Part of the challenge of HIV prevention for transgender populations is that numerous individual, interpersonal, social, and structural factors contribute to their risk. By combining HIV prevention services with complementary medical, legal, and psychosocial services, transgender persons' HIV risk behaviors, risk determinants, and overall health can be affected simultaneously. For maximum health impact, comprehensive HIV prevention for transgender persons warrants efforts targeted to various impact levels-socioeconomic factors, decision-making contexts, long-lasting protections, clinical interventions, and counseling and education. We present current HIV prevention efforts that reach transgender persons and present others for future consideration.

  1. 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…

  2. Combination HIV Prevention: Significance, Challenges, and Opportunities

    PubMed Central

    Celum, Connie; Baeten, Jared M.; Vermund, Sten H.; Wasserheit, Judith N.

    2010-01-01

    No single HIV prevention strategy will be sufficient to control the HIV pandemic. However, a growing number of interventions have shown promise in partially protecting against HIV transmission and acquisition, including knowledge of HIV serostatus, behavioral risk reduction, condoms, male circumcision, needle exchange, treatment of curable sexually transmitted infections, and use of systemic and topical antiretroviral medications by both HIV-infected and uninfected persons. Designing the optimal package of interventions that matches the epidemiologic profile of a target population, delivering that package at the population level, and evaluating safety, acceptability, coverage, and effectiveness, all involve methodological challenges. Nonetheless, there is an unprecedented opportunity to develop “prevention packages” that combine various arrays of evidence-based strategies, tailored to the needs of diverse subgroups and targeted to achieve high coverage for a measurable reduction in population-level HIV transmission. HIV prevention strategies that combine partially effective interventions should be scaled up and evaluated. PMID:20941553

  3. Internet-Based HIV Prevention With At-Home Sexually Transmitted Infection Testing for Young Men Having Sex With Men: Study Protocol of a Randomized Controlled Trial of Keep It Up! 2.0.

    PubMed

    Mustanski, Brian; Madkins, Krystal; Greene, George J; Parsons, Jeffrey T; Johnson, Brent A; Sullivan, Patrick; Bass, Michael; Abel, Rebekah

    2017-01-07

    Human immunodeficiency virus (HIV) infections are increasing among young men who have sex with men (YMSM), yet few HIV prevention programs have studied this population. Keep It Up! (KIU!), an online HIV prevention program tailored to diverse YMSM, was developed to fill this gap. The KIU! 2.0 randomized controlled trial (RCT) was launched to establish intervention efficacy. The objective of the KIU! study is to advance scientific knowledge of technology-based behavioral HIV prevention, as well as improve public health by establishing the efficacy of an innovative electronic health (eHealth) prevention program for ethnically and racially diverse YMSM. The intervention is initiated upon receipt of a negative HIV test result, based on the theory that testing negative is a teachable moment for future prevention behaviors. This is a two-group, active-control RCT of the online KIU! intervention. The intervention condition includes modules that use videos, animation, games, and interactive exercises to address HIV knowledge, motivation for safer behaviors, self-efficacy, and behavioral skills. The control condition reflects HIV information that is readily available on many websites, with the aim to understand how the KIU! intervention improves upon information that is currently available online. Follow-up assessments are administered at 3, 6, and 12 months for each arm. Testing for urethral and rectal sexually transmitted infections (STIs) is completed at baseline and at 12-month follow-up for all participants, and at 3- and 6-month follow-ups for participants who test positive at baseline. The primary behavioral outcome is unprotected anal sex at all follow-up points, and the primary biomedical outcome is incident STIs at 12-month follow-up. Consistent with study aims, the KIU! technology has been successfully integrated into a widely-used health technology platform. Baseline enrollment for the RCT was completed on December 30, 2015 (N=901), and assessment of intervention

  4. Evaluation of a school-based HIV/AIDS peer-led prevention programme: the first intervention trial for children of migrant workers in China.

    PubMed

    Li, S; Huang, H; Cai, Y; Ye, X; Shen, X; Shi, R; Xu, G

    2010-02-01

    The effectiveness of a peer-led education intervention in HIV/AIDS prevention was assessed in the Chinese children of migrant workers. A prospective study was conducted in 12 junior high schools for migrant children. Among the intervention group, a peer-education-based HIV/AIDS prevention was implemented for three months. The results during the baseline survey indicated that the level of knowledge on HIV/AIDS was lower in children of migrant workers. After three months of peer-led intervention, compared with the control group, students in the intervention group positively increased their HIV/AIDS-related knowledge, modified their attitude and improved their protection self-efficacy. Compared with attitude, intervention was more effective in the improvement of knowledge and protection self-efficacy, especially knowledge. The findings suggest that peer-led education was an effective method in improving knowledge, attitude and protection self-efficacy in Chinese children of migrant workers. Heightened concerns targeting the group students were particularly necessary, given their lower level of related knowledge and vulnerability to HIV infection.

  5. Trauma-Informed HIV Prevention and Treatment.

    PubMed

    Sales, Jessica M; Swartzendruber, Andrea; Phillips, Ashley L

    2016-12-01

    The high prevalence of trauma and its negative impact on health and health-promoting behaviors underscore the need for multi-level interventions to address trauma and its associated sequelae to improve physical and mental well-being in both HIV-infected and HIV-uninfected populations. Growing global awareness of the intersection of trauma and HIV has resulted in development and testing of interventions to address trauma in the context of HIV treatment and HIV prevention in the USA and globally. Despite increasing recognition of the widespread nature of trauma and the importance of trauma to HIV transmission around the globe, several gaps remain. Through a survey of the literature, we identified eight studies (published in the past 5 years) describing interventions to address the effects of trauma on HIV-related outcomes. In particular, this study focused on the levels of intervention, populations the interventions were designed to benefit, and types of trauma addressed in the interventions in the context of both HIV prevention and treatment. Remarkably absent from the HIV prevention, interventions reviewed were interventions designed to address violence experienced by men or transgender individuals, in the USA or globally. Given the pervasive nature of trauma experienced generally, but especially among individuals at heightened risk for HIV, future HIV prevention interventions universally should consider becoming trauma-informed. Widespread acknowledgement of the pervasive impact of gender-based violence on HIV outcomes among women has led to multiple calls for trauma-informed care (TIC) approaches to improve the effectiveness of HIV services for HIV-infected women. TIC approaches may be relevant for and should also be tested among men and all groups with high co-occurring epidemics of HIV and trauma (e.g., men who have sex with men (MSM), transgendered populations, injection drug users, sex workers), regardless of type of trauma experience.

  6. 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…

  7. 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…

  8. 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

  9. STD patients’ preferences for HIV prevention strategies

    PubMed Central

    Castro, Jose G; Jones, Deborah L; Weiss, Stephen M

    2014-01-01

    The objective of this pilot study was to explore the knowledge of and preferences regarding effective biomedical interventions among high risk individuals attending a sexually transmitted diseases clinic, and to examine the effect of a brief information intervention on preference. Participants completed a baseline assessment, attended a presentation on human immunodeficiency virus (HIV) prevention methods, and completed a postintervention assessment. Outcome measures included: demographics and sexual risk factors, self-perceived HIV risk, and knowledge and attitudes regarding new biomedical methods of HIV prevention. After the baseline evaluation, participants were provided with information on new biomedical prevention strategies. Participants were given the option to review the information by reading a pamphlet or by viewing a brief video containing the same information. Participants (n=97) were female (n=51) and male (n=46). At baseline, only a small minority of participants were aware of the newer biomedical strategies to prevent HIV infection. Postintervention, 40% endorsed having heard about the use of HIV medications to prevent HIV infection; 72% had heard that male circumcision can decrease the risk of acquiring HIV infection in men; and 73% endorsed knowledge of the potential role of microbicides in decreasing the risk of acquiring HIV. Following the intervention, the most preferred prevention method was male condoms, followed by preexposure prophylaxis, and microbicides. The least preferred methods were male circumcision and female condoms. This study provides preliminary information on knowledge and attitudes regarding newer biomedical interventions to protect against HIV infection. PMID:25540597

  10. [Discussion of HIV control and prevention strategies].

    PubMed

    Lyu, P

    2016-10-06

    Expansion of HIV testing and ART treatment are core strategies for achieving the ambitious global goal of ending the HIV epidemic by the end of 2030, and achieving the "90-90-90" target by 2020. In China, great progress in HIV control and prevention has been made; however, there is room to enhance the effectiveness of HIV-related strategies. In addition, some implemented strategies have not achieved their expected output. To confront the challenge of sexual transmission of HIV, which is the main route of transmission in China, more targeted HIV prevention strategies that lead to their expected outcomes are essential. It is important to strengthen existing strategies that have been proved effective. However, it is also critical to create innovative strategies, and there are five approaches to achieve this. First, a holistic perspective should be adopted, to better understand the current situation and problems. This means intervention strategies should give serious consideration of how to meet the sociocultural needs of target populations rather than merely carry out behavioral interventions. Second, community-based HIV prevention settings should have more important roles in providing HIV-related health care services. Moreover, to improve the effectiveness of these strategies, a problem-led working style should be integrated into HIV prevention measures overall. Third, thoroughly analyzing characteristics of the current HIV epidemic using more evidence-based considerations must be undertaken, to better control HIV sexual transmission. Fourth, continued improvement of AIDS prevention and control mechanisms is needed, to ensure their sustainable development. Last, it is necessary to involve more NGOs in HIV prevention work by strengthening their management and working capacities to provide HIV-related services. Also needed is further improvement in both technical and management capacities, so as to build a stable basis for effective response.

  11. 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.

  12. Cancer Prevention in HIV-Infected Populations

    PubMed Central

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

    2016-01-01

    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

  13. Couple-based HIV prevention for low-income drug users from New York City: a randomized controlled trial to reduce dual risks.

    PubMed

    El-Bassel, Nabila; Gilbert, Louisa; Wu, Elwin; Witte, Susan S; Chang, Mingway; Hill, Jennifer; Remien, Robert H

    2011-10-01

    Dual threats of injection drug use and risky sexual practices continue to increase transmission of HIV and other sexually transmitted Infections (STIs) among drug-using couples in low-income communities in the United States. Two hypotheses were tested: (1) "intervention effect"-whether the HIV risk-reduction intervention provided to the couple or individual partners would be more efficacious in decreasing number of unprotected sexual acts and having a lower cumulative incidence of biologically confirmed STIs over the 12-month follow-up period compared with the attention control condition; and (2) "modality effect"-whether the HIV risk-reduction intervention would be more likely to decrease the number of unprotected sexual acts and have a lower cumulative STI incidence when delivered to a couple compared with the same intervention delivered to an individual. Using a randomized controlled trial, 282 HIV-negative drug-using couples (564 individuals) were randomly assigned to receive either of the following: (1) couple-based risk reduction; (2) individual-based HIV risk reduction, or (3) couple-based wellness promotion, which served as an attention control condition. Over 12-month follow-up, there was a 30% reduction in the incidence rate of unprotected acts of intercourse with the study partners compared with participants in the attention control arm. Moreover, over 12-month follow-up there was a 29% reduction in the same outcome in the couple arm compared with the individual arm with a 41% reduction at the 12-month follow-up. A couple-based approach that addresses drug and sexual risks and targets low-income active drug users may help curb the HIV epidemic.

  14. 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…

  15. Prevention interventions with persons living with HIV/AIDS: state of the science and future directions.

    PubMed

    Gordon, Christopher M; Forsyth, Andrew D; Stall, Ron; Cheever, Laura W

    2005-02-01

    The National Institutes of Health (NIH/NIMH), the Centers for Disease Control and Prevention (CDC), and the HIV/AIDS Bureau of the Health Resources and Services Administration (HRSA) support the CDC's Serostatus Approach to Fighting the HIV Epidemic (SAFE; Janssen et al., 2001). One aim of the strategy is to help individuals living with HIV (and their partners) adopt and sustain HIV and STD risk reduction, treatment adherence, and effective strategies for coping with HIV/AIDS. Efficacious interventions are needed by community organizations and clinics that provide evidence-based services. To expedite translation from research to practice, we convened scientist-practitioners, HIV treatment and prevention providers, and community/consumer members. In this article, we include an overview of prevention trials with HIV-positive persons presented at the meeting, discuss strengths and limitations, recommendations for future research, and discuss sponsoring agencies' plans for advancing prevention tailored for persons living with HIV.

  16. A Peer-Educator Network HIV Prevention Intervention Among Injection Drug Users: Results of a Randomized Controlled Trial in St. Petersburg, Russia

    PubMed Central

    Latkin, Carl A.; Kukhareva, Polina V.; Malov, Sergey V.; Batluk, Julia V.; Shaboltas, Alla V.; Skochilov, Roman V.; Sokolov, Nicolay V.; Verevochkin, Sergei V.; Hudgens, Michael G.; Kozlov, Andrei P.

    2014-01-01

    We evaluated the efficacy of a peer-educator network intervention as a strategy to reduce HIV acquisition among injection drug users (IDUs) and their drug and/or sexual networks. A randomized controlled trial was conducted in St. Petersburg, Russia among IDU index participants and their risk network participants. Network units were randomized to the control or experimental intervention. Only the experimental index participants received training sessions to communicate risk reduction techniques to their network members. Analysis includes 76 index and 84 network participants who were HIV uninfected. The main outcome measure was HIV sero-conversion. The incidence rates in the control and experimental groups were 19.57 (95 % CI 10.74–35.65) and 7.76 (95 % CI 3.51–17.19) cases per 100 p/y, respectively. The IRR was 0.41 (95 % CI 0.15–1.08) without a statistically significant difference between the two groups (log rank test statistic X2 = 2.73, permutation p value = 0.16). Retention rate was 67 % with a third of the loss due to incarceration or death. The results show a promising trend that this strategy would be successful in reducing the acquisition of HIV among IDUs. PMID:23881187

  17. 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…

  18. 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…

  19. HIV-1 vaccines and adaptive trial designs.

    PubMed

    Corey, Lawrence; Nabel, Gary J; Dieffenbach, Carl; Gilbert, Peter; Haynes, Barton F; Johnston, Margaret; Kublin, James; Lane, H Clifford; Pantaleo, Giuseppe; Picker, Louis J; Fauci, Anthony S

    2011-04-20

    Developing a vaccine against the human immunodeficiency virus (HIV) poses an exceptional challenge. There are no documented cases of immune-mediated clearance of HIV from an infected individual, and no known correlates of immune protection. Although nonhuman primate models of lentivirus infection have provided valuable data about HIV pathogenesis, such models do not predict HIV vaccine efficacy in humans. The combined lack of a predictive animal model and undefined biomarkers of immune protection against HIV necessitate that vaccines to this pathogen be tested directly in clinical trials. Adaptive clinical trial designs can accelerate vaccine development by rapidly screening out poor vaccines while extending the evaluation of efficacious ones, improving the characterization of promising vaccine candidates and the identification of correlates of immune protection.

  20. 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.

  1. 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

  2. Spousal communication about HIV prevention in Kenya.

    PubMed

    Chiao, Chi; Mishra, Vinod; Ksobiech, Kate

    2011-11-01

    High HIV rates among cohabiting couples in many African countries have led to greater programmatic emphasis on spousal communication in HIV prevention. This study examines how demographic and socioeconomic characteristics of cohabiting adults influence their dyadic communication about HIV. A central focus of this research is on how the position of women relative to their male partners influences spousal communication about HIV prevention. The authors analyze gaps in spousal age and education and females' participation in household decision making as key factors influencing spousal communication about HIV, while controlling for sexual behaviors of both partners as well as other individual and contextual factors. Data were obtained from the 2003 Kenya Demographic and Health Survey for 1,388 cohabiting couples. Information regarding spousal communication was self-reported, assessing whether both, either, or neither partner ever discussed HIV prevention with the other. Analyses showed higher levels of education for the female partner and participation in household decision making are positively associated with spousal communication about HIV prevention. With females' education and other factors controlled, couples with more educated male partners were more likely to have discussed HIV prevention than couples in which both partners have the same level of education. Spousal communication was also positively associated with household wealth status and exposure to the mass media, but couples in which male partners reported having nonspousal sex in the past year were less likely to have discussed HIV prevention with their spouses. Findings suggest HIV prevention programs should promote female empowerment and encourage male participation in sexual health discussion.

  3. Antibody-Based Preventive and Therapeutic Strategies Against HIV.

    PubMed

    Fabra-Garcia, Amanda; Beltran, Carolina; Sanchez-Merino, Victor; Yuste, Eloisa

    2016-01-01

    Over the years, numerous studies have been carried out demonstrating the role of antibodies in HIV control leading to the development of antibody-based therapeutic and prophylactic strategies. The objective of this review is to provide updated information on the role of antibodies in the prevention and control of HIV infection and the strategies against HIV that have been designed based on this information. Passive transfer of anti-HIV antibodies in animal models has proven the efficacy of certain antibodies in the prevention and treatment of infection. The capacity of antibodies to control the virus was first attributed to their neutralizing capacity. However, we now know that there are other Fc-mediated antibody activities associated with virus protection. When it comes to better understanding protection against HIV, we ought to pay particular attention to mucosal immune responses. The evidence accumulated so far indicates that an effective vaccine against HIV should generate both mucosal IgAs and systemic IgGs. Due to the problematic induction of protective anti-HIV antibodies, several groups have developed alternative approaches based on antibody delivery via gene therapy vectors. Experiments in animal models with these vectors have shown impressive protection levels and this strategy is now being clinically trialed. Taking into account all the information included in this review, it seems evident that anti-HIV-1 antibodies play an important role in virus control and prevention. This review aims to give an overview of the strategies used and the advances in antibody-based preventive and therapeutic strategies against HIV-1.

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

    PubMed

    Short, R V

    2006-05-29

    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 Dollars 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.

  5. 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

  6. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial

    PubMed Central

    2012-01-01

    Background Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact of different intervention models. This protocol describes the SASA! Study: an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. Methods/Design The SASA! Study is a pair-matched cluster randomised controlled trial being conducted in eight communities in Kampala. It is designed to assess the community-level impact of the SASA! intervention on the following six primary outcomes: attitudes towards the acceptability of violence against women and the acceptability of a woman refusing sex (among male and female community members); past year experience of physical intimate partner violence and sexual intimate partner violence (among females); community responses to women experiencing violence (among women reporting past year physical/sexual partner violence); and past year concurrency of sexual partners (among males). 1583 women and men (aged 18–49 years) were surveyed in intervention and control communities prior to intervention implementation in 2007/8. A follow-up cross-sectional survey of community members will take place in 2012. The primary analysis will be an adjusted cluster-level intention to treat analysis, comparing outcomes in intervention and control communities at follow-up. Complementary monitoring and evaluation and qualitative research will be used to explore and describe the process of intervention implementation and the pathways through which change is achieved. Discussion This is one of few

  7. Novel directions in HIV-1 vaccines revealed from clinical trials

    PubMed Central

    Excler, Jean-Louis; Tomaras, Georgia D.; Russell, Nina D.

    2017-01-01

    Purpose of review Considerable HIV-1 vaccine development efforts have been deployed over the past decade. Put into perspective, the results from efficacy trials and the identification of correlates of risk have opened large and unforeseen avenues for vaccine development. Recent findings The Thai efficacy trial, RV144, provided the first evidence that HIV-1 vaccine protection against HIV-1 acquisition could be achieved. The correlate of risk analysis showed that IgG antibodies against the gp120 V2 loop inversely correlated with decreased risk of infection, while Env-specific IgA directly correlated with risk. Further clinical trials will focus on testing new envelope subunit proteins formulated with adjuvants capable of inducing higher and more durable functional antibody responses (both binding and broadly neutralizing antibodies). Moreover, vector-based vaccine regimens that can induce cell-mediated immune responses in addition to humoral responses remain a priority. Summary Future efficacy trials will focus on prevention of HIV-1 transmission in heterosexual population in Africa and men who have sex with men in Asia. The recent successes leading to novel directions in HIV-1 vaccine development are a result of collaboration and commitment among vaccine manufacturers, funders, scientists and civil society stakeholders. Sustained and broad collaborative efforts are required to advance new vaccine strategies for higher levels of efficacy. PMID:23743791

  8. Couple-oriented prenatal HIV counseling for HIV primary prevention: an acceptability study

    PubMed Central

    2010-01-01

    Background A large proportion of the 2.5 million new adult HIV infections that occurred worldwide in 2007 were in stable couples. Feasible and acceptable strategies to improve HIV prevention in a conjugal context are scarce. In the preparatory phase of the ANRS 12127 Prenahtest multi-site HIV prevention trial, we assessed the acceptability of couple-oriented post-test HIV counseling (COC) and men's involvement within prenatal care services, among pregnant women, male partners and health care workers in Cameroon, Dominican Republic, Georgia and India. Methods Quantitative and qualitative research methods were used: direct observations of health services; in-depth interviews with women, men and health care workers; monitoring of the COC intervention and exit interviews with COC participants. Results In-depth interviews conducted with 92 key informants across the four sites indicated that men rarely participated in antenatal care (ANC) services, mainly because these are traditionally and programmatically a woman's domain. However men's involvement was reported to be acceptable and needed in order to improve ANC and HIV prevention services. COC was considered by the respondents to be a feasible and acceptable strategy to actively encourage men to participate in prenatal HIV counseling and testing and overall in reproductive health services. Conclusions One of the keys to men's involvement within prenatal HIV counseling and testing is the better understanding of couple relationships, attitudes and communication patterns between men and women, in terms of HIV and sexual and reproductive health; this conjugal context should be taken into account in the provision of quality prenatal HIV counseling, which aims at integrated PMTCT and primary prevention of HIV. PMID:20403152

  9. Preventing HIV/AIDS in Adolescents.

    ERIC Educational Resources Information Center

    Journal of School Health, 1994

    1994-01-01

    Examines issues in preventing further Human Immunodeficiency Virus (HIV) infection among adolescents, highlighting HIV and other sexually transmitted diseases, substance use, adolescent development, cultural and language diversity, health and social service needs, socioeconomic contexts, and role of media, school, and youth-serving organizations.…

  10. Renewing HIV Prevention Efforts among Youth.

    ERIC Educational Resources Information Center

    Demmer, Craig

    2002-01-01

    Highlights the need to reinvigorate HIV prevention programs among youth, describing an emerging challenge for health practitioners--the belief that safer sex is no longer as important because of advances in treatment for HIV. Suggestions are offered to strengthen programs for youth in the third decade of AIDS (e.g., improve training of HIV…

  11. 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

  12. Strategies for Preventing Mucosal Cell-Associated HIV Transmission

    PubMed Central

    Whaley, Kevin J.; Mayer, Kenneth H.

    2014-01-01

    Human immunodeficiency virus (HIV) may be transmitted through either cell-free virions or leukocytes harboring intracellular HIV in bodily fluids. In recent years, the early initiation of combination antiretroviral therapy leading to virological suppression has resulted in decreased HIV transmission to uninfected partners. Additionally, the efficacy of primary chemoprophylaxis with oral or topical antiretroviral regimens containing tenofovir (with or without emtricitabine) has been demonstrated. However, the efficacy of these approaches may be compromised by suboptimal adherence, decreased drug concentrations in mucosal compartments in women, and genital inflammation. Furthermore, in vitro studies on the effects of tenofovir on cell-associated HIV transmission have produced conflicting results. Preclinical studies suggest that combination preventive approaches may be most effective in stopping the transmission of HIV after mucosal exposure. Since the development of antibodies were found to correlate with protection in the only effective HIV vaccine trial, the administration of preformed mucosal and systemic antibodies may inform the development of safe and effective antibody-based oral, topical, and/or systemic preexposure prophylaxis agents and provide guidance in the development of HIV vaccines that effectively block cell-associated HIV transmission. PMID:25414423

  13. 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

  14. Failure to Identify HIV-Infected Individuals in a Clinical Trial Using a Single HIV Rapid Test for Screening

    PubMed Central

    Piwowar-Manning, Estelle; Fogel, Jessica M.; Laeyendecker, Oliver; Wolf, Shauna; Cummings, Vanessa; Marzinke, Mark A.; Clarke, William; Breaud, Autumn; Wendel, Sarah; Wang, Lei; Swanson, Priscilla; Hackett, John; Mannheimer, Sharon; del Rio, Carlos; Kuo, Irene; Harawa, Nina T.; Koblin, Beryl A.; Moore, Richard; Blankson, Joel N.; Eshleman, Susan H.

    2014-01-01

    Background In the HIV Prevention Trials Network (HPTN) 061 study, 8 (2.3%) of 348 HIV-infected participants identified as HIV uninfected at study enrollment using a single HIV rapid test for screening were found to be HIV infected after additional testing. Objectives To evaluate the performance of different HIV assays for detection of HIV infection in HPTN 061 participants with missed infection and individuals with viral suppression. Methods Plasma samples from 8 HPTN 061 participants, 17 elite controllers, and 101 individuals on antiretroviral treatment (ART) were tested for HIV with 3 rapid tests, 2 laboratory-based immunoassays, and a Western blot assay. The HPTN 061 samples were also tested with 2 HIV RNA assays and an antiretroviral drug assay. Results Of the 8 HPTN 061 participants with missed infection, 1 was an elite controller, 1 was taking ART, 2 were missed because of testing or clerical errors, 1 had recent HIV infection (identified using a multi-assay algorithm), and 3 had acute HIV infection. Two (1.7%) of 118 individuals with viral suppression (both taking ART) had at least 1 false-negative test. Conclusions In clinical trials, HIV infections can be missed for a variety of reasons. Using more than one assay to screen for HIV infection may reduce the number of missed infections. PMID:24710920

  15. Failure to identify HIV-infected individuals in a clinical trial using a single HIV rapid test for screening.

    PubMed

    Piwowar-Manning, Estelle; Fogel, Jessica M; Laeyendecker, Oliver; Wolf, Shauna; Cummings, Vanessa; Marzinke, Mark A; Clarke, William; Breaud, Autumn; Wendel, Sarah; Wang, Lei; Swanson, Priscilla; Hackett, John; Mannheimer, Sharon; Del Rio, Carlos; Kuo, Irene; Harawa, Nina T; Koblin, Beryl A; Moore, Richard; Blankson, Joel N; Eshleman, Susan H

    2014-01-01

    In the HIV Prevention Trials Network (HPTN) 061 study, 8 (2.3%) of 348 HIV-infected participants identified as HIV uninfected at study enrollment using a single HIV rapid test for screening were found to be HIV infected after additional testing. To evaluate the performance of different HIV assays for detection of HIV infection in HPTN 061 participants with missed infection and individuals with viral suppression. Plasma samples from 8 HPTN 061 participants, 17 elite controllers, and 101 individuals on antiretroviral treatment (ART) were tested for HIV with 3 rapid tests, 2 laboratory-based immunoassays, and a Western blot assay. The HPTN 061 samples were also tested with 2 HIV RNA assays and an antiretroviral drug assay. Of the 8 HPTN 061 participants with missed infection, 1 was an elite controller, 1 was taking ART, 2 were missed because of testing or clerical errors, 1 had recent HIV infection (identified using a multi-assay algorithm), and 3 had acute HIV infection. Two (1.7%) of 118 individuals with viral suppression (both taking ART) had at least 1 false-negative test. In clinical trials, HIV infections can be missed for a variety of reasons. Using more than one assay to screen for HIV infection may reduce the number of missed infections.

  16. A Role for Depression in Sexual Risk Reduction for Women? A Meta-Analysis of HIV Prevention Trials with Depression Outcomes

    PubMed Central

    Lennon, Carter A.; Huedo-Medina, Tania B.; Gerwien, Daniel P.; Johnson, Blair T.

    2012-01-01

    Rates of HIV/AIDS and depression in women are significant public health concerns. The current meta-analysis tested the hypothesis that depression levels moderate change in sexual risk behavior in women participating in HIV prevention interventions. Features of the interventions were also explored as possible factors in decreasing levels of depression and sexual risk behavior. Included were HIV primary prevention interventions that measured sexual risk behavior and depression at baseline and follow-up and reported separate results for women. Ten studies (fourteen intervention groups) met the inclusion criteria. The majority of participants (N = 4,195 women) were African American; mean age was 28-years old. Both depression and sexual risk behavior decreased significantly in treatment and control groups from baseline to follow-up. Sexual risk decreased more to the extent that interventions sampled (a) participants with higher baseline levels of depression, (b) older women, (c) Hispanics/Latinas, and (d) members of risk groups (e.g., drug users, homeless). Interventions that included (e) condom provision, (f) information about condoms, and (g) HIV counseling and testing were also more successful in decreasing sexual risk. Finally (h), interventions were more likely to reduce sexual risk behavior when they decreased depression to a large extent relative to baseline levels. Interventions were more likely to decrease depression when they (a) had samples of only women; (b) targeted risk groups; and (c) provided self-management and coping skills. Reducing depression appears to play a role in decreasing sexual risk behavior, suggesting that interventions should actively address depression. PMID:22444458

  17. 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

  18. 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

  19. 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

  20. 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.

  1. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women.

    PubMed

    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

    2012-08-02

    Antiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations. We conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1-seronegative partner in each couple was randomly assigned to one of three study regimens--once-daily tenofovir (TDF), combination tenofovir-emtricitabine (TDF-FTC), or matching placebo--and followed monthly for up to 36 months. At enrollment, the HIV-1-seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services. We enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned to TDF, 1579 to TDF-FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1-seronegative partner was male. Among HIV-1-seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF-FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P<0.001) and of 75% with TDF-FTC (95% CI, 55 to 87; P<0.001). Protective effects of TDF-FTC and TDF alone against HIV-1 were not significantly different (P=0.23), and both study medications significantly reduced the HIV-1 incidence among both men and women. The rate of serious adverse events was similar across the study groups. Eight participants receiving active treatment were found to have been infected with HIV-1 at baseline, and among these eight, antiretroviral resistance developed in two during the

  2. A church-based intervention for families to promote mental health and prevent HIV among adolescents in rural Kenya: Results of a randomized trial.

    PubMed

    Puffer, Eve S; Green, Eric P; Sikkema, Kathleen J; Broverman, Sherryl A; Ogwang-Odhiambo, Rose A; Pian, Jessica

    2016-06-01

    To evaluate a family- and church-based intervention for adolescents and caregivers in rural Kenya to improve family relationships, reduce HIV risk, and promote mental health. The intervention was developed using community-based participatory methods and focused on strengthening family communication. Modules addressed economic, relationship, and HIV-related topics using evidence-based behavioral strategies alongside culturally grounded content. A stepped wedge cluster randomized trial was conducted with 124 families (237 adolescents ages 10 to 16; 203 caregivers) from 4 churches. Participants completed interviewer-administered surveys over 5 rounds. Primary outcomes included family communication, HIV risk knowledge, self-efficacy, and beliefs. Secondary outcomes included parenting, social support, mental health, and adolescent sexual behavior. We estimated intent-to-treat effects via ordinary least squares regression with clustered standard errors. Relative to controls, the intervention group reported better family communication across domains at 1- and 3-months postintervention and higher self-efficacy for risk reduction skills and HIV-related knowledge at 1-month postintervention. Sexually active youth in the intervention reported fewer high-risk behaviors at 1-month postintervention, including unprotected sex or multiple partners. Male caregivers in the intervention reported higher parental involvement at both time points, and youth reported more social support from male caregivers at 3-months postintervention. No effects on secondary outcomes of parenting, social support, and mental health were detected. This intervention holds promise for strengthening positive family processes to protect against negative future outcomes for adolescents. Implementation with religious congregations may be a promising strategy for improving sustainability and scalability of interventions in low-resource settings. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  3. Correlates of HIV vaccine trial participation: an Indian perspective.

    PubMed

    Sahay, Seema; Mehendale, Sanjay; Sane, Suvarna; Brahme, Radhika; Brown, Amishah; Charron, Karen; Beyrer, Chris; Bollinger, Robert; Paranjape, Ramesh

    2005-02-03

    Successful conduct of HIV vaccine trials in a population of great cultural diversity like India could be a challenge. Concerns, knowledge gaps and willingness to participate in future HIV vaccine trials were studied among 349 patients attending three sexually transmitted infections clinics and one reproductive tract infections clinic. Overall willingness to volunteer for HIV vaccine trials was 48%. Women and men at risk of HIV infection were willing to participate in the HIV vaccine trials. Factors associated with increased willingness to participate in these trials were awareness of current HIV vaccine efforts, realization of importance of vaccine for self, concern about adverse events and altruism.

  4. A Review of HIV Prevention Interventions for Juvenile Offenders

    PubMed Central

    Stewart, Angela; Fasciano, John; Brown, Larry K.

    2010-01-01

    Objective To conduct a critical review of all HIV prevention intervention studies conducted with adolescents in juvenile justice settings to inform future intervention development. Method PubMed and PsycInfo database searches were conducted for peer-reviewed, published HIV prevention intervention studies with juvenile offenders. Results Sixteen studies were identified (N = 3,700 adolescents). Half of the projects utilized rigorous methodologies to determine intervention effect on behavior change, such as conducting a randomized controlled trial (n = 8). Nine studies reported behaviors at least 3 months post-intervention and five out of nine showed decreases in sexual risk behavior. Conclusions Several HIV prevention programs with juvenile offenders have led to sexual risk reduction, although effect sizes are modest. Most existing programs have neglected to address the impact of family, mental health, and substance use on HIV risk. More work is needed to develop evidence-based interventions that include HIV prevention strategies relevant and appropriate for the juvenile justice setting. PMID:19741021

  5. 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

    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. 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. 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. The early initiation of ART led to a sustained decrease in genetically linked HIV-1

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

    PubMed Central

    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.

    2016-01-01

    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

  7. Prevention of diarrhoea in children with HIV infection or exposure to maternal HIV infection.

    PubMed

    Humphreys, Eliza H; Smith, Nathan A; Azman, Hana; McLeod, Deanna; Rutherford, George W

    2010-06-16

    Diarrhoea is a major cause of morbidity and mortality among infants and children worldwide, especially in low- and middle-income countries. Human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) is a condition that similarly disproportionately affects low- and middle-income countries; of the nearly 2.1 million children under age 15 years living with HIV/AIDS, the large majority reside in sub-Saharan Africa. Infants and children with HIV infection have more frequent and more severe diarrhoea than children without HIV. Interventions including vitamin A, zinc and cotrimoxazole may contribute substantially to preventing diarrhoea in children with HIV infection or exposure to HIV. We perform a systematic review of randomised controlled trials and nonrandomised studies that examine the effectiveness of vitamin A, zinc and cotrimoxazole on mortality and morbidity from diarrhoea in HIV-infected and -exposed infants and children. Electronic databases including Pubmed, Central and EMBASE were searched without limits to language from 1980 to April 2010. Conference database searches were performed, experts were contacted and bibliographies were handsearched. Randomised controlled trials (RCTs) and nonrandomised studies (NRSs) that examined the effectiveness of the three interventions were included. Two reviewers independently assessed citations for eligibility and double-extracted included studies. Assessment of bias of individual studies was performed independently by both reviewers. Only two summary estimates were performed due to heterogeneity in study design and interventions. Four RCTs were identified for vitamin A. One RCT was identified for zinc. One RCT and two NRSs were identified for cotrimoxazole. Vitamin A reduced mortality overall in children with HIV infection (four studies). A pooled estimate of three studies for reduction in mortality from vitamin A compared to placebo had a relative risk (DerSimonian and Laird method, random effects) of 0

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

    PubMed

    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

    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. 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. 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. 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. ClinicalTrials.gov NCT02337179.

  9. The ENRICH Study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: rationale and design of a mixed methods cluster randomized trial.

    PubMed

    Howard, Andrea A; Hirsch-Moverman, Yael; Saito, Suzue; Gadisa, Tsigereda; Daftary, Amrita; Melaku, Zenebe

    2017-06-01

    Isoniazid preventive therapy (IPT) prevents tuberculosis among HIV-positive individuals, however implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. The ENRICH Study is a mixed methods cluster randomized trial aimed at evaluating the effectiveness and acceptability of a combination intervention package (CIP) to improve IPT implementation in Ethiopia. Ten health centers were randomized to receive the CIP or standard of care. The CIP includes: nurse training and mentorship using a clinical algorithm, tool to identify IPT-eligible family members, and data review at multidisciplinary team meetings; patient transport reimbursement; and adherence support using peer educators and interactive voice response messages. Routine data were abstracted for all newly-enrolled IPT-eligible HIV-positive patients; anticipated sample size was 1400 individuals. A measurement cohort of patients initiating IPT was recruited; target enrollment was 500 individuals, to be followed for the duration of IPT (6-9 months). Inclusion criteria were: HIV-positive; initiated IPT; age ≥18; Amharic-, Oromiffa-, Harari-, or Somali-speaking; and capable of informed consent. Three groups were recruited from CIP health centers for in-depth interviews: IPT initiators; IPT non-initiators; and health care providers. Primary outcomes are: IPT initiation; and IPT completion. Secondary outcomes include: retention; adherence; change in CD4+ count; adverse events; and acceptability. Follow-up is complete. The ENRICH Study evaluates a CIP targeting barriers to IPT implementation. If the CIP is found effective and acceptable, this study has the potential to inform TB prevention strategies for HIV patients in resource-limited countries in sub-Saharan Africa.

  10. A Perspective on Progress and Gaps in HIV Prevention Science

    PubMed Central

    Mesquita, Pedro M.M.; Herold, Betsy C.

    2012-01-01

    Abstract 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

  11. Development and Open Pilot Trial of an HIV-Prevention Intervention Integrating Mobile-Phone Technology for Male Sex Workers in Chennai, India.

    PubMed

    Thomas, Beena; Closson, Elizabeth F; Biello, Katie; Menon, Sunil; Navakodi, Pandiaraja; Dhanalakshmi, A; Mayer, Kenneth H; Safren, Steven A; Mimiaga, Matthew J

    2015-12-29

    In India men who have sex with men and engage in sex work (i.e., male sex workers; MSW) have a high risk of transmitting HIV. Globally, sex workers have become more spatially mobile due to advances in mobile-phone technology. In 2012 in-depth qualitative feedback was garnered from 40 interviews with MSW and four focus groups with 35 key informants (KIs) who had expert knowledge of the local MSW community to inform the design of an HIV-prevention intervention among MSW in Chennai, India. All MSW were recruited during outreach by employees of a Chennai-based organization for MSM (men who have sex with men). The data were analyzed using a descriptive qualitative approach. MSW and KIs discussed the need for intervention content that went beyond basic HIV psychoeducation. They emphasized the importance of addressing psychological distress, alcohol-related risk, and sexual communication skills. Concerns were raised about confidentiality, privacy, and scheduling. Participants endorsed a combination of in-person and mobile-phone-delivered sessions as well as the integration of mobile-phone messaging. These findings served as the basis for the development of a theoretically driven, manual-based intervention incorporating mobile phones. An open pilot assessed the feasibility and acceptability of the intervention with eight MSW. Assessments and HIV testing were administered at baseline, 3, and 6 months post-baseline. Exit interviews were conducted at the conclusion of the intervention. Retention for session attendance and assessment follow-up was 100 %. There was a high level of acceptability for the format, structure, and content. These data show initial promise, feasibility, and acceptability of the intervention.

  12. 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.

  13. Socially-integrated transdisciplinary HIV prevention.

    PubMed

    Friedman, Samuel R; Downing, Martin J; Smyrnov, Pavlo; Nikolopoulos, Georgios; Schneider, John A; Livak, Britt; Magiorkinis, Gkikas; Slobodianyk, Liudmyla; Vasylyeva, Tetyana I; Paraskevis, Dimitrios; Psichogiou, Mina; Sypsa, Vana; Malliori, Melpomeni M; Hatzakis, Angelos

    2014-10-01

    Current ideas about HIV prevention include a mixture of primarily biomedical interventions, socio-mechanical interventions such as sterile syringe and condom distribution, and behavioral interventions. This article presents a framework for socially-integrated transdisciplinary HIV prevention that may improve current prevention efforts. It first describes one socially-integrated transdisciplinary intervention project, the Transmission Reduction Intervention Project. We focus on how social aspects of the intervention integrate its component parts across disciplines and processes at different levels of analysis. We then present socially-integrated perspectives about how to improve combination antiretroviral treatment (cART) processes at the population level in order to solve the problems of the treatment cascade and make "treatment as prevention" more effective. Finally, we discuss some remaining problems and issues in such a social transdisciplinary intervention in the hope that other researchers and public health agents will develop additional socially-integrated interventions for HIV and other diseases.

  14. Faith and HIV prevention: the conceptual framing of HIV prevention among Pentecostal Batswana teenagers

    PubMed Central

    2014-01-01

    Background There is a huge interest by faith-based organizations (FBOs) in sub-Saharan Africa and elsewhere in HIV prevention interventions that build on the religious aspects of being. Successful partnerships between the public health services and FBOs will require a better understanding of the conceptual framing of HIV prevention by FBOS to access for prevention intervention, those concepts the churches of various denominations and their members would support or endorse. This study investigated the conceptual framing of HIV prevention among church youths in Botswana; - a country with one of the highest HIV prevalence in the world. Method Participants were 213 Pentecostal church members (67% female; age range 12 to 23 years; median age = 19 years). We engaged the participants in a mixed-method inductive process to collect data on their implicit framing of HIV prevention concepts, taking into account the centrality of religion concepts to them and the moderating influences of age, gender and sexual experience. After, we analysed the data using multi-dimensional scaling (MDS) and hierarchical cluster analysis (HCA) to map the ways the church youths framed HIV prevention. Results The findings suggest the church youth to conceptually frame their HIV prevention from both faith-oriented and secular-oriented perspectives, while prioritizing the faith-oriented concepts based on biblical teachings and future focus. In their secular-oriented framing of HIV prevention, the church youths endorsed the importance to learn the facts about HIV and AIDS, understanding of community norms that increased risk for HIV and prevention education. However, components of secular-oriented framing of HIV prevention concepts were comparatively less was well differentiated among the youths than with faith-oriented framing, suggesting latent influences of the church knowledge environment to undervalue secular oriented concepts. Older and sexually experienced church youths in their framing

  15. Effective HIV prevention: the indispensable role of social science

    PubMed Central

    Kippax, Susan

    2012-01-01

    This paper examines the ways in which HIV prevention is understood including “biomedical”, “behavioural”, “structural”, and “combination” prevention. In it I argue that effective prevention entails developing community capacity and requires that public health addresses people not only as individuals but also as connected members of groups, networks and collectives who interact (talk, negotiate, have sex, use drugs, etc.) together. I also examine the evaluation of prevention programmes or interventions and argue that the distinction between efficacy and effectiveness is often glossed and that, while efficacy can be evaluated by randomized controlled trials, the evaluation of effectiveness requires long-term descriptive strategies and/or modelling. Using examples from a number of countries, including a detailed account of the Australian HIV prevention response, effectiveness is shown to be dependent not only on the efficacy of the prevention technology or tool but also on the responses of people – individuals, communities and governments – to those technologies. Whether a particular HIV prevention technology is adopted and its use sustained depends on a range of social, cultural and political factors. The paper concludes by calling on biomedical and social scientists to work together and describes a “social public health”. PMID:22713254

  16. Effective HIV prevention: the indispensable role of social science.

    PubMed

    Kippax, Susan

    2012-04-26

    This paper examines the ways in which HIV prevention is understood including "biomedical", "behavioural", "structural", and "combination" prevention. In it I argue that effective prevention entails developing community capacity and requires that public health addresses people not only as individuals but also as connected members of groups, networks and collectives who interact (talk, negotiate, have sex, use drugs, etc.) together. I also examine the evaluation of prevention programmes or interventions and argue that the distinction between efficacy and effectiveness is often glossed and that, while efficacy can be evaluated by randomized controlled trials, the evaluation of effectiveness requires long-term descriptive strategies and/or modelling. Using examples from a number of countries, including a detailed account of the Australian HIV prevention response, effectiveness is shown to be dependent not only on the efficacy of the prevention technology or tool but also on the responses of people - individuals, communities and governments - to those technologies. Whether a particular HIV prevention technology is adopted and its use sustained depends on a range of social, cultural and political factors. The paper concludes by calling on biomedical and social scientists to work together and describes a "social public health".

  17. Randomized pilot trial of a cognitive-behavioral alcohol, self-harm, and HIV prevention program for teens in mental health treatment.

    PubMed

    Esposito-Smythers, Christianne; Hadley, Wendy; Curby, Timothy W; Brown, Larry K

    2017-02-01

    Adolescents with mental health conditions represent a high-risk group for substance use, deliberate self-harm (DSH), and risky sexual behavior. Mental health treatment does not uniformly decrease these risks. Effective prevention efforts are needed to offset the developmental trajectory from mental health problems to these behaviors. This study tested an adjunctive cognitive-behavioral family-based alcohol, DSH, and HIV prevention program (ASH-P) for adolescents in mental healthcare. A two group randomized design was used to compare ASH-P to an assessment only control (AO-C). Participants included 81 adolescents and a parent. Assessments were completed at pre-intervention as well as 1, 6, and 12-months post-enrollment, and included measures of family-based mechanisms and high-risk behaviors. ASH-P relative to AO-C was associated with greater improvements in most family process variables (perceptions of communication and parental disapproval of alcohol use and sexual behavior) as well as less DSH and greater refusal of sex to avoid a sexually transmitted infection. It also had a moderate (but non-significant) effect on odds of binge drinking. No differences were found in suicidal ideation, alcohol use, or sexual intercourse. ASH-P showed initial promise in preventing multiple high-risk behaviors. Further testing of prevention protocols that target multiple high-risk behaviors in clinical samples is warranted.

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

    PubMed Central

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

    2013-01-01

    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 3 conditions: Familias Unidas + PATH, English for Speakers of Other Languages (ESOL) + PATH, and ESOL + HeartPower! for Hispanics (HEART). Participants were assessed at baseline and at 6, 12, 24, and 36 months postbaseline. Results showed that (a) Familias Unidas + PATH was efficacious in preventing and reducing cigarette use relative to both control conditions; (b) Familias Unidas + PATH was efficacious, relative to ESOL + HEART, in reducing illicit drug use; and (c) Familias Unidas + PATH was efficacious, relative to ESOL + PATH, in reducing unsafe sexual behavior. The effects of Familias Unidas + PATH on these distal outcomes were partially mediated by improvements in family functioning. These findings suggest that strengthening the family system, rather than targeting specific health behaviors, may be most efficacious in preventing and/or reducing cigarette smoking, illicit drug use, and unsafe sex in Hispanic adolescents. PMID:18085908

  19. The Ethical Odyssey in Testing HIV Treatment as Prevention

    PubMed Central

    Cohen, Myron S.; McCauley, Marybeth; Sugarman, Jeremy

    2012-01-01

    Background Obtaining the definitive data necessary to determine the safety and efficacy of using antiretroviral treatment (ART) to reduce the sexual transmission of HIV in heterosexual couples encountered an array of ethical challenges that threatened to compromise HPTN 052, the multinational clinical trial addressing this issue that has profound public health implications. Purpose To describe and analyze the major ethical challenges faced in HPTN 052. Methods The ethical issues and modifications of HPTN 052 in response to these issues were catalogued by the principal investigator, the lead coordinator, and the ethicist working on the trial. The major ethical issues that were unique to the trial were then described and analyzed, referring as appropriate to published literature and emerging guidance and policies. Ethical challenges that must be addressed in many clinical trials, such as those related to obtaining informed consent and making provisions for ancillary care, are not described. Results When HPTN 052 was being designed, ethical questions emerged related to the relevance of the research question itself given data from observational research and a range of beliefs about the appropriate means of preventing and treating HIV-infection and AIDS. Further, ethical challenges were faced regarding site selection since there was a scientific need to conduct the research in settings where HIV incidence was high, but alternatives to study participation should be available. As in most HIV prevention research, ethical questions surrounded the determination of the appropriate prevention package for all of those enrolled. During the course of the trial, guidance documents and policies emerged that were of direct relevance to the research questions, calling for a balancing of concerns for the research subjects and trial integrity. When the study results were made public, there was a need to ensure access to the treatment shown to be effective that in some cases differed

  20. 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.

  1. HIV-1 Eradication: Early Trials (and Tribulations).

    PubMed

    Spivak, Adam M; Planelles, Vicente

    2016-01-01

    Antiretroviral therapy (ART) has rendered HIV-1 infection a manageable illness for those with access to treatment. However, ART does not lead to viral eradication owing to the persistence of replication-competent, unexpressed proviruses in long-lived cellular reservoirs. The potential for long-term drug toxicities and the lack of access to ART for most people living with HIV-1 infection have fueled scientific interest in understanding the nature of this latent reservoir. Exploration of HIV-1 persistence at the cellular and molecular level in resting memory CD4(+) T cells, the predominant viral reservoir in patients on ART, has uncovered potential strategies to reverse latency. We review recent advances in pharmacologically based 'shock and kill' HIV-1 eradication strategies, including comparative analysis of early clinical trials. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. 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. |

  3. Facilitators and Barriers to Participation in PrEP HIV Prevention Trials Involving Transgender Male and Female Adolescents and Emerging Adults.

    PubMed

    Fisher, Celia B; Fried, Adam L; Desmond, Margaret; Macapagal, Kathryn; Mustanski, Brian

    2017-06-01

    Despite the disproportionate burden of HIV facing transgender youth, they continue to be under-represented in studies to provide an empirical basis for pre-exposure prophylaxis (PrEP) programs that can meet the unique needs of this population. This study examined facilitators and barriers to participation in a PrEP adherence study, determined through an online survey administered to 90 transgender male and 60 transgender female 14-21-year-olds attracted to cisgender male sexual partners. Approximately 50% reported likely to participate in the PrEP study. Participation facilitators included prior sexual and health service experiences and study access to PrEP and health services. Participation barriers included lack of concern about HIV, potential medication side effects, the logistics of quarterly meetings, remembering to take PrEP daily, and reluctance to discuss gender identity with study staff. Results suggest that successful recruitment and retention of transgender youth in PrEP prevention studies warrant protocols designed to address these barriers.

  4. Socially-Integrated Transdisciplinary HIV Prevention

    PubMed Central

    Downing, Martin J.; Smyrnov, Pavlo; Nikolopoulos, Georgios; Schneider, John A.; Livak, Britt; Magiorkinis, Gkikas; Slobodianyk, Liudmyla; Vasylyeva, Tetyana I.; Paraskevis, Dimitrios; Psichogiou, Mina; Sypsa, Vana; Malliori, Melpomeni M.; Hatzakis, Angelos

    2013-01-01

    Current ideas about HIV prevention include a mixture of primarily biomedical interventions, sociomechanical interventions such as sterile syringe and condom distribution, and behavioral interventions. This article presents a framework for socially-integrated transdisciplinary HIV prevention that may improve current prevention efforts. It first describes one socially-integrated transdisciplinary intervention project, the Transmission Reduction Intervention Project. We focus on how social aspects of the intervention integrate its component parts across disciplines and processes at different levels of analysis. We then present socially-integrated perspectives about how to improve combination antiretroviral treatment (cART) processes at the population level in order to solve the problems of the treatment cascade and make “treatment as prevention” more effective. Finally, we discuss some remaining problems and issues in such a social transdisciplinary intervention in the hope that other researchers and public health agents will develop additional socially-integrated interventions for HIV and other diseases. PMID:24165983

  5. 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

  6. 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.

  7. 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

  8. Preexposure prophylaxis is efficacious for HIV-1 prevention among women using depot medroxyprogesterone acetate for contraception.

    PubMed

    Heffron, Renee; Mugo, Nelly; Were, Edwin; Kiarie, James; Bukusi, Elizabeth A; Mujugira, Andrew; Frenkel, Lisa M; Donnell, Deborah; Ronald, Allan; Celum, Connie; Baeten, Jared M

    2014-11-28

    To evaluate preexposure prophylaxis (PrEP) efficacy for HIV-1 prevention among women using depot medroxyprogesterone acetate (DMPA) for contraception and men whose HIV-1-infected partners use DMPA. Secondary analysis of data from a randomized placebo-controlled trial of daily oral tenofovir and emtricitabine/tenofovir PrEP among heterosexual Kenyan and Ugandan HIV-1 serodiscordant couples. PrEP efficacy for HIV-1 prevention was compared among HIV-1-uninfected women using DMPA versus no hormonal contraception and among HIV-1 uninfected men whose HIV-1-infected female partners used DMPA versus no hormonal contraception. Of 4747 HIV-1 serodiscordant couples, 901 HIV-1-uninfected women used DMPA at some point during follow-up, 1422 HIV-1-uninfected women used no hormonal contraception, 1568 HIV-1-uninfected men had female partners who used DMPA, and 2626 men had female partners who used no hormonal contraception. PrEP efficacy estimates for HIV-1 prevention, compared with placebo, were similar among women using DMPA and those using no hormonal contraception (64.7 and 75.5%, adjusted interaction P = 0.65). Similarly, for men whose female partners used DMPA, PrEP efficacy did not differ from men whose partners used no hormonal contraception (90.0 versus 81.7%, adjusted interaction P = 0.52). PrEP is efficacious for HIV-1 prevention among women using DMPA and men whose partners use DMPA, suggesting PrEP could mitigate the potential increased HIV-1 acquisition and transmission risks that have been associated with DMPA use. Women at risk for HIV-1 choosing DMPA could maintain this contraceptive method and add PrEP to achieve prevention of unintended pregnancy and HIV-1.

  9. HIV/AIDS: vaccines and alternate strategies for treatment and prevention.

    PubMed

    Voronin, Yegor; Phogat, Sanjay

    2010-09-01

    The symposium "HIV/AIDS: Vaccines and Alternate Strategies for Treatment and Prevention" brought together HIV vaccine researchers to discuss the latest developments in the field. From basic discoveries in virus diversity and mechanisms of neutralization by antibodies to nonhuman primate research and clinical trials of vaccine candidates in volunteers, scientists are making great strides in understanding the mechanisms that may protect against HIV and pathways to achieve this protection through vaccination.

  10. 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

  11. 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…

  12. 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…

  13. Telephone delivered interventions for preventing HIV infection in HIV-negative persons.

    PubMed

    van-Velthoven, Michelle H M M T; Tudor Car, Lorainne; Gentry, Sarah; Car, Josip

    2013-05-31

    This is one of the three Cochrane reviews that examine the role of the telephone in HIV/AIDS services. Although HIV infection can be prevented, still a large number of new infections occur. More effective HIV prevention interventions are needed to reduce the number of people newly infected with HIV. Phone calls can be used to potentially more effectively deliver HIV prevention interventions. They have the potential to save time, reduce costs and facilitate easier access. To assess the effectiveness of voice landline and mobile telephone delivered HIV prevention interventions in HIV-negative persons. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, PubMed Central, EMBASE, PsycINFO, Web of Science, Cumulative Index to Nursing & Allied Health, the World Health Organization's Global Health Library and Current Controlled Trials from 1980 to June 2011. We searched the following grey literature sources: Dissertation Abstracts International and the Centre for Agricultural Bioscience International Direct Global Health database, the System for Information on Grey Literature Europe, The Healthcare Management Information Consortium, Google Scholar, Conference on Retroviruses and Opportunistic Infections database, International AIDS Society conference database, AIDS Education Global Information System and reference lists of articles. Randomised controlled trials (RCTs), quasi-randomised controlled trials, controlled before and after studies, and interrupted time series studies comparing the effectiveness of delivering HIV prevention by phone calls to usual care in HIV-negative people regardless of their demographic characteristics and in all settings. Two reviewers independently searched databases, screened citations, assessed study quality and extracted data. A third reviewer resolved any disagreement. Primary outcomes were knowledge about the causes and consequences of HIV/AIDS, change in behaviour, healthcare uptake and clinical outcomes

  14. Adolescent decision making about participation in a hypothetical HIV vaccine trial.

    PubMed

    Alexander, Andreia B; Ott, Mary A; Lally, Michelle A; Sniecinski, Kevin; Baker, Alyne; Zimet, Gregory D

    2015-03-10

    The purpose of this study was to examine the process of adolescent decision-making about participation in an HIV vaccine clinical trial, comparing it to adult models of informed consent with attention to developmental differences. As part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16-19-year-olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semistructured interview about their decision making process when deciding whether or not to enroll in and HIV vaccine trial. An ethnographic content analysis approach was utilized. Twelve concepts related to adolescents' decision-making about participation in an HIV vaccine trial were identified and mapped onto Appelbaum and Grisso's four components of decision making capacity including understanding of vaccines and how they work, the purpose of the study, trial procedures, and perceived trial risks and benefits, an appreciation of their own situation, the discussion and weighing of risks and benefits, discussing the need to consult with others about participation, motivations for participation, and their choice to participate. The results of this study suggest that most adolescents at high risk for HIV demonstrate the key abilities needed to make meaningful decisions about HIV vaccine clinical trial participation. Published by Elsevier Ltd.

  15. Implications of HIV PrEP Trials Results

    PubMed Central

    Anton, Peter; Fletcher, Courtney V.; DeGruttola, Victor; McGowan, Ian; Becker, Stephen; Zwerski, Sheryl; Burns, David

    2011-01-01

    Abstract Six randomized clinical trials have been implemented to examine the efficacy of tenofovir disoproxil fumarate (TDF) and/or TDF/emtricitabine (TDF/FTC) as preexposure prophylaxis for HIV-1 infection (PrEP). Although largely complementary, the six trials have many similar features. As the earliest results become available, an urgent question may arise regarding whether changes should be made in the conduct of the other trials. To consider this in advance, a Consultation on the Implications of HIV Pre-Exposure Prophylaxis (PrEP) Trials Results sponsored by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and the Bill and Melinda Gates Foundation (BMGF) was held on January 29, 2010, at the Natcher Conference Center, NIH, Bethesda, MD. Participants included basic scientists, clinical researchers (including investigators performing the current PrEP trials), and representatives from the U.S. Food and Drug Administration (FDA) and the agencies sponsoring the trials: the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), the BMGF, and the U.S. NIH. We report here a summary of the presentations and highlights of salient discussion topics from this workshop. PMID:20969483

  16. Implications of HIV PrEP trials results.

    PubMed

    Veronese, Fulvia; Anton, Peter; Fletcher, Courtney V; DeGruttola, Victor; McGowan, Ian; Becker, Stephen; Zwerski, Sheryl; Burns, David

    2011-01-01

    Abstract Six randomized clinical trials have been implemented to examine the efficacy of tenofovir disoproxil fumarate (TDF) and/or TDF/emtricitabine (TDF/FTC) as preexposure prophylaxis for HIV-1 infection (PrEP). Although largely complementary, the six trials have many similar features. As the earliest results become available, an urgent question may arise regarding whether changes should be made in the conduct of the other trials. To consider this in advance, a Consultation on the Implications of HIV Pre-Exposure Prophylaxis (PrEP) Trials Results sponsored by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and the Bill and Melinda Gates Foundation (BMGF) was held on January 29, 2010, at the Natcher Conference Center, NIH, Bethesda, MD. Participants included basic scientists, clinical researchers (including investigators performing the current PrEP trials), and representatives from the U.S. Food and Drug Administration (FDA) and the agencies sponsoring the trials: the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), the BMGF, and the U.S. NIH. We report here a summary of the presentations and highlights of salient discussion topics from this workshop.

  17. Prevention of mother-to-child transmission of HIV-1 in Africa.

    PubMed

    Wiktor, S Z; Ekpini, E; Nduati, R W

    1997-01-01

    With the prevalence of HIV among pregnant women higher than 35% in some parts of sub-Saharan Africa, the number of HIV-infected children will continue to grow. It is estimated that almost 70% of the approximately 500,000 children who became infected with HIV in 1995 were born in sub-Saharan Africa. An effective intervention to prevent the vertical transmission of HIV is therefore most urgently needed in Africa. Following the release of the results of the AIDS Clinical Trials Group (ACTG) 076 study, the routine use of zidovudine (AZT) among HIV-infected pregnant women in the US and Europe has resulted in a significant reduction in the rate of mother-to-child vertical HIV transmission. However, most women in Africa will not benefit from these advances in the immediate future due to inadequate prenatal health care, the unavailability of prenatal HIV testing, and the high cost and complexity of the recommended regimen. Researchers need to build upon the findings of developed countries to identify feasible, effective, and implementable interventions to reduce the vertical transmission of HIV as well as to prevent HIV infection among women and to protect the health of HIV-infected women in Africa. Rates and timing of vertical HIV transmission, risk factors associated with vertical HIV transmission, and prevention interventions are discussed.

  18. Social Justice and HIV Vaccine Research in the Age of Pre-Exposure Prophylaxis and Treatment as Prevention

    PubMed Central

    Bailey, Theodore C.; Sugarman, Jeremy

    2014-01-01

    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. PMID:24033297

  19. 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.

  20. HIV vaccine-induced sero-reactivity: a challenge for trial participants, researchers, and physicians.

    PubMed

    Voronin, Yegor; Zinszner, Helene; Karg, Carissa; Brooks, Katie; Coombs, Robert; Hural, John; Holt, Renee; Fast, Pat; Allen, Mary

    2015-03-03

    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. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. 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

  2. Statistical design and analysis plan for an impact evaluation of an HIV treatment and prevention intervention for female sex workers in Zimbabwe: a study protocol for a cluster randomised controlled trial.

    PubMed

    Hargreaves, James R; Fearon, Elizabeth; Davey, Calum; Phillips, Andrew; Cambiano, Valentina; Cowan, Frances M

    2016-01-05

    Pragmatic cluster-randomised trials should seek to make unbiased estimates of effect and be reported according to CONSORT principles, and the study population should be representative of the target population. This is challenging when conducting trials amongst 'hidden' populations without a sample frame. We describe a pair-matched cluster-randomised trial of a combination HIV-prevention intervention to reduce the proportion of female sex workers (FSW) with a detectable HIV viral load in Zimbabwe, recruiting via respondent driven sampling (RDS). We will cross-sectionally survey approximately 200 FSW at baseline and at endline to characterise each of 14 sites. RDS is a variant of chain referral sampling and has been adapted to approximate random sampling. Primary analysis will use the 'RDS-2' method to estimate cluster summaries and will adapt Hayes and Moulton's '2-step' method to adjust effect estimates for individual-level confounders and further adjust for cluster baseline prevalence. We will adapt CONSORT to accommodate RDS. In the absence of observable refusal rates, we will compare the recruitment process between matched pairs. We will need to investigate whether cluster-specific recruitment or the intervention itself affects the accuracy of the RDS estimation process, potentially causing differential biases. To do this, we will calculate RDS-diagnostic statistics for each cluster at each time point and compare these statistics within matched pairs and time points. Sensitivity analyses will assess the impact of potential biases arising from assumptions made by the RDS-2 estimation. We are not aware of any other completed pragmatic cluster RCTs that are recruiting participants using RDS. Our statistical design and analysis approach seeks to transparently document participant recruitment and allow an assessment of the representativeness of the study to the target population, a key aspect of pragmatic trials. The challenges we have faced in the design of this

  3. HIV Prevention and AIDS Education: Resources for Special Educators.

    ERIC Educational Resources Information Center

    Byrom, Elizabeth, Ed.; Katz, Ginger, Ed.

    This guide was developed out of a 5-year project aimed at preventing the transmission of the human immunodeficiency virus (HIV) by promoting HIV prevention and AIDS (acquired immunodeficiency syndrome) education in school health programs. This document includes recommendations of a January, 1989 forum which addressed HIV prevention education for…

  4. 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

  5. Comparison of three composite compliance indices in a trial of self-administered preventive therapy for tuberculosis in HIV-infected Ugandan adults. Uganda-Case Western Reserve University Research Collaboration.

    PubMed

    Pekovic, V; Mayanja, H; Vjecha, M; Johnson, J; Okwera, A; Nsubuga, P; Mugerwa, R; Ellner, J; Whalen, C

    1998-07-01

    Compliance with tuberculosis preventive therapy in a randomized placebo-controlled trial in 2736 HIV-infected Ugandans was measured using urinary isoniazid metabolite testing, clinic attendance, and self-report. Overall, 77% of urine tests were positive, subjects kept 85% of their scheduled visits while on therapy, and 69% reportedly never forgot to take their medication. Different strategies were used for constructing three composite compliance indices in active arms: (1) an unweighted index of the summed scores on scaled compliance measures; (2) a weighted index using weights obtained from a survey of experts on tuberculosis; and (3) a statistically weighted index using principal components analysis. Composite indices were evaluated for reliability, validity, and practical utility. Understanding of the regimen, study arm, subsequent follow-up, tuberculosis status, and urine spot-check result were associated with composite compliance scores. The unweighted index in this study performed as well as the weighted indices.

  6. Gender and HIV / AIDS: transforming prevention programs.

    PubMed

    Gupta, G R

    1995-11-01

    The Women and AIDS Research Program (International Center for Research on Women) has identified a series of obstacles to preventing HIV infection among women, including social norms that mandate female ignorance about sexual matters, women's economic dependence on men, widespread acceptance of male promiscuity, and violence against women. Most AIDS prevention programs fail to challenge these contextual determinants and continue to focus on the promotion of condom use among men. Recommendations to empower women and improve their status are dismissed as long-term measures outside the domain of AIDS prevention. Feasible, however, is the modification of existing AIDS prevention programs to ensure they are gender-sensitive. This would mean measures such as providing services at times that are convenient to women and integrating services to reduce waiting and travelling times. To address the contextual issues at the root of women's vulnerability to HIV, AIDS prevention programs can link up with economic interventions such as credit programs, agricultural extension services, and women's cooperatives. Moreover, AIDS programs can provide HIV-infected women with social support through group educational sessions or counseling. Finally, because improvements in women's socioeconomic status are essential for the success of all AIDS prevention, program managers should be in the forefront of broader struggles to enact policy changes to eliminate gender-based discrimination and inequality.

  7. Vijana Vijiweni II: a cluster-randomized trial to evaluate the efficacy of a microfinance and peer health leadership intervention for HIV and intimate partner violence prevention among social networks of young men in Dar es Salaam.

    PubMed

    Kajula, Lusajo; Balvanz, Peter; Kilonzo, Mrema Noel; Mwikoko, Gema; Yamanis, Thespina; Mulawa, Marta; Kajuna, Deus; Hill, Lauren; Conserve, Donaldson; Reyes, Heathe Luz McNaughton; Leatherman, Sheila; Singh, Basant; Maman, Suzanne

    2016-02-03

    Intimate partner violence (IPV) and sexually transmitted infections (STIs), including HIV, remain important public health problems with devastating health effects for men and women in sub-Saharan Africa. There have been calls to engage men in prevention efforts, however, we lack effective approaches to reach and engage them. Social network approaches have demonstrated effective and sustained outcomes on changing risk behaviors in the U.S. Our team has identified and engaged naturally occurring social networks comprised mostly of young men in Dar es Salaam in an intervention designed to jointly reduce STI incidence and the perpetration of IPV. These stable networks are locally referred to as "camps." In a pilot study we demonstrated the feasibility and acceptability of a combined microfinance and peer health leadership intervention within these camp-based peer networks. We are implementing a cluster-randomized trial to evaluate the efficacy of an intervention combining microfinance with health leadership training in 60 camps in Dar es Salaam, Tanzania. Half of the camps have been randomized to the intervention arm, and half to a control arm. The camps in the intervention arm will receive a combined microfinance and health leadership intervention for a period of two years. The camps in the control arm will receive a delayed intervention. We have enrolled 1,258 men across the 60 study camps. Behavioral surveys will be conducted at baseline, 12-months post intervention launch and 30-month post intervention launch and biological samples will be drawn to test for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT), and Trichomonas vaginalis (TV) at baseline and 30-months. The primary endpoints for assessing intervention impact are IPV perpetration and STI incidence. This is the first cluster-randomized trial targeting social networks of men in sub-Saharan Africa that jointly addresses HIV and IPV perpetration and has both biological and behavioral endpoints. Effective

  8. Integrated prevention of mother-to-child HIV transmission services, antiretroviral therapy initiation, and maternal and infant retention in care in rural north-central Nigeria: a cluster-randomised controlled trial.

    PubMed

    Aliyu, Muktar H; Blevins, Meridith; Audet, Carolyn M; Kalish, Marcia; Gebi, Usman I; Onwujekwe, Obinna; Lindegren, Mary Lou; Shepherd, Bryan E; Wester, C William; Vermund, Sten H

    2016-05-01

    Antiretroviral therapy (ART) and retention in care are essential for the prevention of mother-to-child HIV transmission (PMTCT). We aimed to assess the effect of a family-focused, integrated PMTCT care package. In this parallel, cluster-randomised controlled trial, we pair-matched 12 primary and secondary level health-care facilities located in rural north-central Nigeria. Clinic pairs were randomly assigned to intervention or standard of care (control) by computer-generated sequence. HIV-infected women (and their infants) presenting for antenatal care or delivery were included if they had unknown HIV status at presentation (there was no age limit for the study, but the youngest participant was 16 years old); history of antiretroviral prophylaxis or treatment, but not receiving these at presentation; or known HIV status but had never received treatment. Standard of care included health information, opt-out HIV testing, infant feeding counselling, referral for CD4 cell counts and treatment, home-based services, antiretroviral prophylaxis, and early infant diagnosis. The intervention package added task shifting, point-of-care CD4 testing, integrated mother and infant service provision, and male partner and community engagement. The primary outcomes were the proportion of eligible women who initiated ART and the proportion of women and their infants retained in care at 6 weeks and 12 weeks post partum (assessed by generalised linear mixed effects model with random effects for matched clinic pairs). The trial is registered with ClinicalTrials.gov, number NCT01805752. Between April 1, 2013, and March 31, 2014, we enrolled 369 eligible women (172 intervention, 197 control), similar across groups for marital status, duration of HIV diagnosis, and distance to facility. Median CD4 count was 424 cells per μL (IQR 268-606) in the intervention group and 314 cells per μL (245-406) in the control group (p<0·0001). Of the 369 women included in the study, 363 (98%) had WHO

  9. Leveraging microfinance to impact HIV and financial behaviors among adolescents and their mothers in West Bengal: a cluster randomized trial.

    PubMed

    Spielberg, Freya; Crookston, Benjamin T; Chanani, Sheila; Kim, Jaewhan; Kline, Sean; Gray, Bobbi L

    2013-01-01

    Microfinance can be used to reach women and adolescent girls with HIV prevention education. We report findings from a cluster-randomized control trial among 55 villages in West Bengal to determine the impact of non-formal education on knowledge, attitudes and behaviors for HIV prevention and savings. Multilevel regression models were used to evaluate differences between groups for key outcomes while adjusting for cluster correlation and differences in baseline characteristics. Women and girls who received HIV education showed significant gains in HIV knowledge, awareness that condoms can prevent HIV, self-efficacy for HIV prevention, and confirmed use of clean needles, as compared to the control group. Condom use was rare and did not improve for women. While HIV testing was uncommon, knowledge of HIV-testing resources significantly increased among girls, and trended in the positive direction among women in intervention groups. Conversely, the savings education showed no impact on financial knowledge or behavior change.

  10. CTN-194 (PICCO): design of a trial of citalopram for the prevention of depression and its consequences in HIV-hepatitis C co-infected individuals initiating pegylated interferon/ribavirin therapy.

    PubMed

    Klein, Marina B; Cooper, Curtis; Brouillette, Marie-Josée; Sheehan, Nancy L; Benkelfat, Chawki; Annable, Lawrence; Weston, Francine; Kraus, Deborah; Singer, Joel

    2008-07-01

    Hepatitis C (HCV)-related end stage liver disease is a primary cause of morbidity and mortality in people with HIV. Despite this, co-infected patients have low rates of HCV treatment initiation and completion. This is in large part due to the risk of pegylated-interferon alpha (PEG-IFN-alpha)-related neuropsychiatric complications. We describe the design of a multicentre randomized, placebo-controlled trial that evaluates whether antidepressant prophylaxis is superior to early detection and treatment of depression in increasing the successful completion of HCV therapy. Seventy-six HIV+ adults with chronic HCV infection requiring therapy and with no contraindications to PEG-IFN-alpha/ribavirin will be randomized in a 1:1 ratio to receive citalopram or placebo starting three weeks prior to HCV treatment. A novel aspect of the trial design is the built-in management of emergent depression while maintaining the blinded treatment assignment. This will permit the comparison of prophylactic versus therapeutic use of citalopram. The primary outcome is the average proportion of prescribed PEG-IFN-alpha and ribavirin doses taken per month at weeks 12 and 24, and will be compared between treatment arms. The study will also compare the development of moderate-to-severe depression between treatment arms. A unique feature of this trial will be the use of Telepsychiatry to standardize observer-administered neuropsychiatric evaluations. Assessments of anxiety, quality of life, and adherence to therapy, as well as pathogenetic studies of neuropsychiatric side effects, will be conducted. Intention-to-treat analyses using random regression modeling will be employed to analyze longitudinal data on prescribed PEG-IFN-alpha and ribavirin doses. Survival analyses will be used to compare the time to the development of depression between the two arms. Effective prevention of a broad range of neuropsychiatric symptoms by citalopram has the potential to diminish PEG-IFN-alpha associated

  11. A Plan for the Next Generation of HIV Prevention Research: Seven Key Policy Investigative Challenges

    ERIC Educational Resources Information Center

    Coates, Thomas J.; Szekeres,Gregory

    2004-01-01

    Although HIV prevention research has accomplished much over the last 2 decades, significant challenges remain. The accomplishments have included rapid progression through various stages of research--from descriptive to clinical trials--and the fielding of several Phase 3 trials with biological endpoints. The challenges include developing…

  12. A Plan for the Next Generation of HIV Prevention Research: Seven Key Policy Investigative Challenges

    ERIC Educational Resources Information Center

    Coates, Thomas J.; Szekeres,Gregory

    2004-01-01

    Although HIV prevention research has accomplished much over the last 2 decades, significant challenges remain. The accomplishments have included rapid progression through various stages of research--from descriptive to clinical trials--and the fielding of several Phase 3 trials with biological endpoints. The challenges include developing…

  13. Male circumcision for HIV prevention: Current research and programmatic issues

    PubMed Central

    Weiss, Helen A; Dickson, Kim E; Agot, Kawango; Hankins, Catherine A

    2014-01-01

    Randomized controlled trials in sub-Saharan Africa have shown that adult male circumcision reduces the risk of HIV acquisition in men by about 60%. In this paper we review recent data on the association of male circumcision and HIV/STI in men and women. This includes a summary of data showing some evidence of an effect of male circumcision against genital ulcer disease, HSV-2 infection, HPV and Trichomonas vaginalis, but not Chlamydia trachomatis or Neisseria gonorrhea in men. Longitudinal studies among HIV discordant couples suggest that male circumcision may provide some direct long-term benefit to women, which may start after complete wound-healing. Circumcision may also protect against HIV acquisition in men who have sex with men and practice unprotected anal intercourse (either exclusively or predominantly), although this data is not consistent. To date, there is little evidence from the few studies available of either unsafe practices or reported increases in risky behaviour, or adverse changes in sexual satisfaction and function. As countries in southern and eastern Africa scale up services, operational research will likely be useful to iteratively improve programme delivery and impact, while identifying the best methods of integrating safe male circumcision services into HIV prevention strategies and strengthening health systems. PMID:21042054

  14. Preventing sexual violence and HIV in children.

    PubMed

    Sommarin, Clara; Kilbane, Theresa; Mercy, James A; Moloney-Kitts, Michele; Ligiero, Daniela P

    2014-07-01

    Evidence linking violence against women and HIV has grown, including on the cycle of violence and the links between violence against children and women. To create an effective response to the HIV epidemic, it is key to prevent sexual violence against children and intimate partner violence (IPV) against adolescent girls. Authors analyzed data from national household surveys on violence against children undertaken by governments in Swaziland, Tanzania, Kenya, and Zimbabwe, with support of the Together for Girls initiative, as well as an analysis of evidence on effective programmes. Data show that sexual and physical violence in childhood are linked to negative health outcomes, including increased sexual risk taking (eg, inconsistent condom use and increased number of sexual partners), and that girls begin experiencing IPV (emotional, physical, and sexual) during adolescence. Evidence on effective programmes addressing childhood sexual violence is growing. Key interventions focus on increasing knowledge among children and caregivers by addressing attitudes and practices around violence, including dating relationships. Programmes also seek to build awareness of services available for children who experience violence. Findings include incorporating attention to children into HIV and violence programmes directed to adults; increased coordination and leveraging of resources between these programmes; test transferability of programmes in low- and middle-income countries; and invest in data collection and robust evaluations of interventions to prevent sexual violence and IPV among children. This article contributes to a growing body of evidence on the prevention of sexual violence and HIV in children.

  15. Use of Antiretrovirals for HIV Prevention: What Do We Know and What Don’t We Know?

    PubMed Central

    Grant, Robert

    2013-01-01

    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

  16. 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

  17. Ecodevelopmental HIV Prevention Programs for Hispanic Adolescents

    PubMed Central

    Pantin, Hilda; Schwartz, Seth J.; Sullivan, Summer; Prado, Guillermo; Szapocznik, José

    2006-01-01

    The purpose of this article is to illustrate how an ecodevelopmental perspective on risk and protection can be applied to the study and prevention of unsafe sexual behavior in Hispanic immigrant adolescents. Special attention is given to culturally based ecodevelopmental risk and protective processes that may influence unsafe sexual behavior among Hispanic adolescents. Principles for designing prevention programs to offset these risks are offered on the basis of an ecodevelopmental HIV prevention program that has been developed and is currently being tested. PMID:15554814

  18. Effect of text messaging to deter early resumption of sexual activity after male circumcision for HIV prevention: a randomized controlled trial.

    PubMed

    Odeny, Thomas A; Bailey, Robert C; Bukusi, Elizabeth A; Simoni, Jane M; Tapia, Kenneth A; Yuhas, Krista; Holmes, King K; McClelland, R Scott

    2014-02-01

    Resumption of sex before complete wound healing after male circumcision may increase risk of postoperative surgical complications, and HIV acquisition and transmission. We aimed to determine the effect of text messaging to deter resumption of sex before 42 days postcircumcision. We conducted a randomized trial where men older than18 years who owned mobile phones and had just undergone circumcision were randomized to receive a series of text messages (n = 600) or usual care (n = 600). The primary outcome was self-reported resumption of sex before 42 days. Sex before 42 days was reported by 139 of 491 (28.3%) men in the intervention group and 124 of 493 (25.2%) men in the control group [relative risk = 1.13, 95% confidence interval (CI): 0.91 to 1.38, P = 0.3]. Men were more likely to resume early if they were married or had a live-in sexual partner [adjusted relative risk (aRR) 1.57, 95% CI: 1.18 to 2.08, P < 0.01]; in the month before circumcision had 1 (aRR: 1.50, 95% CI: 1.07 to 2.12, P = 0.02) or more than 1 (aRR: 1.81, 95% CI: 1.24 to 2.66, P < 0.01) sexual partner(s); had primary school or lower education (aRR: 1.62, 95% CI: 1.33 to 1.97, P< 0.001); were employed (aRR: 1.35, 95% CI: 1.05 to 1.72, P = 0.02); or were 21-30 years old (aRR: 1.58, 95% CI: 1.01 to 2.47, P = 0.05), 31-40 years old (aRR: 1.91, 95% CI: 1.18 to 3.09, P < 0.01), or older than 40 years (aRR: 1.76, 95% CI: 1.04 to 2.97, P = 0.03) compared with younger than 21 years. Text messaging as used in this trial did not reduce early resumption of sex after circumcision. We identified key risk factors for early resumption that need to be considered in circumcision programs.

  19. Effect of Text Messaging to Deter Early Resumption of Sexual Activity after Male Circumcision for HIV Prevention: A Randomized Controlled Trial

    PubMed Central

    ODENY, Thomas A.; BAILEY, Robert C.; BUKUSI, Elizabeth A.; SIMONI, Jane M.; TAPIA, Kenneth A.; YUHAS, Krista; HOLMES, King K.; MCCLELLAND, R. Scott

    2013-01-01

    BACKGROUND Resumption of sex before complete wound healing after male circumcision may increase risk of post-operative surgical complications, and HIV acquisition and transmission. We aimed to determine the effect of text messaging to deter resumption of sex before 42 days post-circumcision. METHODS We conducted a randomized trial where men >18 years old who owned mobile phones and had just undergone circumcision were randomized to receive a series of text messages (n=600) or usual care (n=600). The primary outcome was self-reported resumption of sex before 42 days. RESULTS Sex before 42 days was reported by 139/491 (28.3%) men in the intervention group and 124/493 (25.2%) in the control group (relative risk=1.13, 95% CI 0.91-1.38, p=0.3). Men were more likely to resume early if they were married or had a live-in sexual partner (adjusted relative risk [aRR] 1.57, 95% CI 1.18-2.08, p<0.01); in the month before circumcision had one (aRR 1.50, 95% CI 1.07-2.12, p=0.02) or >1 (aRR 1.81, 95% CI 1.24-2.66, p<0.01) sexual partner(s); had primary school or lower education (aRR 1.62, 95% CI 1.33-1.97, p< 0.001); were employed (aRR 1.35, 95% CI 1.05-1.72, p=0.02); or were 21-30 years old (aRR 1.58, 95% CI 1.01-2.47, p=0.05); 31-40 (aRR 1.91, 95% CI 1.18-3.09, p<0.01) or >40 years old (aRR 1.76, 95% CI 1.04-2.97, p=0.03) compared to <21 years old. CONCLUSIONS Text messaging as used in this trial did not reduce early resumption of sex after circumcision. We identified key risk factors for early resumption that need to be considered in circumcision programs. PMID:23846561

  20. 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

  1. Operational Research to Improve HIV Prevention in the United States

    PubMed Central

    Herbst, Jeffrey H.; Glassman, Marlene; Carey, James W.; Painter, Thomas M.; Gelaude, Deborah J.; Fasula, Amy M.; Raiford, Jerris L.; Freeman, Arin E.; Harshbarger, Camilla; Viall, Abigail H.; Purcell, David W.

    2015-01-01

    The HIV/AIDS epidemic in the United States continues despite several recent noteworthy advances in HIV prevention. Contemporary approaches to HIV prevention involve implementing combinations of biomedical, behavioral, and structural interventions in novel ways to achieve high levels of impact on the epidemic. Methods are needed to develop optimal combinations of approaches for improving efficiency, effectiveness, and scalability. This article argues that operational research offers promise as a valuable tool for addressing these issues. We define operational research relative to domestic HIV prevention, identify and illustrate how operational research can improve HIV prevention, and pose a series of questions to guide future operational research. Operational research can help achieve national HIV prevention goals of reducing new infections, improving access to care and optimization of health outcomes of people living with HIV, and reducing HIV-related health disparities. PMID:22217681

  2. Operational research to improve HIV prevention in the United States.

    PubMed

    Herbst, Jeffrey H; Glassman, Marlene; Carey, James W; Painter, Thomas M; Gelaude, Deborah J; Fasula, Amy M; Raiford, Jerris L; Freeman, Arin E; Harshbarger, Camilla; Viall, Abigail H; Purcell, David W

    2012-04-15

    The HIV/AIDS epidemic in the United States continues despite several recent noteworthy advances in HIV prevention. Contemporary approaches to HIV prevention involve implementing combinations of biomedical, behavioral, and structural interventions in novel ways to achieve high levels of impact on the epidemic. Methods are needed to develop optimal combinations of approaches for improving efficiency, effectiveness, and scalability. This article argues that operational research offers promise as a valuable tool for addressing these issues. We define operational research relative to domestic HIV prevention, identify and illustrate how operational research can improve HIV prevention, and pose a series of questions to guide future operational research. Operational research can help achieve national HIV prevention goals of reducing new infections, improving access to care and optimization of health outcomes of people living with HIV, and reducing HIV-related health disparities.

  3. Future paths for HIV vaccine research: Exploiting results from recent clinical trials and current scientific advances.

    PubMed

    Bansal, Geetha P; Malaspina, Angela; Flores, Jorge

    2010-02-01

    More than 60 million individuals have been infected with HIV and approximately half of these individuals have died since the epidemic started. The quest for an effective vaccine to prevent HIV transmission, which is likely to be the most effective approach to halt the epidemic, has been and continues to be an insurmountable challenge. Traditional vaccine strategies that have been effective for other vaccines have proven unsuccessful or impractical for HIV because of safety concerns. Nonetheless, substantial efforts have been directed at the development and clinical testing of HIV vaccines during the past two decades. Four major HIV vaccine efficacy trials conducted by VaxGen Inc (AIDSVAX 003 and AIDSVAX 004) and the NIH-supported HIV Vaccine Trials Network (HVTN 502 and HVTN 503) failed to demonstrate efficacy; however, a recent trial conducted in Thailand (RV144 trial) demonstrated a low level of efficacy, resulting in some renewed optimism. Dissecting the causes for vaccine failure and, more importantly, for the partial level of efficacy observed in the RV144 trial should provide important guidance to the field. This review discusses the ongoing HIV vaccine trials and also highlights recent scientific advances that have provided the field with new leads to invigorate the search for effective vaccines.

  4. 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.

  5. 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

  6. 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…

  7. Prevention of HIV/AIDS Education in Rural Communities III.

    ERIC Educational Resources Information Center

    Torabi, Mohammad R., Ed.

    1998-01-01

    This third special issue of the Health Education Monograph Series on HIV/AIDS Prevention in Rural Communities presents 9 articles on: "Rural Adolescent Views of HIV Prevention: Focus Groups at Two Indiana Rural 4-H Clubs" (William L. Yarber and Stephanie A. Sanders); "Implementing HIV Education: Beyond Curriculum" (Susan…

  8. Transmission and prevention of HIV among heterosexual populations in Australia.

    PubMed

    Persson, Asha; Brown, Graham; McDonald, Ann; Körner, Henrike

    2014-06-01

    In Australia, unlike much of the rest of the world, HIV transmission through heterosexual contact remains a relatively rare occurrence. In consequence, HIV-prevention efforts have been firmly focused on male-to-male sex as the most frequent source of HIV transmission. There are emerging signs that this epidemiological landscape may be shifting, which raises questions about current and future HIV prevention strategies. Over the past decade, national surveillance data have shown an increase in HIV notifications for which exposure to HIV was attributed to heterosexual contact. This paper offers an epidemiological and sociocultural picture of heterosexual HIV transmission in Australia. We outline recent trends in heterosexually acquired HIV and discuss specific factors that shape transmission and prevention among people at risk of HIV infection through heterosexual contact. To illustrate the contextual dynamics surrounding HIV in this diverse population, we detail two key examples: HIV among people from minority ethnic backgrounds in New South Wales; and overseas-acquired HIV among men in Western Australia. We argue that, despite their differences, there are significant commonalities across groups at risk of HIV infection through heterosexual contact, which not only provide opportunities for HIV prevention, but also call for a rethink of the dominant HIV response in Australia.

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

    PubMed

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

    2015-06-15

    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. 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). 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). 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. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  10. Lessons learned from human HIV vaccine trials.

    PubMed

    Pollara, Justin; Easterhoff, David; Fouda, Genevieve G

    2017-05-01

    The ability to induce broadly neutralizing antibody (bNAb) responses is likely essential for development of a globally effective HIV vaccine. Unfortunately, human vaccine trials conducted to date have failed to elicit broad plasma neutralization of primary virus isolates. Despite this limitation, in-depth analysis of the vaccine-induced memory B-cell repertoire can provide valuable insights into the presence and function of subdominant B-cell responses, and identify initiation of antibody lineages that may be on a path towards development of neutralization breadth. Characterization of the functional capabilities of monoclonal antibodies isolated from a HIV-1 vaccine trial with modest efficacy has revealed mechanisms by which non-neutralizing antibodies are presumed to have mediated protection. In addition, B-cell repertoire analysis has demonstrated that vaccine boosts shifted the HIV-specific B-cell repertoire, expanding pools of cells with long third heavy chain complementarity determining regions - a characteristic of some bNAb lineages. Detailed analysis of memory B-cell repertoires and evaluating the effector functions of isolated monoclonal antibodies expands what we can learn from human vaccine trails, and may provide knowledge that can enable rational design of novel approaches to drive maturation of subdominant disfavored bNAb lineages.

  11. A music-based HIV prevention intervention for urban adolescents.

    PubMed

    Lemieux, Anthony F; Fisher, Jeffrey D; Pratto, Felicia

    2008-05-01

    This research examines the process of conducting and evaluating a music-based HIV prevention intervention among urban adolescents, and is informed by the information, motivation, behavioral skills (IMB) model. Musically talented opinion leaders were recruited to write, record, and distribute HIV prevention themed music to their peers to increase HIV prevention motivation, behavioral skills, and behaviors. In this 3-month field experiment, participants were 306 students enrolled in health classes at each of three large multiracial urban high schools (one treatment school; two control schools). Measures of HIV prevention information, motivation, behavioral skills, and behaviors, both pre- and postintervention. Results indicate that the intervention influenced several aspects of HIV prevention motivation, behavioral skills, and condom use and HIV testing behaviors. This research demonstrates that the incorporation of music into HIV prevention interventions for adolescents has the potential to be effective.

  12. An update on multipurpose prevention technologies for the prevention of HIV transmission and pregnancy.

    PubMed

    Friend, David R

    2016-01-01

    Multipurpose Prevention Technologies (MPTs) are designed to address two or more indications from a single product. The overall goal is to prevent unintended pregnancy and transmission of one or more STIs including HIV-1. The topics covered herein are advances in over the past three years. Advances include development of novel intravaginal rings capable of releasing microbicides to prevent transmission of HIV-1 and unintended pregnancy. These rings include the potential to prevent transmission of more than one STI and unintended pregnancy. There are also gels that can potentially accomplish the same thing. Finally, combination of a drug and barrier device are also covered. There has been considerable advance in this field over the past three years. There is one ring currently in a Phase I clinical trial and others are soon to follow. Some of these drug delivery systems are by necessity rather complicated and hence could be prohibitively expensive in the developing world. Conducting multiple clinical trials to support regulatory approval of two or more indications represents a significant barrier. It remains unclear that women will be more motivated to use MPT products than has been observed in recent microbicide-only clinical trials. Despite these challenges, the need for MPTs remain acute hopefully ensuring they will continue to be developed over the coming years.

  13. 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.

  14. PrEP as peri-conception HIV prevention for women and men

    PubMed Central

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

    2016-01-01

    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. PMID:26993627

  15. HIV intervention for providers study: a randomized controlled trial of a clinician-delivered HIV risk-reduction intervention for HIV-positive people.

    PubMed

    Rose, Carol Dawson; Courtenay-Quirk, Cari; Knight, Kelly; Shade, Starley B; Vittinghoff, Eric; Gomez, Cynthia; Lum, Paula J; Bacon, Oliver; Colfax, Grant

    2010-12-15

    Clinician-delivered prevention interventions offer an opportunity to integrate risk-reduction counseling as a routine part of medical care. The HIV Intervention for Providers study, a randomized controlled trial, developed and tested a medical provider HIV prevention training intervention in 4 northern California HIV care clinics. Providers were assigned to either the intervention or control condition (usual care). The intervention arm received a 4-hour training on assessing sexual risk behavior with HIV-positive patients and delivering risk-reduction-oriented prevention messages to patients who reported risk behaviors with HIV-uninfected or unknown-status partners. To compare the efficacy of the intervention versus control on transmission risk behavior, 386 patients of the randomized providers were enrolled. Over six-months of follow-up, patients whose providers were assigned the intervention reported a relative increase in provider-patient discussions of safer sex (OR = 1.49; 95% CI = 1.06 to 2.09), assessment of sexual activity (OR = 1.60; 95% CI = 1.05 to 2.45), and a significant decrease in the number of sexual partners (OR = 0.49, 95% CI = 0.26 to 0.92). These findings show that a brief intervention to train HIV providers to identify risk and provide a prevention message results in increased prevention conversations and significantly reduced the mean number of sexual partners reported by HIV-positive patients.

  16. Female-controlled methods to prevent sexual transmission of HIV.

    PubMed

    Elias, C J; Coggins, C

    1996-12-01

    THE NEED FOR PREVENTION: Women throughout the world face a growing risk of infection with HIV. Consistent condom use, one cornerstone of primary prevention strategy, is not always feasible for many women. Consequently, women urgently need infection prevention technology that is within their personal control. This session will review current efforts to develop and test female-controlled methods for preventing sexual transmission of HIV and other sexually transmitted pathogens. Both physical and chemical methods will be summarized, including recent findings concerning the efficacy and acceptability of the vaginal pouch (female condom), as well as an overview of research on vaginal microbicides. Data from studies of existing over-the-counter spermicides will be reviewed. The wide range of novel microbicidal products currently being evaluated in the laboratory and early clinical trials demonstrate the breadth of possibilities presented by chemical barrier methods. However, formidible challenges face public and private sector research and development efforts. This session will conclude by highlighting several issues related to the clinical evaluation and introduction of female-controlled prevention technology.

  17. Sexual Risk Behavior: HIV, STD, & Teen Pregnancy Prevention

    MedlinePlus

    ... STD Teen Pregnancy Sexual Risk Behaviors: HIV, STD, & Teen Pregnancy Prevention Recommend on Facebook Tweet Share Compartir Many ... and School Health addresses HIV, other STDS, and teen pregnancy through Data collection and analysis Science-based guidance ...

  18. CDC Vital Signs: Daily Pill Can Prevent HIV

    MedlinePlus

    ... Error processing SSI file Daily Pill Can Prevent HIV Reaching people who could benefit from PrEP Language: ... Problem Many people at very high risk for HIV infection are not getting PrEP. PrEP is for ...

  19. Pharmacokinetics of Antiretrovirals In Genital Secretions and Anatomic Sites of HIV Transmission: Implications for HIV Prevention

    PubMed Central

    Trezza, Christine R.; Kashuba, Angela D. M.

    2014-01-01

    The incidence of HIV remains alarmingly high in many parts of the world. Prophylactic use of antiretrovirals, capable of concentrating in the anatomical sites of transmission, may reduce the risk of infection after an unprotected sexual exposure. To date, orally and topically administered antiretrovirals have exhibited variable success in preventing HIV transmission in large-scale clinical trials. Antiretroviral mucosal pharmacokinetics may help explain the outcomes of these investigations. Penetration and accumulation of antiretrovirals into sites of transmission can influence dosing strategies and pre-exposure prophylaxis clinical trial design. Antiretroviral tissue distribution varies widely within and between drug classes, attributed in part to their physicochemical properties and tissue-specific drug transporter expression. Nucleoside (-tide) reverse transcriptase inhibitors, the CCR5 antagonist maraviroc, and the integrase inhibitor raltegravir demonstrate the highest penetration into the male and female reproductive tracts and colorectal tissue relative to blood. This review will describe antiretroviral exposure in anatomic sites of transmission, and place these findings in context with the prevention of HIV and the efficacy of pre-exposure prophylactic strategies. PMID:24859035

  20. Cancer clinical trials in persons with HIV infection.

    PubMed

    Little, Richard F

    2017-01-01

    The era of modern HIV therapeutics is well underway. The cancer and infectious disease epidemiology of HIV disease has markedly altered as populations are availed to the benefits of antiretroviral therapy (ARV). The types of cancers occurring among those with HIV infection has broadened but the case burden in absolute numbers is very low relative to the background population. There are fewer incident cases of the AIDS-defining cancers (aggressive B-cell lymphomas, Kaposi's sarcoma, and cervical cancer). There is an increased risk for certain non-AIDS-defining cancers, but these occur somewhat sporadically relative to clinical trial enrollment. The changing epidemiology of cancer in HIV poses challenges as well as opportunities for participation of persons with HIV in cancer therapy clinical trials. There are excellent examples of cancer trials that inform cancer therapy for patients with HIV infection. Examples include those from HIV-specific trials and from trials mainly focused on the background population that included patients with HIV infection. Interpretation of clinical trials to guide therapy for those with HIV infection and cancer largely depends on data that does not include HIV-infected patients. The ability to extend clinical trial findings to populations not included in clinical trials remains problematic for a variety of populations, including those with HIV or AIDS. Careful prioritization of studies designed to bridge this gap is needed. However, there are published studies that serve as excellent examples bridging these gaps and the portfolio of cancer therapy trials underway will inform HIV and cancer better than at any time in the past.

  1. HIV prevention and education in state prison systems: an update.

    PubMed

    Lyons, Thomas; Osunkoya, Emmanuel; Anguh, Ivonne; Adefuye, Adedeji; Balogun, Joseph

    2014-04-01

    The prevalence rate of HIV infection in jails and prisons is approximately 5 times the rate in the U.S. general population. The authors surveyed state prison officials to assess HIV testing and HIV prevention policies--specifically voluntary testing, group HIV prevention counseling, and peer education--in the 50 states and to determine whether those policies are associated with the characteristics of the state and its prison population.

  2. Computer-Assisted HIV Prevention for Youth With Substance Use Disorders

    PubMed Central

    Marsch, Lisa A.; Grabinski, Michael J.; Bickel, Warren K.; Desrosiers, Alethea; Guarino, Honoria; Muehlbach, Britta; Solhkhah, Ramon; Taufique, Shilpa; Acosta, Michelle

    2011-01-01

    We developed an interactive, customizable, Web-based program focused on the prevention of HIV, sexually transmitted infections, and hepatitis among youth. Results from a randomized, controlled trial with youth in treatment for substance use demonstrated that this Web-based tool, when provided as an adjunct to an educator-delivered prevention intervention, increased accurate prevention knowledge, increased intentions to carefully choose partners, and was perceived as significantly more useful relative to the educator-delivered intervention when provided alone. Results suggest this Web-based program may be effective and engaging and may increase the adoption of effective HIV and disease prevention science for youth. Limitations are discussed. PMID:21190405

  3. Primary Care Providers' HIV Prevention Practices Among Older Adults

    PubMed Central

    Davis, Tracy; Teaster, Pamela B.; Thornton, Alice; Watkins, John F.; Alexander, Linda; Zanjani, Faika

    2016-01-01

    Purpose To explore primary care providers' HIV prevention practices for older adults. Primary care providers' perceptions and awareness were explored to understand factors that affect their provision of HIV prevention materials and HIV screening for older adults. Design and Method Data were collected through 24 semistructured interviews with primary care providers (i.e., physicians, physician assistants, and nurse practitioners) who see patients older than 50 years. Results Results reveal facilitators and barriers of HIV prevention for older adults among primary care providers and understanding of providers' HIV prevention practices and behaviors. Individual, patient, institutional, and societal factors influenced HIV prevention practices among participants, for example, provider training and work experience, lack of time, discomfort in discussing HIV/AIDS with older adults, stigma, and ageism were contributing factors. Furthermore, factors specific to primary and secondary HIV prevention were identified, for instance, the presence of sexually transmitted infections influenced providers' secondary prevention practices. Implications HIV disease, while preventable, is increasing among older adults. These findings inform future research and interventions aimed at increasing HIV prevention practices in primary care settings for patients older than 50. PMID:25736425

  4. Mobile health applications for HIV prevention and care in Africa.

    PubMed

    Forrest, Jamie I; Wiens, Matthew; Kanters, Steve; Nsanzimana, Sabin; Lester, Richard T; Mills, Edward J

    2015-11-01

    More people have mobile phones in Africa than at any point in history. Mobile health (m-health), the use of mobile phones to support the delivery of health services, has expanded in recent years. Several models have been proposed for conceptualizing m-health in the fields of maternal-child health and chronic diseases. We conducted a literature review of m-health interventions for HIV prevention and care in African countries and present the findings in the context of a simplified framework. Our review identified applications of m-health for HIV prevention and care categorized by the following three themes: patient-care focused applications, such as health behavior change, health system-focused applications, such as reporting and data collection, and population health-focused applications, including HIV awareness and testing campaigns. The potential for m-health in Africa is numerous and should not be limited only to direct patient-care focused applications. Although the use of smart phone technology is on the rise in Africa, text messaging remains the primary mode of delivering m-health interventions. The rate at which mobile phone technologies are being adopted may outpace the rate of evaluation. Other methods of evaluation should be considered beyond only randomized-controlled trials.

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

    PubMed

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

    2011-02-01

    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.

  6. Preventing HIV infection: educating the general public.

    PubMed

    Kroger, F

    1991-01-01

    This essay discusses the rationale for targeting HIV prevention programs to the general public, as opposed to focusing strictly on high-risk populations. The author first considers varying definitions of the term "general public," then explains the goal of general public education programs. Additionally, the author lays down the theoretical foundations of general audience education programs and weights related research findings. Finally, he offers recommendations for future practice. Noting the complex socioecological elements involved in health behavior, the author argues in favor of a broad definition for the general public. This broad outlook allows programs to still target high-risk population while not bypassing low-risk persons, who are sometimes treated as irrelevant because they do not contribute to excess morbidity or mortality. When it comes to HIV educational programs for the general public, their goals should be to instruct the public on how the virus is transmitted, to allay unfounded fears, and to increase the level of support for AIDS prevention and control. Such a program would require a theoretical basis drawn from multiple sources: health education, health communication, clinical and social psychology, and social marketing. The author concludes by proving recommendations designed to reinforce existing programs: 1) strengthen efforts to ensure that all people are educated about HIV and to encourage people to treat AIDS patients with compassion; 2) continue to explore for the most effective communication channels; 3) strengthen the communication infrastructure for those who are disenfranchised from health education; and 4) strengthen evaluation efforts of health communication programs.

  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. Common Factors in Effective HIV Prevention Programs

    PubMed Central

    Swendeman, Dallas; Flannery, Diane; Rice, Eric; Adamson, David M.; Ingram, Barbara

    2010-01-01

    We propose a set of common factors in evidence-based interventions (EBI) for HIV prevention, which cut across theoretical models of behavior change. Three existing literatures support this agenda: (1) Common factors in psychotherapy; (2) core elements from the Centers for Disease Control and Prevention EBIs; and (3) component analyses of EBI. To stimulate discussion among prevention researchers, we propose a set of common factors at the highest level of abstraction that describe what all effective programs do: (1) establish a framework to understand behavior change; (2) convey issue-specific and population-specific information necessary for healthy actions; (3) build cognitive, affective, and behavioral self-management skills; (4) address environmental barriers to implementing health behaviors; and (5) provide tools to develop ongoing social and community support for healthy actions. A focus on common factors will enhance research on new HIV prevention interventions, encourage collaboration among researchers, provide guidelines for adapting EBI, and simplify and speed the adoption of EBI for providers. PMID:18830813

  9. Prison privatization and HIV prevention in Australia.

    PubMed

    Cregan, J

    Prison privatization is being increasingly discussed as an alternative that might help drive down the cost of corrections in Canada. An Australian conference recently addressed prison privatization. Australia has a long history with privatizing corrections and historically being the site of private penal colonies. Private and State-owned corporations own and manage Australian prisons and the balance of private and public sector activity within the prisons is discussed. HIV/AIDS care and prevention programs provide bleach distribution, education programs for staff and inmates, and safety training. Moral issues debating how much time and money is allocated to HIV/AIDS are addressed. Private operators of prisons have no financial incentive to educate, rehabilitate, or release prisoners.

  10. Immunotherapies to prevent mother-to-child transmission of HIV.

    PubMed

    Hicar, Mark D

    2013-03-01

    Although pharmacological interventions have been successful in reducing prevention of maternal to child transmission (PMTCT) of HIV, there is concern that complete elimination through this mode of transmission will require other measures. Immunotherapies in infants or pregnant mothers may be able to eradicate this form of transmission. A recent vaccine trial in adults showed encouraging results, but as in most HIV safety and efficacy vaccine trials, the question of MTCT was not addressed. Concentrating transmission studies and vaccine studies in the setting of MTCT offers several advantages. MTCT has a generally reproducible known transmission rate and has been successfully used to assess pharmacological interventions on decreasing transmission. Even in resource poor settings, the infrastructure for neonatal vaccination is already in place. Although rare, both passive and active vaccination trials have been successfully completed in pediatric populations. Unfortunately, little success in affecting MTCT has been shown. Largely, a correlate of protection in any type of transmission, including MTCT, is unknown. Data supports a role for antibodies in effecting strain and transmission during MTCT. The role of antibodies in MTCT is reviewed with a focus on recent passive immunization and considerations for future studies.

  11. Community engagement and investment in biomedical HIV prevention research for youth: rationale, challenges, and approaches.

    PubMed

    Ellen, Jonathan M; Wallace, Melissa; Sawe, Fredrick K; Fisher, Kevin

    2010-07-01

    There has been a growing awareness of the importance of engaging communities in the development, testing, and eventual dissemination of biomedical strategies. Community engagement offers many benefits but comes with many challenges. This article will discuss these benefits and challenges and describe two examples of community engagement, Connect to Protect in the United States, and the South African Studies on HIV in Adolescents Project in South Africa, that represent investment in community engagement as preparation for biomedical HIV prevention clinical trials for youth.

  12. From prenatal HIV testing of the mother to prevention of sexual HIV transmission within the couple.

    PubMed

    Desgrées-du-Loû, Annabel; Brou, Hermann; Traore, Annick Tijou; Djohan, Gerard; Becquet, Renaud; Leroy, Valeriane

    2009-09-01

    The first step in preventing mother-to-child HIV transmission (PMTCT) programmes is offering HIV counselling and testing to pregnant women. In developing countries where HIV testing remains rare, it represents a unique opportunity for many women to learn their HIV status. This prenatal HIV testing is not only the entry point to prevention of mother-to-child HIV transmission, but also an occasion for women to sensitize their male partner to sexual risks. Here we explore if these women, HIV-tested as mothers, apply the prevention recommendations they also receive as women. In the Ditrame Plus PMTCT program in Abidjan, Côte d'Ivoire, two cohorts of women (475 HIV-infected women and 400 HIV-negative women) were followed up two years after the pregnancy when they were offered prenatal HIV testing. In each cohort, we compared the proportion of women who communicated with their regular partner on sexual risks, prior to and after prenatal HIV testing. We analysed socio-demographic factors related to this communication. We measured two potential conjugal outcomes of women HIV testing: the level of condom use at sex resumption after delivery and the risk of union break-up. Prenatal HIV testing increased conjugal communication regarding sexual risks, whatever the woman's serostatus. This communication was less frequent for women in a polygamous union or not residing with their partner. Around 30% of women systematically used condoms at sex resumption. Among HIV infected ones, conjugal talk on sexual risks was related to improved condom use. After HIV testing, more HIV-infected women separated from their partners than HIV-uninfected women, despite very few negative reactions from the notified partners. In conclusion, offering prenatal HIV counselling and testing is an efficient tool for sensitizing women and their partners to HIV prevention. But sexual prevention in a conjugal context remains difficult and need to be specifically addressed.

  13. 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

  14. 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

  15. Community-based HIV clinical trials: an integrated approach in underserved, rural, minority communities.

    PubMed

    Corbie-Smith, Giselle; Isler, Malika Roman; Miles, Margaret Shandor; Banks, Bahby

    2012-01-01

    Although racial and ethnic minorities have disproportionately high rates of HIV infection, these groups are underrepresented in HIV-related clinical trials. This illustrates the need for more innovation in attempts to engage underrepresented populations in calls for interdisciplinary and translational research. Eleven focus groups and 35 interviews were conducted with people living with HIV/AIDS (PLWHA) to explore the perspectives of rural community leaders, service providers, and PLWHA about bringing HIV-related research, including clinical trials, into rural communities. Over a period of 3 months in spring 2007, we collected qualitative data from three sources: Community leaders, service providers, and PLWHA. Text data were analyzed using the constant comparative method and content analysis techniques of theme identification. Respondents want an integrated approach to HIV research that builds trust, meets community needs, and respects their values. They conceptualize HIV research as part of a broader spectrum of HIV testing, prevention, and care, and suggest integrating HIV trials with existing community services, organizations, and structures, engaging various segments of the community, and conducting research using a personal approach. These findings support calls for more relevant, translational, and engaged research. An integrated approach may be an important innovation to transform the research enterprise to meet these goals and more directly improve the health of individuals.

  16. The magnitude of key HIV prevention challenges in the United States: implications for a new national HIV prevention plan.

    PubMed

    Holtgrave, David R; McGuire, Jean Flatley; Milan, Jesse

    2007-07-01

    The Centers for Disease Control and Prevention has undertaken an advisory process to update its national HIV prevention plan. We offer observations on the magnitude of HIV prevention challenges in the United States and reflect on how these challenges might influence the structure of a new HIV prevention plan. We recommend a plan structure that (1) is based on fundamental principles of prevention, (2) enables accountability and mid-course correction, and (3) if achieved, would result in historic changes in the US HIV epidemic. The recommended plan structure would differentially prioritize serostatus determination and prevention and care interventions for people living with HIV while retaining goals directed at high-risk HIV-negative and general population members.

  17. The Magnitude of Key HIV Prevention Challenges in the United States: Implications for a New National HIV Prevention Plan

    PubMed Central

    Holtgrave, David R.; McGuire, Jean Flatley; Milan, Jesse

    2007-01-01

    The Centers for Disease Control and Prevention has undertaken an advisory process to update its national HIV prevention plan. We offer observations on the magnitude of HIV prevention challenges in the United States and reflect on how these challenges might influence the structure of a new HIV prevention plan. We recommend a plan structure that (1) is based on fundamental principles of prevention, (2) enables accountability and mid-course correction, and (3) if achieved, would result in historic changes in the US HIV epidemic. The recommended plan structure would differentially prioritize serostatus determination and prevention and care interventions for people living with HIV while retaining goals directed at high-risk HIV-negative and general population members. PMID:17538048

  18. Impact of tuberculosis screening and isoniazid preventive therapy on incidence of tuberculosis and death in patients with HIV infection receiving care in public clinics in Rio de Janeiro, Brazil: the Tuberculosis/HIV in Rio de Janeiro (THRio) study: a stepped wedge, cluster randomized trial

    PubMed Central

    Durovni, Betina; Saraceni, Valeria; Moulton, Lawrence H.; Pacheco, Antonio G.; Cavalcante, Solange C.; King, Bonnie S.; Cohn, Silvia; Efron, Anne; Chaisson, Richard E.; Golub, Jonathan E.

    2014-01-01

    Summary Background Preventive therapy for tuberculosis among HIV-infected patients is effective but has not been widely implemented in moderate/high-burden settings. Objectives To determine the impact of widespread use of isoniazid preventive therapy on rates of tuberculosis and death in HIV-infected individuals in Brazil. Design Stepped wedge, cluster randomized trial Participants Patients actively enrolled in 29 HIV clinics in Rio de Janeiro, Brazil Control period Standard of care Intervention period Staff training in tuberculosis screening, performance of tuberculin skin tests and use of isoniazid preventive therapy. Randomization Clinics were randomly allocated a date to begin the intervention period with two clinics beginning the intervention every 2 months starting September 1 2005. Main outcome measures Tuberculosis incidence alone or combined with death in the control versus intervention periods through August 31 2009. Results Among 17,413 patients in the THRio cohort, 12,816 were eligible for the intervention. Overall, there were 475 tuberculosis cases and 838 deaths. The intervention increased the rate of patients receiving skin tests from 19/100 person-years to 59/100 person-years, and from 36/100 person-years to 144/100 person-years for those eligible for isoniazid preventive therapy. In the control period, 221 tuberculosis cases were diagnosed (1·31/100 person-years) compared to 254 (1·10/100 person-years) in the intervention (unadjusted hazard ratio (HR)=0·87;95%CI:0·69–1·10). Rates of tuberculosis incidence or death were 3·64 and 3·04/100 person-years, respectively (HR=0·76; 95%CI:0·66–0·87). When adjusted for age, sex, entry CD4 count and use of antiretroviral therapy, the HR for tuberculosis was 0·73 (95%CI:0·54–0·99) and for tuberculosis or death was 0·69 (95%CI:0·57–0·83). Among 12,196 patients remaining in care (secondary analyses, 399 tuberculosis cases and 656 deaths), the adjusted HR of tuberculosis alone and combined

  19. HIV in Indian prisons: Risk behaviour, prevalence, prevention & treatment

    PubMed Central

    Dolan, Kate; Larney, Sarah

    2010-01-01

    Background & Objectives: HIV is a major health challenge for prison authorities. HIV in prisons has implications for HIV in the general community. The aim of this paper was to gather information on HIV risk, prevalence, prevention and treatment in prisons in India. Methods: Relevant published and unpublished reports and information were sought in order to provide a coherent picture of the current situation relating to HIV prevention, treatment and care in prisons in India. Information covered prison management and population statistics, general conditions in prisons, provision of general medical care and the HIV situation in prison. Results: No data on drug injection in prison were identified. Sex between men was reported to be common in some Indian prisons. A national study found that 1.7 per cent of inmates were HIV positive. Some prisons provided HIV education. Condom provision was considered illegal. A few prisoners received drug treatment for drug use, HIV infection or co-infection with sexually transmitted infections (STIs). Interpretation & conclusions: HIV prevalence in prisons in India was higher than that in the general community. Regular monitoring of information on HIV risk behaviours and prevalence in Indian prisons is strongly recommended. Evidence based treatment for drug injectors and nation-wide provision of HIV prevention strategies are urgently required. Voluntary counselling, testing and treatment for HIV and STIs should be provided. PMID:21245617

  20. Male circumcision, attitudes to HIV prevention and HIV status: a cross-sectional study in Botswana, Namibia and Swaziland.

    PubMed

    Andersson, Neil; Cockcroft, Anne

    2012-01-01

    In efficacy trials male circumcision (MC) protected men against HIV infection. Planners need information relevant to MC programmes in practice. In 2008, we interviewed 2915 men and 4549 women aged 15-29 years in representative cluster samples in Botswana, Namibia and Swaziland, asking about socio-economic characteristics, knowledge and attitudes about HIV and MC and MC history. We tested finger prick blood samples for HIV. We calculated weighted frequencies of MC knowledge and attitudes, and MC history and HIV status. Multivariate analysis examined associations between MC and other variables and HIV status. In Botswana, 11% of young men reported MC, 28% in Namibia and 8% in Swaziland; mostly (75% in Botswana, 94% - mostly Herero - in Namibia and 68% in Swaziland) as infants or children. Overall, 6.5% were HIV positive (8.3% Botswana, 2.6% Namibia and 9.1% Swaziland). Taking other variables into account, circumcised men were as likely as uncircumcised men to be HIV positive. Nearly half of the uncircumcised young men planned to be circumcised; two-thirds of young men and women planned to have their sons circumcised. Some respondents had inaccurate beliefs and unhelpful views about MC and HIV, with variation between countries. Between 9 and 15% believed a circumcised man is fully protected against HIV; 20-26% believed men need not be tested for HIV before MC; 14-26% believed HIV-positive men who are circumcised cannot transmit the virus; and 8-34% thought it was "okay for a circumcised man to expect sex without a condom". Inaccurate perceptions about protection from MC could lead to risk compensation and reduce women's ability to negotiate safer sex. More efforts are needed to raise awareness about the limitations of MC protection, especially for women, and to study the interactions between MC roll out programmes and primary HIV prevention programmes.

  1. HIV screening reactivity due to donor participation in HIV vaccine trials.

    PubMed

    Kitchen, A D; Hewitt, P E

    2009-08-01

    We report two instances of human immunodeficiency virus (HIV) serological screening reactivity in blood donations which were subsequently determined to be due to donor participation in HIV vaccine trials. Both donations were screen reactive with atypical patterns on confirmation; no definitive conclusion could be given for either donor. Subsequent questioning identified that both donors had been involved in HIV vaccine trials. In both cases the screening and confirmation identified the presence of HIV antibodies, although vaccine induced. While clinical trials of vaccines are important, the implications of some need careful consideration if they are not to adversely impact other areas of healthcare.

  2. 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

  3. Practice brief: adolescents and HIV clinical trials: ethics, culture, and context.

    PubMed

    MacQueen, Kathleen M; Karim, Quarraisha Abdool

    2007-01-01

    One quarter of HIV infections globally occur among young people 15 to 24 years of age, and more than half of all new infections are in people younger than 25 years. Clearly, there is a need to identify and implement effective HIV prevention strategies among at-risk teens. Some of the most effective options for slowing the epidemic are biomedical, and several promising methods are in development, including microbicides, vaccines, and preexposure prophylaxis (PREP, or the daily use of antiretrovirals to prevent the acquisition of HIV). There is widespread reluctance to enroll minors in such biomedical prevention trials because of concerns about vulnerability related to physical maturity, experiential maturity, and diminished autonomy as well as legal and social challenges that vary across and within nations. However, excluding minors from trials misses an important opportunity to evaluate the effectiveness, acceptability, and safety of innovative interventions under the best conditions for identifying and resolving potential problems. The challenges of including minors in HIV prevention trials are highlighted through the example of one rural South African community that has been particularly devastated by the HIV epidemic.

  4. 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.

  5. Lopinavir/ritonavir monotherapy as a nucleoside analogue-sparing strategy to prevent HIV-1 mother-to-child transmission: the ANRS 135 PRIMEVA phase 2/3 randomized trial.

    PubMed

    Tubiana, Roland; Mandelbrot, Laurent; Le Chenadec, Jérome; Delmas, Sandrine; Rouzioux, Christine; Hirt, Deborah; Treluyer, Jean-Marc; Ekoukou, Dieudonné; Bui, Eda; Chaix, Marie-Laure; Blanche, Stéphane; Warszawski, Josiane

    2013-09-01

    Prevention of mother-to-child transmission (PMTCT) of human immunodeficiency virus (HIV) is usually based on zidovudine-containing regimens, despite potential toxicities. This multicenter trial evaluated whether lopinavir/ritonavir (LPV/r) monotherapy in HIV type 1-infected women not requiring antiretrovirals for themselves could control maternal viral load (VL).  Overall, 105 pregnant women with baseline VL <30 000 copies/mL and CD4 ≥350 cells/µL were randomized to start open-label LPV/r 400/100 mg twice daily alone (monotherapy group, n = 69) or combined with zidovudine/lamivudine 300/150 mg twice daily (triple therapy group, n = 36) from 26 gestational weeks to delivery. According to a Fleming 2-stage phase 2 design, monotherapy was considered to be efficacious if at least 59 patients achieved VL <200 copies/mL at 8 weeks of treatment (primary endpoint). Secondary endpoints were VL at delivery and tolerance.  Monotherapy was efficacious as defined: 62 women in the monotherapy group achieved VL <200 copies/mL at 34 weeks' gestation (ie, 8 weeks of treatment; 89.9%; 95% confidence interval [CI], 80.2%-95.8%). At delivery, proportions with VL <200 copies/mL were similar in the monotherapy and triple therapy groups (92.8% vs 97.2%; P = .66); however, fewer had VL <50 copies/mL in the monotherapy group (78.3% vs 97.2%; P = .01). Changes for intolerance were less frequent in the monotherapy than in the triple therapy group (1.4% vs 11.1%, respectively; P = .046). Cesarean delivery and preterm delivery rates did not differ. All children were liveborn; 1 case of HIV-1 transmission occurred in the triple therapy group, none in the monotherapy group (95% CI upper limit = 5.2%).  LPV/r monotherapy achieved satisfactory virologic efficacy in women treated solely for PMTCT, providing proof of concept for future nucleoside-sparing strategies.

  6. Sustaining youth peer HIV / STD prevention education.

    PubMed

    Kauffman, C; Hue, L

    1997-01-01

    This article describes an adolescent, peer-education training program in Jamaica that was developed and operated by the Red Cross Societies of Jamaica and the US and was funded by AIDSCAP. The program aimed to develop a training system to prepare youth peer educators in preventing the spread of HIV infections and sexually transmitted diseases. The goal was to increase knowledge about, change attitudes toward, and develop prevention skills for HIV/AIDS. The initial program was to be replicated on a large scale and be sustainable over time. The program was developed in response to the 1500+ Jamaicans diagnosed with AIDS and the 20,000 or so with HIV infections. Transmission is mostly heterosexual. 15% of girls and 47% of boys are sexually active by 14 years of age, and almost 50% of syphilis and gonorrhea cases are among adolescents. The national training program relies on peer educators, aged 14-19 years, who are literate to the 6th-grade level. Training sessions are conducted for 10-21 persons/session for 27 hours over 3 weekends. Training relies on engaging games and activities. Trainees are taught how to facilitate 14 specific activities, including the correct way to use a condom. Peer educators work together in groups of twos or threes among groups of 10-15 adolescents, aged 10-15 years. By the third year of operation, most of the systems and materials were in place and the program expanded; cost-benefit analysis revealed that costs were returned. The program has continued with a variety of funds and delivery systems and new funding will likely shift the program emphasis. The program has survived with the enthusiasm and support of the trainers. Other start-up programs should ensure the involvement of youth at all stages of development.

  7. HIV prevention and low-income Chilean women

    PubMed Central

    CIANELLI, ROSINA; FERRER, LILIAN; MCELMURRY, BEVERLY J.

    2008-01-01

    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. PMID:18432428

  8. Involving faith-based organizations in adolescent HIV prevention.

    PubMed

    Williams, Terrinieka T; Griffith, Derek M; Pichon, Latrice C; Campbell, Bettina; Allen, Julie Ober; Sanchez, Jennifer C

    2011-01-01

    The rates of sexually transmitted infections (STIs; including HIV/AIDS) among African Americans in Flint, Michigan, are among the highest in the state. In Genesee County, where Flint is located, the incidence of HIV/AIDS cases increased at an average rate of 24% each year from 2003 to 2007 for adolescents between the ages of 13 and 19. YOUR Blessed Health (YBH) is a multilevel, faith-based HIV prevention program designed to increase HIV awareness and knowledge and reduce HIV risk behaviors among African American congregations. This article describes one of the five components of the intervention--training of faith leaders to implement a sexual health curriculum for adolescents in their congregations. Staff from YOUR Center, a community-based HIV service organization, and researchers from the University of Michigan, School of Public Health, partnered with faith-based organizations (FBOs) to address HIV/AIDS in Flint, Michigan. Participating FBOs selected faith leaders to be trained by YOUR Center staff to implement the YBH program in their congregations. Using the HIV Outreach, Prevention and Education (HOPE) curriculum, faith leaders from 20 FBOs provided HIV education to 212 adolescents in Flint, Michigan. Study findings demonstrate that faith leaders who participate in specific and ongoing HIV prevention education training can be useful sexual health resources for youth in faith-based settings. Implications for research and practice highlight the advantages of continued partnerships between FBOs and public health professionals in future HIV prevention efforts for adolescents.

  9. 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

  10. Prevention of Sexually Transmitted Diseases in HIV-Infected Individuals.

    PubMed

    Quilter, Laura; Dhanireddy, Shireesha; Marrazzo, Jeanne

    2017-04-01

    Prevention of sexually transmitted infections (STIs) is an important part of the care of the HIV-infected individual. STIs have been associated with increased risk of transmission and acquisition of HIV. Among HIV-infected persons, treatment failures and high recurrence rates of some STIs are more common. Despite the recognized importance of prevention and discussion of sexual health, rates of screening for STIs are suboptimal. Moreover, rates of STIs such as syphilis continue to increase particularly in men who have sex with men (MSM). This review focuses on the most common STIs seen among HIV-infected individuals and recommendations for screening and prevention.

  11. Immunotherapy with Canarypox Vaccine and Interleukin-2 for HIV-1 Infection: Termination of a Randomized Trial

    PubMed Central

    Smith, Kendall A; Andjelic, Sofija; Popmihajlov, Zoran; Kelly-Rossini, Liza; Sass, Aquanette; Lesser, Martin; Benkert, Steven; Waters, Cory; Ruitenberg, Joyce; Bellman, Paul

    2007-01-01

    Objectives: To determine whether immunotherapy of chronic HIV-1 infection can prevent or attenuate viremia upon antiviral discontinuation. Design: This was a Phase II randomized, partially double blinded, 2×2 factorial study of three steps of 12 wk/step. Step I involved four groups: (1) vaccine placebo, (2) vaccine (ALVAC, vCP1452), (3) placebo + interleukin 2 (IL-2), and (4) vaccine + IL-2. Step II involved a 12-wk diagnostic treatment interruption (DTI). Step III involved an extension of the DTI for an additional 12 wk. Setting: The Weill-Cornell General Clinical Research Center. Participants: Chronically infected HIV-1 positive adults with undetectable HIV-1 levels and > 400 CD4+ T cells/μl. Interventions An HIV canarypox vaccine (vCP1452) and vaccine placebo, administered every 4 wk for four doses, and low-dose IL-2 administered daily for 12–24 wk. Outcome measures: Primary endpoints: (1) Proportion of participants with undetectable plasma HIV RNA during trial Step II, (2) mean log10 HIV RNA copies/ml ([HIV]) from weeks 21–25, and (3) proportion of individuals eligible for trial Step III. Results: 44 participants were randomized, but 16 withdrew or were withdrawn before completing Step II. As all participants underwent viral relapse in Step II, the study was terminated after 28 participants completed Step II. Among the four groups, there was no difference in mean [HIV] or the proportion of individuals with < log10 4.48 HIV; no difference between the mean [HIV] of the two groups that received ALVAC (n = 17) versus placebo (n = 11); and no significant difference between the mean [HIV] of the two groups that received IL-2 (n = 11) versus placebo (n = 17). Conclusions: Neither ALVAC (vCP1452) nor low-dose daily IL-2 nor their combination prevented the relapse of viremia upon discontinuation of antiviral therapy. PMID:17260026

  12. 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

  13. 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

  14. The Lancet Infectious Diseases HIV Prevention Resource Center.

    PubMed

    McConnell, John

    2016-10-01

    In collaboration with the US Centers for Diseases Control and Prevention (CDC), The Lancet Infectious Diseases has launched a free HIV prevention resource centre (http://hivprevent.thelancet.com). Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. 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.

  16. Impact of School-Based HIV Prevention Program in Post-Conflict Liberia

    ERIC Educational Resources Information Center

    Atwood, Katharine A.; Kennedy, Stephen B.; Shamblen, Steve; Tegli, Jemee; Garber, Salome; Fahnbulleh, Pearl W.; Korvah, Prince M.; Kolubah, Moses; Mulbah-Kamara, Comfort; Fulton, Shannon

    2012-01-01

    This paper presents findings of a feasibility study to adapt and evaluate the impact of an evidence-based HIV prevention intervention on sexual risk behaviors of in-school 6th grade youth in post-conflict Liberia (n = 812). The study used an attention-matched, group randomized controlled trial. Four matched pairs of elementary/middle schools in…

  17. Impact of School-Based HIV Prevention Program in Post-Conflict Liberia

    ERIC Educational Resources Information Center

    Atwood, Katharine A.; Kennedy, Stephen B.; Shamblen, Steve; Tegli, Jemee; Garber, Salome; Fahnbulleh, Pearl W.; Korvah, Prince M.; Kolubah, Moses; Mulbah-Kamara, Comfort; Fulton, Shannon

    2012-01-01

    This paper presents findings of a feasibility study to adapt and evaluate the impact of an evidence-based HIV prevention intervention on sexual risk behaviors of in-school 6th grade youth in post-conflict Liberia (n = 812). The study used an attention-matched, group randomized controlled trial. Four matched pairs of elementary/middle schools in…

  18. Factors associated with incarceration and incident human immunodeficiency virus (HIV) infection among injection drug users participating in an HIV vaccine trial in Bangkok, Thailand, 1999-2003.

    PubMed

    Suntharasamai, Pravan; Martin, Michael; Vanichseni, Suphak; van Griensven, Frits; Mock, Philip A; Pitisuttithum, Punnee; Tappero, Jordan W; Sangkum, Udomsak; Kitayaporn, Dwip; Gurwith, Marc; Choopanya, Kachit

    2009-02-01

    To determine if incarceration was associated with human immunodeficiency virus (HIV) infection and identify risk factors for incarceration among injection drug users (IDUs) participating in an HIV vaccine trial in Bangkok. The AIDSVAX B/E HIV vaccine trial was a randomized, double-blind, placebo-controlled study. A proportional hazards model was used to evaluate demographic characteristics, risk behavior and incarceration as predictors of HIV infection and generalized estimation equation logistic regression analysis to investigate demographic characteristics and risk behaviors for predictors of incarceration. The trial was conducted in Bangkok Metropolitan Administration drug-treatment clinics, 1999-2003. A total of 2546 HIV-uninfected IDUs enrolled in the trial. HIV testing was performed and an interviewer-administered questionnaire was used to assess risk behavior and incarceration at baseline and every 6 months for a total of 36 months. HIV incidence was 3.4 per 100 person-years [95% confidence interval (CI), 3.0-3.9] and did not differ among vaccine and placebo recipients. In multivariable analysis, being in jail (P < 0.04), injecting (P < 0.0001), injecting daily (P < 0.0001) and sharing needles (P = 0.02) were associated with HIV infection and methadone maintenance was protective (P = 0.0006). Predictors of incarceration in multivariable analysis included: male sex (P = 0.04), younger age (P < 0.0001), less education (P = 0.001) and being in jail (P < 0.0001) or prison (P < 0.0001) before enrollment. Among IDUs in the AIDSVAX B/E trial, incarceration in jail was associated with incident HIV infection. IDUs in Thailand remain at high risk of HIV infection and additional prevention tools are needed urgently. HIV prevention services, including methadone, should be made available to IDUs.

  19. 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…

  20. 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…

  1. 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…

  2. 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…

  3. 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…

  4. 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…

  5. Motivators of enrolment in HIV vaccine trials: a review of HIV vaccine preparedness studies.

    PubMed

    Dhalla, Shayesta; Poole, Gary

    2011-11-01

    HIV vaccine preparedness studies (VPS) are important precursors to HIV vaccine trials. As well, they contribute to an understanding of motivators and barriers for participation in hypothetical HIV vaccine trials. Motivators can take the form of altruism and a desire for social benefits. Perceived personal benefits, including psychological, personal, and financial well-being, may also motivate participation. The authors performed a systematic review of HIV VPS using the Cochrane Database for Systematic Reviews, Medline, PubMed, Embase, and Google Scholar. The authors independently searched the literature for individual HIV VPS that examined motivators of participation in a hypothetical HIV vaccine trial, using the same search strategy. As the denominators employed in the literature varied across studies, the denominators were standardized to the number of respondents per survey item, regardless of their willingness to participate (WTP) in an HIV vaccine trial. The authors retrieved eight studies on social benefits (i.e., altruism) and 11 studies on personal benefits conducted in the Organization for Economic Co-operation and Development (OECD) countries, as well as 19 studies on social benefits and 20 studies on personal benefits in the non-OECD countries. Various different forms of altruism were found to be the major motivators for participation in an HIV vaccine trial in both the OECD and the non-OECD countries. In a large number of studies, protection from HIV was cited as a personal motivator for participation in a hypothetical HIV vaccine trial in the OECD and the non-OECD countries. Knowledge of motivators can inform and target recruitment for HIV vaccine trials, although it must be remembered that hypothetical motivators may not always translate into motivators in an actual vaccine trial.

  6. The economics of HIV prevention strategies in NSW.

    PubMed

    Hales, James R

    2010-01-01

    HIV in Australia was first diagnosed in NSW in the early 1980s, and has had a significant effect on public health. The NSW Government commenced its investment in HIV/AIDS in 1984 and the investment now encompasses research, primary and secondary prevention, and care, treatment and support for people living with HIV/AIDS. A recent study examined the historical impact of the HIV/AIDS epidemic and projected its future impact in NSW. The analysis indicates that the NSW HIV/AIDS investment program has been highly effective in reducing HIV transmission, and has also been cost effective in: avoiding future health-care costs; life years saved; and quality of life benefits. The analysis also indicates that any scaling back of prevention initiatives would result in an increase in the number of people living with HIV.

  7. Prevention on parent to child transmission of HIV - what is new?

    PubMed

    Lala, Mamatha M; Merchant, Rashid H

    2012-11-01

    Prevention of Mother-To-Child Transmission (PMTCT) of HIV has been at the forefront of research in the field of HIV/AIDS since the PACTG 076 proved successful in 1994. This was followed by many trials with single, dual, or triple Anti Retroviral Therapy (ART), with or without breast-feeding, with different modes of delivery. These trials aimed and promised to find a relatively simple, low-cost intervention that could virtually eliminate the risk of HIV transmission from mother to child, cutting across all geographic boundaries. However, translation of the findings from most of these research studies into successful national PMTCT programs and health policies has not been optimal. In the west, parent to child transmission of HIV has been virtually eliminated due to universal coverage, screening, planned conception wherever possible, thorough evaluation and appropriate antenatal, intranatal and postnatal interventions. In contrast, in resource limited settings where the magnitude of the problem is the greatest accounting for more than 95 % of all vertical transmissions of HIV, there is a constant struggle dealing with the birth of an infected infant every minute. It is time to make optimal choices to prevent the transmission of HIV from an infected mother to her child and virtually eliminate this largely preventable scourge in children.

  8. 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

  9. HIV Vaccine Trials Network: activities and achievements of the first decade and beyond

    PubMed Central

    Kublin, James G; Morgan, Cecilia A; Day, Tracey A; Gilbert, Peter B; Self, Steve G; McElrath, M Juliana; Corey, Lawrence

    2012-01-01

    The HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and educators facilitating the development of HIV/AIDS preventive vaccines. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity, to testing vaccine efficacy. Over the past decade, the HVTN has aimed to improve the process of designing, implementing and analyzing vaccine trials. Several major achievements include streamlining protocol development while maintaining input from diverse stakeholders, establishing a laboratory program with standardized assays and systems allowing for reliable immunogenicity assessments across trials, setting statistical standards for the field and actively engaging with site communities. These achievements have allowed the HVTN to conduct over 50 clinical trials and make numerous scientific contributions to the field. PMID:23243491

  10. 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

  11. 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.

  12. Rapid HIV screening: missed opportunities for HIV diagnosis and prevention.

    PubMed

    Patel, Pragna; Bennett, Berry; Sullivan, Timothy; Parker, Monica M; Heffelfinger, James D; Sullivan, Patrick S

    2012-05-01

    Although rapid HIV tests increase the number of persons who are aware of their HIV status, they may fail to detect early HIV infection. To evaluate the sensitivity for early HIV infection of several rapid tests and third- and fourth-generation assays compared with nucleic acid amplification testing (NAAT). Sensitivity for early HIV infection was evaluated using 62 NAAT-positive/WB-negative or indeterminate specimens from the CDC Acute HIV Infection study. Specimens underwent third-generation testing with Genetic Systems 1/2+O(®) and rapid testing with Multispot HIV-1/HIV-2. A subset was also tested with four FDA-approved rapid tests and Determine HIV-1 Antigen/Antibody Rapid Test(®) and Architect HIV Antigen/Antibody Combo(®), both fourth-generation tests. Of 99,111 specimens screened from April 2006 to March 2008, 62 met the definition for early HIV infection (60 NAAT-positive/seronegative and 2 NAAT-positive/Western blot indeterminate). Third-generation testing correctly detected antibody in 34 specimens (55%; 95% confidence interval (CI): 42-67); Multispot detected antibody in 16 (26%; 95% CI: 16-38). Of the 62 specimens, 33 (53%) had sufficient quantity for further testing. Rapid test sensitivities for early HIV infection ranged from 22-33% compared with 55-57% for the third-generation assay and 76-88% for the fourth-generation tests. Many rapid HIV tests failed to detect half of the early HIV infection cases in whom antibody was present. Programs that screen high-incidence populations with rapid tests should consider supplemental testing with NAAT or other antigen-based tests. These data support the need for more sensitive antigen-based point-of-care screening tests for early HIV infection. Published by Elsevier B.V.

  13. Empowering peer group leaders for HIV prevention in Malawi.

    PubMed

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

    2013-09-01

    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. 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. We used inductive content analysis and comparisons within and between cases. 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. 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. 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. © 2013 Sigma Theta Tau International.

  14. Ethical issues in HIV prevention research with people who inject drugs.

    PubMed

    Sugarman, Jeremy; Rose, Scott M; Metzger, David

    2014-04-01

    Injection drug use continues to significantly contribute to new infections with HIV. Moreover, conducting HIV prevention research with people who inject drugs (PWIDs) can be complicated for an array of practical, social, legal, and ethical reasons. It is critical that these research efforts are sensitive to the particular vulnerabilities associated with injection drug use as well as those related to being at risk of acquiring HIV so as to minimize harm to participants in research. To describe how we addressed some of these ethical challenges during the course of a large-scale multinational randomized HIV prevention trial involving PWIDs, which was successfully completed. The ethical issues encountered during the life cycle of the trial were cataloged by the principal investigator, study coordinator, and ethicist working on the trial. Relevant study documents were then reviewed to provide pertinent details. The ethical issues unique to the trial were then described. Before implementation, the trial faced particularly complex challenges related to the vulnerability of PWIDs, where HIV seroincidence rates in the population were high and legal policies and stigma regarding injection drug use was severe. Accordingly, a rapid policy assessment was commissioned, and a series of community engagement activities were conducted. During the trial, in addition to using careful standard operating procedures regarding all aspects of trial conduct and extensive staff training, the trial standardized informed consent procedures and assessed them. Furthermore, social harms were monitored along with physical harms and adverse events. Following the decision to close the study, it was critical to develop an orderly and safe process for closing it. The issue of post-trial access to the study medication and a complex intervention also surfaced for consideration. The issues described in this article are necessarily limited to how they manifested themselves within the context of a

  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 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