Brief Report: High Sensitivity and Specificity of the Cepheid Xpert HIV-1 Qualitative Point-of-Care Test Among Newborns in Botswana.

PubMed

Ibrahim, Maryanne; Moyo, Sikhulile; Mohammed, Terence; Mupfumi, Lucy; Gaseitsiwe, Simani; Maswabi, Kenneth; Ajibola, Gbolahan; Gelman, Rebecca; Batlang, Oganne; Sakoi, Maureen; Auletta-Young, Chloe; Makhema, Joseph; Lockman, Shahin; Shapiro, Roger L

2017-08-15

HIV point-of-care (POC) testing allows for early infant HIV diagnosis and treatment, but POC accuracy at birth and in the setting of antiretroviral prophylaxis for the prevention of mother-to-child HIV transmission is unknown. We evaluated the Cepheid Xpert HIV-1 Qual POC test against the Roche Taqman HIV-1 DNA polymerase chain reaction (PCR) platform using dried blood spots from 15 HIV-infected and 75 HIV-exposed uninfected newborns. These infants were screened for HIV at <96 hours of life at 5 hospital maternity wards in Botswana; all infants received postexposure antiretroviral prophylaxis with single-dose nevirapine and zidovudine, and most mothers received 3-drug antiretroviral therapy in pregnancy and at delivery. Fourteen of the 15 PCR positive samples tested positive by Cepheid POC, yielding a sensitivity of 93.3% (95% confidence interval: 68.1 to 99.8). Baseline viral load among positive infants ranged from <40 to >10,000,000 copies/mL, with a median of 2403 copies/mL. The HIV RNA for the infant with false-negative POC testing was 1661 copies/mL. Of note, 2 infants with low HIV RNA (<40 and 272 copies/mL) were correctly identified as HIV positive by Cepheid POC. All the 75 PCR-negative samples tested negative by Cepheid POC, yielding a specificity of 100% (95% confidence interval: 96.1 to 100). Our study demonstrates high sensitivity and specificity for the Cepheid POC assay in the first week of life despite early infection and antiretroviral prophylaxis. This platform may be a useful approach for adding early infant HIV diagnosis to current testing programs.

Comparative evaluation of the Aptima HIV-1 Quant Dx assay and COBAS TaqMan HIV-1 v2.0 assay using the Roche High Pure System for the quantification of HIV-1 RNA in plasma.

PubMed

Schalasta, Gunnar; Börner, Anna; Speicher, Andrea; Enders, Martin

2016-03-01

Quantification of human immunodeficiency virus type 1 (HIV-1) RNA in plasma has become the standard of care in the management of HIV-infected patients. There are several commercially available assays that have been implemented for the detection of HIV-1 RNA in plasma. Here, the new Hologic Aptima® HIV-1 Quant Dx assay (Aptima HIV) was compared to the Roche COBAS® TaqMan® HIV-1 Test v2.0 for use with the High Pure System (HPS/CTM). The performance characteristics of the assays were assessed using commercially available HIV reference panels, dilution of the WHO 3rd International HIV-1 RNA International Standard (WHO-IS) and plasma from clinical specimens. Assay performance was determined by linear regression, Deming correlation analysis and Bland-Altman analysis. Testing of HIV-1 reference panels revealed excellent agreement. The 61 clinical specimens quantified in both assays were linearly associated and strongly correlated. The Aptima HIV assay offers performance comparable to that of the HPS/CTM assay and, as it is run on a fully automated platform, a significantly improved workflow.

Aptima HIV-1 Quant Dx--A fully automated assay for both diagnosis and quantification of HIV-1.

PubMed

Nair, Sangeetha Vijaysri; Kim, Hee Cheol; Fortunko, Jacqueline; Foote, Tracy; Peling, Tashi; Tran, Cuong; Nugent, Charles Thomas; Joo, Sunghae; Kang, Youna; Wilkins, Bana; Lednovich, Kristen; Worlock, Andrew

2016-04-01

Separate assays are available for diagnosis and viral load (VL) monitoring of HIV-1. Studies have shown that using a single test for both confirmatory diagnosis and VL increases linkage to care. To validate a single assay for both diagnosis and VL monitoring of HIV-1 on the fully automated Panther platform. Validate the assay by assessing specificity, sensitivity, subtype detection, seroconversion, reproducibility and linearity. Also assess diagnostic agreement with the Procleix(®) Ultrio Elite™ discriminatory assay (Procleix), and agreement of VL results (method comparison) with Ampliprep/COBAS TaqMan HIV-1 version 2.0 (CAP/CTM), using clinical samples. The assay was specific (100%) and sensitive with a 95% limit of detection of 12 copies/mL with the 3rd WHO standards. Aptima detected HIV in seroconversion panels 6 and 11 days before p24 antigen and antibody tests, respectively. Diagnostic agreement with Procleix, was 100%. Regression analysis showed good agreement of VL results between Aptima and CAP/CTM with a slope of 1.02, intercept of 0.07, and correlation coefficient (R(2)) of 0.97. Aptima was more sensitive than CAP/CTM. Equivalent quantification was seen on testing clinical samples and isolates belonging to HIV group M, N, O and P and commercially available subtype panels. Assay results were linear (R(2) 0.9994) with standard deviation of <0.17 log copies across assay range. The good specificity, sensitivity, precision, subtype performance and clinical agreement with other assays demonstrated by Aptima combined with the complete automation provided by the Panther platform makes Aptima a good candidate for both VL monitoring and diagnosis of HIV-1. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study.

PubMed

Fidler, Sarah; Lewis, Heather; Meyerowitz, Jodi; Kuldanek, Kristin; Thornhill, John; Muir, David; Bonnissent, Alice; Timson, Georgina; Frater, John

2017-10-20

There is a global need for HIV viral load point-of-care (PoC) assays to monitor patients receiving antiretroviral therapy. UNICORN was the first study of an off-label protocol using whole blood finger-prick samples tested with and without a simple three minute spin using a clinic-room microcentrifuge. Two PoC assays were evaluated in 40 HIV-positive participants, 20 with detectable and 20 with undetectable plasma viral load (pVL) (<20 copies/ml). Using 100 µl finger-prick blood samples, the Cepheid Xpert HIV-1 Viral Load and HIV-1 Qual cartridges were compared with laboratory pVL assessment (TaqMan, Roche). For participants with undetectable viraemia by TaqMan, there was poor concordance without centrifugation with the TaqMan platform with only 40% 'undetectable' using Xpert VL and 25% 'not detected' using the Qual assay. After a 3 minute spin, 100% of samples were undetectable using either assay, showing full concordance with the TaqMan assay. Defining a lower limit of detection of 1000 copies/ml when including a spin, there was 100% concordance with the TaqMan platform with strong correlation (rho 0.95 and 0.94; p < 0.0001 for both assays). When including a simple microcentrifugation step, finger-prick PoC testing was a quick and accurate approach for assessing HIV viraemia, with excellent concordance with validated laboratory approaches.

Establishing diagnostic cut-off criteria for the COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative test through validation against the Amplicor DNA test v1.5 for infant diagnosis using dried blood spots.

PubMed

Maritz, Jean; Preiser, Wolfgang; van Zyl, Gert U

2012-02-01

As antibody testing cannot confirm HIV-1 infection in children less than 18 months of age, diagnosis in these children depends on nucleic acid testing. The COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) (CAP/CTM, Roche(®) Molecular Systems, Inc., Branchburg, NJ) HIV-1 Qualitative test is a total nucleic acid real-time PCR assay utilising whole EDTA blood or dried blood spots (DBS), which recently replaced the Roche(®) AMPLICOR(®) DNA test v1.5 (Amplicor) as the diagnostic HIV PCR assay in many South African laboratories. For the Amplicor assay, stringent diagnostic criteria were previously formulated for the local population, and a comparison reported the CAP/CTM's sensitivity at 99.7% and specificity at 100% for both sample types compared to these Amplicor criteria. To validate the assay prior to introduction in our laboratory and to define stringent diagnostic cut-off criteria. Whole EDTA blood samples from patients younger than 18 months sent for routine HIV-1 diagnosis were tested by Amplicor, and positive results were confirmed from DBS. CAP/CTM assays were subsequently performed from DBS. The CAP/CTM had a sensitivity of 98.8% and a specificity of 97.1%, but a positive predictive value (PPV) of only 78.7% compared to the Amplicor assay. Samples positive by CAP/CTM but negative by Amplicor displayed poor amplification curves compared to concordant positive samples. Upon re-testing those with sufficient material available by CAP/CTM, all showed negative results. The decreased PPV may either be due to false positive CAP/CTM results, or increased sensitivity compared to the Amplicor assay. Criteria were formulated for defining presumed false-positive results. Copyright © 2011 Elsevier B.V. All rights reserved.

TaqMan 5′-Nuclease Human Immunodeficiency Virus Type 1 PCR Assay with Phage-Packaged Competitive Internal Control for High-Throughput Blood Donor Screening

PubMed Central

Drosten, C.; Seifried, E.; Roth, W. K.

2001-01-01

Screening of blood donors for human immunodeficiency virus type 1 (HIV-1) infection by PCR permits the earlier diagnosis of HIV-1 infection compared with that by serologic assays. We have established a high-throughput reverse transcription (RT)-PCR assay based on 5′-nuclease PCR. By in-tube detection of HIV-1 RNA with a fluorogenic probe, the 5′-nuclease PCR technology (TaqMan PCR) eliminates the risk of carryover contamination, a major problem in PCR testing. We outline the development and evaluation of the PCR assay from a technical point of view. A one-step RT-PCR that targets the gag genes of all known HIV-1 group M isolates was developed. An internal control RNA detectable with a heterologous 5′-nuclease probe was derived from the viral target cDNA and was packaged into MS2 coliphages (Armored RNA). Because the RNA was protected against digestion with RNase, it could be spiked into patient plasma to control the complete sample preparation and amplification process. The assay detected 831 HIV-1 type B genome equivalents per ml of native plasma (95% confidence interval [CI], 759 to 936 HIV-1 B genome equivalents per ml) with a ≥95% probability of a positive result, as determined by probit regression analysis. A detection limit of 1,195 genome equivalents per ml of (individual) donor plasma (95% CI, 1,014 to 1,470 genome equivalents per ml of plasma pooled from individuals) was achieved when 96 samples were pooled and enriched by centrifugation. Up to 4,000 plasma samples per PCR run were tested in a 3-month trial period. Although data from the present pilot feasibility study will have to be complemented by a large clinical validation study, the assay is a promising approach to the high-throughput screening of blood donors and is the first noncommercial test for high-throughput screening for HIV-1. PMID:11724836

Leukodepletion as a Point-of-Care Method for Monitoring HIV-1 Viral Load in Whole Blood

PubMed Central

Titchmarsh, Logan; Zeh, Clement; Verpoort, Thierry; Allain, Jean-Pierre

2014-01-01

In order to limit the interference of HIV-1 cellular nucleic acids in estimating viral load (VL), the feasibility of leukodepletion of a small whole-blood (WB) volume to eliminate only leukocyte cell content was investigated, using a selection of filters. The efficacy of leukocyte filtration was evaluated by counting, CD45 quantitative PCR, and HIV-1 DNA quantification. Plasma HIV-1 was tested by real-time reverse transcription (RT)-PCR. A specific, miniaturized filter was developed and tested for leukocyte and plasma virus retention, WB sample dilution, and filtration parameters in HIV-1-spiked WB samples. This device proved effective to retain >99.9% of white blood cells in 100 μl of WB without affecting plasma VL. The Samba sample preparation chemistry was adapted to use a leukodepleted WB sample for VL monitoring using the point-of-care Samba-1 semiautomated system. The clinical performance of the assay was evaluated by testing 207 consecutive venous EDTA WB samples from HIV-1-infected patients attending a CD4 testing clinic. Most patients were on antiretroviral treatment (ART), but their VL status was unknown. Compared to the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test, the new Samba assay had a concordance of 96.5%. The use of the Samba system with a VL test for WB might contribute to HIV-1 ART management and reduce loss-to-follow-up rates in resource-limited settings. PMID:25428162

TaqMan PCR for Detection of Vibrio cholerae O1, O139, Non-O1, and Non-O139 in Pure Cultures, Raw Oysters, and Synthetic Seawater†

PubMed Central

Lyon, W. J.

2001-01-01

Vibrio cholerae is recognized as a leading human waterborne pathogen. Traditional diagnostic testing for Vibrio is not always reliable, because this bacterium can enter a viable but nonculturable state. Therefore, nucleic acid-based tests have emerged as a useful alternative to traditional enrichment testing. In this article, a TaqMan PCR assay is presented for quantitative detection of V. cholerae in pure cultures, oysters, and synthetic seawater. Primers and probe were designed from the nonclassical hemolysin (hlyA) sequence of V. cholerae strains. This probe was applied to DNA from 60 bacterial strains comprising 21 genera. The TaqMan PCR assay was positive for all of the strains of V. cholerae tested and negative for all other species of Vibrio tested. In addition, none of the other genera tested was amplified with the TaqMan primers and probe used in this study. The results of the TaqMan PCR with raw oysters and spiked with V. cholerae serotypes O1 and O139 were comparable to those of pure cultures. The sensitivity of the assay was in the range of 6 to 8 CFU g−1 and 10 CFU ml−1 in spiked raw oyster and synthetic seawater samples, respectively. The total assay could be completed in 3 h. Quantification of the Vibrio cells was linear over at least 6 log units. The TaqMan probe and primer set developed in this study can be used as a rapid screening tool for the presence of V. cholerae in oysters and seawater without prior isolation and characterization of the bacteria by traditional microbiological methods. PMID:11571173

Rapid HIV-1 testing during labor: a multicenter study.

PubMed

Bulterys, Marc; Jamieson, Denise J; O'Sullivan, Mary Jo; Cohen, Mardge H; Maupin, Robert; Nesheim, Steven; Webber, Mayris P; Van Dyke, Russell; Wiener, Jeffrey; Branson, Bernard M

2004-07-14

Timely testing of women in labor with undocumented human immunodeficiency virus (HIV) status could enable immediate provision of antiretroviral prophylaxis. To determine the feasibility and acceptance of rapid HIV testing among women in labor and to assess rapid HIV assay performance. The Mother-Infant Rapid Intervention At Delivery (MIRIAD) study implemented 24-hour counseling and voluntary rapid HIV testing for women in labor at 16 US hospitals from November 16, 2001, through November 15, 2003. A rapid HIV-1 antibody test for whole blood was used. Acceptance of HIV testing; sensitivity, specificity, and predictive value of the rapid test; time from blood collection to patient notification of results. There were 91,707 visits to the labor and delivery units in the study, 7381 of which were by eligible women without documentation of HIV testing. Of these, 5744 (78%) women were approached for rapid HIV testing and 4849 (84%) consented. HIV-1 test results were positive for 34 women (prevalence = 7/1000). Sensitivity and specificity of the rapid test were 100% and 99.9%, respectively; positive predictive value was 90% compared with 76% for enzyme immunoassay (EIA). Factors independently associated with higher test acceptance included younger age, being black or Hispanic, gestational age less than 32 weeks, and having had no prenatal care. Lower acceptance was associated with being admitted between 4 pm and midnight, particularly on Friday nights, but this may be explained in part by fewer available personnel. Median time from blood collection to patient notification of result was 66 minutes (interquartile range, 45-120 minutes), compared with 28 hours for EIA (P<.001). Rapid HIV testing is feasible and delivers accurate and timely test results for women in labor. It provides HIV-positive women prompt access to intrapartum and neonatal antiretroviral prophylaxis, proven to reduce perinatal HIV transmission, and may be particularly applicable to higher-risk populations.

Evaluation of Hologic Aptima HIV-1 Quant Dx Assay on the Panther System on HIV Subtypes

PubMed Central

Hack, Holly R.; Nair, Sangeetha V.; Worlock, Andrew; Malia, Jennifer A.; Peel, Sheila A.; Jagodzinski, Linda L.

2016-01-01

Quantitation of the HIV-1 viral load in plasma is the current standard of care for clinical monitoring of HIV-infected individuals undergoing antiretroviral therapy. This study evaluated the analytical and clinical performances of the Aptima HIV-1 Quant Dx assay (Hologic, San Diego, CA) for monitoring viral load by using 277 well-characterized subtype samples, including 171 cultured virus isolates and 106 plasma samples from 35 countries, representing all major HIV subtypes, recombinants, and circulating recombinant forms (CRFs) currently in circulation worldwide. Linearity of the Aptima assay was tested on each of 6 major HIV-1 subtypes (A, B, C, D, CRF01_AE, and CRF02_AG) and demonstrated an R2 value of ≥0.996. The performance of the Aptima assay was also compared to those of the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 v.2 (CAP/CTM) and Abbott m2000 RealTime HIV-1 (RealTime) assays on all subtype samples. The Aptima assay values averaged 0.21 log higher than the CAP/CTM values and 0.30 log higher than the RealTime values, and the values were >0.4 log higher than CAP/CTM values for subtypes F and G and than RealTime values for subtypes C, F, and G and CRF02_AG. Two samples demonstrated results with >1-log differences from RealTime results. When the data were adjusted by the average difference, 94.9% and 87.0% of Aptima results fell within 0.5 log of the CAP/CTM and RealTime results, respectively. The linearity and accuracy of the Aptima assay in correctly quantitating all major HIV-1 subtypes, coupled with the completely automated format and high throughput of the Panther system, make this system well suited for reliable measurement of viral load in the clinical laboratory. PMID:27510829

HIV-1 tropism testing in subjects achieving undetectable HIV-1 RNA: diagnostic accuracy, viral evolution and compartmentalization.

PubMed

Pou, Christian; Codoñer, Francisco M; Thielen, Alexander; Bellido, Rocío; Pérez-Álvarez, Susana; Cabrera, Cecilia; Dalmau, Judith; Curriu, Marta; Lie, Yolanda; Noguera-Julian, Marc; Puig, Jordi; Martínez-Picado, Javier; Blanco, Julià; Coakley, Eoin; Däumer, Martin; Clotet, Bonaventura; Paredes, Roger

2013-01-01

Technically, HIV-1 tropism can be evaluated in plasma or peripheral blood mononuclear cells (PBMCs). However, only tropism testing of plasma HIV-1 has been validated as a tool to predict virological response to CCR5 antagonists in clinical trials. The preferable tropism testing strategy in subjects with undetectable HIV-1 viremia, in whom plasma tropism testing is not feasible, remains uncertain. We designed a proof-of-concept study including 30 chronically HIV-1-infected individuals who achieved HIV-1 RNA <50 copies/mL during at least 2 years after first-line ART initiation. First, we determined the diagnostic accuracy of 454 and population sequencing of gp120 V3-loops in plasma and PBMCs, as well as of MT-2 assays before ART initiation. The Enhanced Sensitivity Trofile Assay (ESTA) was used as the technical reference standard. 454 sequencing of plasma viruses provided the highest agreement with ESTA. The accuracy of 454 sequencing decreased in PBMCs due to reduced specificity. Population sequencing in plasma and PBMCs was slightly less accurate than plasma 454 sequencing, being less sensitive but more specific. MT-2 assays had low sensitivity but 100% specificity. Then, we used optimized 454 sequence data to investigate viral evolution in PBMCs during viremia suppression and only found evolution of R5 viruses in one subject. No de novo CXCR4-using HIV-1 production was observed over time. Finally, Slatkin-Maddison tests suggested that plasma and cell-associated V3 forms were sometimes compartmentalized. The absence of tropism shifts during viremia suppression suggests that, when available, testing of stored plasma samples is generally safe and informative, provided that HIV-1 suppression is maintained. Tropism testing in PBMCs may not necessarily produce equivalent biological results to plasma, because the structure of viral populations and the diagnostic performance of tropism assays may sometimes vary between compartments. Thereby, proviral DNA tropism testing

Evaluation of four rapid tests for diagnosis and differentiation of HIV-1 and HIV-2 infections in Guinea-Conakry, West Africa.

PubMed

Chaillet, Pascale; Tayler-Smith, Katie; Zachariah, Rony; Duclos, Nanfack; Moctar, Diallo; Beelaert, Greet; Fransen, Katrien

2010-09-01

With both HIV-1 and HV-2 prevalent in Guinea-Conakry, accurate diagnosis and differentiation is crucial for treatment purposes. Thus, four rapid HIV tests were evaluated for their HIV-1 and HIV-2 diagnostic and discriminative capacity for use in Guinea-Conakry. These included SD Bioline HIV 1/2 3.0 (Standard Diagnostics Inc.), Genie II HIV1/HIV2 (Bio-Rad), First Response HIV Card Test 1-2.0 (PMC Medical) and Immunoflow HIV1-HIV2 (Core Diagnostics). Results were compared with gold standard tests (INNO-LIA HIV-I/II Score) and NEW LAV BLOT II (Bio-Rad). Four hundred and forty three sequential stored HIV-positive serum samples, of known HIV-type, were evaluated. Genie II HIV1/HIV2, Immunoflow HIV1-HIV2 and SD Bioline HIV 1/2 3.0 had 100% sensitivity (95% CI, 98.9-100%) while for First Response HIV Card Test 1-2.0 this was 99.5% (95% CI, 98.2%-99.9%). In terms of discriminatory capacity, Genie II HIV1/HIV2 identified 382/ 384(99.5%) HIV-1 samples, 49/ 52(95%) HIV-2 and 7/7(100%) HIV-positive untypable samples. Immunoflow HIV1-HIV2 identified 99% HIV-1, 67% HIV-2 and all HIV-positive untypable samples. First Response HIV Card Test 1-2.0 identified 94% HIV-1, 64% HIV-2 and 57% HIV-positive untypable samples. SD-Bioline HIV 1/2 3.0 was the worst overall performer identifying 65% HIV-1, 69% HIV-2 and all HIV-positive untypable samples. The use of SD Bioline HIV 1/2 3.0 (the current standard in Guinea-Conakry) as a discriminatory HIV test is poor and may be best replaced by Immunoflow HIV1-HIV2. Copyright 2010 Royal Society of Tropical Medicine and Hygiene. Published by Elsevier Ltd. All rights reserved.

Evaluation of the Aptima HIV-1 Quant Dx Assay Using Plasma and Dried Blood Spots

PubMed Central

Sahoo, Malaya K.; Varghese, Vici; White, Elizabeth; Winslow, Meg; Katzenstein, David A.; Shafer, Robert W.

2016-01-01

HIV-1 RNA quantitation in plasma, or virus load testing, is the primary method by which the response to antiretroviral therapy is monitored. Here we describe evaluation of the Aptima HIV-1 Quant Dx assay (Aptima) performed on the automated Panther system. The clinical performance of Aptima was compared to that of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test v2.0 (CAP/CTM) using 162 EDTA plasma samples collected from patients undergoing HIV-1 monitoring. Overall agreement was 84.0% (136/162), with a kappa statistic of 0.723 (standard error, 0.047; 95% confidence interval [CI], 0.630 to 0.815), indicating substantial agreement. Using the 86 clinical samples quantifiable by both methods, Passing-Bablok regression revealed a regression line of Y = (1.069 × X) − 0.346 (95% CI of the slope [1.003 to 1.139] and intercept [−0.666 to −0.074]), and Bland-Altman analysis demonstrated a mean difference (Aptima-CAP/CTM) of −0.075 log10 copies/ml (95% limits of agreement of −0.624 to 0.475), consistent with negative bias. Comparison of Aptima results for paired dried blood spot (DBS) and plasma specimens archived from participants in the Peninsula AIDS Research Cohort Study (PARC) demonstrated an overall agreement of 94.7% (90/95) when 1,000 copies/ml was used as the threshold. In conclusion, the Aptima HIV-1 Quant Dx assay provides a suitable alternative for HIV-1 monitoring in plasma and DBS. PMID:27535684

Evaluation of the Aptima HIV-1 Quant Dx Assay Using Plasma and Dried Blood Spots.

PubMed

Sahoo, Malaya K; Varghese, Vici; White, Elizabeth; Winslow, Meg; Katzenstein, David A; Shafer, Robert W; Pinsky, Benjamin A

2016-10-01

HIV-1 RNA quantitation in plasma, or virus load testing, is the primary method by which the response to antiretroviral therapy is monitored. Here we describe evaluation of the Aptima HIV-1 Quant Dx assay (Aptima) performed on the automated Panther system. The clinical performance of Aptima was compared to that of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test v2.0 (CAP/CTM) using 162 EDTA plasma samples collected from patients undergoing HIV-1 monitoring. Overall agreement was 84.0% (136/162), with a kappa statistic of 0.723 (standard error, 0.047; 95% confidence interval [CI], 0.630 to 0.815), indicating substantial agreement. Using the 86 clinical samples quantifiable by both methods, Passing-Bablok regression revealed a regression line of Y = (1.069 × X) - 0.346 (95% CI of the slope [1.003 to 1.139] and intercept [-0.666 to -0.074]), and Bland-Altman analysis demonstrated a mean difference (Aptima-CAP/CTM) of -0.075 log10 copies/ml (95% limits of agreement of -0.624 to 0.475), consistent with negative bias. Comparison of Aptima results for paired dried blood spot (DBS) and plasma specimens archived from participants in the Peninsula AIDS Research Cohort Study (PARC) demonstrated an overall agreement of 94.7% (90/95) when 1,000 copies/ml was used as the threshold. In conclusion, the Aptima HIV-1 Quant Dx assay provides a suitable alternative for HIV-1 monitoring in plasma and DBS. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Improving clinical laboratory efficiency: a time-motion evaluation of the Abbott m2000 RealTime and Roche COBAS AmpliPrep/COBAS TaqMan PCR systems for the simultaneous quantitation of HIV-1 RNA and HCV RNA.

PubMed

Amendola, Alessandra; Coen, Sabrina; Belladonna, Stefano; Pulvirenti, F Renato; Clemens, John M; Capobianchi, M Rosaria

2011-08-01

Diagnostic laboratories need automation that facilitates efficient processing and workflow management to meet today's challenges for expanding services and reducing cost, yet maintaining the highest levels of quality. Processing efficiency of two commercially available automated systems for quantifying HIV-1 and HCV RNA, Abbott m2000 system and Roche COBAS Ampliprep/COBAS TaqMan 96 (docked) systems (CAP/CTM), was evaluated in a mid/high throughput workflow laboratory using a representative daily workload of 24 HCV and 72 HIV samples. Three test scenarios were evaluated: A) one run with four batches on the CAP/CTM system, B) two runs on the Abbott m2000 and C) one run using the Abbott m2000 maxCycle feature (maxCycle) for co-processing these assays. Cycle times for processing, throughput and hands-on time were evaluated. Overall processing cycle time was 10.3, 9.1 and 7.6 h for Scenarios A), B) and C), respectively. Total hands-on time for each scenario was, in order, 100.0 (A), 90.3 (B) and 61.4 min (C). The interface of an automated analyzer to the laboratory workflow, notably system set up for samples and reagents and clean up functions, are as important as the automation capability of the analyzer for the overall impact to processing efficiency and operator hands-on time.

Evaluation of Hologic Aptima HIV-1 Quant Dx Assay on the Panther System on HIV Subtypes.

PubMed

Manak, Mark M; Hack, Holly R; Nair, Sangeetha V; Worlock, Andrew; Malia, Jennifer A; Peel, Sheila A; Jagodzinski, Linda L

2016-10-01

Quantitation of the HIV-1 viral load in plasma is the current standard of care for clinical monitoring of HIV-infected individuals undergoing antiretroviral therapy. This study evaluated the analytical and clinical performances of the Aptima HIV-1 Quant Dx assay (Hologic, San Diego, CA) for monitoring viral load by using 277 well-characterized subtype samples, including 171 cultured virus isolates and 106 plasma samples from 35 countries, representing all major HIV subtypes, recombinants, and circulating recombinant forms (CRFs) currently in circulation worldwide. Linearity of the Aptima assay was tested on each of 6 major HIV-1 subtypes (A, B, C, D, CRF01_AE, and CRF02_AG) and demonstrated an R(2) value of ≥0.996. The performance of the Aptima assay was also compared to those of the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 v.2 (CAP/CTM) and Abbott m2000 RealTime HIV-1 (RealTime) assays on all subtype samples. The Aptima assay values averaged 0.21 log higher than the CAP/CTM values and 0.30 log higher than the RealTime values, and the values were >0.4 log higher than CAP/CTM values for subtypes F and G and than RealTime values for subtypes C, F, and G and CRF02_AG. Two samples demonstrated results with >1-log differences from RealTime results. When the data were adjusted by the average difference, 94.9% and 87.0% of Aptima results fell within 0.5 log of the CAP/CTM and RealTime results, respectively. The linearity and accuracy of the Aptima assay in correctly quantitating all major HIV-1 subtypes, coupled with the completely automated format and high throughput of the Panther system, make this system well suited for reliable measurement of viral load in the clinical laboratory. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Pooled nucleic acid testing increases the diagnostic yield of acute HIV infections in a high-risk population compared to 3rd and 4th generation HIV enzyme immunoassays.

PubMed

Krajden, Mel; Cook, Darrel; Mak, Annie; Chu, Ken; Chahil, Navdeep; Steinberg, Malcolm; Rekart, Michael; Gilbert, Mark

2014-09-01

We compared a 3rd generation (gen) and two 4th gen HIV enzyme immunoassays (EIA) to pooled nucleic acid testing (PNAT) for the identification of pre- and early seroconversion acute HIV infection (AHI). 9550 specimens from males >18 year from clinics attended by men who have sex with men were tested by Siemens ADVIA Centaur(®) HIV 1/O/2 (3rd gen) and HIV Combo (4th gen), as well as by Abbott ARCHITECT(®) HIV Ag/Ab Combo (4th gen). Third gen non-reactive specimens were also tested by Roche COBAS(®) Ampliprep/COBAS® TaqMan HIV-1 Test v.2 in pools of 24 samples. Sensitivity and specificity of the three EIAs for AHI detection were compared. 7348 persons contributed 9435 specimens and had no evidence of HIV infection, 79 (94 specimens) had established HIV infection, 6 (9 specimens) had pre-seroconversion AHI and 9 (12 specimens) had early seroconversion AHI. Pre-seroconversion AHI cases were not detected by 3rd gen EIA, whereas 2/6 (33.3%) were detected by Siemens 4th gen, 4/6 (66.7%) by Abbott 4th gen and 6/6 (100%) by PNAT. All three EIAs and PNAT detected all individuals with early seroconversion AHI. Overall sensitivity/specificity for the EIAs relative to WB or NAT resolved infection status was 93.6%/99.9% for Siemens 3rd gen, 95.7%/99.7% for Siemens 4th gen and 97.9%/99.2% for Abbott 4th gen. While both 4th gen EIAs demonstrated improved sensitivity for AHI compared to 3rd gen EIA, PNAT identified more AHI cases than either 4th gen assay. PNAT is likely to remain a useful strategy to identify AHI in high-risk populations. Copyright © 2014 Elsevier B.V. All rights reserved.

Diagnosing acute HIV infection: The performance of quantitative HIV-1 RNA testing (viral load) in the 2014 laboratory testing algorithm.

PubMed

Wu, Hsiu; Cohen, Stephanie E; Westheimer, Emily; Gay, Cynthia L; Hall, Laura; Rose, Charles; Hightow-Weidman, Lisa B; Gose, Severin; Fu, Jie; Peters, Philip J

2017-08-01

New recommendations for laboratory diagnosis of HIV infection in the United States were published in 2014. The updated testing algorithm includes a qualitative HIV-1 RNA assay to resolve discordant immunoassay results and to identify acute HIV-1 infection (AHI). The qualitative HIV-1 RNA assay is not widely available; therefore, we evaluated the performance of a more widely available quantitative HIV-1 RNA assay, viral load, for diagnosing AHI. We determined that quantitative viral loads consistently distinguished AHI from a false-positive immunoassay result. Among 100 study participants with AHI and a viral load result, the estimated geometric mean viral load was 1,377,793copies/mL. Copyright © 2017 Elsevier B.V. All rights reserved.

Performance of the Alere Determine™ HIV-1/2 Ag/Ab Combo Rapid Test with algorithm-defined acute HIV-1 infection specimens.

PubMed

Parker, Monica M; Bennett, S Berry; Sullivan, Timothy J; Fordan, Sally; Wesolowski, Laura G; Wroblewski, Kelly; Gaynor, Anne M

2018-05-14

The capacity of HIV Antigen/Antibody (Ag/Ab) immunoassays (IA) to detect HIV-1 p24 antigen has resulted in improved detection of HIV-1 infections in comparison to Ab-only screening assays. Since its introduction in the US, studies have shown that the Determine HIV-1/2 Ag/Ab Combo assay (Determine Ag/Ab) detects HIV infection earlier than laboratory-based IgM/IgG-sensitive IAs, but its sensitivity for HIV-1 p24 Ag detection is reduced compared to laboratory-based Ag/Ab assays. However, further evaluation is needed to assess its capacity to detect acute HIV-1 infection. To assess the performance of Determine Ag/Ab in serum from acute HIV-1 infections. Select serum specimens that screened reactive on a laboratory-based Ag/Ab IA or IgM/IgG Ab-only IA, with a negative or indeterminate supplemental antibody test and detectable HIV-1 RNA were retrospectively tested with Determine Ag/Ab. Results were compared with those of the primary screening immunoassay to evaluate concordance within this set of algorithm-defined acute infections. Of 159 algorithm-defined acute HIV-1 specimens, Determine Ag/Ab was reactive for 105 resulting in 66.0% concordance. Of 125 that were initially detected by a laboratory-based Ag/Ab IA, 81 (64.8%) were reactive by Determine Ag/Ab. A total of 34 acute specimens were initially detected by a laboratory-based IgM/IgG Ab-only IA and 24 (70.6%) of those were reactive by Determine Ag/Ab. Due to their enhanced sensitivity, laboratory-based Ag/Ab IAs continue to be preferred over the Determine Ag/Ab as the screening method used by laboratories conducting HIV diagnostic testing on serum and plasma specimens. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Field comparison of OraQuick® ADVANCE Rapid HIV-1/2 antibody test and two blood-based rapid HIV antibody tests in Zambia

PubMed Central

2012-01-01

Background Zambia’s national HIV testing algorithm specifies use of two rapid blood based antibody assays, Determine®HIV-1/2 (Inverness Medical) and if positive then Uni-GoldTM Recombigen HIV-1/2 (Trinity Biotech). Little is known about the performance of oral fluid based HIV testing in Zambia. The aims of this study are two-fold: 1) to compare the diagnostic accuracy (sensitivity and specificity) under field conditions of the OraQuick® ADVANCE® Rapid HIV-1/2 (OraSure Technologies, Inc.) to two blood-based rapid antibody tests currently in use in the Zambia National Algorithm, and 2) to perform a cost analysis of large-scale field testing employing the OraQuick®. Methods This was a operational retrospective research of HIV testing and questionnaire data collected in 2010 as part of the ZAMSTAR (Zambia South Africa TB and AIDS reduction) study. Randomly sampled individuals in twelve communities were tested consecutively with OraQuick® test using oral fluid versus two blood-based rapid HIV tests, Determine® and Uni-GoldTM. A cost analysis of four algorithms from health systems perspective were performed: 1) Determine® and if positive, then Uni-GoldTM (Determine®/Uni-GoldTM); based on current algorithm, 2) Determine® and if positive, then OraQuick® (Determine®/OraQuick®), 3) OraQuick® and if positive, then Determine® (OraQuick®/Determine®), 4) OraQuick® and if positive, then Uni-GoldTM (OraQuick®/Uni-GoldTM). This information was then used to construct a model using a hypothetical population of 5,000 persons with varying prevalence of HIV infection from 1–30%. Results 4,458 participants received both a Determine® and OraQuick® test. The sensitivity and specificity of the OraQuick® test were 98.7 (95%CI, 97.5–99.4) and 99.8 (95%CI, 99.6–99.9), respectively when compared to HIV positive serostatus. The average unit costs per algorithm were US$3.76, US$4.03, US$7.35, and US$7.67 for Determine®/Uni-GoldTM, Determine®/OraQuick®, Ora

Discordances with HIV-1 RNA quantitative determinations by three commercial assays in Pointe Noire, Republic of Congo.

PubMed

Bruzzone, Bianca; Bisio, Francesca; Caligiuri, Patrizia; Mboungou, Franc A Mayinda; Nigro, Nicola; Sticchi, Laura; Ventura, Agostina; Saladini, Francesco; Zazzi, Maurizio; Icardi, Giancarlo; Viscoli, Claudio

2014-07-01

Accurate HIV-1 RNA quantitation is required to support the scale up of antiretroviral therapy in African countries. Extreme HIV-1 genetic variability in Africa may affect the ability of commercially available assays to detect and quantify HIV-1 RNA accurately. The aim of this study was to compare three real-time PCR assays for quantitation of plasma HIV-1 RNA levels in patients from the Republic of Congo, an area with highly diversified HIV-1 subtypes and recombinants. The Abbott RealTime HIV-1, BioMérieux HIV-1 EasyQ test 1.2 and Cobas AmpliPrep/Cobas TaqMan HIV-1 1.0 were compared for quantitation of HIV-1 RNA in 37 HIV-1 seropositive pregnant women enrolled in the Kento-Mwana project for prevention of mother-to-child transmission in Pointe-Noire, Republic of Congo. The sample panel included a variety of HIV-1 subtypes with as many as 21 (56.8%) putative unique recombinant forms. Qualitative detection of HIV-1 RNA was concordant by all three assays in 33/37 (89.2%) samples. Of the remaining 4 (10.8%) samples, all were positive by Roche, three by Abbott and none by BioMérieux. Differences exceeding 1Log in positive samples were found in 4/31 (12.9%), 10/31 (32.3%) and 5/31 (16.1%) cases between Abbott and BioMérieux, Roche and BioMérieux, and Abbott and Roche, respectively. In this sample panel representative of highly polymorphic HIV-1 in Congo, the agreement among the three assays was moderate in terms of HIV-1 RNA detectability and rather inconsistent in terms of quantitation. Copyright © 2014. Published by Elsevier B.V.

Options to Expand HIV Viral Load Testing in South Africa: Evaluation of the GeneXpert® HIV-1 Viral Load Assay

PubMed Central

Gous, Natasha; Scott, Lesley; Berrie, Leigh; Stevens, Wendy

2016-01-01

Background Expansion of HIV viral load (VL) testing services are required to meet increased targets for monitoring patients on antiretroviral treatment. South Africa currently tests >4million VLs per annum in 16 highly centralised, automated high-throughput laboratories. The Xpert HIV-1 VL assay (Cepheid) was evaluated against in-country predicates, the Roche Cobas Taqmanv2 and Abbott HIV-1RT, to investigate options for expanding VL testing using GeneXpert’s random access, polyvalent capabilities and already established footprint in South Africa with the Xpert MTB/RIF assay (207 sites). Additionally, the performance of Xpert HIV-1VL on alternative, off-label specimen types, Dried Blood Spots (DBS) and whole blood, was investigated. Method Precision, accuracy (agreement) and clinical misclassification (1000cp/ml) of Xpert HIV-1VL plasma was compared to Taqmanv2 (n = 155) and Abbott HIV-1 RT (n = 145). Misclassification of Xpert HIV-1VL was further tested on DBS (n = 145) and whole blood (n = 147). Results Xpert HIV-1VL demonstrated 100% concordance with predicate platforms on a standardised frozen, plasma panel (n = 42) and low overall percentage similarity CV of 1.5% and 0.9% compared to Taqmanv2 and Abbott HIV-1 RT, respectively. On paired plasma clinical specimens, Xpert HIV-1VL had low bias (SD 0.32–0.37logcp/ml) and 3% misclassification at the 1000cp/ml threshold compared to Taqmanv2 (fresh) and Abbott HIV-1 RT (frozen), respectively. Xpert HIV-1VL on whole blood and DBS increased misclassification (upward) by up to 14% with increased invalid rate. All specimen testing was easy to perform and compatible with concurrent Xpert MTB/RIF Tuberculosis testing on the same instrument. Conclusion The Xpert HIV-1VL on plasma can be used interchangeably with existing predicate platforms in South Africa. Whole blood and DBS testing requires further investigation, but polyvalency of the GeneXpert offers a solution to extending VL testing services. PMID:27992495

Options to Expand HIV Viral Load Testing in South Africa: Evaluation of the GeneXpert® HIV-1 Viral Load Assay.

PubMed

Gous, Natasha; Scott, Lesley; Berrie, Leigh; Stevens, Wendy

2016-01-01

Expansion of HIV viral load (VL) testing services are required to meet increased targets for monitoring patients on antiretroviral treatment. South Africa currently tests >4million VLs per annum in 16 highly centralised, automated high-throughput laboratories. The Xpert HIV-1 VL assay (Cepheid) was evaluated against in-country predicates, the Roche Cobas Taqmanv2 and Abbott HIV-1RT, to investigate options for expanding VL testing using GeneXpert's random access, polyvalent capabilities and already established footprint in South Africa with the Xpert MTB/RIF assay (207 sites). Additionally, the performance of Xpert HIV-1VL on alternative, off-label specimen types, Dried Blood Spots (DBS) and whole blood, was investigated. Precision, accuracy (agreement) and clinical misclassification (1000cp/ml) of Xpert HIV-1VL plasma was compared to Taqmanv2 (n = 155) and Abbott HIV-1 RT (n = 145). Misclassification of Xpert HIV-1VL was further tested on DBS (n = 145) and whole blood (n = 147). Xpert HIV-1VL demonstrated 100% concordance with predicate platforms on a standardised frozen, plasma panel (n = 42) and low overall percentage similarity CV of 1.5% and 0.9% compared to Taqmanv2 and Abbott HIV-1 RT, respectively. On paired plasma clinical specimens, Xpert HIV-1VL had low bias (SD 0.32-0.37logcp/ml) and 3% misclassification at the 1000cp/ml threshold compared to Taqmanv2 (fresh) and Abbott HIV-1 RT (frozen), respectively. Xpert HIV-1VL on whole blood and DBS increased misclassification (upward) by up to 14% with increased invalid rate. All specimen testing was easy to perform and compatible with concurrent Xpert MTB/RIF Tuberculosis testing on the same instrument. The Xpert HIV-1VL on plasma can be used interchangeably with existing predicate platforms in South Africa. Whole blood and DBS testing requires further investigation, but polyvalency of the GeneXpert offers a solution to extending VL testing services.

Comparative evaluation of the Cobas Amplicor HIV-1 Monitor Ultrasensitive Test, the new Cobas AmpliPrep/Cobas Amplicor HIV-1 Monitor Ultrasensitive Test and the Versant HIV RNA 3.0 assays for quantitation of HIV-1 RNA in plasma samples.

PubMed

Berger, Annemarie; Scherzed, Lina; Stürmer, Martin; Preiser, Wolfgang; Doerr, Hans Wilhelm; Rabenau, Holger Felix

2005-05-01

There are several commercially available assays for the quantitation of HIV RNA. A new automated specimen preparation system, the Cobas AmpliPrep, was developed to automate this last part of the PCR. We compared the results obtained by the Roche Cobas Amplicor HIV-1 Monitor Ultrasensitive Test (MCA, manual sample preparation) with those by the Versant HIV-1 RNA 3.0 assay (bDNA). Secondly we compared the MCA with the new Cobas AmpliPrep/Cobas Amplicor HIV Monitor Ultrasensitive Test (CAP/CA, automated specimen preparation) by investigating clinical patient samples and a panel of HIV-1 non-B subtypes. Furthermore, we assessed the assay throughput and workflow (especially hands-on time) for all three assays. Seventy-two percent of the 140 investigated patient samples gave concordant results in the bDNA and MCA assays. The MCA values were regularly higher than the bDNA values. One sample was detected only by the MCA within the linear range of quantification. In contrast, 38 samples with results <50 copies/ml in the MCA showed in the bDNA results between 51 and 1644 copies/ml (mean value 74 copies/ml); 21 of these specimens were shown to have detectable HIV RNA < 50 copies/ml in the MCA assay. The overall agreement between the MCA and the CAP/CA was 94.3% (551/584). The quantification results showed significant correlation, although the CAP/CA generated values slightly lower than those generated by the manual procedure. We found that the CAP/CA produced comparable results with the MCA test in a panel of HIV-1 non-B subtypes. All three assays showed comparable results. The bDNA provides a high sample throughput without the need of full automation. The new CAP/CA provides reliable test results with no HIV-subtype specific influence and releases time for other works in the laboratory; thus it is suitable for routine diagnostic PCR.

Effectiveness of the U.S. National HIV Testing Day Campaigns in Promoting HIV Testing: Evidence from CDC-Funded HIV Testing Sites, 2010

PubMed Central

Mulatu, Mesfin S.

2014-01-01

Objectives We assessed if HIV testing and diagnoses increased during the week of National HIV Testing Day (NHTD) and if characteristics of people who were tested varied compared with control weeks. Methods We analyzed HIV testing data from the 2010 National HIV Prevention Program Monitoring and Evaluation system to compare NHTD week (June 24–30, 2010) with two control weeks (January 7–13, 2010, and August 12–18, 2010) for the number of HIV testing events and new HIV-positive diagnoses, by demographics and other HIV-related variables. Characteristics associated with testing during NHTD week compared with control weeks were identified using Chi-square analyses. Results In 2010, an average of 15,000 more testing events were conducted and 100 more new HIV-positive diagnoses were identified during NHTD week than during the control weeks (p<0.001). Compared with control weeks, people tested during NHTD week were significantly less likely to be aged 20–29 years and non-Hispanic white and significantly more likely to be (1) aged ≥50 years, (2) non-Hispanic black or African American, (3) men who have sex with men, (4) low-risk heterosexuals, (5) tested with a rapid HIV test, or (6) tested in a non-health-care setting. Conclusion In 2010, CDC-funded HIV testing events and new HIV-positive diagnoses increased during NHTD week compared with control weeks. HIV testing programs increased the use of rapid tests and returned a high percentage of test results. NHTD campaigns reached populations disproportionately affected by HIV and further expanded testing to people traditionally less likely to be tested. Incorporating strategies used during NHTD in programs conducted throughout the year may assist in increasing HIV testing and the number of HIV-positive diagnoses. PMID:25177056

Performance of an Early Infant Diagnostic Test, AmpliSens DNA-HIV-FRT, Using Dried Blood Spots Collected from Children Born to Human Immunodeficiency Virus-Infected Mothers in Ukraine

PubMed Central

Shanmugam, Vedapuri; Azarskova, Marianna; Nguyen, Shon; Hurlston, Mackenzie; Sabatier, Jennifer; Zhang, Guoqing; Osmanov, Saladin; Ellenberger, Dennis; Yang, Chunfu; Vitek, Charles; Liulchuk, Maria; Nizova, Natalya

2015-01-01

An accurate accessible test for early infant diagnosis (EID) is crucial for identifying HIV-infected infants and linking them to treatment. To improve EID services in Ukraine, dried blood spot (DBS) samples obtained from 237 HIV-exposed children (≤18 months of age) in six regions in Ukraine in 2012 to 2013 were tested with the AmpliSens DNA-HIV-FRT assay, the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) HIV-1 Qual test, and the Abbott RealTime HIV-1 Qualitative assay. In comparison with the paired whole-blood results generated from AmpliSens testing at the oblast HIV reference laboratories in Ukraine, the sensitivity was 0.99 (95% confidence interval [CI], 0.95 to 1.00) for the AmpliSens and Roche CAP/CTM Qual assays and 0.96 (95% CI, 0.90 to 0.98) for the Abbott Qualitative assay. The specificity was 1.00 (95% CI, 0.97 to 1.00) for the AmpliSens and Abbott Qualitative assays and 0.99 (95% CI, 0.96 to 1.00) for the Roche CAP/CTM Qual assay. McNemar analysis indicated that the proportions of positive results for the tests were not significantly different (P > 0.05). Cohen's kappa (0.97 to 0.99) indicated almost perfect agreement among the three tests. These results indicated that the AmpliSens DBS and whole-blood tests performed equally well and were comparable to the two commercially available EID tests. More importantly, the performance characteristics of the AmpliSens DBS test meets the World Health Organization EID test requirements; implementing AmpliSens DBS testing might improve EID services in resource-limited settings. PMID:26447114

Performance of an Early Infant Diagnostic Test, AmpliSens DNA-HIV-FRT, Using Dried Blood Spots Collected from Children Born to Human Immunodeficiency Virus-Infected Mothers in Ukraine.

PubMed

Chang, Joy; Tarasova, Tetyana; Shanmugam, Vedapuri; Azarskova, Marianna; Nguyen, Shon; Hurlston, Mackenzie; Sabatier, Jennifer; Zhang, Guoqing; Osmanov, Saladin; Ellenberger, Dennis; Yang, Chunfu; Vitek, Charles; Liulchuk, Maria; Nizova, Natalya

2015-12-01

An accurate accessible test for early infant diagnosis (EID) is crucial for identifying HIV-infected infants and linking them to treatment. To improve EID services in Ukraine, dried blood spot (DBS) samples obtained from 237 HIV-exposed children (≤18 months of age) in six regions in Ukraine in 2012 to 2013 were tested with the AmpliSens DNA-HIV-FRT assay, the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) HIV-1 Qual test, and the Abbott RealTime HIV-1 Qualitative assay. In comparison with the paired whole-blood results generated from AmpliSens testing at the oblast HIV reference laboratories in Ukraine, the sensitivity was 0.99 (95% confidence interval [CI], 0.95 to 1.00) for the AmpliSens and Roche CAP/CTM Qual assays and 0.96 (95% CI, 0.90 to 0.98) for the Abbott Qualitative assay. The specificity was 1.00 (95% CI, 0.97 to 1.00) for the AmpliSens and Abbott Qualitative assays and 0.99 (95% CI, 0.96 to 1.00) for the Roche CAP/CTM Qual assay. McNemar analysis indicated that the proportions of positive results for the tests were not significantly different (P > 0.05). Cohen's kappa (0.97 to 0.99) indicated almost perfect agreement among the three tests. These results indicated that the AmpliSens DBS and whole-blood tests performed equally well and were comparable to the two commercially available EID tests. More importantly, the performance characteristics of the AmpliSens DBS test meets the World Health Organization EID test requirements; implementing AmpliSens DBS testing might improve EID services in resource-limited settings. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Uridine Metabolism in HIV-1-Infected Patients: Effect of Infection, of Antiretroviral Therapy and of HIV-1/ART-Associated Lipodystrophy Syndrome

PubMed Central

Domingo, Pere; Torres-Torronteras, Javier; Pomar, Virginia; Giralt, Marta; Domingo, Joan Carles; Gutierrez, Maria del Mar; Gallego-Escuredo, José M.; Mateo, Maria Gracia; Cano-Soldado, Pedro; Fernandez, Irene; Pastor-Anglada, Marçal; Vidal, Francesc; Villarroya, Francesc; Andreu, Antoni; Marti, Ramon

2010-01-01

Background Uridine has been advocated for the treatment of HIV-1/HAART-associated lipodystrophy (HALS), although its metabolism in HIV-1-infected patients is poorly understood. Methods Plasma uridine concentrations were measured in 35 controls and 221 HIV-1-infected patients and fat uridine in 15 controls and 19 patients. The diagnosis of HALS was performed following the criteria of the Lipodystrophy Severity Grading Scale. Uridine was measured by a binary gradient-elution HPLC method. Analysis of genes encoding uridine metabolizing enzymes in fat was performed with TaqMan RT-PCR. Results Median plasma uridine concentrations for HIV-1-infected patients were 3.80 µmol/l (interquartile range: 1.60), and for controls 4.60 µmol/l (IQR: 1.8) (P = 0.0009). In fat, they were of 6.0 (3.67), and 2.8 (4.65) nmol/mg of protein, respectively (P = 0.0118). Patients with a mixed HALS form had a median plasma uridine level of 4.0 (IC95%: 3.40–4.80) whereas in those with isolated lipoatrophy it was 3.25 (2.55–4.15) µmol/l/l (P = 0.0066). The expression of uridine cytidine kinase and uridine phosphorylase genes was significantly decreased in all groups of patients with respect to controls. A higher expression of the mRNAs for concentrative nucleoside transporters was found in HIV-1-infected patients with respect to healthy controls. Conclusions HIV-1 infection is associated with a decrease in plasma uridine and a shift of uridine to the adipose tissue compartment. Antiretroviral therapy was not associated with plasma uridine concentrations, but pure lipoatrophic HALS was associated with significantly lower plasma uridine concentrations. PMID:21085568

Re-testing and misclassification of HIV-2 and HIV-1&2 dually reactive patients among the HIV-2 cohort of The West African Database to evaluate AIDS collaboration

PubMed Central

Tchounga, Boris K; Inwoley, Andre; Coffie, Patrick A; Minta, Daouda; Messou, Eugene; Bado, Guillaume; Minga, Albert; Hawerlander, Denise; Kane, Coumba; Eholie, Serge P; Dabis, François; Ekouevi, Didier K

2014-01-01

Introduction West Africa is characterized by the circulation of HIV-1 and HIV-2. The laboratory diagnosis of these two infections as well as the choice of a first-line antiretroviral therapy (ART) is challenging, considering the limited access to second-line regimens. This study aimed at confirming the classification of HIV-2 and HIV-1&2 dually reactive patients followed up in the HIV-2 cohort of the West African Database to evaluate AIDS collaboration. Method A cross-sectional survey was conducted from March to December 2012 in Burkina Faso, Côte d’Ivoire and Mali among patients classified as HIV-2 or HIV-1&2 dually reactive according to the national HIV testing algorithms. A 5-ml blood sample was collected from each patient and tested in a single reference laboratory in Côte d’Ivoire (CeDReS, Abidjan) with two immuno-enzymatic tests: ImmunoCombII® (HIV-1&2 ImmunoComb BiSpot – Alere) and an in-house ELISA test, approved by the French National AIDS and hepatitis Research Agency (ANRS). Results A total of 547 patients were included; 57% of them were initially classified as HIV-2 and 43% as HIV-1&2 dually reactive. Half of the patients had CD4≥500 cells/mm3 and 68.6% were on ART. Of the 312 patients initially classified as HIV-2, 267 (85.7%) were confirmed as HIV-2 with ImmunoCombII® and in-house ELISA while 16 (5.1%) and 9 (2.9%) were reclassified as HIV-1 and HIV-1&2, respectively (Kappa=0.69; p<0.001). Among the 235 patients initially classified as HIV-1&2 dually reactive, only 54 (23.0%) were confirmed as dually reactive with ImmunoCombII® and in-house ELISA, while 103 (43.8%) and 33 (14.0%) were reclassified as HIV-1 and HIV-2 mono-infected, respectively (kappa= 0.70; p<0.001). Overall, 300 samples (54.8%) were concordantly classified as HIV-2, 63 (11.5%) as HIV-1&2 dually reactive and 119 (21.8%) as HIV-1 (kappa=0.79; p<0.001). The two tests gave discordant results for 65 samples (11.9%). Conclusions Patients with HIV-2 mono-infection are correctly

75 FR 22814 - Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-30

... Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral... Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus... Acid Test (NAT) and Hepatitis C Virus (HCV) NAT, on testing individual samples or pooled samples from...

Ethnic Comparisons in HIV Testing Attitudes, HIV Testing, and Predictors of HIV Testing Among Black and White College Students.

PubMed

Moore, Melanie P; Javier, Sarah J; Abrams, Jasmine A; McGann, Amanda Wattenmaker; Belgrave, Faye Z

2017-08-01

This study's primary aim was to examine ethnic differences in predictors of HIV testing among Black and White college students. We also examined ethnic differences in sexual risk behaviors and attitudes toward the importance of HIV testing. An analytic sample of 126 Black and 617 White undergraduatestudents aged 18-24 were analyzed for a subset of responses on the American College Health Association-National College Health Assessment II (ACHA-NCHA II) (2012) pertaining to HIV testing, attitudes about the importance of HIV testing, and sexual risk behaviors. Predictors of HIV testing behavior were analyzed using logistic regression. t tests and chi-square tests were performed to access differences in HIV test history, testing attitudes, and sexual risk behaviors. Black students had more positive attitudes toward testing and were more likely to have been tested for HIV compared to White students. A greater number of sexual partners and more positive HIV testing attitudes were significant predictors of HIV testing among White students, whereas relationship status predicted testing among Black students. Older age and history of ever having sex were significant predictors of HIV testing for both groups. There were no significant differences between groups in number of sexual partners or self-reports in history of sexual experience (oral, vaginal, or anal). Factors that influence HIV testing may differ across racial/ethnic groups. Findings support the need to consider racial/ethnic differences in predictors of HIV testing during the development and tailoring of HIV testing prevention initiatives targeting college students.

Evaluation of the performance of Abbott m2000 and Roche COBAS Ampliprep/COBAS Taqman assays for HIV-1 viral load determination using dried blood spots and dried plasma spots in Kenya.

PubMed

Zeh, Clement; Ndiege, Kenneth; Inzaule, Seth; Achieng, Rebecca; Williamson, John; Chih-Wei Chang, Joy; Ellenberger, Dennis; Nkengasong, John

2017-01-01

Routine HIV viral load testing is not widely accessible in most resource-limited settings, including Kenya. To increase access to viral load testing, alternative sample types like dried blood spots (DBS), which overcome the logistic barriers associated with plasma separation and cold chain shipment need to be considered and evaluated. The current study evaluated matched dried blood spots (DBS) and dried plasma spots (DPS) against plasma using the Abbott M 2000 (Abbott) and Roche Cobas Ampliprep/Cobas TaqMan (CAP/CTM) quantitative viral load assays in western Kenya. Matched plasma DBS and DPS were obtained from 200 HIV-1 infected antiretroviral treatment (ART)-experienced patients attending patient support centers in Western Kenya. Standard quantitative assay performance parameters with accompanying 95% confidence intervals (CI) were assessed at the assays lower detection limit (400cps/ml for CAP/CTM and 550cps/ml for Abbott) using SAS version 9.2. Receiver operating curves (ROC) were further used to assess viral-load thresholds with best assay performance (reference assay CAP/CTM plasma). Using the Abbott test, the sensitivity and specificity, respectively, for DPS were (97.3%, [95%CI: 93.2-99.2] and 98.1% [95%CI: 89.7-100]) and those for DBS (93.9% [95%CI: 88.8-97.2] and 88.0% [95%CI: 82.2-92.4]). The correlation and agreement using paired plasma and DPS/DBS were strong, with r2 = 90.5 and rc = 68.1. The Bland-Altman relative percent change was 95.3 for DPS, (95%CI: 90.4-97.7) and 73.6 (95%CI: 51.6-86.5) for DBS. Using the CAP/CTM assay, the sensitivity for DBS was significantly higher compared to DPS (100.0% [95% CI: 97.6-100.0] vs. 94.7% [95%CI: 89.8-97.7]), while the specificity for DBS was lower: 4%, [95% CI: 0.4-13.7] compared to DPS: 94.0%, [95% CI: 83.5-98.7]. When compared under different clinical relevant thresholds, the accuracy for the Abbott assay was 95% at the 1000cps/ml cut-off with a sensitivity and specificity of 96.6% [95% CI 91.8-98.7] and 90

Evaluation of the performance of Abbott m2000 and Roche COBAS Ampliprep/COBAS Taqman assays for HIV-1 viral load determination using dried blood spots and dried plasma spots in Kenya

PubMed Central

Ndiege, Kenneth; Inzaule, Seth; Achieng, Rebecca; Williamson, John; Chih-Wei Chang, Joy; Ellenberger, Dennis; Nkengasong, John

2017-01-01

Background Routine HIV viral load testing is not widely accessible in most resource-limited settings, including Kenya. To increase access to viral load testing, alternative sample types like dried blood spots (DBS), which overcome the logistic barriers associated with plasma separation and cold chain shipment need to be considered and evaluated. The current study evaluated matched dried blood spots (DBS) and dried plasma spots (DPS) against plasma using the Abbott M 2000 (Abbott) and Roche Cobas Ampliprep/Cobas TaqMan (CAP/CTM) quantitative viral load assays in western Kenya. Methods Matched plasma DBS and DPS were obtained from 200 HIV-1 infected antiretroviral treatment (ART)-experienced patients attending patient support centers in Western Kenya. Standard quantitative assay performance parameters with accompanying 95% confidence intervals (CI) were assessed at the assays lower detection limit (400cps/ml for CAP/CTM and 550cps/ml for Abbott) using SAS version 9.2. Receiver operating curves (ROC) were further used to assess viral-load thresholds with best assay performance (reference assay CAP/CTM plasma). Results Using the Abbott test, the sensitivity and specificity, respectively, for DPS were (97.3%, [95%CI: 93.2–99.2] and 98.1% [95%CI: 89.7–100]) and those for DBS (93.9% [95%CI: 88.8–97.2] and 88.0% [95%CI: 82.2–92.4]). The correlation and agreement using paired plasma and DPS/DBS were strong, with r2 = 90.5 and rc = 68.1. The Bland-Altman relative percent change was 95.3 for DPS, (95%CI: 90.4–97.7) and 73.6 (95%CI: 51.6–86.5) for DBS. Using the CAP/CTM assay, the sensitivity for DBS was significantly higher compared to DPS (100.0% [95% CI: 97.6–100.0] vs. 94.7% [95%CI: 89.8–97.7]), while the specificity for DBS was lower: 4%, [95% CI: 0.4–13.7] compared to DPS: 94.0%, [95% CI: 83.5–98.7]. When compared under different clinical relevant thresholds, the accuracy for the Abbott assay was 95% at the 1000cps/ml cut-off with a sensitivity and

Determination of HIV Status in African Adults With Discordant HIV Rapid Tests.

PubMed

Fogel, Jessica M; Piwowar-Manning, Estelle; Donohue, Kelsey; Cummings, Vanessa; Marzinke, Mark A; Clarke, William; Breaud, Autumn; Fiamma, Agnès; Donnell, Deborah; Kulich, Michal; Mbwambo, Jessie K K; Richter, Linda; Gray, Glenda; Sweat, Michael; Coates, Thomas J; Eshleman, Susan H

2015-08-01

In resource-limited settings, HIV infection is often diagnosed using 2 rapid tests. If the results are discordant, a third tie-breaker test is often used to determine HIV status. This study characterized samples with discordant rapid tests and compared different testing strategies for determining HIV status in these cases. Samples were previously collected from 173 African adults in a population-based survey who had discordant rapid test results. Samples were classified as HIV positive or HIV negative using a rigorous testing algorithm that included two fourth-generation tests, a discriminatory test, and 2 HIV RNA tests. Tie-breaker tests were evaluated, including rapid tests (1 performed in-country), a third-generation enzyme immunoassay, and two fourth-generation tests. Selected samples were further characterized using additional assays. Twenty-nine samples (16.8%) were classified as HIV positive and 24 of those samples (82.8%) had undetectable HIV RNA. Antiretroviral drugs were detected in 1 sample. Sensitivity was 8.3%-43% for the rapid tests; 24.1% for the third-generation enzyme immunoassay; 95.8% and 96.6% for the fourth-generation tests. Specificity was lower for the fourth-generation tests than the other tests. Accuracy ranged from 79.5% to 91.3%. In this population-based survey, most HIV-infected adults with discordant rapid tests were virally suppressed without antiretroviral drugs. Use of individual assays as tie-breaker tests was not a reliable method for determining HIV status in these individuals. More extensive testing algorithms that use a fourth-generation screening test with a discriminatory test and HIV RNA test are preferable for determining HIV status in these cases.

Systematic Review of the Performance of HIV Viral Load Technologies on Plasma Samples

PubMed Central

Sollis, Kimberly A.; Smit, Pieter W.; Fiscus, Susan; Ford, Nathan; Vitoria, Marco; Essajee, Shaffiq; Barnett, David; Cheng, Ben; Crowe, Suzanne M.; Denny, Thomas; Landay, Alan; Stevens, Wendy; Habiyambere, Vincent; Perrins, Jos; Peeling, Rosanna W.

2014-01-01

Background Viral load (VL) monitoring is the standard of care in developing country settings for detecting HIV treatment failure. Since 2010 the World Health Organization has recommended a phase-in approach to VL monitoring in resource-limited settings. We conducted a systematic review of the accuracy and precision of HIV VL technologies for treatment monitoring. Methods and Findings A search of Medline and Embase was conducted for studies evaluating the accuracy or reproducibility of commercially available HIV VL assays. 37 studies were included for review including evaluations of the Amplicor Monitor HIV-1 v1.5 (n = 25), Cobas TaqMan v2.0 (n = 11), Abbott RealTime HIV-1 (n = 23), Versant HIV-1 RNA bDNA 3.0 (n = 15), Versant HIV-1 RNA kPCR 1.0 (n = 2), ExaVir Load v3 (n = 2), and NucliSens EasyQ v2.0 (n = 1). All currently available HIV VL assays are of sufficient sensitivity to detect plasma virus levels at a lower detection limit of 1,000 copies/mL. Bias data comparing the Abbott RealTime HIV-1, TaqMan v2.0 to the Amplicor Monitor v1.5 showed a tendency of the Abbott RealTime HIV-1 to under-estimate results while the TaqMan v2.0 overestimated VL counts. Compared to the Amplicor Monitor v1.5, 2–26% and 9–70% of results from the Versant bDNA 3.0 and Abbott RealTime HIV-1 differed by greater than 0.5log10. The average intra and inter-assay variation of the Abbott RealTime HIV-1 were 2.95% (range 2.0–5.1%) and 5.44% (range 1.17–30.00%) across the range of VL counts (2log10–7log10). Conclusions This review found that all currently available HIV VL assays are of sufficient sensitivity to detect plasma VL of 1,000 copies/mL as a threshold to initiate investigations of treatment adherence or possible treatment failure. Sources of variability between VL assays include differences in technology platform, plasma input volume, and ability to detect HIV-1 subtypes. Monitoring of individual patients should be performed on the same

Human anti-HIV IgM detection by the OraQuick ADVANCE® Rapid HIV 1/2 Antibody Test.

PubMed

Guillon, Geraldine; Yearwood, Graham; Snipes, Casey; Boschi, Daniel; Reed, Michael R

2018-01-01

The Centers for Disease Control and Prevention (CDC) and many public health jurisdictions continue to advocate for the most sensitive rapid HIV test that is available. Currently, the recommendation is to utilize tests that can detect HIV infection biomarkers within 30 days of infection, when initial immune responses are mounted. The infected patient's IgM response is often used to detect acute infection within a 20-25 days window after infection. This requirement applies to lab-based testing with automated analyzers and rapid, point of care (POC) testing used for screening in a non-clinical setting. A recent study has demonstrated that POC tests using a Protein A-based detection system can detect samples with predominantly HIV-1 IgM reactivity (Moshgabadi et al., 2015). The OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test (OraQuick ADVANCE ®) also uses Protein A as the detection protein in the antibody-binding colloidal gold conjugate, so it is expected that the OraQuick ADVANCE ® Test will also detect samples with predominantly IgM reactivity. This report definitively demonstrates that the OraQuick ADVANCE ® Test can detect IgM antibodies during an acute infection window period of approximately 20-25 days after infection, and is therefore suitable for use in testing environments requiring adherence to current CDC recommendations.

Bat white-nose syndrome: a real-time TaqMan polymerase chain reaction test targeting the intergenic spacer region of Geomyces destructanstructans.

USGS Publications Warehouse

Muller, Laura K.; Lorch, Jeffrey M.; Lindner, Daniel L.; O'Connor, Michael; Gargas, Andrea; Blehert, David S.

2013-01-01

The fungus Geomyces destructans is the causative agent of white-nose syndrome (WNS), a disease that has killed millions of North American hibernating bats. We describe a real-time TaqMan PCR test that detects DNA from G. destructans by targeting a portion of the multicopy intergenic spacer region of the rRNA gene complex. The test is highly sensitive, consistently detecting as little as 3.3 fg of genomic DNA from G. destructans. The real-time PCR test specifically amplified genomic DNA from G. destructans but did not amplify target sequence from 54 closely related fungal isolates (including 43 Geomyces spp. isolates) associated with bats. The test was further qualified by analyzing DNA extracted from 91 bat wing skin samples, and PCR results matched histopathology findings. These data indicate the real-time TaqMan PCR method described herein is a sensitive, specific, and rapid test to detect DNA from G. destructans and provides a valuable tool for WNS diagnostics and research.

Testing in the HIV Counselling and Testing (HCT) campaign, HIV risk behaviours and ART enrolment in South Africa.

PubMed

Onoya, D; Mohlabane, N; Maduna, V; van Zyl, J; Sewpaul, R; Naidoo, Y

2016-07-01

To examine the association between testing in the 2010 HIV Testing and Counselling (HCT) campaign with HIV risk behaviours and enrolment on ART. Data for this study were collected as part of a nationally representative cross-sectional household survey conducted in 2012 in South Africa. Consenting participants completed a structured questionnaire and provided a dry blood spot specimen which was tested for HIV antibodies and antiretroviral drugs. Multinomial logistic regression was used to examine the association between HIV testing history and explanatory variables of interest. There was no association between testing in the 2010 HCT campaign and condom use at last sex, number of sexual partnerships or HIV knowledge. Individuals who tested in the HCT campaign were more likely to disclose their status (COR 2.6, 95% CI: 1.71-3.8) and those who tested HIV positive in the campaign were more likely to be receiving ART (COR 1.8, 95% CI: 1.1-2.9). Testing in the HCT campaign was associated with having received both pretest and post-test counselling while testing before the campaign was associated with having received HIV results with no counselling (COR 2.1, 95% CI: 1.2-3.8). We highlight the success of the 2010 HCT campaign in improving HIV status disclosure and enrolment on ART as well as shortcomings on HIV risk behaviours and HIV knowledge. These may be related to issues of quality assurance in the counselling process. Our results further highlight possible HCT counselling inconsistencies across sectors requiring stronger public-private partnership in the delivery of HCT in South Africa. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

National HIV Testing Day at CDC-funded HIV counseling, testing, and referral sites--United States, 1994-1998.

PubMed

2000-06-23

CDC-funded human immunodeficiency virus (HIV) counseling, testing, and referral sites are an integral part of national HIV prevention efforts (1). Voluntary counseling, testing, and referral opportunities are offered to persons at risk for HIV infection at approximately 11,000 sites, including dedicated HIV counseling and testing sites, sexually transmitted disease (STD) clinics, drug-treatment centers, hospitals, and prisons. Services also are offered to women in family planning and prenatal/obstetric clinics to increase HIV prevention efforts among women and decrease the risk for perinatal HIV transmission. To increase use of HIV counseling, testing, and referral services by those at risk for HIV infection, in 1995, the National Association of People with AIDS designated June 27 each year as National HIV Testing Day. This report compares use of CDC-funded counseling, testing, and referral services the week before and the week of June 27 from 1994 through 1998 and documents the importance of a national public health campaign designed to increase knowledge of HIV serostatus.

HIV testing behaviors of a cohort of HIV-positive racial/ethnic minority YMSM.

PubMed

Phillips, Gregory; Hightow-Weidman, Lisa B; Arya, Monisha; Fields, Sheldon D; Halpern-Felsher, Bonnie; Outlaw, Angulique Y; Wohl, Amy R; Hidalgo, Julia

2012-10-01

The HIV epidemic in the United States has disproportionately affected young racial/ethnic minority men who have sex with men (YMSM). However, HIV testing rates among young men of color remain low. Within this sample of racial/ethnic minority YMSM (n = 363), the first HIV test was a median of 2 years after men who have sex with men sexual debut. Individuals with less than 1 year between their first negative and first positive HIV test were significantly more likely to identify the reason for their first negative test as being sick (OR = 2.99; 95 % CI 1.23-7.27). This may suggest that these YMSM may have experienced symptoms of acute HIV infection. Of major concern is that many YMSM in our study tested positive for HIV on their first HIV test. Given recommendations for at least annual HIV testing, our findings reveal that medical providers YMSM need to know the importance of regular testing.

Performance of NucliSens HIV-1 EasyQ Version 2.0 compared with six commercially available quantitative nucleic acid assays for detection of HIV-1 in China.

PubMed

Xu, Sihong; Song, Aijing; Nie, Jianhui; Li, Xiuhua; Wang, Youchun

2010-10-01

Six HIV-1 viral load assays have been widely used in China. These include the Cobas Amplicor HIV-1 Monitor Version 1.5 ('Amplicor'), Cobas AmpliPrep/Cobas TaqMan HIV-1 test Version 1.0 ('CAP/CTM'), Versant HIV-1 RNA Version 3.0 (branched DNA [bDNA]-based assay; 'Versant bDNA'), Abbott RealTime HIV-1 assay ('Abbott RealTime'), NucliSens HIV-1 QT (nucleic acid sequence-based amplification assay; 'NucliSens NASBA'), and NucliSens EasyQ HIV-1 Version 1.1 ('EasyQ V1.1'). Recently, an updated version of EasyQ V1.1, NucliSens EasyQ HIV-1 Version 2.0 ('EasyQ V2.0') was introduced into China. It is important to evaluate the impact of HIV-1 genotypes on the updated assay compared with the other commercial available assays in China. A total of 175 plasma samples with different HIV-1 clades prevalent in China were collected from treatment-naïve patients. The viral loads of those samples were determined with the seven HIV-1 viral load assays, and the quantitative differences between them were evaluated. Overall, EasyQ V2.0 exhibited a significant correlation (R = 0.769-0.850, p ≤ 0.001) and high agreement (94.77-97.13%, using the Bland-Altman model) with the other six assays. Although no significant differences between EasyQ V2.0 and the other six assays were observed when quantifying clade B' samples, there were statistically significant differences between EasyQ V2.0 and the Amplicor, Versant bDNA, and Abbott RealTime assays when quantifying clade BC samples, and between EasyQ V2.0 and the Versant bDNA and Abbott RealTime assays when quantifying clade AE samples. For clade BC samples, the quantitative differences between EasyQ V2.0 and the Amplicor, Versant bDNA, and Abbott RealTime assays exceeded 0.5 log(10) IU/mL in approximately 50% of samples and exceeded 1 log(10) IU/mL in approximately 15% of samples. For clade AE samples, the quantitative differences between EasyQ V2.0 and the CAP/CTM, Versant bDNA, and Abbott RealTime assays exceeded 0.5 log(10) IU/mL in

Effects of schistosomiasis on susceptibility to HIV-1 infection and HIV-1 viral load at HIV-1 seroconversion: A nested case-control study.

PubMed

Downs, Jennifer A; Dupnik, Kathryn M; van Dam, Govert J; Urassa, Mark; Lutonja, Peter; Kornelis, Dieuwke; de Dood, Claudia J; Hoekstra, Pytsje; Kanjala, Chifundo; Isingo, Raphael; Peck, Robert N; Lee, Myung Hee; Corstjens, Paul L A M; Todd, Jim; Changalucha, John M; Johnson, Warren D; Fitzgerald, Daniel W

2017-09-01

Schistosomiasis affects 218 million people worldwide, with most infections in Africa. Prevalence studies suggest that people with chronic schistosomiasis may have higher risk of HIV-1 acquisition and impaired ability to control HIV-1 replication once infected. We hypothesized that: (1) pre-existing schistosome infection may increase the odds of HIV-1 acquisition and that the effects may differ between men and women, and (2) individuals with active schistosome infection at the time of HIV-1 acquisition may have impaired immune control of HIV-1, resulting in higher HIV-1 viral loads at HIV-1 seroconversion. We conducted a nested case-control study within a large population-based survey of HIV-1 transmission in Tanzania. A population of adults from seven villages was tested for HIV in 2007, 2010, and 2013 and dried blood spots were archived for future studies with participants' consent. Approximately 40% of this population has Schistosoma mansoni infection, and 2% has S. haematobium. We tested for schistosome antigens in the pre- and post-HIV-1-seroconversion blood spots of people who acquired HIV-1. We also tested blood spots of matched controls who did not acquire HIV-1 and calculated the odds that a person with schistosomiasis would become HIV-1-infected compared to these matched controls. Analysis was stratified by gender. We compared 73 HIV-1 seroconverters with 265 controls. Women with schistosome infections had a higher odds of HIV-1 acquisition than those without (adjusted OR = 2.8 [1.2-6.6], p = 0.019). Schistosome-infected men did not have an increased odds of HIV-1 acquisition (adjusted OR = 0.7 [0.3-1.8], p = 0.42). We additionally compared HIV-1 RNA levels in the post-seroconversion blood spots in HIV-1 seroconverters with schistosomiasis versus those without who became HIV-infected in 2010, before antiretroviral therapy was widely available in the region. The median whole blood HIV-1 RNA level in the 15 HIV-1 seroconverters with schistosome infection was

Association of sexual risk behaviour with previous HIV testing among voluntary HIV counselling and testing clients in Kigali, Rwanda.

PubMed

Stalter, Randy; Chen, Mario; Uwizeye, Glorieuse; Mutunge, Elise; Ahayo, Anita; Mugwaneza, Placidie; Shumbusho, Fabienne; Wesson, Jennifer

2016-12-01

With increased coverage of voluntary HIV counselling and testing (VCT) in Rwanda and a greater focus on repeat testing of key populations, it is important to understand whether the right clients are returning for repeat testing and if repeat testing is effective at reducing risk. We assessed the association between repeat testing and recent sexual risk behaviours among 1852 first time or repeat HIV testing clients in Kigali who had had sex, using data from a cross-sectional survey. Repeat testing was associated with being female, older and type of occupation. Multivariable analyses indicate that individuals who tested for HIV 1-2 times (aOR = 1.52, 95% CI: 1.08, 2.15) and 3+ times (aOR = 1.51, 95% CI: 1.06, 2.17) previously were more likely to report recent unprotected sex. Those with 3+ previous tests were more likely to have recently had multiple sexual partners (aOR = 2.19, 95% CI: 1.22, 3.92). However, a significant decrease in HIV prevalence is shown as individuals receive more HIV tests in their lifetime (p < 0.001). These findings show that individuals who report high-risk behaviours are returning for repeat tests. However, VCT may not be successful at addressing certain sexual risk behaviours. Therefore more intensive counselling or additional HIV prevention services may be needed. © The Author(s) 2016.

Acute HIV Discovered During Routine HIV Screening With HIV Antigen-Antibody Combination Tests in 9 US Emergency Departments.

PubMed

White, Douglas A E; Giordano, Thomas P; Pasalar, Siavash; Jacobson, Kathleen R; Glick, Nancy R; Sha, Beverly E; Mammen, Priya E; Hunt, Bijou R; Todorovic, Tamara; Moreno-Walton, Lisa; Adomolga, Vincent; Feaster, Daniel J; Branson, Bernard M

2018-01-05

Newer combination HIV antigen-antibody tests allow detection of HIV sooner after infection than previous antibody-only immunoassays because, in addition to HIV-1 and -2 antibodies, they detect the HIV-1 p24 antigen, which appears before antibodies develop. We determine the yield of screening with HIV antigen-antibody tests and clinical presentations for new diagnoses of acute and established HIV infection across US emergency departments (EDs). This was a retrospective study of 9 EDs in 6 cities with HIV screening programs that integrated laboratory-based antigen-antibody tests between November 1, 2012, and December 31, 2015. Unique patients with newly diagnosed HIV infection were identified and classified as having either acute HIV infection or established HIV infection. Acute HIV infection was defined as a repeatedly reactive antigen-antibody test result, a negative HIV-1/HIV-2 antibody differentiation assay, or Western blot result, but detectable HIV ribonucleic acid (RNA); established HIV infection was defined as a repeatedly reactive antigen-antibody test result and a positive HIV-1/HIV-2 antibody differentiation assay or Western blot result. The primary outcomes were the number of new HIV diagnoses and proportion of patients with laboratory-defined acute HIV infection. Secondary outcomes compared reason for visit and the clinical presentation of acute HIV infection. In total, 214,524 patients were screened for HIV and 839 (0.4%) received a new diagnosis, of which 122 (14.5%) were acute HIV infection and 717 (85.5%) were established HIV infection. Compared with patients with established HIV infection, those with acute HIV infection were younger, had higher RNA and CD4 counts, and were more likely to have viral syndrome (41.8% versus 6.5%) or fever (14.3% versus 3.4%) as their reason for visit. Most patients with acute HIV infection displayed symptoms attributable to acute infection (median symptom count 5 [interquartile range 3 to 6]), with fever often

Evaluation of sensitivity of TaqMan RT-PCR for rubella virus detection in clinical specimens.

PubMed

Okamoto, Kiyoko; Mori, Yoshio; Komagome, Rika; Nagano, Hideki; Miyoshi, Masahiro; Okano, Motohiko; Aoki, Yoko; Ogura, Atsushi; Hotta, Chiemi; Ogawa, Tomoko; Saikusa, Miwako; Kodama, Hiroe; Yasui, Yoshihiro; Minagawa, Hiroko; Kurata, Takako; Kanbayashi, Daiki; Kase, Tetsuo; Murata, Sachiko; Shirabe, Komei; Hamasaki, Mitsuhiro; Kato, Takashi; Otsuki, Noriyuki; Sakata, Masafumi; Komase, Katsuhiro; Takeda, Makoto

2016-07-01

An easy and reliable assay for detection of the rubella virus is required to strengthen rubella surveillance. Although a TaqMan RT-PCR assay for detection of the rubella virus has been established in Japan, its utility for diagnostic purposes has not been tested. To allow introduction of the TaqMan RT-PCR into the rubella surveillance system in Japan, the sensitivity of the assay was determined using representative strains for all genotypes and clinical specimens. The detection limits of the method for individual genotypes were examined using viral RNA extracted from 13 representative strains. The assay was also tested at 10 prefectural laboratories in Japan, designated as local reference laboratories for measles and rubella, to allow nationwide application of the assay. The detection limits and amplification efficiencies of the assay were similar among all the representative strains of the 13 genotypes. The TaqMan RT-PCR could detect approximately 90% of throat swab and urine samples taken up to 5days of illness. These samples were determined positive by a highly sensitive nested RT-PCR. The TaqMan RT-PCR could detect at least 10 pfu of rubella virus. Although the sensitivity was somewhat lower than that of the conventional nested RT-PCR, the TaqMan RT-PCR could be more practical to routine tests for rubella laboratory diagnosis and detection in view of the rapid response and reducing risks of contamination. Copyright © 2016 Elsevier B.V. All rights reserved.

Screening Yield of HIV Antigen/Antibody Combination and Pooled HIV RNA Testing for Acute HIV Infection in a High-Prevalence Population.

PubMed

Peters, Philip J; Westheimer, Emily; Cohen, Stephanie; Hightow-Weidman, Lisa B; Moss, Nicholas; Tsoi, Benjamin; Hall, Laura; Fann, Charles; Daskalakis, Demetre C; Beagle, Steve; Patel, Pragna; Radix, Asa; Foust, Evelyn; Kohn, Robert P; Marmorino, Jenni; Pandori, Mark; Fu, Jie; Samandari, Taraz; Gay, Cynthia L

2016-02-16

Although acute HIV infection contributes disproportionately to onward HIV transmission, HIV testing has not routinely included screening for acute HIV infection. To evaluate the performance of an HIV antigen/antibody (Ag/Ab) combination assay to detect acute HIV infection compared with pooled HIV RNA testing. Multisite, prospective, within-individual comparison study conducted between September 2011 and October 2013 in 7 sexually transmitted infection clinics and 5 community-based programs in New York, California, and North Carolina. Participants were 12 years or older and seeking HIV testing, without known HIV infection. All participants with a negative rapid HIV test result were screened for acute HIV infection with an HIV Ag/Ab combination assay (index test) and pooled human immunodeficiency virus 1 (HIV-1) RNA testing. HIV RNA testing was the reference standard, with positive reference standard result defined as detectable HIV-1 RNA on an individual RNA test. Number and proportion with acute HIV infections detected. Among 86,836 participants with complete test results (median age, 29 years; 75.0% men; 51.8% men who have sex with men), established HIV infection was diagnosed in 1158 participants (1.33%) and acute HIV infection was diagnosed in 168 participants (0.19%). Acute HIV infection was detected in 134 participants with HIV Ag/Ab combination testing (0.15% [95% CI, 0.13%-0.18%]; sensitivity, 79.8% [95% CI, 72.9%-85.6%]; specificity, 99.9% [95% CI, 99.9%-99.9%]; positive predictive value, 59.0% [95% CI, 52.3%-65.5%]) and in 164 participants with pooled HIV RNA testing (0.19% [95% CI, 0.16%-0.22%]; sensitivity, 97.6% [95% CI, 94.0%-99.4%]; specificity, 100% [95% CI, 100%-100%]; positive predictive value, 96.5% [95% CI, 92.5%-98.7%]; sensitivity comparison, P < .001). Overall HIV Ag/Ab combination testing detected 82% of acute HIV infections detectable by pooled HIV RNA testing. Compared with rapid HIV testing alone, HIV Ag/Ab combination testing

HIV Testing Beliefs in a Predominantly Hispanic Community Health Center During the Routine HIV Testing Era: Does English Language Ability Matter?

PubMed Central

Amspoker, Amber B.; Lalani, Naina; Patuwo, Beverly; Kallen, Michael; Street, Richard; Viswanath, Kasisomayajula; Giordano, Thomas P.

2013-01-01

Abstract The Hispanic population in the U.S. carries a disproportionate burden of HIV. Despite the high prevalence of HIV, many Hispanics remain untested for HIV. The purpose of this study conducted in a predominantly Hispanic-serving community health center in a high HIV prevalence area was to understand patient beliefs of who should be tested for HIV in the routine HIV testing era. Survey participants were presented with nine populations of people that should be tested for HIV based on CDC HIV testing recommendations. Of the 90 participants (67.1% Hispanic) who answered the HIV testing beliefs question, only approximately 45% were aware that all adults and teenagers should be HIV tested. Only 30% correctly identified all nine populations of people that should be tested for HIV based on CDC HIV testing recommendations. Our study suggests that Hispanics are either unaware of or disagree with the latest CDC recommendations for routine HIV testing of all persons ages 13–64 in high HIV prevalence areas. Improving knowledge of the current HIV epidemiologic profile in the U.S. and the most recent routine HIV testing recommendations may improve HIV testing rates in Hispanic communities. PMID:23305261

Determinants and prevalence of late HIV testing in Tijuana, Mexico.

PubMed

Carrizosa, Claudia M; Blumberg, Elaine J; Hovell, Melbourne F; Martinez-Donate, Ana P; Garcia-Gonzalez, Gregorio; Lozada, Remedios; Kelley, Norma J; Hofstetter, C Richard; Sipan, Carol L

2010-05-01

Timely diagnosis of HIV is essential to improve survival rates and reduce transmission of the virus. Insufficient progress has been made in effecting earlier HIV diagnoses. The Mexican border city of Tijuana has one of the highest AIDS incidence and mortality rates in all of Mexico. This study examined the prevalence and potential correlates of late HIV testing in Tijuana, Mexico. Late testers were defined as participants who had at least one of: (1) an AIDS-defining illness within 1 year of first positive HIV test; (2) a date of AIDS diagnosis within 1 year of first positive HIV test; or (3) an initial CD4 cell count below 200 cells per microliter within 1 year of first positive HIV test. Medical charts of 670 HIV-positive patients from two HIV/AIDS public clinics in Tijuana were reviewed and abstracted; 362 of these patients were interviewed using a cross-sectional survey. Using multivariate logistic regression, we explored potential correlates of late HIV testing based on the Behavioral Ecological Model. From 342 participants for whom late testing could be determined, the prevalence of late testing was 43.2%. Multivariate logistic regression results (n = 275) revealed five significant correlates of late testing: "I preferred not to know I had HIV" (adjusted odds ratio [AOR] = 2.78, 1.46-5.31); clinic (AOR = 1.90, 1.06-3.41); exposure to peers engaging in high-risk sexual behavior (AOR = 1.14, 1.02-1.27); stigma regarding HIV-infected individuals (AOR = 0.65, 0.47-0.92); and stigma regarding HIV testing (AOR = 0.66, 0.45-0.97). These findings may inform the design of interventions to increase timely HIV testing and help reduce HIV transmission in the community at large.

HIV Self-Testing Increases HIV Testing Frequency in High Risk Men Who Have Sex with Men: A Randomized Controlled Trial.

PubMed

Katz, David A; Golden, Matthew R; Hughes, James P; Farquhar, Carey; Stekler, Joanne D

2018-04-24

Self-testing may increase HIV testing and decrease the time people with HIV are unaware of their status, but there is concern that absence of counseling may result in increased HIV risk. Seattle, Washington. We randomly assigned 230 high-risk HIV-negative men who have sex with men (MSM) to have access to oral fluid HIV self-tests at no cost versus testing as usual .for 15 months. The primary outcome was self-reported number of HIV tests during follow-up. To evaluate self-testing's impact on sexual behavior, we compared the following between arms: non-HIV-concordant condomless anal intercourse (CAI) and number of male CAI partners in the last 3 months (measured at 9 and 15 months) and diagnosis with a bacterial sexually transmitted infection (STI: early syphilis, gonorrhea, chlamydial infection) at the final study visit (15 months). A post hoc analysis compared the number of STI tests reported during follow-up. Men randomized to self-testing reported significantly more HIV tests during follow-up (mean=5.3, 95%CI=4.7-6.0) than those randomized to testing as usual (3.6, 3.2-4.0; p<.0001), representing an average increase of 1.7 tests per participant over 15 months. Men randomized to self-testing reported using an average of 3.9 self-tests. Self-testing was non-inferior with respect to all markers of HIV risk. Men in the self-testing arm reported significantly fewer STI tests during follow-up (mean=2.3, 95%CI=1.9-2.7) than men in the control arm (3.2, 2.8-3.6; p=0.0038). Access to free HIV self-testing increased testing frequency among high-risk MSM and did not impact sexual behavior or STI acquisition.

Potential for false positive HIV test results with the serial rapid HIV testing algorithm.

PubMed

Baveewo, Steven; Kamya, Moses R; Mayanja-Kizza, Harriet; Fatch, Robin; Bangsberg, David R; Coates, Thomas; Hahn, Judith A; Wanyenze, Rhoda K

2012-03-19

Rapid HIV tests provide same-day results and are widely used in HIV testing programs in areas with limited personnel and laboratory infrastructure. The Uganda Ministry of Health currently recommends the serial rapid testing algorithm with Determine, STAT-PAK, and Uni-Gold for diagnosis of HIV infection. Using this algorithm, individuals who test positive on Determine, negative to STAT-PAK and positive to Uni-Gold are reported as HIV positive. We conducted further testing on this subgroup of samples using qualitative DNA PCR to assess the potential for false positive tests in this situation. Of the 3388 individuals who were tested, 984 were HIV positive on two consecutive tests, and 29 were considered positive by a tiebreaker (positive on Determine, negative on STAT-PAK, and positive on Uni-Gold). However, when the 29 samples were further tested using qualitative DNA PCR, 14 (48.2%) were HIV negative. Although this study was not primarily designed to assess the validity of rapid HIV tests and thus only a subset of the samples were retested, the findings show a potential for false positive HIV results in the subset of individuals who test positive when a tiebreaker test is used in serial testing. These findings highlight a need for confirmatory testing for this category of individuals.

1 Patient acceptability and feasibility of HIV testing in emergency departments in the UK - a systematic review and meta-analysis.

PubMed

Lungu, Nicola

2017-12-01

NICE 2016 HIV testing guidelines now include the recommendation to offer HIV testing in Emergency Departments, in areas of high prevalence, 1 to everyone who is undergoing blood tests. 23% of England's local authorities are areas of high HIV prevalence (>2/1000) and are therefore eligible. 2 So far very few Emergency Departments have implemented routine HIV testing. This systematic review assesses evidence for two implementation considerations: patient acceptability (how likely a patient will accept an HIV test when offered in an Emergency Department), and feasibility, which incorporates staff training and willingness, and department capacity, (how likely Emergency Department staff will offer an HIV test to an eligible patient), both measured by surrogate quantitative markers. Three medical databases were systematically searched for reports of non-targeted HIV testing in UK Emergency Departments. A total of 1584 unique papers were found, 9 full text articles were critically appraised, and 7 studies included in meta-analysis. There is a combined patient sample of 1 01 975. The primary outcome, patient acceptability of HIV testing in Emergency Departments (number of patients accepting an HIV test, as a proportion of those offered) is 54.1% (CI 40.1, 68.2). Feasibility (number of tests offered, as a proportion of eligible patients) is 36.2% (CI 9.8, 62.4). For an Emergency Department considering introducing routine HIV testing, this review suggests an opt-out publicity-lead strategy. Utilising oral fluid and blood tests would lead to the greatest proportion of eligible patients accepting an HIV test. For individual staff who are consenting patients for HIV testing, it may be encouraging to know that there is >50% chance the patient will accept an offer of testing.emermed;34/12/A860-a/T1F1T1Table 1Summary table of data extracted from final 7 studies, with calculated acceptability and feasibility if appropriate, and GRADE score. Studies listed in chronological

HIV coping self-efficacy: a key to understanding stigma and HIV test acceptance among incarcerated men in Jamaica.

PubMed

Andrinopoulos, Katherine; Kerrigan, Deanna; Figueroa, J Peter; Reese, Richard; Ellen, Jonathan M

2010-03-01

Although prisons have been noted as important venues for HIV testing, few studies have explored the factors within this context that may influence HIV test acceptance. Moreover, there is a dearth of research related to HIV and incarcerated populations in middle and low-income countries, where both the burden of HIV and the number of people incarcerated is higher compared to high-income countries. This study explores the relationship between HIV coping self-efficacy, HIV-related stigma, and HIV test acceptance in the largest prisons in Jamaica. A random sample of inmates (n=298) recruited from an HIV testing demonstration project were asked to complete a cross-sectional quantitative survey. Participants who reported high HIV coping self-efficacy (adjusted odds ratio (AOR) 1.86: 95% confidence interval CI 1.24-2.78, p-value=0.003), some perceived risk of HIV (AOR 2.51: 95% (CI) 1.57-4.01, p-value=0.000), and low HIV testing stigma (AOR 1.71: 95% CI 1.05-2.79, p-value=0.032) were more likely to test for HIV. Correlates of HIV coping self-efficacy included external and internal HIV stigma (AOR 1.28: 95% CI 1.25-1.32, p-value=0.000 and AOR 1.76: 95% CI 1.34-2.30, p-value=0.000, respectively), social support (AOR 2.09: 95% CI 1.19-3.68, p-value=0.010), and HIV knowledge (AOR 2.33: 95% CI 1.04-5.22, p-value=0.040). Policy and programs should focus on the interrelationships of these constructs to increase participation in HIV testing in prison.

Opt-out of voluntary HIV testing: a Singapore hospital's experience.

PubMed

Chua, Arlene C; Leo, Yee Sin; Cavailler, Philippe; Chu, Christine; Ng, Aloysius; Ng, Oon Tek; Krishnan, Prabha

2012-01-01

Since 2008, the Singapore Ministry of Health (MOH) has expanded HIV testing by increasing anonymous HIV test sites, as well as issuing a directive to hospitals to offer routine voluntary opt out inpatient HIV testing. We reviewed this program implemented at the end of 2008 at Tan Tock Seng Hospital (TTSH), the second largest acute care general hospital in Singapore. From January 2009 to December 2010, all inpatients aged greater or equal than 21 years were screened for HIV unless they declined or were not eligible for screening. We reviewed the implementation of the Opt Out testing policy. There were a total of 93,211 admissions; 41,543 patients were included based on HIV screening program eligibility criteria. Among those included, 79% (n = 32,675) opted out of HIV screening. The overall acceptance rate was 21%. Majority of eligible patients who were tested (63%) were men. The mean age of tested patients was 52 years. The opt out rate was significantly higher among females (OR: 1.5, 95%CI: 1.4-1.6), aged >60 years (OR: 2.3, 95%CI: 2.2-2.4) and Chinese ethnicity (OR: 1.7, 95%CI:1.6-1.8). The false positive rate of the HIV screening test is 0.56%. The proportion of patients with HIV infection among those who underwent HIV screening is 0.18%. All 16 confirmed HIV patients were linked to care. The default opt-in rate of inpatient HIV testing was low at Tan Tock Seng Hospital, Singapore. Efforts to address individual HIV risk perception and campaigns against HIV stigma are needed to encourage more individuals to be tested for HIV.

Potential for false positive HIV test results with the serial rapid HIV testing algorithm

PubMed Central

2012-01-01

Background Rapid HIV tests provide same-day results and are widely used in HIV testing programs in areas with limited personnel and laboratory infrastructure. The Uganda Ministry of Health currently recommends the serial rapid testing algorithm with Determine, STAT-PAK, and Uni-Gold for diagnosis of HIV infection. Using this algorithm, individuals who test positive on Determine, negative to STAT-PAK and positive to Uni-Gold are reported as HIV positive. We conducted further testing on this subgroup of samples using qualitative DNA PCR to assess the potential for false positive tests in this situation. Results Of the 3388 individuals who were tested, 984 were HIV positive on two consecutive tests, and 29 were considered positive by a tiebreaker (positive on Determine, negative on STAT-PAK, and positive on Uni-Gold). However, when the 29 samples were further tested using qualitative DNA PCR, 14 (48.2%) were HIV negative. Conclusion Although this study was not primarily designed to assess the validity of rapid HIV tests and thus only a subset of the samples were retested, the findings show a potential for false positive HIV results in the subset of individuals who test positive when a tiebreaker test is used in serial testing. These findings highlight a need for confirmatory testing for this category of individuals. PMID:22429706

HIV Testing

MedlinePlus

... NAT means. Taking pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) may also reduce the accuracy of NAT if you have HIV. An antigen/antibody test looks for both HIV antibodies and antigens. Antibodies ...

Comparative evaluation of the Bio-Rad Geenius HIV-1/2 Confirmatory Assay and the Bio-Rad Multispot HIV-1/2 Rapid Test as an alternative differentiation assay for CLSI M53 algorithm-I.

PubMed

Malloch, L; Kadivar, K; Putz, J; Levett, P N; Tang, J; Hatchette, T F; Kadkhoda, K; Ng, D; Ho, J; Kim, J

2013-12-01

The CLSI-M53-A, Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus (HIV) Infection; Approved Guideline includes an algorithm in which samples that are reactive on a 4th generation EIA screen proceed to a supplemental assay that is able to confirm and differentiate between antibodies to HIV-1 and HIV-2. The recently CE-marked Bio-Rad Geenius HIV-1/2 Confirmatory Assay was evaluated as an alternative to the FDA-approved Bio-Rad Multispot HIV-1/HIV-2 Rapid Test which has been previously validated for use in this new algorithm. This study used reference samples submitted to the Canadian - NLHRS and samples from commercial sources. Data was tabulated in 2×2 tables for statistical analysis; sensitivity, specificity, predictive values, kappa and likelihood ratios. The overall performance of the Geenius and Multispot was very high; sensitivity (100%, 100%), specificity (96.3%, 99.1%), positive (45.3, 181) and negative (0, 0) likelihood ratios respectively, high kappa (0.96) and low bias index (0.0068). The ability to differentiate HIV-1 (99.2%, 100%) and HIV-2 (98.1%, 98.1%) Ab was also very high. The Bio-Rad Geenius HIV-1/2 Confirmatory Assay is a suitable alternative to the validated Multispot for use in the second stage of CLSI M53 algorithm-I. The Geenius has additional features including traceability and sample and cassette barcoding that improve the quality management/assurance of HIV testing. It is anticipated that the CLSI M53 guideline and assays such as the Geenius will reduce the number of indeterminate test results previously associated with the HIV-1 WB and improve the ability to differentiate HIV-2 infections. Crown Copyright © 2013. Published by Elsevier B.V. All rights reserved.

Opt-out of Voluntary HIV Testing: A Singapore Hospital's Experience

PubMed Central

Chua, Arlene C.; Leo, Yee Sin; Cavailler, Philippe; Chu, Christine; Ng, Aloysius; Ng, Oon Tek; Krishnan, Prabha

2012-01-01

Introduction Since 2008, the Singapore Ministry of Health (MOH) has expanded HIV testing by increasing anonymous HIV test sites, as well as issuing a directive to hospitals to offer routine voluntary opt out inpatient HIV testing. We reviewed this program implemented at the end of 2008 at Tan Tock Seng Hospital (TTSH), the second largest acute care general hospital in Singapore. Methods and Findings From January 2009 to December 2010, all inpatients aged greater or equal than 21 years were screened for HIV unless they declined or were not eligible for screening. We reviewed the implementation of the Opt Out testing policy. There were a total of 93,211 admissions; 41,543 patients were included based on HIV screening program eligibility criteria. Among those included, 79% (n = 32,675) opted out of HIV screening. The overall acceptance rate was 21%. Majority of eligible patients who were tested (63%) were men. The mean age of tested patients was 52 years. The opt out rate was significantly higher among females (OR: 1.5, 95%CI: 1.4–1.6), aged >60 years (OR: 2.3, 95%CI: 2.2–2.4) and Chinese ethnicity (OR: 1.7, 95%CI:1.6–1.8). The false positive rate of the HIV screening test is 0.56%. The proportion of patients with HIV infection among those who underwent HIV screening is 0.18%. All16 confirmed HIV patients were linked to care. Conclusion The default opt-in rate of inpatient HIV testing was low at Tan Tock Seng Hospital, Singapore. Efforts to address individual HIV risk perception and campaigns against HIV stigma are needed to encourage more individuals to be tested for HIV. PMID:22493708

Demographic variations in HIV testing history among emergency department patients: implications for HIV screening in US emergency departments

PubMed Central

Merchant, Roland C; Catanzaro, Bethany M; Seage, George R; Mayer, Kenneth H; Clark, Melissa A; DeGruttola, Victor G; Becker, Bruce M

2011-01-01

Objective To determine the proportion of emergency department (ED) patients who have been tested for human immunodeficiency virus (HIV) infection and assess if patient history of HIV testing varies according to patient demographic characteristics. Design From July 2005–July 2006, a random sample of 18–55-year-old English-speaking patients being treated for sub-critical injury or illness at a northeastern US ED were interviewed on their history of HIV testing. Logistic regression models were created to compare patients by their history of being tested for HIV according to their demography. Odds ratios (ORs) with 95% confidence intervals (CIs) were estimated. Results Of 2107 patients surveyed who were not known to be HIV-infected, the median age was 32 years; 54% were male, 71% were white, and 45% were single/never married; 49% had private health-care insurance and 45% had never been tested for HIV. Of the 946 never previously tested for HIV, 56.1% did not consider themselves at risk for HIV. In multivariable logistic regression analyses, those less likely to have been HIV tested were male (OR: 1.32 [1.37–2.73]), white (OR: 1.93 [1.37–2.73]), married (OR: 1.53 [1.12–2.08]), and had private health-care insurance (OR: 2.10 [1.69–2.61]). There was a U-shaped relationship between age and history of being tested for HIV; younger and older patients were less likely to have been tested. History of HIV testing and years of formal education were not related. Conclusion Almost half of ED patients surveyed had never been tested for HIV. Certain demographic groups are being missed though HIV diagnostic testing and screening programmes in other settings. These groups could potentially be reached through universal screening. PMID:19564517

Impact of a Routine, Opt-Out HIV Testing Program on HIV Testing and Case Detection in North Carolina Sexually-Transmitted Disease Clinics

PubMed Central

Klein, Pamela W.; Messer, Lynne C.; Myers, Evan R.; Weber, David J.; Leone, Peter A.; Miller, William C.

2016-01-01

The impact of routine, opt-out HIV testing programs in clinical settings is inconclusive. The objective of this study was to estimate the impact of an expanded, routine HIV testing program in North Carolina sexually transmitted disease (STD) clinics on HIV testing and case detection. Adults aged 18–64 who received an HIV test in a North Carolina STD clinic July 1, 2005 through June 30, 2011 were included in this analysis, dichotomized at the date of implementation on November 1, 2007. HIV testing and case detection counts and rates were analyzed using interrupted time series analysis, and Poisson and multilevel logistic regression. Pre-intervention, 426 new HIV-infected cases were identified from 128,029 tests (0.33%), whereas 816 new HIV-infected cases were found from 274,745 tests post-intervention (0.30%). Pre-intervention, HIV testing increased by 55 tests per month (95% confidence interval [CI]: 41, 72), but only 34 tests per month (95% CI: 26, 42) post-intervention. Increases in HIV testing rates were most pronounced in females and non-Hispanic whites. A slight pre-intervention decline in case detection was mitigated by the intervention (mean difference [MD]=0.01; 95% CI: −0.02, 0.05). Increases in case detection rates were observed among females and non-Hispanic blacks. The impact of a routine HIV screening in North Carolina STD clinics was marginal, with the greatest benefit among persons not traditionally targeted for HIV testing. The use of a pre-intervention comparison period identified important temporal trends that otherwise would have been ignored. PMID:24825338

HIV testing behaviour among heterosexual migrants in Amsterdam.

PubMed

Stolte, I G; Gras, M; Van Benthem, B H; Coutinho, R A; van den Hoek, J A

2003-08-01

This cross-sectional study among heterosexual migrant groups in south-eastern Amsterdam, the city area where the largest migrant groups live, provides an insight into HIV testing behaviour in this particular group. Participants were recruited at street locations (May 1997-July 1998) and interviewed using structured questionnaires. They also donated saliva for HIV testing. In total, 705 males and 769 females were included in this study (Afro-Surinamese (45%), Dutch-Antilleans (15%) and West Africans (40%)). Prior HIV testing was reported by 38% of all migrants (556/1479), of which only a minority (28%) had actively requested HIV testing. Multivariate logistic regression showed that not actively requesting HIV testing was more likely among younger (< 23 years) migrants, especially women (ORwomen: 4.79, p < 0.01, ORmen: 1.81, p < 0.05). Furthermore, women without previous STI treatment (OR 2.19, p < 0.05) with Afro-Surinamese ethnicity (OR 2.12, p < 0.05), men without health insurance (OR 2.17, p < 0.05) and with low education (p < 0.01) were also more likely to not actively request HIV testing. Active requests for HIV testing in case of HIV risk should be facilitated by promoting HIV testing and by improving accurate self-assessment of risk for HIV infection, especially among the groups that do not actively request HIV testing. This would increase HIV awareness and provide the opportunity of better medical care earlier in HIV infection.

HIV testing and burden of HIV infection in black cancer patients in Johannesburg, South Africa: a cross-sectional study.

PubMed

Sengayi, Mazvita; Babb, Chantal; Egger, Matthias; Urban, Margaret I

2015-03-18

HIV infection is a known risk factor for cancer but little is known about HIV testing patterns and the burden of HIV infection in cancer patients. We did a cross-sectional analysis to identify predictors of prior HIV testing and to quantify the burden of HIV in black cancer patients in Johannesburg, South Africa. The Johannesburg Cancer Case-control Study (JCCCS) recruits newly-diagnosed black cancer patients attending public referral hospitals for oncology and radiation therapy in Johannesburg . All adult cancer patients enrolled into the JCCCS from November 2004 to December 2009 and interviewed on previous HIV testing were included in the analysis. Patients were independently tested for HIV-1 using a single ELISA test . The prevalence of prior HIV testing, of HIV infection and of undiagnosed HIV infection was calculated. Multivariate logistic regression models were fitted to identify factors associated with prior HIV testing. A total of 5436 cancer patients were tested for HIV of whom 1833[33.7% (95% CI=32.5-35.0)] were HIV-positive. Three-quarters of patients (4092 patients) had ever been tested for HIV. The total prevalence of undiagnosed HIV infection was 11.5% (10.7-12.4) with 34% (32.0-36.3) of the 1833 patients who tested HIV-positive unaware of their infection. Men >49 years [OR 0.49(0.39-0.63)] and those residing in rural areas [OR 0.61(0.39-0.97)] were less likely to have been previously tested for HIV. Men with at least a secondary education [OR 1.79(1.11-2.90)] and those interviewed in recent years [OR 4.13(2.62 - 6.52)] were likely to have prior testing. Women >49 years [OR 0.33(0.27-0.41)] were less likely to have been previously tested for HIV. In women, having children <5 years [OR 2.59(2.04-3.29)], hormonal contraceptive use [OR 1.33(1.09-1.62)], having at least a secondary education [OR:2.08(1.45-2.97)] and recent year of interview [OR 6.04(4.45-8.2)] were independently associated with previous HIV testing. In a study of newly diagnosed black

Comparison of Versant HBV DNA 3.0 and COBAS AmpliPrep-COBAS TaqMan assays for hepatitis B DNA quantitation: Possible clinical implications.

PubMed

Garbuglia, A R; Angeletti, C; Lauria, F N; Zaccaro, P; Cocca, A M; Pisciotta, M; Solmone, M; Capobianchi, M R

2007-12-01

We compared two commercial assays for HBV DNA quantitation, Versant HBV 3.0, System 340 (bDNA; Bayer Diagnostics) and COBAS AmpliPrep-COBAS TaqMan HBV Test (TaqMan; Roche Diagnostics). Analytical sensitivity, calculated on WHO International Standard, predicted 95% detection rate at 11.4 and 520.2IU/ml for TaqMan and bDNA, respectively. Specificity, established on 50 blood donor samples, was 100% and 84% for TaqMan and bDNA, respectively. When using clinical samples, HBV DNA was detected by TaqMan in 21/55 samples negative to bDNA. Mean values of HBV DNA obtained with bDNA were higher than those obtained with TaqMan (4.09log(10)+/-1.90 versus 3.39log(10)+/-2.41, p<0.001), and 24.4% of samples showed differences in viral load values >0.5log(10), without association with HBV genotype. There was a good correlation for HBV DNA concentrations measured by the two assays (r=0.94; p<0.001) within the overlapping range, and the distribution of results with respect to relevant clinical threshold recently confirmed (20,000 and 2000IU/ml) was similar. Approximately 50% of samples with low HBV DNA, appreciated by TaqMan but not by bDNA, were successfully sequenced in pol region, where drug resistance mutations are located.

Service impact of a change in HIV-1 viral load quantification assay.

PubMed

Tipple, Craig; Oomeer, Soonita; Dosekun, Olamide; Mackie, Nicola

2014-01-01

Due to discontinuation of the Siemens Versant HIV-1 RNA (bDNA) assay in the UK, our laboratory switched to the Roche Cobas Ampliprep/Taqman HIV-1 viral load (VL) assay (Roche) in April 2013. This assay has a lower cut-off of 20 RNA copies/mL (compared with <50 for the Siemens assay). Our laboratory demonstrated previously that a significant proportion (18%) of patients undetectable using bDNA HIV-1 RNA quantification exhibited low level viraemia (LLV) using the new assay. Local guidelines recommend that patients stable on therapy receive twice-yearly VLs. We evaluated the impact of the introduction of the new assay on our clinical service. A retrospective cohort analysis of treated patients with stable undetectable VL by bDNA (<50 copies/mL) followed by ≥ one low-level (<400 copies/mL) VL with the Roche assay. Demographic data were collected in addition to frequency of VL testing and genotypic resistance assays. Referrals to virtual clinic (VC) were recorded. Patients were identified using laboratory data and information collected from electronic patient records. RESULTS were analyzed with SPSS v18. One hundred and ninety patients were included. 79.5% male; 60.6% homosexual; mean age of 46 years. Duration on stable treatment was 46.35 (std. dev. 38.15) months. Current treatment regimens were 43.3% PI-based; 43.3% NNRTI-based and 13.7% other. Patients were stratified into VL 20-49 copies/mL (n=109); VL 50-199 copies/mL (n=71) and VL 200-399 copies/mL (n=10). In total, there were 471 VLs measured of which 274 were additional as a result of the assay switch. This resulted in six HIV-1 genotype requests and 16 VC discussions (Table 1). Longer duration on HAART was associated with reduced frequency of VL testing. The relative risk of ongoing detectability according to drug class are: PI 1.62 (95% CI 1.18-2.21); NNRTI 0.507 (95% CI 0.30-0.85) and other 1.09 (95% CI 0.48-2.43). Changes in assay can result in difficulties in interpretation of patient results. The assay

Initial outcomes of provider-initiated routine HIV testing and counseling during outpatient care at a rural Ugandan hospital: risky sexual behavior, partner HIV testing, disclosure, and HIV care seeking.

PubMed

Kiene, Susan M; Bateganya, Moses; Wanyenze, Rhoda; Lule, Haruna; Nantaba, Harriet; Stein, Michael D

2010-02-01

Provider-initiated routine HIV testing is being scaled up throughout the world, however, little is known about the outcomes of routine HIV testing on subsequent behavior. This study examined the initial outcomes of provider-initiated routine HIV testing at a rural Ugandan hospital regarding partner HIV testing, sexual risk behavior, disclosure, and HIV care seeking. In a prospective cohort study, 245 outpatients receiving routine HIV testing completed baseline and 3-month follow-up interviews. After receiving routine HIV testing the percentage of participants engaging in risky sex decreased from 70.1% to 50.3% among HIV-negative and from 75.0% to 53.5% among HIV-positive participants, the percentage knowing their partner(s)' HIV status increased from 18.7% to 34.3% of HIV-negative and from 14.3% to 35.7% of HIV-positive participants. Among those reporting risky sex at baseline, HIV-positive participants were more likely to eliminate risky sex in general and specifically to become abstinent at follow-up than were HIV-negative participants. Similarly, unmarried participants who were risky at baseline were more likely to become safe in general, become abstinent, and start 100% condom use than were married/cohabitating participants. Rates of disclosure were high. Over 85% of those who tested HIV positive enrolled in care. Routine HIV testing in this setting may promote earlier HIV diagnosis and access to care but leads to only modest reductions in risky sexual behavior. To fully realize the potential HIV prevention benefits of routine HIV testing an emphasis on tailored risk-reduction counseling may be necessary.

HIV-1 infection using dried blood spots can be confirmed by Bio-Rad Geenius™ HIV 1/2 confirmatory assay.

PubMed

Fernández McPhee, Carolina; Álvarez, Patricia; Prieto, Luis; Obiang, Jacinta; Avedillo, Pedro; Vargas, Antonio; Rojo, Pablo; Abad, Carlota; Ramos, José Tomás; Holguín, Africa

2015-02-01

Confirmatory assays for HIV diagnosis are not well implemented in low-income countries with limited infrastructures. Geenius™ HIV 1/2 Confirmatory Assay is a single-use immunochromatographic test for the confirmation and differentiation of individual HIV-1/2 antibodies validated in venous whole blood, serum and plasma. However, dried blood specimens (DBS) are easier to collect, store and transport than plasma/serum in remote settings from limited resource countries and mobile populations. To evaluate the confirmatory assay Geenius™ HIV 1/2 for HIV diagnosis using DBS specimens. We collected DBS from 70 Guinean women previously diagnosed as HIV-1 infected by rapid tests using whole blood samples in Equatorial Guinea and from 25 HIV-negative Guinean women and HIV-exposed infants diagnosed by molecular testing in Madrid. Geenius HIV 1/2 was performed by eluting two drops of dried blood from each patient and following the manufacturer instructions for the assay but using 40μl of the eluted blood as specimen. The results obtained were confirmed by western blot. Geenius™ HIV 1/2 successfully confirmed the HIV-1 positive and negative infection in all tested DBS specimens, providing 100% specificity [95% Confidence Interval (CI): 86.2%-100%]. No HIV 1/2 coinfections were found in the study cohort. This is the first report that proves a good performance of Geenius™ HIV 1/2 for the HIV-1 infection confirmation using only two drops of dried blood. Our results approve the utility of this confirmatory assay using DBS when a lack of adequate infrastructure to collect, store or transport plasma/serum is found. DBS are a practical alternative to plasma/serum for HIV serological diagnosis. Copyright © 2015 Elsevier B.V. All rights reserved.

Can trained lay providers perform HIV testing services? A review of national HIV testing policies.

PubMed

Flynn, David E; Johnson, Cheryl; Sands, Anita; Wong, Vincent; Figueroa, Carmen; Baggaley, Rachel

2017-01-04

Only an estimated 54% of people living with HIV are aware of their status. Despite progress scaling up HIV testing services (HTS), a testing gap remains. Delivery of HTS by lay providers may help close this testing gap, while also increasing uptake and acceptability of HIV testing among key populations and other priority groups. 50 National HIV testing policies were collated from WHO country intelligence databases, contacts and testing program websites. Data regarding lay provider use for HTS was extracted and collated. Our search had no geographical or language restrictions. This data was then compared with reported data from the Global AIDS Response Progress Reporting (GARPR) from July 2015. Forty-two percent of countries permit lay providers to perform HIV testing and 56% permit lay providers to administer pre-and post-test counseling. Comparative analysis with GARPR found that less than half (46%) of reported data from countries were consistent with their corresponding national HIV testing policy. Given the low uptake of lay provider use globally and their proven use in increasing HIV testing, countries should consider revising policies to support lay provider testing using rapid diagnostic tests.

Increasing HIV testing engagement through provision of home HIV self-testing kits for patients who decline testing in the emergency department: a pilot randomisation study.

PubMed

Patel, Anuj V; Abrams, Samuel M; Gaydos, Charlotte A; Jett-Goheen, Mary; Latkin, Carl A; Rothman, Richard E; Hsieh, Yu-Hsiang

2018-06-14

Up to 60% of patients decline routine HIV testing offer in US emergency departments (EDs). The objective of this study is to determine whether the provision of HIV self-testing (HIVST) kit would increase engagement of HIV testing among these HIV test 'Decliners'. Patients who declined a test offered in an ED-based triage nurse-driven HIV screening programme were enrolled and randomised to either the HIVST or the control group. The patients in the HIVST group received HIVST kits to take home, were encouraged to report test results to an established internet-based STI/HIV testing recruitment website 'I Want the Kit' (IWTK) and received five referral cards for their peers to request HIVST kits from IWTK. The control group received pamphlets about publicly available HIV testing sites. HIV testing from both groups after enrolment was determined via telephone follow-up at 1 month. Testing rate ratio (RR) was determined using χ 2 tests. Fifty-two patients were randomised to the HIVST group and 48 to the control group. Among all 64 patients completing any follow-up, 14/29 (48%) patients in the HIVST group tested themselves at home with the provided kit. Four of these had never had an HIV test. Only 2/35 (6%) in the control group reported having an HIV test after enrolment (RR: 8.45 (95% CI: 2.09 to 34.17)). 57% (8/14) in the HIVST group reported test results to IWTK. Provision of HIVST kits supplements ED-based screening programme and significantly improved engagement of HIV testing among those test 'Decliners' in the ED. NCT03021005, results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Sexual Behaviors and HIV/Syphilis Testing Among Transgender Individuals in China: Implications for Expanding HIV Testing Services

PubMed Central

Best, John; Tang, Weiming; Zhang, Ye; Han, Larry; Liu, Fengying; Huang, Shujie; Yang, Bin; Wei, Chongyi; Tucker, Joseph D.

2015-01-01

Background HIV and syphilis are disproportionately common among transgender individuals globally, yet few studies have investigated transgender HIV/syphilis risk and testing in low and middle-income nations. We conducted an online survey of men who have sex with men (MSM) and transgender individuals to examine sexual behaviors, and HIV/syphilis testing in China. Methods We recruited MSM and transgender individuals from two-major Chinese lesbian, gay, bisexual, and transgender (LGBT) web platforms. Chi-square and logistic regression were used to compare risk behaviors, HIV and syphilis testing history, and prevalence between transgender individuals and other MSM. Results Among the 1320 participants, 52 (3·9%) self-identified as transgender. Demographics, including education, employment, and marital status were similar between both groups, while transgender individuals were older. Condomless anal intercourse rate was comparable between the groups. Transgender individuals were less likely to report ever testing for HIV (34·6% VS 62·0%) and syphilis (15·7% VS 31·2%) with adjusted ORs of 0·36 (95% CI 0·20–0·65) and 0·42 (95% CI 0·20–0·91), respectively. We found a trend towards higher HIV prevalence among transgender individuals (11·1% VS5·7%, P=0·12). Conclusion Transgender individuals have suboptimal HIV and syphilis testing rates in China. Given the substantial risk behaviors and burden of HIV/STI in the general Chinese MSM population and lack of knowledge about transgender individuals, enhanced HIV/syphilis testing programs for transgender individuals in China are needed. PMID:25868142

The cobas p 630 instrument: a dedicated pre-analytic solution to optimize COBAS® AmpliPrep/COBAS® TaqMan® system workflow and turn-around-time.

PubMed

Vallefuoco, L; Sorrentino, R; Spalletti Cernia, D; Colucci, G; Portella, G

2012-12-01

The cobas p 630, a fully automated pre-analytical instrument for primary tube handling recently introduced to complete the Cobas(®) TaqMan systems portfolio, was evaluated in conjunction with: the COBAS(®) AmpliPrep/COBAS(®) TaqMan HBV Test, v2.0, COBAS(®) AmpliPrep/COBAS(®) TaqMan HCV Test, v1.0 and COBAS(®) AmpliPrep/COBAS(®) TaqMan HIV Test, v2.0. The instrument performance in transferring samples from primary to secondary tubes, its impact in improving COBAS(®) AmpliPrep/COBAS(®) TaqMan workflow and hands-on reduction and the risk of possible cross-contamination were assessed. Samples from 42 HBsAg positive, 42 HCV and 42 HIV antibody (Ab) positive patients as well as 21 healthy blood donors were processed with or without automated primary tubes. HIV, HCV and HBsAg positive samples showed a correlation index of 0.999, 0.987 and of 0.994, respectively. To assess for cross-contamination, high titer HBV DNA positive samples, HCV RNA and HIV RNA positive samples were distributed in the cobas p 630 in alternate tube positions, adjacent to negative control samples within the same rack. None of the healthy donor samples showed any reactivity. Based on these results, the cobas p 630 can improve workflow and sample tracing in laboratories performing molecular tests, and reduce turnaround time, errors, and risks. Copyright © 2012 Elsevier B.V. All rights reserved.

Implementing a routine, voluntary HIV testing program in a Massachusetts county prison.

PubMed

Liddicoat, Rebecca V; Zheng, Hui; Internicola, Jeanne; Werner, Barbara G; Kazianis, Arthur; Golan, Yoav; Rubinstein, Eric P; Freedberg, Kenneth A; Walensky, Rochelle P

2006-11-01

Although U.S. prison inmates have higher rates of HIV infection than the general population, most inmates are not routinely tested for HIV infection at prison entry. The study objective was to implement a routine, voluntary HIV testing program in a Massachusetts county prison. During admission, inmates were given group HIV pre-test counseling and were subsequently offered private HIV testing. This intervention was compared to a control period during which HIV testing was provided only upon inmate or physician request. Between November 2004 and April 2005, 1,004 inmates met inclusion criteria and were offered routine, voluntary HIV testing. Of these, 734 (73.1%) accepted, 2 (0.3%) were HIV-infected, and 457 (45.5%) had been tested for HIV in the previous year. The testing rate of 73.1% was significantly increased from the rate of 18.0% (318 of 1,723) during the control period (p<0.001). Among the inmates tested for HIV in the prior year, 78.2% had received their last HIV test in the prison setting. Careful attention should be paid to prevent redundancy of testing efforts in the prison population. Implementing a routine HIV testing program among prison inmates greatly increased testing rates compared to on-request testing.

Evaluation of clinical sensitivity and specificity of hepatitis B virus (HBV), hepatitis C virus, and human immunodeficiency Virus-1 by cobas MPX: Detection of occult HBV infection in an HBV-endemic area.

PubMed

Ha, Jihye; Park, Younhee; Kim, Hyon-Suk

2017-11-01

Transfusion-transmitted infectious diseases remain a major concern for blood safety, particularly with hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Nucleic acid testing (NAT) in donor screening shortens the serologically negative window period and reduces virus transmission. The cobas MPX (Roche Molecular Systems, Inc., Branchburg, New Jersey) is a recently developed multiplex qualitative PCR system that enables the simultaneous detection of HBV, HCV, and HIV with improved sensitivity and throughput using cobas 6800 and 8800 instruments. The aim of this study was to conduct an evaluation of the clinical sensitivity and specificity of cobas MPX detection of HBV, HCV, and HIV in clinical specimens. Among samples referred for HBV, HCV, and HIV-1 quantification at Severance Hospital, Yonsei University College of Medicine, positive samples were selected to evaluate sensitivity. A total of 843 samples was tested using both cobas MPX and COBAS AmpliPrep/COBAS TaqMan Tests for HBV, HCV, and HIV-1 using the cobas 8800 system and a COBAS TaqMan 96 analyzer, respectively. Samples that showed discrepancies were confirmed by nested PCR. The cobas MPX achieved excellent sensitivity and specificity for the detection of HBV, HCV, and HIV-1 in clinical samples. We found that the lower limit of detection (LOD) of blood screening by NAT actually improves clinical sensitivity, and occult HBV infection prevalence among healthy employees of the hospital was rather high. Copyright © 2017 Elsevier B.V. All rights reserved.

Barriers and Facilitators to HIV Testing Among Women

PubMed Central

McDougall, Graham J.; Dalmida, Safiya George; Foster, Pamela Payne; Burrage, Joe

2017-01-01

Aim The purpose of this secondary analysis was to analyze for barriers and facilitators to HIV testing in women attending community health clinics. Introduction The Centers for Disease Control and Prevention (CDC), reported that all women account for 20% or 1 in 5 of new HIV cases (CDC, 2012). Of those new cases in heterosexual women, 5,300 were Black, 1,300 were White, and 1,200 were Hispanic/Latina. The CDC estimated that in 2012 there were 9,268 individuals living with a diagnosis of HIV or AIDS, of which 19% were women. Results The existing de-identified data consisted of thirty individual interviews conducted using a semi-structured interview guide was collected as the initial phase of the parent study, “HIV Testing and Women’s Attitudes on HIV Vaccine Trials”. This secondary analysis addressed the identification of key obstacles to HIV testing and only those related portions of the transcripts were analyzed. The major themes identified were familiarity with testing, stigma, fear, perceived risks, and access to care. Conclusion The themes implicated the need to further assess women for barriers and facilitators to testing, tailor community based interventions that have the ability to decrease fear and stigma, increase trust in testing methods and offer counseling to positive results. PMID:29607406

Repeat HIV Testing at Voluntary Testing and Counseling Centers in Croatia: Successful HIV Prevention or Failure to Modify Risk Behaviors?

PubMed Central

Matković Puljić, Vlatka; Kosanović Ličina, Mirjana Lana; Kavić, Marija; Nemeth Blažić, Tatjana

2014-01-01

HIV testing plays a critical role in preventing the spread of the virus and identifying infected individuals in need of care. Voluntary counseling and testing centers (VCTs) not only conduct testing but they also provide counseling. Since a proportion of people who test negative for HIV on their previous visit will return for retesting, the frequency of retesting and the characteristics of those who retest may provide insights into the efficacy of testing and counseling strategies. In this cross-sectional, retrospective study of 1,482 VCT clients in Croatia in 2010, 44.3% had been tested for HIV before. The rate of repeat HIV testing is lower in Croatia than in other countries. Men who have sex with men (MSM) clients, those with three or more sexual partners in the last 12 months, consistent condom users with steady partners, and intravenous drug users were more likely to be repeat testers. This finding suggests that clients presenting for repeat HIV testing are those who self-identify as being at a higher risk of infection. Our data showed that testing positive for HIV was not associated with repeat testing. However, the effects of repeat testing on HIV epidemiology needs to be explored. PMID:24705595

Evaluation of the Cobas TaqMan MTB Test for the Detection of Mycobacterium tuberculosis Complex According to Acid-Fast-Bacillus Smear Grades in Respiratory Specimens

PubMed Central

Huh, Hee Jae; Koh, Won-Jung; Song, Dong Joon

2014-01-01

We evaluated the performance of the Cobas TaqMan MTB test (Roche Diagnostics, Basel, Switzerland), stratified by acid-fast bacilli (AFB) smear grades. The sensitivity of this test in smear-positive specimens was >95% in all grades, while that in trace and negative specimens was 85.3% and 34.4%, respectively. PMID:25428157

HIV prevalence, attitudes and behaviour in clients of a confidential HIV testing and counselling centre in Uganda.

PubMed

Müller, O; Barugahare, L; Schwartländer, B; Byaruhanga, E; Kataaha, P; Kyeyune, D; Heckmann, W; Ankrah, M

1992-08-01

To describe clients, operation and impact of an African public HIV testing and counselling centre. Analysis of samples from clients attending the AIDS Information Centre (AIC) in Kampala, Uganda in early 1991. HIV-1-positive and HIV-negative consecutive clients (250 of each), 86 consecutive couples, and 200 consecutive clients who were HIV-negative in 1990 and were attending for their repeat test. HIV seroprevalence rates, attitudes, behaviour and behaviour change. HIV-1 prevalence was 28% overall, 24% in men and 35% in women. Reasons for taking the HIV test were a planned marriage or a new relationship (27%; 84% in couples), to plan for the future (35%), distrust of sexual partner (14%) and illness or disease/death (not HIV-specific) of partner (20%). The majority of the reported intentions in response to a positive or a negative HIV test result were positive, demonstrating the ability to cope with this information. Of repeat clients, two (1%) had become HIV-1-positive. The majority of repeat clients reported one sexual partner only (67%) or sexual abstinence (25%). Compared with pre-test information from AIC clients attending for the first time, repeat clients reported casual sexual contacts less often (6 versus 25%) and, of those, the majority used condoms. Our study demonstrates the demand for and the feasibility of confidential HIV testing and counseling services in Uganda, and illustrates the value of these services in achieving behaviour changes. Such services should be considered an additional approach for the reduction of HIV transmission in Africa, especially in areas with high HIV seroprevalence rates.

Written Informed-Consent Statutes and HIV Testing

PubMed Central

Ehrenkranz, Peter D.; Pagán, José A.; Begier, Elizabeth M.; Linas, Benjamin; Madison, Kristin; Armstrong, Katrina

2009-01-01

Background Almost 1 million Americans are infected with HIV, yet it is estimated that as many as 250,000 of them do not know their serostatus. This study examined whether people residing in states with statutes requiring written informed consent prior to HIV testing were less likely to report a recent HIV test. Methods The study is based on survey data from the 2004 Behavioral Risk Factor Surveillance System. Logistic regression was used to assess the association between residence in a state with a pre-test written informed-consent requirement and individual self-report of recent HIV testing. The regression analyses controlled for potential state- and individual-level confounders. Results Almost 17% of respondents reported that they had been tested for HIV in the prior 12 months. Ten states had statutes requiring written informed consent prior to routine HIV testing; nine of those were analyzed in this study. After adjusting for other state- and individual-level factors, people who resided in these nine states were less likely to report a recent history of HIV testing (OR=0.85; 95% CI=0.80, 0.90). The average marginal effect was −0.02 (p<0.001, 95%CI= −0.03, −0.01); thus, written informed-consent statutes are associated with a 12% reduction in HIV testing from the baseline testing level of 17%. The association between a consent requirement and lack of testing was greatest among respondents who denied HIV risk factors, were non-Hispanic whites, or who had higher levels of education. Conclusions This study’s findings suggest that the removal of written informed-consent requirements might promote the non–risk-based routine-testing approach that the CDC advocates in its new testing guidelines. PMID:19423271

Advantages of the rapid HIV-1 test in occupational accidents with potentially contaminated material among health workers.

PubMed

Machado, A A; Martinez, R; Haikal, A A; Rodrigues da Silva, M C

2001-01-01

In occupational accidents involving health professionals handling potentially contaminated material, the decision to start or to continue prophylactic medication against infection by Human Immunodeficiency Virus (HIV) has been based on the ELISA test applied to a blood sample from the source patient. In order to rationalize the prophylactic use of antiretroviral agents, a rapid serologic diagnostic test of HIV infection was tested by the enzymatic immunoabsorption method (SUDS HIV 1+2, MUREX) and compared to conventional ELISA (Abbott HIV-1/ HIV-2 3rd Generation plus EIA). A total of 592 cases of occupational accidents were recorded at the University Hospital of Ribeirão Preto from July 1998 to April 1999. Of these, 109 were simultaneously evaluated by the rapid test and by ELISA HIV. The rapid test was positive in three cases and was confirmed by ELISA and in one the result was inconclusive and later found to be negative by ELISA. In the 106 accidents in which the rapid test was negative no prophylactic medication was instituted, with an estimated reduction in costs of US$ 2,889.35. In addition to this advantage, the good correlation of the rapid test with ELISA, the shorter duration of stress and the absence of exposure of the health worker to the adverse effects of antiretroviral agents suggest the adoption of this test in Programs of Attention to Accidents with Potentially Contaminated Material.

HIV-1 Drug Resistance and Resistance Testing

PubMed Central

Clutter, Dana S; Jordan, Michael R; Bertagnolio, Silvia; Shafer, Robert W

2016-01-01

The global scale-up of antiretroviral (ARV) therapy (ART) has led to dramatic reductions in HIV-1 mortality and incidence. However, HIV drug resistance (HIVDR) poses a potential threat to the long-term success of ART and is emerging as a threat to the elimination of AIDS as a public health problem by 2030. In this review we describe the genetic mechanisms, epidemiology, and management of HIVDR at both individual and population levels across diverse economic and geographic settings. To describe the genetic mechanisms of HIVDR, we review the genetic barriers to resistance for the most commonly used ARVs and describe the extent of cross-resistance between them. To describe the epidemiology of HIVDR, we summarize the prevalence and patterns of transmitted drug resistance (TDR) and acquired drug resistance (ADR) in both high-income and low- and middle-income countries (LMICs). We also review to two categories of HIVDR with important public health relevance: (i) pre-treatment drug resistance (PDR), a World Health Organization-recommended HIVDR surveillance metric and (ii) and pre-exposure prophylaxis (PrEP)-related drug resistance, a type of ADR that can impact clinical outcomes if present at the time of treatment initiation. To summarize the implications of HIVDR for patient management, we review the role of genotypic resistance testing and treatment practices in both high-income and LMIC settings. In high-income countries where drug resistance testing is part of routine care, such an understanding can help clinicians prevent virological failure and accumulation of further HIVDR on an individual level by selecting the most efficacious regimens for their patients. Although there is reduced access to diagnostic testing and to many ARVs in LMIC, understanding the scientific basis and clinical implications of HIVDR is useful in all regions in order to shape appropriate surveillance, inform treatment algorithms, and manage difficult cases. PMID:27587334

Correlates of HIV Testing Among Abused Women in South Africa

PubMed Central

Adams, Julie L.; Hansen, Nathan B.; Fox, Ashley M.; Taylor, Baishakhi B.; van Rensburg, Madri Jansen; Mohlahlane, Rakgadi; Sikkema, Kathleen J.

2012-01-01

Gender-based violence increases a woman’s risk for HIV but little is known about her decision to get tested. We interviewed 97 women seeking abuse-related services from a nongovernmental organization (NGO) in Johannesburg, South Africa. Forty-six women (47%) had been tested for HIV. Caring for children (odds ratio [OR] = 0.27, 95% confidence interval [CI] = [0.07, 1.00]) and conversing with partner about HIV (OR = 0.13, 95% CI = [0.02, 0.85]) decreased odds of testing. Stronger risk-reduction intentions (OR = 1.27, 95% CI = [1.01, 1.60]) and seeking help from police (OR = 5.51, 95% CI = [1.18, 25.76]) increased odds of testing. Providing safe access to integrated services and testing may increase testing in this population. Infection with HIV is highly prevalent in South Africa where an estimated 16.2% of adults between the ages of 15 and 49 have the virus. The necessary first step to stemming the spread of HIV and receiving life-saving treatment is learning one’s HIV serostatus through testing. Many factors may contribute to someone’s risk of HIV infection and many barriers may prevent testing. One factor that does both is gender-based violence. PMID:21727154

Safety and immunogenicity of HIV-1 Tat toxoid in immunocompromised HIV-1-infected patients.

PubMed

Gringeri, A; Santagostino, E; Muça-Perja, M; Mannucci, P M; Zagury, J F; Bizzini, B; Lachgar, A; Carcagno, M; Rappaport, J; Criscuolo, M; Blattner, W; Burny, A; Gallo, R C; Zagury, D

1998-01-01

To antagonize the deleterious effects of the HIV-1 toxin extracellular Tat on uninfected immune cells, we developed a new strategy of anti-HIV-1 vaccine using an inactivated but immunogenic Tat (Tat toxoid). Tat toxoid has been assayed for safety and immunogenicity in seropositive patients. The phase I vaccine clinical trial testing Tat toxoid preparation in Seppic Isa 51 oil adjuvant was performed on 14 HIV-1-infected asymptomatic although biologically immunocompromised individuals (500-200 CD4+ cells/mm3). Following as many as 8 injections, no clinical defects were observed. All patients exhibited an antibody (Ab) response to Tat, and some had cell-mediated immunity (CMI) as evaluated by skin test in vivo and T-cell proliferation in vitro. These results provide initial evidence of safety and potency of Tat toxoid vaccination in HIV-1-infected individuals.

Effects of human SAMHD1 polymorphisms on HIV-1 susceptibility

DOE Office of Scientific and Technical Information (OSTI.GOV)

White, Tommy E.; Brandariz-Nuñez, Alberto; Valle-Casuso, Jose Carlos

SAMHD1 is a human restriction factor that prevents efficient infection of macrophages, dendritic cells and resting CD4+ T cells by HIV-1. Here we explored the antiviral activity and biochemical properties of human SAMHD1 polymorphisms. Our studies focused on human SAMHD1 polymorphisms that were previously identified as evolving under positive selection for rapid amino acid replacement during primate speciation. The different human SAMHD1 polymorphisms were tested for their ability to block HIV-1, HIV-2 and equine infectious anemia virus (EIAV). All studied SAMHD1 variants block HIV-1, HIV-2 and EIAV infection when compared to wild type. We found that these variants did notmore » lose their ability to oligomerize or to bind RNA. Furthermore, all tested variants were susceptible to degradation by Vpx, and localized to the nuclear compartment. We tested the ability of human SAMHD1 polymorphisms to decrease the dNTP cellular levels. In agreement, none of the different SAMHD1 variants lost their ability to reduce cellular levels of dNTPs. Finally, we found that none of the tested human SAMHD1 polymorphisms affected the ability of the protein to block LINE-1 retrotransposition. - Highlights: • Human SAMHD1 single-nucleotide polymorphisms block HIV-1 and HIV-2 infection. • SAMHD1 polymorphisms do not affect its ability to block LINE-1 retrotransposition. • SAMHD1 polymorphisms decrease the cellular levels of dNTPs.« less

Plasma cytokine levels and risk of HIV type 1 (HIV-1) transmission and acquisition: a nested case-control study among HIV-1-serodiscordant couples.

PubMed

Kahle, Erin M; Bolton, Michael; Hughes, James P; Donnell, Deborah; Celum, Connie; Lingappa, Jairam R; Ronald, Allan; Cohen, Craig R; de Bruyn, Guy; Fong, Youyi; Katabira, Elly; McElrath, M Juliana; Baeten, Jared M

2015-05-01

A heightened proinflammatory state has been hypothesized to enhance human immunodeficiency virus type 1 (HIV-1) transmission - both susceptibility of HIV-1-exposed persons and infectiousness of HIV-1-infected persons. Using prospective data from heterosexual African couples with HIV-1 serodiscordance, we conducted a nested case-control analysis to assess the relationship between cytokine concentrations and the risk of HIV-1 acquisition. Case couples (n = 120) were initially serodiscordant couples in which HIV-1 was transmitted to the seronegative partner during the study; control couples (n = 321) were serodiscordant couples in which HIV-1 was not transmitted to the seronegative partner. Differences in a panel of 30 cytokines were measured using plasma specimens from both HIV-1-susceptible and HIV-1-infected partners. Plasma was collected before seroconversion for cases. For both HIV-1-infected and HIV-1-susceptible partners, cases and controls had significantly different mean responses in cytokine panels (P < .001, by the Hotelling T(2) test), suggesting a broadly different pattern of immune activation for couples in which HIV-1 was transmitted, compared with couples without transmission. Individually, log10 mean concentrations of interleukin 10 (IL-10) and CXCL10 were significantly higher for both HIV-1-susceptible and HIV-1-infected case partners, compared with HIV-1-susceptible and HIV-1-infected control partners (P < .01 for all comparisons). In multivariate analysis, HIV-1 transmission was significantly associated with elevated CXCL10 concentrations in HIV-1-susceptible partners (P = .001) and with elevated IL-10 concentrations in HIV-1-infected partners (P = .02). Immune activation, as measured by levels of cytokine markers, particularly elevated levels of IL-10 and CXCL1, are associated with increased HIV-1 susceptibility and infectiousness. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All

HIV Testing Trends: Southeastern Pennsylvania, 2002–2010

PubMed Central

Yehia, Baligh R.; Harhay, Michael O.; Fetzer, Bradley; Brady, Kathleen A.; Long, Judith A.

2014-01-01

Abstract There are limited data on HIV testing trends after 2006 when the Centers for Disease Control and Prevention (CDC) introduced opt-out HIV testing with the aims of identifying HIV-infected persons early and linking them to care. We used data from the Southeastern Pennsylvania Household Health Survey between 2002 and 2010 to evaluate HIV testing over time. 50,698 adult (≥18 years) survey respondents were included. HIV testing increased after the CDC recommendations: 42.1% of survey respondents received testing at least once in 2002 versus 51.4% in 2010, p<0.001. Testing trends increased among all demographic groups, but existing differences in testing before 2006 persisted after that year as follows: younger patients, racial/ethnic minorities, patients on Medicaid were all more likely to get tested than their counterparts. Blacks and patients seeking care in community health centers had the fastest rise in HIV testing. The probability of HIV testing in Blacks was 0.56 (95% CI 0.54–0.60) in 2002 and increased to 0.73 (0.70–0.76) by 2010. Patients seeking care in community health centers had a probability of HIV testing of 0.57 (0.47–0.66) in 2002, which increased to 0.69 (0.60–0.77) by 2010. In comparison, patients in private clinics had an HIV testing probability of 0.40 (0.36–0.43) in 2002 compared to 0.47 (0.40–0.54) in 2010. HIV testing is increasing, particularly among ethnic minorities and in community health centers. However, testing remains to be improved in that setting and across all clinic types. PMID:24742326

Detection and quantification of genetically modified organisms using very short, locked nucleic acid TaqMan probes.

PubMed

Salvi, Sergio; D'Orso, Fabio; Morelli, Giorgio

2008-06-25

Many countries have introduced mandatory labeling requirements on foods derived from genetically modified organisms (GMOs). Real-time quantitative polymerase chain reaction (PCR) based upon the TaqMan probe chemistry has become the method mostly used to support these regulations; moreover, event-specific PCR is the preferred method in GMO detection because of its high specificity based on the flanking sequence of the exogenous integrant. The aim of this study was to evaluate the use of very short (eight-nucleotide long), locked nucleic acid (LNA) TaqMan probes in 5'-nuclease PCR assays for the detection and quantification of GMOs. Classic TaqMan and LNA TaqMan probes were compared for the analysis of the maize MON810 transgene. The performance of the two types of probes was tested on the maize endogenous reference gene hmga, the CaMV 35S promoter, and the hsp70/cryIA(b) construct as well as for the event-specific 5'-integration junction of MON810, using plasmids as standard reference molecules. The results of our study demonstrate that the LNA 5'-nuclease PCR assays represent a valid and reliable analytical system for the detection and quantification of transgenes. Application of very short LNA TaqMan probes to GMO quantification can simplify the design of 5'-nuclease assays.

The relationship of reported HIV risk and history of HIV testing among emergency department patients.

PubMed

Merchant, Roland C; Freelove, Sarah M; Langan, Thomas J; Clark, Melissa A; Mayer, Kenneth H; Seage, George R; DeGruttola, Victor G

2010-01-01

Among a random sample of emergency department (ED) patients, we sought to determine the extent to which reported risk for human immunodeficiency virus (HIV) is related to ever having been tested for HIV. A random sample of patients (aged 18-64 years) from an adult, urban, northeastern United States, academic ED were surveyed about their history of ever having been tested for HIV and their reported HIV risk behaviors. A reported HIV risk score was calculated from the survey responses and divided into 4 levels, based on quartiles of the risk scores. Pearson's X(2) testing was used to compare HIV testing history and level of reported HIV risk. Logistic regression models were created to investigate the association between level of reported HIV risk and the outcome of ever having been tested for HIV. Of the 557 participants, 62.1% were female. A larger proportion of females than males (71.4% vs 60.6%; P < 0.01) reported they had been tested for HIV. Among the 211 males, 11.4% reported no HIV risk, and among the 346 females, 10.7% reported no HIV risk. The proportion of those who had been tested for HIV was greater among those reporting any risk compared with those reporting no risk for females (75.4% vs 37.8%; P < 0.001), but not for males (59.9% vs 66.7%; P < 0.52). However, certain high-risk behaviors, such as a history of injection-drug use, were associated with prior HIV testing for both genders. In the logistic regression analyses, there was no relationship between increasing level of reported HIV risk and a history of ever having been tested for HIV for males. For females, a history of ever having been tested was related to increasing level of reported risk, but not in a linear fashion. The relationship between reported HIV risk and history of testing among these ED patients was complex and differed by gender. Among these patients, having greater risk did not necessarily mean a higher likelihood of ever having been tested for HIV.

Bat white-nose syndrome: A real-time TaqMan polymerase chain reaction test targeting the intergenic spacer region of Geomyces destructans

Treesearch

Laura K Muller; Jeffrey M. Lorch; Daniel L. Lindner; Michael O' Connor; Andrea Gargas; David S. Blehert

2013-01-01

The fungus Geomyces destructans is the causative agent of white-nose syndrome (WNS), a disease that has killed millions of North American hibernating bats. We describe a real-time TaqMan PCR test that detects DNA from G. destructans by targeting a portion of the multicopy intergenic spacer region of the rRNA gene complex. The...

Anti-HIV-1 Activity of Flavonoid Myricetin on HIV-1 Infection in a Dual-Chamber In Vitro Model

PubMed Central

Pasetto, Silvana; Pardi, Vanessa; Murata, Ramiro Mendonça

2014-01-01

HIV infection by sexual transmission remains an enormous global health concern. More than 1 million new infections among women occur annually. Microbicides represent a promising prevention strategy that women can easily control. Among emerging therapies, natural small molecules such as flavonoids are an important source of new active substances. In this study we report the in vitro cytotoxicity and anti-HIV-1 and microbicide activity of the following flavonoids: Myricetin, Quercetin and Pinocembrin. Cytotoxicity tests were conducted on TZM-bl, HeLa, PBMC, and H9 cell cultures using 0.01–100 µM concentrations. Myricetin presented the lowest toxic effect, with Quercetin and Pinocembrin relatively more toxic. The anti-HIV-1 activity was tested with TZM-bl cell plus HIV-1 BaL (R5 tropic), H9 and PBMC cells plus HIV-1 MN (X4 tropic), and the dual tropic (X4R5) HIV-1 89.6. All flavonoids showed anti-HIV activity, although Myricetin was more effective than Quercetin or Pinocembrin. In TZM-bl cells, Myricetin inhibited ≥90% of HIV-1 BaL infection. The results were confirmed by quantification of HIV-1 p24 antigen in supernatant from H9 and PBMC cells following flavonoid treatment. In H9 and PBMC cells infected by HIV-1 MN and HIV-1 89.6, Myricetin showed more than 80% anti-HIV activity. Quercetin and Pinocembrin presented modest anti-HIV activity in all experiments. Myricetin activity was tested against HIV-RT and inhibited the enzyme by 49%. Microbicide activities were evaluated using a dual-chamber female genital tract model. In the in vitro microbicide activity model, Myricetin showed promising results against different strains of HIV-1 while also showing insignificant cytotoxic effects. Further studies of Myricetin should be performed to identify its molecular targets in order to provide a solid biological foundation for translational research. PMID:25546350

Discordant HIV Test Results: Implications on Perinatal and Haemotransfusion Screening for HIV Infection, Cape Coast, Ghana.

PubMed

Tetteh, Ato Kwamena; Agyarko, Edward

2017-01-01

Screening results of 488 pregnant women aged 15-44 years whose blood samples had been tested on-site, using First Response® HIV 1/2, and confirmed with INNO-LIA™ HIV I/II Score were used. Of this total, 178 were reactive (HIV I, 154; HIV II, 2; and HIV I and HIV II, 22). Of the 154 HIV I-reactive samples, 104 were confirmed to be HIV I-positive and 2 were confirmed to be HIV II-positive, while 48 were confirmed to be negative [false positive rate = 17.44% (13.56-21.32)]. The two HIV II samples submitted were confirmed to be negative with the confirmatory test. For the 22 HIV I and HIV II samples, 7 were confirmed to be HIV I-positive and 1 was confirmed to be HIV I- and HIV II-positive, while 14 were confirmed to be negative. Of the 310 nonreactive samples, 6 were confirmed to be HIV I-positive and 1 was confirmed to be HIV II-positive [false negative rate = 5.79% (1.63-8.38)], while 303 were negative. False negative outcomes will remain unconfirmed, with no management options for the client. False negative rate of 5.79% requires attention, as its resultant implications on control of HIV/AIDS could be dire.

HIV testing behaviors among female sex workers in Southwest China.

PubMed

Hong, Yan; Zhang, Chen; Li, Xiaoming; Fang, Xiaoyi; Lin, Xiuyun; Zhou, Yuejiao; Liu, Wei

2012-01-01

Despite the recognized importance of HIV testing in prevention, care and treatment, HIV testing remains low in China. Millions of female sex workers (FSW) play a critical role in China's escalating HIV epidemic. Limited data are available regarding HIV testing behavior among this at-risk population. This study, based on a cross-sectional survey of 1,022 FSW recruited from communities in Southwest China, attempted to address the literature gap. Our data revealed that 48% of FSW ever took HIV testing; older age, less education, working in higher-income commercial sex venues and better HIV knowledge were associated with HIV testing. Those who never took HIV testing were more likely to engage in high-risk behaviors including inconsistent condom use with clients and stable partners. A number of psychological and structural barriers to testing were also reported. We call for culturally appropriate interventions to reduce HIV risks and promote HIV testing for vulnerable FSW in China.

Addressing Unmet Need for HIV Testing in Emergency Care Settings: A Role for Computer-facilitated Rapid HIV Testing?

PubMed Central

Kurth, Ann E.; Severynen, Anneleen; Spielberg, Freya

2014-01-01

HIV testing in emergency departments (EDs) remains underutilized. We evaluated a computer tool to facilitate rapid HIV testing in an urban ED. Randomly assigned non-acute adult ED patients to computer tool (‘CARE’) and rapid HIV testing before standard visit (n=258) or to standard visit (n=259) with chart access. Assessed intervention acceptability and compared noted HIV risks. Participants were 56% non-white, 58% male; median age 37 years. In the CARE arm nearly all (251/258) completed the session and received HIV results; 4 declined test consent. HIV risks were reported by 54% of users and there was one confirmed HIV-positive and 2 false-positives (seroprevalence 0.4%, 95% CI 0.01–2.2%). Half (55%) preferred computerized, over face-to-face, counseling for future HIV testing. In standard arm, one HIV test and 2 referrals for testing occurred. Computer-facilitated HIV testing appears acceptable to ED patients. Future research should assess cost-effectiveness compared with staff-delivered approaches. PMID:23837807

Performance of HIV Rapid Tests Among Breastfeeding, Malawian Infants.

PubMed

Smith, Emily R; Sheahan, Anna D; Heyderman, Robert S; Miller, William C; Wheeler, Stephanie; Hudgens, Michael; Nelson, Julie A E; Dube, Queen; Van Rie, Annelies

2017-04-01

Timely, accurate and affordable testing algorithms at point-of-care are critical for early infant HIV diagnosis and initiation of antiretroviral therapy in the postpartum period. We aimed to assess the utility of HIV rapid tests for young, breast-fed HIV-exposed infants in resource limited, high HIV burden settings. We collected data on the performance of 2 commonly used rapid tests (Determine and Unigold) in Malawi between 2008 and 2012 or at the University of North Carolina between 2014 and 2015. For each 3-month interval between ages 3 and 18 months, we calculated the sensitivity, specificity, positive and negative predictive values of each test compared with the HIV DNA/RNA PCR gold standard. We also assessed the utility of each rapid test to diagnose incident HIV infection during the breastfeeding period. Among 121 HIV-exposed infants who were negative at age 6 weeks, 21 (17.2%) became infected by 18 months. At 3 months of age, both rapid tests had minimal clinical value with specificity values of 7.0% [95% confidence interval (CI): 2.3-15.7] for Determine and 19.4% (95% CI: 11.1-30.5) for Unigold. Starting at age 6 and 9 months, the Unigold test could be used as a screening tool in the follow-up of HIV-exposed infants with specificity values of 83.7% (95% CI: 74.4-89.9) and 97.7% (95% CI: 94.6-99.7), respectively. Starting at age 12 months, the type of test became less important as both tests performed well in identifying HIV-free children, although both tests failed to detect some incident HIV infections. Updated guidelines for the use of rapid tests in young HIV-exposed children that explicitly take type of test and infant age into account are urgently needed to ensure optimal care for the 1.5 million HIV-exposed infants born annually.

Low utilization of HIV testing during pregnancy: What are the barriers to HIV testing for women in rural India?

PubMed

Sinha, Gita; Dyalchand, Ashok; Khale, Manisha; Kulkarni, Gopal; Vasudevan, Shubha; Bollinger, Robert C

2008-02-01

Sixty percent of India's HIV cases occur in rural residents. Despite government policy to expand antenatal HIV screening and prevention of maternal-to-child transmission (PMTCT), little is known about HIV testing among rural women during pregnancy. Between January and March 2006, a cross-sectional sample of 400 recently pregnant women from rural Maharashtra was administered a questionnaire regarding HIV awareness, risk, and history of antenatal HIV testing. Thirteen women (3.3%) reported receiving antenatal HIV testing. Neither antenatal care utilization nor history of sexually transmitted infection (STI) symptoms influenced odds of receiving HIV testing. Women who did not receive HIV testing, compared with women who did, were 95% less likely to have received antenatal HIV counseling (odds ratio = 0.05, 95% confidence interval: 0.02 to 0.17) and 80% less aware of an existing HIV testing facility (odds ratio = 0.19, 95% confidence interval: 0.04 to 0.75). Despite measurable HIV prevalence, high antenatal care utilization, and STI symptom history, recently pregnant rural Indian women report low HIV testing. Barriers to HIV testing during pregnancy include lack of discussion by antenatal care providers and lack of awareness of existing testing services. Provider-initiated HIV counseling and testing during pregnancy would optimize HIV prevention for women throughout rural India.

Self-testing for HIV: a new option for HIV prevention?

PubMed

Spielberg, Freya; Levine, Ruth O; Weaver, Marcia

2004-10-01

Self-testing has the potential to be an innovative component to community-wide HIV-prevention strategies. This testing method could serve populations who do not have access to standard voluntary counselling and testing services or because of privacy concerns, stigma, transport costs, or other barriers do not use facility-based, standard HIV testing. This paper reviews recent research on the acceptability, feasibility, and cost of rapid testing and home-specimen collection for HIV, and suggests that self-testing may be another important strategy for diagnosing HIV infection. Several research questions are posed that should be answered before self-testing is realised.

Pressured HIV testing "in the name of love": a mixed methods analysis of pressured HIV testing among men who have sex with men in China.

PubMed

Ong, Jason J; Wu, Dan; Huang, Wenting; Fu, Hongyun; Desmond, Nicola; Ma, Wei; Kang, Dianmin; Liao, Meizhen; Marley, Gifty; Wei, Chongyi; Tang, Weiming; Liu, Chuncheng; Zhang, Ye; Pan, Stephen W; Yang, Bin; Yang, Ligang; Huang, Shujie; Tucker, Joseph D

2018-03-01

HIV testing has rapidly expanded into diverse, decentralized settings. While increasing accessibility to HIV testing is beneficial, it may lead to unintended consequences such as being pressured to test. We examined the frequency, correlates and contexts of pressured HIV testing among Chinese men who have sex with men (MSM) using mixed methods. We conducted an online survey of MSM (N = 1044) in May 2017. Pressured HIV testing was defined as being forced to test for HIV. We conducted logistic regression analysis to determine the associations between pressured HIV testing and socio-demographic and sexual behavioural factors. Follow-up interviews (n = 17) were conducted with men who reported pressured testing and we analysed qualitative data using a thematic analysis approach. Ninety-six men (9.2%) reported experiencing pressure to test for HIV. Regular male sex partners were the most common source of pressure (61%, 59/96), and the most common form of pressure was a threat to end a relationship with the one who was being pressured (39%, 37/96). We found a higher risk of pressured testing in men who had only used HIV self-testing compared to men who had never self-tested (AOR 2.39 (95%CI: 1.38 to 4.14)). However, this relationship was only significant among men with low education (AOR 5.88 (95% CI: 1.92 to 17.99)) and not among men with high education (AOR 1.62 (95% CI: 0.85 to 3.10)). After pressured testing, about half of men subsequently tested for HIV (55%, 53/96) without pressure - none reported being diagnosed with HIV. Consistent with this finding, qualitative data suggest that perceptions of pressure existed on a continuum and depended on the relationship status of the one who pressured them. Although being pressured to test was accompanied by negative feelings, men who were pressured into testing often changed their attitude towards HIV testing, testing behaviours, sexual behaviours and relationship with the one who pressured them to test. Pressured HIV

Increased adolescent HIV testing with a hybrid mobile strategy in Uganda and Kenya.

PubMed

Kadede, Kevin; Ruel, Theodore; Kabami, Jane; Ssemmondo, Emmanuel; Sang, Norton; Kwarisiima, Dalsone; Bukusi, Elizabeth; Cohen, Craig R; Liegler, Teri; Clark, Tamara D; Charlebois, Edwin D; Petersen, Maya L; Kamya, Moses R; Havlir, Diane V; Chamie, Gabriel

2016-09-10

We sought to increase adolescent HIV testing across rural communities in east Africa and identify predictors of undiagnosed HIV. Hybrid mobile testing. We enumerated 116 326 adolescents (10-24 years) in 32 communities of Uganda and Kenya ( NCT01864603): 98 694 (85%) reported stable (≥6 months of prior year) residence. In each community we performed hybrid testing: 2-week multidisease community health campaign that included HIV testing, followed by home-based testing of community health campaign nonparticipants. We measured adolescent HIV testing coverage and prevalence, and determined predictors of newly diagnosed HIV among HIV-infected adolescents using multivariable logistic regression. A total of 86 421 (88%) stable adolescents tested for HIV; coverage was 86, 90, and 88% in early (10-14), mid (15-17), and late (18-24) adolescents, respectively. Self-reported prior testing was 9, 26, and 55% in early, mid, and late adolescents tested, respectively. HIV prevalence among adolescents tested was 1.6 and 0.6% in Ugandan women and men, and 7.1 and 1.5% in Kenyan women and men, respectively. Prevalence increased in mid-adolescence for women and late adolescence for men. Among HIV-infected adolescents, 58% reported newly diagnosed HIV. In multivariate analysis of HIV-infected adolescents, predictors of newly diagnosed HIV included male sex [odds ratio (OR) = 1.97 (95% confidence interval (CI): 1.42-2.73)], Ugandan residence [OR = 2.63 (95% CI: 2.08-3.31)], and single status [OR = 1.62 (95% CI: 1.23-2.14) vs. married)]. The SEARCH hybrid strategy tested 88% of stable adolescents for HIV, a substantial increase over the 28% reporting prior testing. The majority (57%) of HIV-infected adolescents were new diagnoses. Mobile HIV testing for adults should be leveraged to reach adolescents for HIV treatment and prevention.

Correlates of HIV testing refusal among emergency department patients in the opt-out testing era.

PubMed

Setse, Rosanna W; Maxwell, Celia J

2014-05-01

Opt-out HIV screening is recommended by the CDC for patients in all healthcare settings. We examined correlates of HIV testing refusal among urban emergency department (ED) patients. Confidential free HIV screening was offered to 32,633 ED patients in an urban tertiary care facility in Washington, DC, during May 2007-December 2011. Demographic differences in testing refusals were examined using χ(2) tests and generalized linear models. HIV testing refusal rates were 47.7 % 95 % CI (46.7-48.7), 11.7 % (11.0-12.4), 10.7 % (10.0-11.4), 16.9 % (15.9-17.9) and 26.9 % (25.6-28.2) in 2007, 2008, 2009, 2010 and 2011 respectively. Persons 33-54 years of age [adjusted prevalence ratio (APR) 1.42, (1.36-1.48)] and those ≥ 55 years [APR 1.39 (1.31-1.47)], versus 33-54 years; and females versus males [APR 1.07 (1.02-1.11)] were more likely to refuse testing. Opt-out HIV testing is feasible and sustainable in urban ED settings. Efforts are needed to encourage testing among older patients and women.

Detection of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in Pools of Sera Negative for Antibodies to HIV-1 and HIV-2

PubMed Central

Morandi, Pierre-Alain; Schockmel, Gérard A.; Yerly, Sabine; Burgisser, Philippe; Erb, Peter; Matter, Lukas; Sitavanc, Radan; Perrin, Luc

1998-01-01

A total of 234 pools were prepared from 10,692 consecutive serum samples negative for antibodies to human immunodeficiency virus type 1 (HIV-1) and HIV-2 collected at five virological laboratories (average pool size, 45 serum samples). Pools were screened for the presence of HIV-1 RNA by a modified commercial assay (Amplicor HIV-1 Monitor test) which included an additional polyethylene glycol (PEG) precipitation step prior to purification of viral RNA (PEG Amplicor assay). The sensitivity of this assay for HIV-1 RNA detection in individual serum samples within pools matches that of standard commercial assays for individual serum samples, i.e., 500 HIV-1 RNA copies per ml. Five pools were identified as positive, and each one contained one antibody-negative, HIV-1 RNA-positive serum sample, corresponding to an average of 1 infected sample per 2,138 serum samples. Retrospective analysis revealed that the five HIV-1 RNA-positive specimens originated from individuals who had symptomatic primary HIV-1 infection at the time of sample collection and who were also positive for p24 antigenemia. We next assessed the possibility of performing the prepurification step by high-speed centrifugation (50,000 × g for 80 min) of 1.5-ml pools containing 25 μl of 60 individual serum samples, of which only 1 contained HIV-1 RNA (centrifugation Amplicor assay). The sensitivity of this assay also matches the sensitivities of standard commercial assays for HIV-1 RNA detection in individual serum samples. The results demonstrate that both assays with pooled sera can be applied to the screening of large numbers of serum samples in a time- and cost-efficient manner. PMID:9620372

Development of SYBR Green and TaqMan quantitative real-time PCR assays for hepatopancreatic parvovirus (HPV) infecting Penaeus monodon in India.

PubMed

Yadav, Reena; Paria, Anutosh; Mankame, Smruti; Makesh, M; Chaudhari, Aparna; Rajendran, K V

2015-12-01

Hepatopancreatic parvovirus (HPV) infects Penaeus monodon and causes mortality in the larval stages. Further, it has been implicated in the growth retardation in cultured P. monodon. Though different geographical isolates of HPV show large sequence variations, a sensitive PCR assay specific to Indian isolate has not yet been reported. Here, we developed a sensitive SYBR Green-based and TaqMan real-time PCR for the detection and quantification of the virus. A 441-bp PCR amplicon was cloned in pTZ57 R/T vector and the plasmid copy number was estimated. A 10-fold serial dilution of the plasmid DNA from 1 × 10(9) copies to 1 copy was prepared and used as the standard. The primers were tested initially using the standard on a conventional PCR format to determine the linearity of detection. The standards were further tested on real-time PCR format using SYBR Green and TaqMan chemistry and standard curves were generated based on the Ct values from three well replicates for each dilution. The assays were found to be sensitive, specific and reproducible with a wide dynamic range (1 × 10(9) to 10 copies) with coefficient of regression (R(2)) > 0.99, calculated average slope -3.196 for SYBR Green assay whereas, for TaqMan assay it was >0.99 and -3.367, respectively. The intra- and inter-assay variance of the Ct values ranged from 0.26% to 0.94% and 0.12% to 0.81%, respectively, for SYBR Green assay, and the inter-assay variance of the Ct values for TaqMan assay ranged from 0.07% to 1.93%. The specificity of the assays was proved by testing other DNA viruses of shrimp such as WSSV, IHHNV and MBV. Standardized assays were further tested to detect and quantify HPV in the post-larvae of P. monodon. The result was further compared with conventional PCR to test the reproducibility of the test. The assay was also used to screen Litopeneaus vannamei, Macrobrachium rosenbergii and Scylla serrata for HPV. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluation of the Cobas TaqMan MTB test for the detection of Mycobacterium tuberculosis complex according to acid-fast-bacillus smear grades in respiratory specimens.

PubMed

Huh, Hee Jae; Koh, Won-Jung; Song, Dong Joon; Ki, Chang-Seok; Lee, Nam Yong

2015-02-01

We evaluated the performance of the Cobas TaqMan MTB test (Roche Diagnostics, Basel, Switzerland), stratified by acid-fast bacilli (AFB) smear grades. The sensitivity of this test in smear-positive specimens was >95% in all grades, while that in trace and negative specimens was 85.3% and 34.4%, respectively. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Addressing unmet need for HIV testing in emergency care settings: a role for computer-facilitated rapid HIV testing?

PubMed

Kurth, Ann E; Severynen, Anneleen; Spielberg, Freya

2013-08-01

HIV testing in emergency departments (EDs) remains underutilized. The authors evaluated a computer tool to facilitate rapid HIV testing in an urban ED. Randomly assigned nonacute adult ED patients were randomly assigned to a computer tool (CARE) and rapid HIV testing before a standard visit (n = 258) or to a standard visit (n = 259) with chart access. The authors assessed intervention acceptability and compared noted HIV risks. Participants were 56% nonWhite and 58% male; median age was 37 years. In the CARE arm, nearly all (251/258) of the patients completed the session and received HIV results; four declined to consent to the test. HIV risks were reported by 54% of users; one participant was confirmed HIV-positive, and two were confirmed false-positive (seroprevalence 0.4%, 95% CI [0.01, 2.2]). Half (55%) of the patients preferred computerized rather than face-to-face counseling for future HIV testing. In the standard arm, one HIV test and two referrals for testing occurred. Computer-facilitated HIV testing appears acceptable to ED patients. Future research should assess cost-effectiveness compared with staff-delivered approaches.

Willingness to undergo HIV testing in the Kintampo districts of Ghana.

PubMed

Abokyi, L V; Zandoh, C; Mahama, E; Sulemana, A; Adda, R; Amenga-Etego, S; Baiden, F; Owusu-Agyei, S

2014-03-01

HIV testing is currently a major prevention intervention and remains an entry point to early treatment, care and support. Uptake is however low and alternative approaches are currently being adopted. An HIV module was incorporated into the routine survey of the Kintampo Health and Demographic Surveillance System (KHDSS) to assess the willingness of adults living in the Kintampo North and South districts to undergo HIV testing. The study was a descriptive cross-sectional household survey. Univariate and multivariate analysis were used to identify predictors of the willingness to undergo HIV testing. Respondents were community members aged 15 to 49 years and selected from randomly generated household listings from the KHDSS. A total of 11,604 respondents were interviewed, 10,982 (94.6%) of respondents had good general knowledge on HIV/AIDS. Among those with knowledge about HIV/AIDS, 10,819 (98.5%) indicated their willingness to get tested for HIV. Rural residents were more willing to undergo HIV testing than urban dwellers Odds ratio=1.42 (95% Confidence interval: 1.03, 1.96; P-value=0.031). Respondents with primary education were more likely to go for testing relative to those without any education OR=2.02 (95% CI: 0.87, 4.70; P-value=0.046). Expressed willingness to test for HIV is high in this population. Exploring community and population-based interventions to HIV testing and counseling could increase uptake of HIV testing services and should be considered. The underlying motivations need to be explored in order to translate willingness into actual testing.

HIV risk behavior before and after HIV counseling and testing in jail: a pilot study.

PubMed

Beckwith, Curt G; Liu, Tao; Bazerman, Lauri B; DeLong, Allison K; Desjardins, Simon F; Poshkus, Michael M; Flanigan, Timothy P

2010-04-01

Jail incarceration represents an opportunity to deliver HIV counseling and testing (C&T) services to persons at increased risk of infection. However, jails can be chaotic with rapid turnover of detainees. We conducted a pilot study to investigate the feasibility of comparing the effect of different approaches to HIV C&T in jail on subsequent HIV risk behaviors among persons testing HIV negative. Consecutive cohorts of newly incarcerated jail detainees were recruited with 132 subjects completing standard HIV C&T as per jail protocol and 132 subjects completing rapid testing with an individualized counseling session. Risk behavior was assessed and compared at baseline and 6 weeks after jail release. Among the 264 male participants, preincarceration substance use and sexual risk were common. The follow-up visit was completed by 59% of eligible participants. There were no differences in postrelease HIV risk behavior between the 2 arms but there was an overall decrease in risk behavior after jail release for the cohort. In addition, all participants in the rapid arm received rapid HIV test results compared with participants receiving 28% of conventional test results. Jail incarceration represents an important public health opportunity to deliver HIV C&T. This study demonstrated (1) feasibility in delivering rapid HIV testing combined with individualized counseling to jail detainees, (2) improved test result delivery rates, and (3) success with evaluating risk behaviors during the transition from jail to the community. Further research is needed to determine the optimal approach to HIV C&T in jail with the goal of increasing awareness of HIV serostatus and decreasing HIV risk behavior.

Assessing Willingness to Test for HIV among Men who have Sex with Men Using Conjoint Analysis, Evidence for Uptake of the FDA-approved at-Home HIV Test

PubMed Central

Lee, Sung-Jae; Brooks, Ronald; Bolan, Robert K.; Flynn, Risa

2013-01-01

Men who have sex with men (MSM) in the United States represent a vulnerable population with lower rates of HIV testing. There are various specific attributes of HIV testing that may impact willingness to test (WTT) for HIV. Identifying specific attributes influencing patients’ decisions around WTT for HIV is critical to ensure improved HIV testing uptake. This study examined WTT for HIV by using conjoint analysis, an innovative method for systematically estimating consumer preferences across discrete attributes. WTT for HIV was assessed across eight hypothetical HIV testing scenarios varying across seven dichotomous attributes: location (home vs. clinic), price (free vs. $50), sample collection (finger prick vs. blood), timeliness of results (immediate vs. 1–2 weeks), privacy (anonymous vs. confidential), results given (by phone vs. in-person), and type of counseling (brochure vs. in-person). Seventy-five MSM were recruited from a community based organization providing HIV testing services in Los Angeles to participate in conjoint analysis. WTT for HIV score was based on a 100-point scale. Scores ranged from 32.2 to 80.3 for eight hypothetical HIV testing scenarios. Price of HIV testing (free vs. $50) had the highest impact on WTT (impact score=31.4, SD=29.2, p<.0001), followed by timeliness of results (immediate vs. 1–2 weeks) (impact score=13.9, SD=19.9, p=<.0001) and testing location (home vs. clinic) (impact score=10.3, SD=22.8, p=.0002). Impacts of other HIV testing attributes were not significant. Conjoint analysis method enabled direct assessment of HIV testing preferences and identified specific attributes that significantly impact WTT for HIV among MSM. This method provided empirical evidence to support the potential uptake of the newly FDA-approved over-the-counter HIV home-test kit with immediate results, with cautionary note on the cost of the kit. PMID:23651439

HIV-1 drug resistance and resistance testing.

PubMed

Clutter, Dana S; Jordan, Michael R; Bertagnolio, Silvia; Shafer, Robert W

2016-12-01

The global scale-up of antiretroviral (ARV) therapy (ART) has led to dramatic reductions in HIV-1 mortality and incidence. However, HIV drug resistance (HIVDR) poses a potential threat to the long-term success of ART and is emerging as a threat to the elimination of AIDS as a public health problem by 2030. In this review we describe the genetic mechanisms, epidemiology, and management of HIVDR at both individual and population levels across diverse economic and geographic settings. To describe the genetic mechanisms of HIVDR, we review the genetic barriers to resistance for the most commonly used ARVs and describe the extent of cross-resistance between them. To describe the epidemiology of HIVDR, we summarize the prevalence and patterns of transmitted drug resistance (TDR) and acquired drug resistance (ADR) in both high-income and low- and middle-income countries (LMICs). We also review to two categories of HIVDR with important public health relevance: (i) pre-treatment drug resistance (PDR), a World Health Organization-recommended HIVDR surveillance metric and (ii) and pre-exposure prophylaxis (PrEP)-related drug resistance, a type of ADR that can impact clinical outcomes if present at the time of treatment initiation. To summarize the implications of HIVDR for patient management, we review the role of genotypic resistance testing and treatment practices in both high-income and LMIC settings. In high-income countries where drug resistance testing is part of routine care, such an understanding can help clinicians prevent virological failure and accumulation of further HIVDR on an individual level by selecting the most efficacious regimens for their patients. Although there is reduced access to diagnostic testing and to many ARVs in LMIC, understanding the scientific basis and clinical implications of HIVDR is useful in all regions in order to shape appropriate surveillance, inform treatment algorithms, and manage difficult cases. Copyright © 2016 Elsevier B

Evaluation of simple rapid HIV assays and development of national rapid HIV test algorithms in Dar es Salaam, Tanzania.

PubMed

Lyamuya, Eligius F; Aboud, Said; Urassa, Willy K; Sufi, Jaffer; Mbwana, Judica; Ndugulile, Faustin; Massambu, Charles

2009-02-18

Suitable algorithms based on a combination of two or more simple rapid HIV assays have been shown to have a diagnostic accuracy comparable to double enzyme-linked immunosorbent assay (ELISA) or double ELISA with Western Blot strategies. The aims of this study were to evaluate the performance of five simple rapid HIV assays using whole blood samples from HIV-infected patients, pregnant women, voluntary counseling and testing attendees and blood donors, and to formulate an alternative confirmatory strategy based on rapid HIV testing algorithms suitable for use in Tanzania. Five rapid HIV assays: Determine HIV-1/2 (Inverness Medical), SD Bioline HIV 1/2 3.0 (Standard Diagnostics Inc.), First Response HIV Card 1-2.0 (PMC Medical India Pvt Ltd), HIV1/2 Stat-Pak Dipstick (Chembio Diagnostic System, Inc) and Uni-Gold HIV-1/2 (Trinity Biotech) were evaluated between June and September 2006 using 1433 whole blood samples from hospital patients, pregnant women, voluntary counseling and testing attendees and blood donors. All samples that were reactive on all or any of the five rapid assays and 10% of non-reactive samples were tested on a confirmatory Inno-Lia HIV I/II immunoblot assay (Immunogenetics). Three hundred and ninety samples were confirmed HIV-1 antibody positive, while 1043 were HIV negative. The sensitivity at initial testing of Determine, SD Bioline and Uni-Gold was 100% (95% CI; 99.1-100) while First Response and Stat-Pak had sensitivity of 99.5% (95% CI; 98.2-99.9) and 97.7% (95% CI; 95.7-98.9), respectively, which increased to 100% (95% CI; 99.1-100) on repeat testing. The initial specificity of the Uni-Gold assay was 100% (95% CI; 99.6-100) while specificities were 99.6% (95% CI; 99-99.9), 99.4% (95% CI; 98.8-99.7), 99.6% (95% CI; 99-99.9) and 99.8% (95% CI; 99.3-99.9) for Determine, SD Bioline, First Response and Stat-Pak assays, respectively. There was no any sample which was concordantly false positive in Uni-Gold, Determine and SD Bioline assays. An

Benefits and costs of HIV testing.

PubMed

Bloom, D E; Glied, S

1991-06-28

The benefits and costs of human immunodeficiency virus (HIV) testing in employment settings are examined from two points of view: that of private employers whose profitability may be affected by their testing policies and that of public policy-makers who may affect social welfare through their design of regulations related to HIV testing. The results reveal that HIV testing is clearly not cost-beneficial for most firms, although the benefits of HIV testing may outweigh the costs for some large firms that offer generous fringe-benefit packages and that recruit workers from populations in which the prevalence of HIV infection is high. The analysis also indicates that the testing decisions of unregulated employers are not likely to yield socially optimal economic outcomes and that existing state and federal legislation related to HIV testing in employment settings has been motivated primarily by concerns over social equity.

Multi-ethnic perspective of uptake of HIV testing and HIV-related stigma: a cross-sectional population-based study.

PubMed

Wong, Li Ping

2013-01-01

The objective of this study was to identify demographic characteristics and correlates of the uptake of HIV testing, willingness to be tested and perceived HIV-related stigma of Malaysian lay public. A cross-sectional computer-assisted telephone interview survey of a representative sample of multiracial Malaysians aged 18 years and above was conducted between December and July 2011. The survey collected information on demographics, knowledge about HIV transmission and religious beliefs on attitudes to HIV/AIDS. A total of 2271 households were successfully interviewed. The response rate was 48.65%. The HIV transmission knowledge score ranged from 0 to 15 (mean =10.56; SD±2.42). Three of the most common misconceptions about HIV transmission were mosquito bite (42.8%), eating in a restaurant where the cook is HIV positive (20.4%) and using a public toilet (20.1%). Only 20.6% reported ever having been tested for HIV, 49.1% reported a willingness to be tested for HIV and 30.3% had no intention of getting an HIV test. Low-risk perception (63.7%) constitutes a major barrier to HIV testing. Being Malay and Chinese (relative to Indian) were the strongest predictors of low-risk perception. Other significant predictors of low-risk perception were being male, being married and living in an urban locality. Perceived self-stigma if tested positive for HIV was prevalent (78.8%). Multivariate findings showed that being female, Malay, low income, living in rural localities and public stigma were significant correlates of self-stigma. These findings warrant interventions to reduce the disproportionate HIV transmission misconception, barriers to HIV testing and stigma and discriminative attitudes to involve considerations of sociocultural economic and demographic characteristics.

HIV voluntary counseling and testing: an experience from India.

PubMed

Vajpayee, Madhu; Mojumdar, Kamalika; Raina, Meenakshi; Mishra, Sharad; Sreenivas, Vibhuti

2009-07-01

Despite proof of voluntary counseling and testing (VCT) effectiveness in HIV disease prevention and management, there are limited reports on experience with pre- and post-HIV-test counseling in developing countries. In view of this, we aimed to bring to the fore the voluntary counseling and testing experience at a tertiary healthcare center. The present study was conducted at the voluntary counseling and testing center of a tertiary healthcare center and the National HIV Reference Center. Participants were 1169 men and 581 females attending the VCT clinic from February 2005 to March 2006. Odds ratios were calculated for each of the variable to analyze the strength of association with HIV sero-status. Out of 1750 patients, 322 (27.5%) males and 156 females (26.9%) tested HIV-positive. HIV-sero-positivity was observed to be associated to participant age (approximately 1.5 for 25-44 yrs age group), marital status (2.3 times in married patients), primary or lower education level (1.5 times), citing spouse death/HIV-infected spouse as the reason for seeking VCT (2.2 times) and reporting a history of risk behavior as reason for getting tested. This study aims to evaluate the effectiveness of existing client initiated voluntary counseling and testing facility in the light of a recent recommendation by WHO/UNAIDS for the implementation of provider initiated voluntary counseling services. Through this study, we could also highlight socio-demographic factors, like education and age, and reasons stated by participants for seeking VCT, which were associated with HIV-positive status and put an individual at a higher risk of HIV infection.

‘Men usually say that HIV testing is for women’: Gender dynamics & perceptions of HIV testing in Lesotho

PubMed Central

DiCarlo, Abby L.; Mantell, Joanne E.; Remien, Robert H.; Zerbe, Allison; Morris, Danielle; Pitt, Blanche; Abrams, Elaine J.; El-Sadr, Wafaa

2014-01-01

In Lesotho, men have lower HIV testing rates, less contact with HIV clinical settings, and less knowledge of HIV prevention than women. However, women’s HIV prevalence has consistently remained higher than men’s. This paper explores gender norms, sexual decision-making, and perceptions of HIV among a sample of Basotho men and women in order to understand how these factors influence HIV testing and prevention. Two hundred women and 30 men were interviewed in Lesotho between April–July 2011. Participants reported reluctance among women to share information about HIV prevention and testing with men, and resistance of men to engage with testing and/or prevention services. Findings demonstrate a critical need for educational initiatives for men, among other strategies to engage men with HIV testing and prevention. This study highlights how gender issues shape perceptions of HIV and sexual decision-making and underlines the importance of engaging men along with women in HIV prevention efforts. More studies are needed to determine the most effective strategies to inform and engage men. PMID:24854495

'Men usually say that HIV testing is for women': gender dynamics and perceptions of HIV testing in Lesotho.

PubMed

DiCarlo, Abby L; Mantell, Joanne E; Remien, Robert H; Zerbe, Allison; Morris, Danielle; Pitt, Blanche; Abrams, Elaine J; El-Sadr, Wafaa M

2014-01-01

In Lesotho, men have lower HIV testing rates, less contact with HIV clinical settings and less knowledge of HIV prevention than women. However, women's HIV prevalence has consistently remained higher than men's. This paper explores gender norms, sexual decision-making and perceptions of HIV among a sample of Basotho men and women in order to understand how these factors influence HIV testing and prevention. A total of 200 women and 30 men were interviewed in Lesotho between April and July 2011. Participants reported reluctance among women to share information about HIV prevention and testing with men, and resistance of men to engage with testing and/or prevention services. Findings demonstrate a critical need for educational initiatives for men, among other strategies, to engage men with HIV testing and prevention. This study highlights how gender issues shape perceptions of HIV and sexual decision-making and underlines the importance of engaging men along with women in HIV prevention efforts. More studies are needed to determine the most effective strategies to inform and engage men.

Opt-out HIV testing in prison: informed and voluntary?

PubMed

Rosen, David L; Golin, Carol E; Grodensky, Catherine A; May, Jeanine; Bowling, J Michael; DeVellis, Robert F; White, Becky L; Wohl, David A

2015-01-01

HIV testing in prison settings has been identified as an important mechanism to detect cases among high-risk, underserved populations. Several public health organizations recommend that testing across health-care settings, including prisons, be delivered in an opt-out manner. However, implementation of opt-out testing within prisons may pose challenges in delivering testing that is informed and understood to be voluntary. In a large state prison system with a policy of voluntary opt-out HIV testing, we randomly sampled adult prisoners in each of seven intake prisons within two weeks after their opportunity to be HIV tested. We surveyed prisoners' perception of HIV testing as voluntary or mandatory and used multivariable statistical models to identify factors associated with their perception. We also linked survey responses to lab records to determine if prisoners' test status (tested or not) matched their desired and perceived test status. Thirty-eight percent (359/936) perceived testing as voluntary. The perception that testing was mandatory was positively associated with age less than 25 years (adjusted relative risk [aRR]: 1.45, 95% confidence interval [CI]: 1.24, 1.71) and preference that testing be mandatory (aRR: 1.81, 95% CI: 1.41, 2.31) but negatively associated with entry into one of the intake prisons (aRR: 0.41 95% CI: 0.27, 0.63). Eighty-nine percent of prisoners wanted to be tested, 85% were tested according to their wishes, and 82% correctly understood whether or not they were tested. Most prisoners wanted to be HIV tested and were aware that they had been tested, but less than 40% understood testing to be voluntary. Prisoners' understanding of the voluntary nature of testing varied by intake prison and by a few individual-level factors. Testing procedures should ensure that opt-out testing is informed and understood to be voluntary by prisoners and other vulnerable populations.

Opt-out HIV testing in prison: Informed and voluntary?

PubMed Central

Rosen, David L.; Golin, Carol E.; Grodensky, Catherine A.; May, Jeannine; Bowling, J. Michael; DeVellis, Robert F.; White, Becky L.; Wohl, David A.

2014-01-01

HIV testing in prison settings has been identified as an important mechanism to detect cases among high-risk, underserved populations. Several public health organizations recommend that testing across healthcare settings, including prisons, be delivered in an opt-out manner. However, implementation of opt-out testing within prisons may pose challenges in delivering testing that is informed and understood to be voluntary. In a large state prison system with a policy of voluntary opt-out HIV testing, we randomly sampled adult prisoners in each of seven intake prisons within two weeks after their opportunity to be HIV tested. We surveyed prisoners’ perception of HIV testing as voluntary or mandatory and used multivariable statistical models to identify factors associated with their perception. We also linked survey responses to lab records to determine if prisoners’ test status (tested or not) matched their desired and perceived test status. Thirty eight percent (359/936) perceived testing as voluntary. The perception that testing was mandatory was positively associated with age less than 25 years (adjusted relative risk [aRR]: 1.45, 95% CI: 1.24, 1.71) and preference that testing be mandatory (aRR: 1.81, 95% CI: 1.41, 2.31), but negatively associated with entry into one of the intake prisons (aRR: 0.41 95% CI: 0.27, 0.63). Eighty-nine percent of prisoners wanted to be tested, 85% were tested according to their wishes, and 82% correctly understood whether or not they were tested. Most prisoners wanted to be HIV tested and were aware that they had been tested, but less than 40% understood testing to be voluntary. Prisoners’ understanding of the voluntary nature of testing varied by intake prison and by a few individual-level factors. Testing procedures should ensure that opt-out testing is informed and understood to be voluntary by prisoners and other vulnerable populations. PMID:25506799

HIV testing in community pharmacies and retail clinics: a model to expand access to screening for HIV infection.

PubMed

Weidle, Paul J; Lecher, Shirley; Botts, Linda W; Jones, LaDawna; Spach, David H; Alvarez, Jorge; Jones, Rhondette; Thomas, Vasavi

2014-01-01

To test the feasibility of offering rapid point-of-care human immunodeficiency virus (HIV) testing at community pharmacies and retail clinics. Pilot program to determine how to implement confidential HIV testing services in community pharmacies and retail clinics. 21 community pharmacies and retail clinics serving urban and rural patients in the United States, from August 2011 to July 2013. 106 community pharmacy and retail clinic staff members. A model was developed to implement confidential HIV counseling and testing services using community pharmacy and retail clinic staff as certified testing providers, or through collaborations with organizations that provide HIV testing. Training materials were developed and sites selected that serve patients from urban and rural areas to pilot test the model. Each site established a relationship with its local health department for HIV testing policies, developed referral lists for confirmatory HIV testing/care, secured a CLIA Certificate of Waiver, and advertised the service. Staff were trained to perform a rapid point-of-care HIV test on oral fluid, and provide patients with confidential test results and information on HIV. Patients with a preliminary positive result were referred to a physician or health department for confirmatory testing and, if needed, HIV clinical care. Number of HIV tests completed and amount of time required to conduct testing. The 21 participating sites administered 1,540 HIV tests, with 1,087 conducted onsite by staff during regular working hours and 453 conducted at 37 different HIV testing events (e.g., local health fairs). The median amount of time required for pretest counseling/consent, waiting for test results, and posttest counseling was 4, 23, and 3 minutes, respectively. A majority of the sites (17) said they planned to continue HIV testing after the project period ended and would seek assistance or support from the local health department, a community-based organization, or an AIDS

Distance to testing sites and its association with timing of HIV diagnosis.

PubMed

Cope, Anna B; Powers, Kimberly A; Serre, Marc L; Escamilla, Veronica; Emch, Michael E; Leone, Peter A; Mobley, Victoria L; Miller, William C

2016-11-01

Early HIV diagnosis enables prompt treatment initiation, thereby contributing to decreased morbidity, mortality, and transmission. We aimed to describe the association between distance from residence to testing sites and HIV disease stage at diagnosis. Using HIV surveillance data, we identified all new HIV diagnoses made at publicly funded testing sites in central North Carolina during 2005-2013. Early-stage HIV was defined as acute HIV (antibody-negative test with a positive HIV RNA) or recent HIV (normalized optical density <0.8 on the BED assay for non-AIDS cases); remaining diagnoses were considered post-early-stage HIV. Street distance between residence at diagnosis and (1) the closest testing site and (2) the diagnosis site was dichotomized at 5 miles. We fit log-binomial models using generalized estimating equations to estimate prevalence ratios (PR) and robust 95% confidence intervals (CI) for post-early-stage diagnoses by distance. Models were adjusted for race/ethnicity and testing period. Most of the 3028 new diagnoses were black (N = 2144; 70.8%), men who have sex with men (N = 1685; 55.7%), and post-early-stage HIV diagnoses (N = 2010; 66.4%). Overall, 1145 (37.8%) cases traveled <5 miles for a diagnosis. Among cases traveling ≥5 miles for a diagnosis, 1273 (67.6%) lived <5 miles from a different site. Residing ≥5 miles from a testing site was not associated with post-early-stage HIV (adjusted PR, 95% CI: 0.98, 0.92-1.04), but traveling ≥5 miles for a diagnosis was associated with higher post-early HIV prevalence (1.07, 1.02-1.13). Most of the elevated prevalence observed in cases traveling ≥5 miles for a diagnosis occurred among those living <5 miles from a different site (1.09, 1.03-1.16). Modest increases in post-early-stage HIV diagnosis were apparent among persons living near a site, but choosing to travel longer distances to test. Understanding reasons for increased travel distances could improve accessibility and

Comparative evaluation of the QUANTIPLEX HIV-1 RNA 2.0 and 3.0 (bDNA) assays and the AMPLICOR HIV-1 MONITOR v1.5 test for the quantitation of human immunodeficiency virus type 1 RNA in plasma.

PubMed

Anastassopoulou, C G; Touloumi, G; Katsoulidou, A; Hatzitheodorou, H; Pappa, M; Paraskevis, D; Lazanas, M; Gargalianos, P; Hatzakis, A

2001-01-01

HIV-1 RNA measurements from 84 plasma specimens obtained with the QUANTIPLEX HIV-1 RNA 2.0 and 3.0 (bDNA) assays (Chiron Diagnostics, Emeryville, CA) and with the AMPLICOR HIV-1 MONITOR Test, version 1.5 with ultra-sensitive specimen preparation (Roche Diagnostic Systems, Inc., Branchburg, NJ) were compared. The absolute RNA values of tested specimens differed significantly between bDNA 2.0 and bDNA 3.0 or Monitor v1.5 measurements (Wilcoxon signed-rank test P<0.001). Results generated with bDNA 3.0 or with Monitor v1.5 were approximately twofold greater than those generated with bDNA 2.0, with smaller differences at higher HIV-1 RNA levels and greater differences at RNA levels below 1000 copies per ml. Although highly correlated (r=0.92 and 0.86, respectively), viral load data generated with bDNA 2.0 and either bDNA 3.0 or Monitor v1.5 were in poor agreement. Concordant results (difference in log(10) copies per ml <0.5) were found at frequencies of 80% for bDNA 2.0 and bDNA 3.0 and only at 58.5% for bDNA 2.0 and Monitor v1.5. In contrast, bDNA 3.0 and Monitor v1.5 measurements were highly correlated (r=0.96) and in good agreement (92.7%).

Basis and Statistical Design of the Passive HIV-1 Antibody Mediated Prevention (AMP) Test-of-Concept Efficacy Trials.

PubMed

Gilbert, Peter B; Juraska, Michal; deCamp, Allan C; Karuna, Shelly; Edupuganti, Srilatha; Mgodi, Nyaradzo; Donnell, Deborah J; Bentley, Carter; Sista, Nirupama; Andrew, Philip; Isaacs, Abby; Huang, Yunda; Zhang, Lily; Capparelli, Edmund; Kochar, Nidhi; Wang, Jing; Eshleman, Susan H; Mayer, Kenneth H; Magaret, Craig A; Hural, John; Kublin, James G; Gray, Glenda; Montefiori, David C; Gomez, Margarita M; Burns, David N; McElrath, Julie; Ledgerwood, Julie; Graham, Barney S; Mascola, John R; Cohen, Myron; Corey, Lawrence

2017-01-01

Anti-HIV-1 broadly neutralizing antibodies (bnAbs) have been developed as potential agents for prevention of HIV-1 infection. The HIV Vaccine Trials Network and the HIV Prevention Trials Network are conducting the Antibody Mediated Prevention (AMP) trials to assess whether, and how, intravenous infusion of the anti-CD4 binding site bnAb, VRC01, prevents HIV-1 infection. These are the first test-of-concept studies to assess HIV-1 bnAb prevention efficacy in humans. The AMP trials are two parallel phase 2b HIV-1 prevention efficacy trials conducted in two cohorts: 2700 HIV-uninfected men and transgender persons who have sex with men in the United States, Peru, Brazil, and Switzerland; and 1500 HIV-uninfected sexually active women in seven countries in sub-Saharan Africa. Participants are randomized 1:1:1 to receive an intravenous infusion of 10 mg/kg VRC01, 30 mg/kg VRC01, or a control preparation every 8 weeks for a total of 10 infusions. Each trial is designed (1) to assess overall prevention efficacy (PE) pooled over the two VRC01 dose groups vs. control and (2) to assess VRC01 dose and laboratory markers as correlates of protection (CoPs) against overall and genotype- and phenotype-specific infection. Each AMP trial is designed to have 90% power to detect PE > 0% if PE is ≥ 60%. The AMP trials are also designed to identify VRC01 properties (i.e., concentration and effector functions) that correlate with protection and to provide insight into mechanistic CoPs. CoPs are assessed using data from breakthrough HIV-1 infections, including genetic sequences and sensitivities to VRC01-mediated neutralization and Fc effector functions. The AMP trials test whether VRC01 can prevent HIV-1 infection in two study populations. If affirmative, they will provide information for estimating the optimal dosage of VRC01 (or subsequent derivatives) and identify threshold levels of neutralization and Fc effector functions associated with high-level protection, setting a benchmark

Basis and Statistical Design of the Passive HIV-1 Antibody Mediated Prevention (AMP) Test-of-Concept Efficacy Trials

PubMed Central

Gilbert, Peter B.; Juraska, Michal; deCamp, Allan C.; Karuna, Shelly; Edupuganti, Srilatha; Mgodi, Nyaradzo; Donnell, Deborah J.; Bentley, Carter; Sista, Nirupama; Andrew, Philip; Isaacs, Abby; Huang, Yunda; Zhang, Lily; Capparelli, Edmund; Kochar, Nidhi; Wang, Jing; Eshleman, Susan H.; Mayer, Kenneth H.; Magaret, Craig A.; Hural, John; Kublin, James G.; Gray, Glenda; Montefiori, David C.; Gomez, Margarita M.; Burns, David N.; McElrath, Julie; Ledgerwood, Julie; Graham, Barney S.; Mascola, John R.; Cohen, Myron; Corey, Lawrence

2017-01-01

Background Anti-HIV-1 broadly neutralizing antibodies (bnAbs) have been developed as potential agents for prevention of HIV-1 infection. The HIV Vaccine Trials Network and the HIV Prevention Trials Network are conducting the Antibody Mediated Prevention (AMP) trials to assess whether, and how, intravenous infusion of the anti-CD4 binding site bnAb, VRC01, prevents HIV-1 infection. These are the first test-of-concept studies to assess HIV-1 bnAb prevention efficacy in humans. Methods The AMP trials are two parallel phase 2b HIV-1 prevention efficacy trials conducted in two cohorts: 2700 HIV-uninfected men and transgender persons who have sex with men in the United States, Peru, Brazil, and Switzerland; and 1500 HIV-uninfected sexually active women in seven countries in sub-Saharan Africa. Participants are randomized 1:1:1 to receive an intravenous infusion of 10 mg/kg VRC01, 30 mg/kg VRC01, or a control preparation every 8 weeks for a total of 10 infusions. Each trial is designed (1) to assess overall prevention efficacy (PE) pooled over the two VRC01 dose groups vs. control and (2) to assess VRC01 dose and laboratory markers as correlates of protection (CoPs) against overall and genotype- and phenotype-specific infection. Results Each AMP trial is designed to have 90% power to detect PE > 0% if PE is ≥ 60%. The AMP trials are also designed to identify VRC01 properties (i.e., concentration and effector functions) that correlate with protection and to provide insight into mechanistic CoPs. CoPs are assessed using data from breakthrough HIV-1 infections, including genetic sequences and sensitivities to VRC01-mediated neutralization and Fc effector functions. Conclusions The AMP trials test whether VRC01 can prevent HIV-1 infection in two study populations. If affirmative, they will provide information for estimating the optimal dosage of VRC01 (or subsequent derivatives) and identify threshold levels of neutralization and Fc effector functions associated with high

Cost and efficiency of a hybrid mobile multi-disease testing approach with high HIV testing coverage in East Africa

PubMed Central

Chang, Wei; Chamie, Gabriel; Mwai, Daniel; Clark, Tamara D.; Thirumurthy, Harsha; Charlebois, Edwin D.; Petersen, Maya; Kabami, Jane; Ssemmondo, Emmanuel; Kadede, Kevin; Kwarisiima, Dalsone; Sang, Norton; Bukusi, Elizabeth A.; Cohen, Craig R.; Kamya, Moses; Havlir, Diane V.; Kahn, James G.

2016-01-01

Background In 2013-14, we achieved 89% adult HIV testing coverage using a hybrid testing approach in 32 communities in Uganda and Kenya (SEARCH: NCT01864603). To inform scalability, we sought to determine: 1) overall cost and efficiency of this approach; and 2) costs associated with point-of-care (POC) CD4 testing, multi-disease services, and community mobilization. Methods We applied micro-costing methods to estimate costs of population-wide HIV testing in 12 SEARCH Trial communities. Main intervention components of the hybrid approach are census, multi-disease community health campaigns (CHC), and home-based testing (HBT) for CHC non-attendees. POC CD4 tests were provided for all HIV-infected participants. Data were extracted from expenditure records, activity registers, staff interviews, and time and motion logs. Results The mean cost per adult tested for HIV was $20.5 (range: $17.1 - $32.1) [2014 US$], including a POC CD4 test at $16 per HIV+ person identified. Cost per adult tested for HIV was $13.8 at CHC vs. $31.7 via HBT. The cost per HIV+ adult identified was $231 ($87 - $1,245), with variability due mainly to HIV prevalence among persons tested (i.e., HIV positivity rate). The marginal costs of multi-disease testing at CHCs were $1.16/person for hypertension and diabetes, and $0.90 for malaria. Community mobilization constituted 15.3% of total costs. Conclusions The hybrid testing approach achieved very high HIV testing coverage, with POC CD4, at costs similar to previously reported mobile, home-based, or venue-based HIV testing approaches in sub-Saharan Africa. By leveraging HIV infrastructure, multi-disease services were offered at low marginal costs. PMID:27741031

Offering self-administered oral HIV testing to truck drivers in Kenya to increase testing: a randomized controlled trial.

PubMed

Kelvin, Elizabeth A; George, Gavin; Mwai, Eva; Nyaga, Eston; Mantell, Joanne E; Romo, Matthew L; Odhiambo, Jacob O; Starbuck, Lila; Govender, Kaymarlin

2018-01-01

We conducted a randomized controlled trial among 305 truck drivers from two North Star Alliance roadside wellness clinics in Kenya to see if offering HIV testing choices would increase HIV testing uptake. Participants were randomized to be offered (1) a provider-administered rapid blood (finger-prick) HIV test (i.e., standard of care [SOC]) or (2) a Choice between SOC or a self-administered oral rapid HIV test with provider supervision in the clinic. Participants in the Choice arm who refused HIV testing in the clinic were offered a test kit for home use with phone-based posttest counseling. We compared HIV test uptake using the Mantel Haenszel odds ratio (OR) adjusting for clinic. Those in the Choice arm had higher odds of HIV test uptake than those in the SOC arm (OR = 1.5), but the difference was not statistically significant (p = 0.189). When adding the option to take an HIV test kit for home use, the Choice arm had significantly greater odds of testing uptake (OR = 2.8, p = 0.002). Of those in the Choice arm who tested, 26.9% selected the SOC test, 64.6% chose supervised self-testing in the clinic, and 8.5% took a test kit for home use. Participants varied in the HIV test they selected when given choices. Importantly, when participants who refused HIV testing in the clinic were offered a test kit for home use, an additional 8.5% tested. Offering truck drivers a variety of HIV testing choices may increase HIV testing uptake in this key population.

A new TaqMan method for the reliable diagnosis of Ehrlichia spp. in canine whole blood.

PubMed

Thomson, Kirsty; Yaaran, Tal; Belshaw, Alex; Curson, Lucia; Tisi, Laurence; Maurice, Sarah; Kiddle, Guy

2018-06-18

Ehrlichiosis is an important emerging infectious disease of the canid family and humans worldwide. To date, no extensive evaluation or validation of a molecular diagnostic test for ehrlichiosis has been published. Here, we present data for a newly designed TaqMan assay and compare its performance to a commercial technology (PCRun®). Both of these real-time methods of analysis were evaluated using a comprehensive number of prospective and retrospective samples collected from dogs exhibiting symptoms of ehrlichiosis. Whole blood samples collected from dogs, retrospectively in the United Kingdom and prospectively in Israel, were analysed for the presence of Ehrlichia canis and Ehrlichia minasensis DNA using the TaqMan PCR, developed specifically for this study. The results were compared to those of a real time commercial isothermal amplification method (PCRun® system developed by Biogal Galed Labs ACS, Galed, Israel). The sensitivity and specificity (CI: 95%) of the TaqMan PCR and PCRun® were both determined to be 100% and absolute, for all of the samples tested. Interestingly, both tests were demonstrated to be highly comparable, irrespective of differences in amplification chemistry or sequences targeted. Host differences, incidence of disease and geographical location of the isolates had little impact on the positivity recorded by each of the diagnostic methods. It was evident that both amplification methods were equally suited for diagnosing canine ehrlichiosis and while the PCRun® clearly amplified all clinically relevant Ehrlichia species known to infect dogs and humans, the TaqMan method was more specific for E. canis and E. minasensis. This work demonstrates that despite good analytical sensitivities and specificities for Ehrlichia spp. neither method could fully account for the clinical diagnosis of thrombocytopenia.

HIV testing practices and the potential role of HIV self-testing among men who have sex with men in Mexico

PubMed Central

Oldenburg, Catherine E.; Biello, Katie B.; Perez-Brumer, Amaya G.; Rosenberger, Joshua; Novak, David S.; Mayer, Kenneth H.; Mimiaga, Matthew J.

2016-01-01

Objective To characterize HIV testing practices among men who have sex with men (MSM) in Mexico and intention to use HIV self-testing. Methods In 2012, members of one of the largest social/sexual networking websites for MSM in Latin America completed an anonymous online survey. This analysis was restricted to HIV-uninfected MSM residing in Mexico. Multivariable logistic regression models were fit to assess factors associated with HIV testing and intention to use an HIV self-test. Results Of 4,537 respondents, 70.9% reported ever having an HIV test, of whom 75.5% reported testing at least yearly. The majority (94.3%) indicated that they would use an HIV home self-test if it were available. Participants identifying as bisexual less often reported ever HIV testing compared to those identifying as gay/homosexual (aOR=0.52, 95%CI: 0.44-0.62). Having a physical exam in the past year was associated with increased ever HIV testing (aOR=4.35, 95%CI: 3.73-5.07), but associated with decreased interest in HIV self-testing (aOR=0.66, 95%CI: 0.48-0.89). Conclusions High intention to use HIV home self-testing supports the use of this method as an acceptable alternative to clinic- or hospital-based HIV testing. PMID:27020081

Delayed-type hypersensitivity skin test responses to PPD and other antigens among BCG-vaccinated HIV-1-infected and healthy children and adolescents.

PubMed

Costa, Natalia Moriya Xavierda; Albuquerque, Maly de; Lins, Janaína Bacelar Acioli; Alvares-Junior, João Teixeira; Stefani, Mariane Martins de Araújo

2011-10-01

Among HIV-1-infected patients, CD4+ T cell counts are well-established markers of cell-mediated immunity. Delayed-type hypersensitivity (DTH) skin tests can be used to evaluate in vivo cell-mediated immunity to common antigens. DTH responses to tuberculin purified protein derivative (PPD), sporotrichin, trichophytin, candidin and streptokinase/streptodornase antigens were assessed. Thirty-six HIV-1-infected children/adolescents and 56 age- and sex-matched HIV-1/HIV-2-seronegative participants were tested. All participants had a BCG scar. Fisher's exact test was used to evaluate significant differences between groups (p<0.05). The main characteristics of the HIV-1 patients were as follows: median age 8.1 years; 20/36 were males; 35 were vertical transmission cases; 34 were AIDS cases under antiretroviral therapy; median viral load = 3.04 log10 copies/ml; median CD4+ T cell count = 701 cells/μl. A total of 25% (9/36) and 87.5% (49/56) of HIV-1-infected and healthy participants, respectively, displayed DTH reactivity to at least one antigen (p<0.001). Among HIV-1-infected participants, reactivity to candidin predominated (8/36, 22.2%), while PPD positivity prevailed among healthy participants (40/56, 71.4%). PPD reactivity in the HIV-1-positive group was 8.3% (p<0.01). The median PPD induration was 2.5mm (range: 2-5mm) in the HIV-1 group and 6.0 mm among healthy participants (range: 3-15 mm). There was no correlation between PPD positivity and age. No correlation between CD4+ T cell counts and DTH reactivity was observed among HIV-1-infected patients. DTH skin test responses, including PPD reactivity, were significantly lower among HIV-1-infected participants compared to healthy controls, which likely reflects advanced disease and T cell depletion.

Voluntary HIV counselling and testing among men in rural western Uganda: Implications for HIV prevention

PubMed Central

Bwambale, Francis M; Ssali, Sarah N; Byaruhanga, Simon; Kalyango, Joan N; Karamagi, Charles AS

2008-01-01

Background Voluntary HIV counselling and testing (VCT) is one of the key strategies in the prevention and control of HIV/AIDS in Uganda. However, the utilization of VCT services particularly among men is low in Kasese district. We therefore conducted a study to determine the prevalence and factors associated with VCT use among men in Bukonzo West health sub-district, Kasese district. Methods A population-based cross-sectional study employing both quantitative and qualitative techniques of data collection was conducted between January and April 2005. Using cluster sampling, 780 men aged 18 years and above, residing in Bukonzo West health sub-district, were sampled from 38 randomly selected clusters. Data was collected on VCT use and independent variables. Focus group discussions (4) and key informant interviews (10) were also conducted. Binary logistic regression was performed to determine the predictors of VCT use among men. Results Overall VCT use among men was 23.3% (95% CI 17.2–29.4). Forty six percent (95% CI 40.8–51.2) had pre-test counselling and 25.9% (95%CI 19.9–31.9) had HIV testing. Of those who tested, 96% returned for post-test counselling and received HIV results. VCT use was higher among men aged 35 years and below (OR = 2.69, 95%CI 1.77–4.07), the non-subsistence farmers (OR = 2.37, 95%CI 2.37), the couple testing (OR = 2.37, 95%CI 1.02–8.83) and men with intention to disclose HIV test results to sexual partners (OR = 1.64, 95%CI 1.04–2.60). The major barriers to VCT use among men were poor utilization of VCT services due to poor access, stigma and confidentiality of services. Conclusion VCT use among men in Bukonzo West, Kasese district was low. In order to increase VCT use among men, the VCT programme needs to address HIV stigma and improve access and confidentiality of VCT services. Among the more promising interventions are the use of routine counselling and testing for HIV of patients seeking health care in health units, home based

Evaluation of simple rapid HIV assays and development of national rapid HIV test algorithms in Dar es Salaam, Tanzania

PubMed Central

2009-01-01

Background Suitable algorithms based on a combination of two or more simple rapid HIV assays have been shown to have a diagnostic accuracy comparable to double enzyme-linked immunosorbent assay (ELISA) or double ELISA with Western Blot strategies. The aims of this study were to evaluate the performance of five simple rapid HIV assays using whole blood samples from HIV-infected patients, pregnant women, voluntary counseling and testing attendees and blood donors, and to formulate an alternative confirmatory strategy based on rapid HIV testing algorithms suitable for use in Tanzania. Methods Five rapid HIV assays: Determine™ HIV-1/2 (Inverness Medical), SD Bioline HIV 1/2 3.0 (Standard Diagnostics Inc.), First Response HIV Card 1–2.0 (PMC Medical India Pvt Ltd), HIV1/2 Stat-Pak Dipstick (Chembio Diagnostic System, Inc) and Uni-Gold™ HIV-1/2 (Trinity Biotech) were evaluated between June and September 2006 using 1433 whole blood samples from hospital patients, pregnant women, voluntary counseling and testing attendees and blood donors. All samples that were reactive on all or any of the five rapid assays and 10% of non-reactive samples were tested on a confirmatory Inno-Lia HIV I/II immunoblot assay (Immunogenetics). Results Three hundred and ninety samples were confirmed HIV-1 antibody positive, while 1043 were HIV negative. The sensitivity at initial testing of Determine, SD Bioline and Uni-Gold™ was 100% (95% CI; 99.1–100) while First Response and Stat-Pak had sensitivity of 99.5% (95% CI; 98.2–99.9) and 97.7% (95% CI; 95.7–98.9), respectively, which increased to 100% (95% CI; 99.1–100) on repeat testing. The initial specificity of the Uni-Gold™ assay was 100% (95% CI; 99.6–100) while specificities were 99.6% (95% CI; 99–99.9), 99.4% (95% CI; 98.8–99.7), 99.6% (95% CI; 99–99.9) and 99.8% (95% CI; 99.3–99.9) for Determine, SD Bioline, First Response and Stat-Pak assays, respectively. There was no any sample which was concordantly false

Cost-effectiveness of finding new HIV diagnoses using rapid HIV testing in community-based organizations.

PubMed

Shrestha, Ram K; Clark, Hollie A; Sansom, Stephanie L; Song, Binwei; Buckendahl, Holly; Calhoun, Cindy B; Hutchinson, Angela B; Heffelfinger, James D

2008-01-01

We assessed the cost-effectiveness of determining new human immunodeficiency virus (HIV) diagnoses using rapid HIV testing performed by community-based organizations (CBOs) in Kansas City, Missouri, and Detroit, Michigan. The CBOs performed rapid HIV testing during April 2004 through March 2006. In Kansas City, testing was performed in a clinic and in outreach settings. In Detroit, testing was performed in outreach settings only. Both CBOs used mobile testing vans. Measures of effectiveness were the number of HIV tests performed and the number of people notified of new HIV diagnoses, based on rapid tests. We retrospectively collected program costs, including those for personnel, test kits, mobile vans, and facility space. The CBO in Kansas City tested a mean of 855 people a year in its clinic and 703 people a year in outreach settings. The number of people notified of new HIV diagnoses was 19 (2.2%) in the clinic and five (0.7%) in outreach settings. The CBO in Detroit tested 976 people a year in outreach settings, and the number notified of new HIV diagnoses was 15 (1.5%). In Kansas City, the cost per person notified of a new HIV diagnosis was $3,637 in the clinic and $16,985 in outreach settings. In the Detroit outreach settings, the cost per notification was $13,448. The cost of providing a new HIV diagnosis was considerably higher in the outreach settings than in the clinic. The variation can be largely explained by differences in the number of undiagnosed infections among the people tested and by the costs of purchasing and operating a mobile van.

Monitoring anonymous HIV testing in Estonia from 2005 to 2015.

PubMed

Rüütel, K; Kallavus, K; Tomera, I

2018-02-01

In Estonia, a network of anonymous and free of charge HIV testing sites has been operating since 1988. Services are provided by health care organizations and financed by the National Institute for Health Development from the state budget. The objective of this analysis was to assess anonymous HIV testing in Estonia from 2005 to 2015. We used data collected from the National Institute for Health Development's annual reports, Health Board and Estonian Health Insurance Fund. In Estonia, more than 200 000 HIV-tests are performed annually, and of these approximately 5-6% are within anonymous HIV testing sites. The percentage tested with rapid tests in anonymous testing sites has increased from 15% in 2010 to 53% in 2015. Furthermore, up to 65% of all newly diagnosed HIV-cases have been detected in these sites. The proportion of HIV-positive tests has decreased from 3.8% to 0.5% in anonymous testing sites and from 0.3% to 0.1% in general health care. Simultaneously, the cost of detecting one new HIV case has increased almost six times. This analysis reveals that anonymous HIV testing services are well accepted by the general population as well as vulnerable populations. The positivity rate among those tested in anonymous testing sites remains higher than among all people tested, showing that the sites reach more of those who are at higher risk of HIV. In the light of decreasing positivity rate, more attention should be paid to people with higher HIV risk and increasing access to testing in community based settings. © 2018 British HIV Association.

Correlates of HIV/STD testing and willingness to test among rural-to-urban migrants in China.

PubMed

Wang, Bo; Li, Xiaoming; Stanton, Bonita; McGuire, James

2010-08-01

This study investigates socio-demographic, behavioral, psychological, and structural factors associated with self-reported HIV/STD testing and willingness to test among 1,938 Chinese migrants. Overall, 6% and 14% of participants had ever been tested for HIV and STD, respectively. The results of multivariate analyses indicate that working at entertainment sectors, engaging in commercial sex, and utilization of health care were positively associated with both HIV and STD testing. Younger age, selling blood, perceived peer sexual risk involvement, and satisfaction with life were associated with HIV testing only. Female gender, early sexual debut, multiple sexual partners, and perceived vulnerability to HIV/STD were associated with STD testing only. Male gender, having premarital sex, perceived higher severity of and vulnerability to HIV/STD, and utilization of health care were associated with willingness to be tested for both HIV and STD. Interventions designed to raise the perception of vulnerability to HIV/STD and to improve access to and utilization of health care may be effective in encouraging more HIV testing in this vulnerable population.

Misdiagnosis of HIV infection during a South African community-based survey: implications for rapid HIV testing

PubMed Central

Kufa, Tendesayi; Kharsany, Ayesha BM; Cawood, Cherie; Khanyile, David; Lewis, Lara; Grobler, Anneke; Chipeta, Zawadi; Bere, Alfred; Glenshaw, Mary; Puren, Adrian

2017-01-01

Abstract Introduction: We describe the overall accuracy and performance of a serial rapid HIV testing algorithm used in community-based HIV testing in the context of a population-based household survey conducted in two sub-districts of uMgungundlovu district, KwaZulu-Natal, South Africa, against reference fourth-generation HIV-1/2 antibody and p24 antigen combination immunoassays. We discuss implications of the findings on rapid HIV testing programmes. Methods: Cross-sectional design: Following enrolment into the survey, questionnaires were administered to eligible and consenting participants in order to obtain demographic and HIV-related data. Peripheral blood samples were collected for HIV-related testing. Participants were offered community-based HIV testing in the home by trained field workers using a serial algorithm with two rapid diagnostic tests (RDTs) in series. In the laboratory, reference HIV testing was conducted using two fourth-generation immunoassays with all positives in the confirmatory test considered true positives. Accuracy, sensitivity, specificity, positive predictive value, negative predictive value and false-positive and false-negative rates were determined. Results: Of 10,236 individuals enrolled in the survey, 3740 were tested in the home (median age 24 years (interquartile range 19–31 years), 42.1% males and HIV positivity on RDT algorithm 8.0%). From those tested, 3729 (99.7%) had a definitive RDT result as well as a laboratory immunoassay result. The overall accuracy of the RDT when compared to the fourth-generation immunoassays was 98.8% (95% confidence interval (CI) 98.5–99.2). The sensitivity, specificity, positive predictive value and negative predictive value were 91.1% (95% CI 87.5–93.7), 99.9% (95% CI 99.8–100), 99.3% (95% CI 97.4–99.8) and 99.1% (95% CI 98.8–99.4) respectively. The false-positive and false-negative rates were 0.06% (95% CI 0.01–0.24) and 8.9% (95% CI 6.3–12.53). Compared to true positives

Rapid HIV Testing in Dental Practices

PubMed Central

Abel, Stephen N.; Pereyra, Margaret; Liguori, Terri; Pollack, Harold A.; Metsch, Lisa R.

2012-01-01

Despite increasing discussion about the dental care setting as a logical, potentially fruitful venue for rapid HIV testing, dentists’ willingness to take on this task is unclear. Semistructured interviews with 40 private practice dentists revealed their principal concerns regarding offering patients HIV testing were false results, offending patients, viewing HIV testing as outside the scope of licensure, anticipating low patient acceptance of HIV testing in a dental setting, expecting inadequate reimbursement, and potential negative impact on the practice. Dentists were typically not concerned about transmission risks, staff opposition to testing, or making referrals for follow-up after a positive result. A larger cultural change may be required to engage dentists more actively in primary prevention and population-based HIV screening. PMID:22397342

Testing the fathers: carrying out HIV and STI tests on partners of pregnant women.

PubMed

Dhairyawan, R; Creighton, S; Sivyour, L; Anderson, J

2012-04-01

Opt out antenatal HIV testing has significantly reduced mother to child transmission of HIV, but seroconversion during pregnancy from undiagnosed HIV positive male partners remains a risk. The authors report on a pilot initiative for sexual health and HIV screening for male partners of women attending antenatal ultrasound examination at Homerton Hospital, London. Men attending with their female partners for routine ultrasound examination between 1 August 2010 and 31 January 2011 were offered on-site serology for HIV, syphilis, hepatitis B and hepatitis C and urine testing for Neiserria gonorrhoeae and Chlamydia trachomatis. were followed up through the genitourinary medicine service. Referral pathways were established for men with positive results. 1243 male partners of 2400 women attended ultrasound examinations, of whom 430 accepted testing (acceptance rate 35% and coverage rate 18%). Median age was 32 years (range 19-52). 112/430 (26%) male partners were of black ethnicity. 41% had previously had a HIV test. There was no difference in prior HIV testing between whites and non-whites. 16 infections were diagnosed, including two cases of hepatitis C, eight cases of hepatitis B and six cases of C trachomatis. No HIV diagnoses were made. The authors have shown that it is acceptable and feasible to engage heterosexual men for testing in this setting. Of those men who accepted HIV testing, more than half had never been previously tested. 4% of men tested had an infection, which had the potential to affect the outcome of the pregnancy.

Cost and quality of life analysis of HIV self-testing and facility-based HIV testing and counselling in Blantyre, Malawi.

PubMed

Maheswaran, Hendramoorthy; Petrou, Stavros; MacPherson, Peter; Choko, Augustine T; Kumwenda, Felistas; Lalloo, David G; Clarke, Aileen; Corbett, Elizabeth L

2016-02-19

HIV self-testing (HIVST) has been found to be highly effective, but no cost analysis has been undertaken to guide the design of affordable and scalable implementation strategies. Consecutive HIV self-testers and facility-based testers were recruited from participants in a community cluster-randomised trial ( ISRCTN02004005 ) investigating the impact of offering HIVST in addition to facility-based HIV testing and counselling (HTC). Primary costing studies were undertaken of the HIVST service and of health facilities providing HTC to the trial population. Costs were adjusted to 2014 US$ and INT$. Recruited participants were asked about direct non-medical and indirect costs associated with accessing either modality of HIV testing, and additionally their health-related quality of life was measured using the EuroQol EQ-5D. A total of 1,241 participants underwent either HIVST (n = 775) or facility-based HTC (n = 446). The mean societal cost per participant tested through HIVST (US$9.23; 95 % CI: US$9.14-US$9.32) was lower than through facility-based HTC (US$11.84; 95 % CI: US$10.81-12.86). Although the mean health provider cost per participant tested through HIVST (US$8.78) was comparable to facility-based HTC (range: US$7.53-US$10.57), the associated mean direct non-medical and indirect cost was lower (US$2.93; 95 % CI: US$1.90-US$3.96). The mean health provider cost per HIV positive participant identified through HIVST was higher (US$97.50) than for health facilities (range: US$25.18-US$76.14), as was the mean cost per HIV positive individual assessed for anti-retroviral treatment (ART) eligibility and the mean cost per HIV positive individual initiated onto ART. In comparison to the facility-testing group, the adjusted mean EQ-5D utility score was 0.046 (95 % CI: 0.022-0.070) higher in the HIVST group. HIVST reduces the economic burden on clients, but is a costlier strategy for the health provider aiming to identify HIV positive individuals for treatment. The

Laboratory evaluation of the Liat HIV Quant (IQuum) whole-blood and plasma HIV-1 viral load assays for point-of-care testing in South Africa.

PubMed

Scott, Lesley; Gous, Natasha; Carmona, Sergio; Stevens, Wendy

2015-05-01

Point-of-care (POC) HIV viral load (VL) testing offers the potential to reduce turnaround times for antiretroviral therapy monitoring, offer near-patient acute HIV diagnosis in adults, extend existing centralized VL services, screen women in labor, and prompt pediatrics to early treatment. The Liat HIV Quant plasma and whole-blood assays, prerelease version, were evaluated in South Africa. The precision, accuracy, linearity, and agreement of the Liat HIV Quant whole-blood and plasma assays were compared to those of reference technologies (Roche CAP CTMv2.0 and Abbott RealTime HIV-1) on an HIV verification plasma panel (n = 42) and HIV clinical specimens (n = 163). HIV Quant plasma assay showed good performance, with a 2.7% similarity coefficient of variation (CV) compared to the Abbott assay and a 1.8% similarity CV compared to the Roche test on the verification panel, and 100% specificity. HIV Quant plasma had substantial agreement (pc [concordance correlation] = 0.96) with Roche on clinical specimens and increased variability (pc = 0.73) in the range of <3.0 log copies/ml range with the HIV Quant whole-blood assay. HIV Quant plasma assay had good linearity (2.0 to 5.0 log copies/ml; R(2) = 0.99). Clinical sensitivity at a viral load of 1,000 copies/ml of the HIV Quant plasma and whole-blood assays compared to that of the Roche assay (n = 94) was 100% (confidence interval [CI], 95.3% to 100%). The specificity of HIV Quant plasma was 88.2% (CI, 63.6% to 98.5%), and that for whole blood was 41.2% (CI, 18.4% to 67.1%). No virological failure (downward misclassification) was missed. Liat HIV Quant plasma assay can be interchanged with existing VL technology in South Africa. Liat HIV Quant whole-blood assay would be advantageous for POC early infant diagnosis at birth and adult adherence monitoring and needs to be evaluated further in this clinical context. LIAT cartridges currently require cold storage, but the technology is user-friendly and robust. Clinical cost and

Laboratory Evaluation of the Liat HIV Quant (IQuum) Whole-Blood and Plasma HIV-1 Viral Load Assays for Point-of-Care Testing in South Africa

PubMed Central

Gous, Natasha; Carmona, Sergio; Stevens, Wendy

2015-01-01

Point-of-care (POC) HIV viral load (VL) testing offers the potential to reduce turnaround times for antiretroviral therapy monitoring, offer near-patient acute HIV diagnosis in adults, extend existing centralized VL services, screen women in labor, and prompt pediatrics to early treatment. The Liat HIV Quant plasma and whole-blood assays, prerelease version, were evaluated in South Africa. The precision, accuracy, linearity, and agreement of the Liat HIV Quant whole-blood and plasma assays were compared to those of reference technologies (Roche CAP CTMv2.0 and Abbott RealTime HIV-1) on an HIV verification plasma panel (n = 42) and HIV clinical specimens (n = 163). HIV Quant plasma assay showed good performance, with a 2.7% similarity coefficient of variation (CV) compared to the Abbott assay and a 1.8% similarity CV compared to the Roche test on the verification panel, and 100% specificity. HIV Quant plasma had substantial agreement (pc [concordance correlation] = 0.96) with Roche on clinical specimens and increased variability (pc = 0.73) in the range of <3.0 log copies/ml range with the HIV Quant whole-blood assay. HIV Quant plasma assay had good linearity (2.0 to 5.0 log copies/ml; R2 = 0.99). Clinical sensitivity at a viral load of 1,000 copies/ml of the HIV Quant plasma and whole-blood assays compared to that of the Roche assay (n = 94) was 100% (confidence interval [CI], 95.3% to 100%). The specificity of HIV Quant plasma was 88.2% (CI, 63.6% to 98.5%), and that for whole blood was 41.2% (CI, 18.4% to 67.1%). No virological failure (downward misclassification) was missed. Liat HIV Quant plasma assay can be interchanged with existing VL technology in South Africa. Liat HIV Quant whole-blood assay would be advantageous for POC early infant diagnosis at birth and adult adherence monitoring and needs to be evaluated further in this clinical context. LIAT cartridges currently require cold storage, but the technology is user-friendly and robust. Clinical cost and

Development and validation of a real-time TaqMan assay for the detection and enumeration of Pseudomonas fluorescens ATCC 13525 used as a challenge organism in testing of food equipments.

PubMed

Saha, Ratul; Bestervelt, Lorelle L; Donofrio, Robert S

2012-02-01

Pseudomonas fluorescens ATCC 13525 is used as the challenge organism to evaluate the efficacy of the clean-in-place (CIP) process of food equipment (automatic ice-maker) as per NSF/ANSI Standard 12. Traditional culturing methodology is presently used to determine the concentration of the challenge organism, which takes 48 h to confirm the cell density. Storage of the challenge preparation in the refrigerator might alter the cell density as P. fluorescens is capable of growing at 4 °C. Also, background organism can grow on the Pseudomonas F agar (PFA) used for the recovery of P. fluorescens thus affecting the results of the test. Real-time TaqMan assay targeting the cpn60 gene was developed for the enumeration and the identification of P. fluorescens because of its specificity, accuracy, and shorter turnaround time. The TaqMan primer-probe pair developed using the Allele ID® 7.0 probe design software was highly specific and sensitive for the target organism. The sensitivity of the assay was 10 colony forming units (CFU)/mL. The assay was also successful in determining the concentration of the challenge preparation within 2 h. Based on these observations, TaqMan assay targeting the cpn60 gene can be efficiently used for strain level identification and enumeration of bacteria. Pseudomonas fluorescens ATCC 13525 is used as a challenge organism in the efficacy testing of clean-in-place process of food equipments. Currently, culturing technique is used for its identification and estimation, which is not only time-consuming but also prone to error. Real-time TaqMan assay is more specific, sensitive, and accurate along with a shorter turnaround time compared to culturing techniques, thereby increasing the overall quality of the testing methodology to evaluate the clean-in-place process critical for the food industry to protect public health and safety. © 2012 Institute of Food Technologists®

HIV/AIDS testing at ports of entry in China.

PubMed

Lai, Dejian; Hwang, Lu-Yu; Beasley, R Palmer

2011-05-01

In 2007 the Chinese government issued regulations requiring HIV/AIDS testing for Chinese citizens returning at ports of entry if they had resided outside China for 1 year or longer. Three years after publication and partial implementation of the regulations, the Chinese government decided to eliminate compulsory HIV/AIDS testing of returning Chinese. We examine the history of China's HIV/AIDS testing regulations on entry-exit populations, showing how China has gradually altered its policy. As of December 2010, the policy of compulsory HIV/AIDS testing of returning Chinese has been abandoned; however, the regulations still compel HIV/AIDS testing for other groups inside China. Our review sheds new light on the dynamics of regulatory changes in the last 3 years. The Chinese experience that we observed may provide useful insights for policymakers in other parts of the world.

Remaining Gap in HIV Testing Uptake Among Female Sex Workers in Iran.

PubMed

Shokoohi, Mostafa; Noori, Atefeh; Karamouzian, Mohammad; Sharifi, Hamid; Khajehkazemi, Razieh; Fahimfar, Noushin; Hosseini-Hooshyar, Samira; Kazerooni, Parvin Afsar; Mirzazadeh, Ali

2017-08-01

We estimated the prevalence of recent HIV testing (i.e., having an HIV test during the last 12 months and knew the results) among 1295 HIV-negative Iranian female sex workers (FSW) in 2015. Overall, 70.4% (95% confidence intervals: 59.6, 79.3) of the participants reported a recent HIV testing. Concerns about their HIV status (83.2%) was reported as the most common reason for HIV testing. Incarceration history, having >5 paying partners, having >1 non-paying partner, receiving harm reduction services, utilizing healthcare services, and knowing an HIV testing site were significantly associated with recent HIV testing. In contrast, outreach participants, having one non-paying sexual partner, and self-reported inconsistent condom use reduced the likelihood of recent HIV testing. HIV testing uptake showed a ~2.5 times increase among FSW since 2010. While these findings are promising and show improvement over a short period, HIV testing programs should be expanded particularly through mobile and outreach efforts.

HIV testing practices and the potential role of HIV self-testing among men who have sex with men in Mexico.

PubMed

Oldenburg, Catherine E; Biello, Katie B; Perez-Brumer, Amaya G; Rosenberger, Joshua; Novak, David S; Mayer, Kenneth H; Mimiaga, Matthew J

2017-03-01

The objective of this study was to characterize HIV testing practices among men who have sex with men in Mexico and intention to use HIV self-testing. In 2012, members of one of the largest social/sexual networking websites for men who have sex with men in Latin America completed an anonymous online survey. This analysis was restricted to HIV-uninfected men who have sex with men residing in Mexico. Multivariable logistic regression models were fit to assess factors associated with HIV testing and intention to use a HIV self-test. Of 4537 respondents, 70.9% reported ever having a HIV test, of whom 75.5% reported testing at least yearly. The majority (94.3%) indicated that they would use a HIV home self-test if it were available. Participants identifying as bisexual less often reported ever HIV testing compared to those identifying as gay/homosexual (adjusted odds ratio = 0.52, 95% confidence interval: 0.44-0.62). Having a physical exam in the past year was associated with increased ever HIV testing (adjusted odds ratio = 4.35, 95% confidence interval: 3.73-5.07), but associated with decreased interest in HIV self-testing (adjusted odds ratio = 0.66, 95% confidence interval: 0.48-0.89). The high intention to use HIV home self-testing supports the use of this method as an acceptable alternative to clinic- or hospital-based HIV testing.

Factors associated with HIV testing history and returning for HIV test results among men who have sex with men in Thailand.

PubMed

Wimonsate, Wipas; Naorat, Sathapana; Varangrat, Anchalee; Phanuphak, Praphan; Kanggarnrua, Kamolset; McNicholl, Janet; Akarasewi, Passakorn; van Griensven, Frits

2011-05-01

We evaluated factors associated with HIV testing history and returning for HIV test results among 2,049 Thai men who have sex with men. Of men, 50.3% reported prior HIV testing and 24.9% returned for HIV test results. Factors associated with prior HIV testing were male sex work, older age, employed, living away from the family, insertive anal sex role, history of drug use and having heard of effective HIV/AIDS treatment. Factors associated with returning for HIV test results were male sex work, older age, lack of a family confidant, history of sexually transmitted infections, and testing HIV negative in this study.

Comparison of turnaround time and total cost of HIV testing before and after implementation of the 2014 CDC/APHL Laboratory Testing Algorithm for diagnosis of HIV infection.

PubMed

Chen, Derrick J; Yao, Joseph D

2017-06-01

Updated recommendations for HIV diagnostic laboratory testing published by the Centers for Disease Control and Prevention and the Association of Public Health Laboratories incorporate 4th generation HIV immunoassays, which are capable of identifying HIV infection prior to seroconversion. The purpose of this study was to compare turnaround time and cost between 3rd and 4th generation HIV immunoassay-based testing algorithms for initially reactive results. The clinical microbiology laboratory database at Mayo Clinic, Rochester, MN was queried for 3rd generation (from November 2012 to May 2014) and 4th generation (from May 2014 to November 2015) HIV immunoassay results. All results from downstream supplemental testing were recorded. Turnaround time (defined as the time of initial sample receipt in the laboratory to the time the final supplemental test in the algorithm was resulted) and cost (based on 2016 Medicare reimbursement rates) were assessed. A total of 76,454 and 78,998 initial tests were performed during the study period using the 3rd generation and 4th generation HIV immunoassays, respectively. There were 516 (0.7%) and 581 (0.7%) total initially reactive results, respectively. Of these, 304 (58.9%) and 457 (78.7%) were positive by supplemental testing. There were 10 (0.01%) cases of acute HIV infection identified with the 4th generation algorithm. The most frequent tests performed to confirm an HIV-positive case using the 3rd generation algorithm, which were reactive initial immunoassay and positive HIV-1 Western blot, took a median time of 1.1 days to complete at a cost of $45.00. In contrast, the most frequent tests performed to confirm an HIV-positive case using the 4th generation algorithm, which included a reactive initial immunoassay and positive HIV-1/-2 antibody differentiation immunoassay for HIV-1, took a median time of 0.4 days and cost $63.25. Overall median turnaround time was 2.2 and 1.5 days, and overall median cost was $63.90 and $72.50 for

Cognitive factors associated with the willingness for HIV testing among pregnant women in China.

PubMed

Li, Chunrong; Yang, Liu; Kong, Jinwang

2014-01-01

The spread of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic in the worldwide trend is not contained effectively. The pregnant women infected HIV seriously in the high HIV epidemic areas in China. The transmission of HIV to child may be cut off if HIV positive mother was found early by HIV testing. Pregnant women mandatorily received the HIV counseling and testing services. Most of them did not know the knowledge about HIV prevention and were not willing to receive HIV testing actively. Willingness for HIV testing among pregnant women was investigated, which can help to promote them to take up HIV testing actively. This study assessed the prevalence of the willingness for HIV testing and cognitive factors associated with it. A cross-sectional survey was conducted to 500 pregnant women via face-to-face interviews with anonymous structured questionnaire guided by the Health Belief Model (HBM). The prevalence of the willingness for HIV testing was 58.60%. Perceived higher susceptibility to HIV (multivariate-adjusted odds ratio (ORm) = 2.02, 95% confidence interval (CI): 1.40-5.06), more knowledge for HIV (ORm = 1.92, 95% CI: 1.11-3.87) and perceived less social stigma (ORm = 0.80, 95% CI: 0.34-0.91) were associated with higher willingness for HIV testing among pregnant women. To prevent HIV mother to children transmission, it is necessary to enhance knowledge for HIV, change cognitive factors and increase willingness for HIV testing among pregnant women.

A simple semi-rapid HIV-1&2 confirmatory immunoassay using magnetic particles.

PubMed

Sommerfelt, Maja A; Ohlsson, Irene; Flolid, Irene; Thorstensson, Rigmor; Sørensen, Birger

2004-02-01

The Bionor HIV-1&2 Confirmatory Test is a semi-rapid simple immunoassay based on magnetic particles for the confirmation of serological status to human immunodeficiency virus (HIV). The specificity and sensitivity of this assay was evaluated by comparison with the Diagnostic Biotechnology HIV-1 Western blot (WB) 2.2 and the HIV-2/SBL-6669 WB. Bionor's confirmatory test demonstrated 98% specificity when testing sero-negative blood donors and false positive sera in screening tests compared to 81.5 and 71.6%, respectively, using the HIV-1 WB. The sensitivity of this assay for HIV-1 antibody positive sera was 97.9% compared to the WB which was 99.5%. When testing confirmed HIV-2 antibody positive samples, 2/100 scored negative using this confirmatory test similar to other HIV-2 peptide-based line immunoassays available commercially, whilst 8/100 were indeterminate reacting to HIV-2 membrane antigens only. Bionor's confirmatory test detected HIV-1 seropositivity earlier than the WB in longitudinal seroconversion panels and could discriminate between HIV-1 and -2 infection. The number of indeterminate responses was generally reduced significantly using Bionor's confirmatory test compared to the HIV-1 WB. The greater specificity, speed and ease of interpretation of Bionor's confirmatory test renders it an attractive and cost effective alternative to the WB for confirming HIV serological status worldwide.

Comparative Performance of Three Viral Load Assays on Human Immunodeficiency Virus Type 1 (HIV-1) Isolates Representing Group M (Subtypes A to G) and Group O: LCx HIV RNA Quantitative, AMPLICOR HIV-1 MONITOR Version 1.5, and Quantiplex HIV-1 RNA Version 3.0

PubMed Central

Swanson, Priscilla; Soriano, Vincent; Devare, Sushil G.; Hackett, John

2001-01-01

The performance of the LCx HIV RNA Quantitative (LCx HIV), AMPLICOR HIV-1 MONITOR version 1.5 (MONITOR v1.5), and Quantiplex HIV-1 RNA version 3.0 (bDNA v3.0) viral load assays was evaluated with 39 viral isolates (3 A, 7 B, 6 C, 4 D, 8 E, 4 F, 1 G, 4 mosaic, and 2 group O). Quantitation across the assay dynamic ranges was assessed using serial fivefold dilutions of the viruses. In addition, sequences of gag-encoded p24 (gag p24), pol-encoded integrase, and env-encoded gp41 were analyzed to assign group and subtype and to assess nucleotide mismatches at primer and probe binding sites. For group M isolates, quantification was highly correlated among all three assays. In contrast, only the LCx HIV assay reliably quantified group O isolates. The bDNA v3.0 assay detected but consistently underquantified group O viruses, whereas the MONITOR v1.5 test failed to detect group O viruses. Analysis of target regions revealed fewer primer or probe mismatches in the LCx HIV assay than in the MONITOR v1.5 test. Consistent with the high level of nucleotide conservation is the ability of the LCx HIV assay to quantify efficiently human immunodeficiency virus type 1 group M and the genetically diverse group O. PMID:11230396

Estimation of the Percentage of Newly Diagnosed HIV-Positive Persons Linked to HIV Medical Care in CDC-Funded HIV Testing Programs.

PubMed

Wang, Guoshen; Pan, Yi; Seth, Puja; Song, Ruiguang; Belcher, Lisa

2017-01-01

Missing data create challenges for determining progress made in linking HIV-positive persons to HIV medical care. Statistical methods are not used to address missing program data on linkage. In 2014, 61 health department jurisdictions were funded by Centers for Disease Control and Prevention (CDC) and submitted data on HIV testing, newly diagnosed HIV-positive persons, and linkage to HIV medical care. Missing or unusable data existed in our data set. A new approach using multiple imputation to address missing linkage data was proposed, and results were compared to the current approach that uses data with complete information. There were 12,472 newly diagnosed HIV-positive persons from CDC-funded HIV testing events in 2014. Using multiple imputation, 94.1% (95% confidence interval (CI): [93.7%, 94.6%]) of newly diagnosed persons were referred to HIV medical care, 88.6% (95% CI: [88.0%, 89.1%]) were linked to care within any time frame, and 83.6% (95% CI: [83.0%, 84.3%]) were linked to care within 90 days. Multiple imputation is recommended for addressing missing linkage data in future analyses when the missing percentage is high. The use of multiple imputation for missing values can result in a better understanding of how programs are performing on key HIV testing and HIV service delivery indicators.

Telephone communication of HIV testing results for improving knowledge of HIV infection status.

PubMed

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

2013-01-31

This is one of three Cochrane reviews that examine the role of the telephone in HIV/AIDS services. Both in developed and developing countries there is a large proportion of people who do not know they are infected with HIV. Knowledge of one's own HIV serostatus is necessary to access HIV support, care and treatment and to prevent acquisition or further transmission of HIV. Using telephones instead of face-to-face or other means of HIV test results delivery could lead to more people receiving their HIV test results. To assess the effectiveness of telephone use for delivery of HIV test results and post-test counselling.To evaluate the effectiveness of delivering HIV test results by telephone, we were interested in whether they can increase the proportion of people who receive their HIV test results and the number of people knowing their HIV status. We searched The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PubMed Central, PsycINFO, ISI Web of Science, Cumulative Index to Nursing & Allied Health (CINAHL), WHOs The Global Health Library and Current Controlled Trials from 1980 to June 2011. We also searched grey literature sources such as Dissertation Abstracts International,CAB Direct Global Health, OpenSIGLE, The Healthcare Management Information Consortium, Google Scholar, Conference on Retroviruses and Opportunistic Infections, International AIDS Society and AEGIS Education Global Information System, and reference lists of relevant studies for this review. Randomised controlled trials (RCTs), quasi-randomised controlled trials (qRCTs), controlled before and after studies (CBAs), and interrupted time series (ITS) studies comparing the effectiveness of telephone HIV test results notification and post-test counselling to face-to-face or other ways of HIV test result delivery in people regardless of their demographic characteristics and in all settings. Two reviewers independently searched, screened, assessed study quality and extracted data. A

Internet-based cohort study of HIV testing over 1 year among men who have sex with men living in England and exposed to a social marketing intervention promoting testing.

PubMed

Hickson, Ford; Tomlin, Keith; Hargreaves, James; Bonell, Chris; Reid, David; Weatherburn, Peter

2015-02-01

Increasing HIV testing among men who have sex with men (MSM) is a major policy goal in the UK. Social marketing is a common intervention to increase testing uptake. We used an online panel of MSM to examine rates of HIV testing behaviour and the impact of a social marketing intervention on them. MSM in England were recruited to a longitudinal internet panel through community websites and a previous survey. Following an enrolment survey, respondents were invited to self-complete 13 surveys at monthly intervals throughout 2011. A unique alphanumeric code linked surveys for individuals. Rates of HIV testing were compared relative to prompted recognition of a multi-part media campaign aiming to normalise HIV testing. Of 3386 unique enrolments, 2047 respondents were included in the analysis, between them submitting 15,353 monthly surveys (equivalent to 1279 years of follow-up), and recording 1517 HIV tests taken, giving an annual rate of tests per participant of 1.19 (95% CI 1.13 to 1.25). Tests were highly clustered in individuals (61% reported no test during the study). Testing rates were higher in London, single men and those aged 25-34 years. Only 7.6% recognised the intervention when prompted. After controlling for sociodemographic characteristics and exposure to other health promotion campaigns, intervention recognition was not associated with increased likelihood of testing. Higher rates of testing were strongly associated with higher number of casual sexual partners and how recently men had HIV tested before study enrolment. This social marketing intervention was not associated with increased rates of HIV testing. More effective promotion of HIV testing is needed among MSM in England to reduce the average duration of undiagnosed infection. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Assessment of recent HIV testing among older adults in the United States.

PubMed

Guo, Yuqi; Sims, Omar T

2017-10-01

Older adults are the fastest growing segment of people living with HIV, and unfortunately many are unaware of their HIV status. Many providers are reluctant to ask older adults about their sexual histories, evaluate their risk factors, and test for HIV, and older adults have low perception of HIV risk. Using data from the 2013 to 2014 National Health and Nutrition Examination Survey, this study assessed the prevalence of recent HIV testing among older adults in the United States (n = 1,056) and identified predictors and barriers to recent HIV testing. The prevalence of recent HIV testing was 28%. Recent HIV testing was associated positively with male gender, education level, having public insurance, having same sex sexual behavior, African, and Hispanic ethnicity, whereas age, income-to-poverty ratio, and Asian ethnicity were associated negatively with recent HIV testing. Public health social workers are advised that targeted HIV testing for Asian, economically disadvantaged, female older adults is needed to increase HIV awareness and detection and to decrease late diagnosis of HIV. Provided public insurance was identified as a predictor of recent HIV testing, facilitating economically disadvantaged older adults' eligibility for public insurance that will likely improve access to HIV testing services and increase HIV testing rates.

Implementation and Operational Research: Strengthening HIV Test Access and Treatment Uptake Study (Project STATUS): A Randomized Trial of HIV Testing and Counseling Interventions.

PubMed

McNaghten, A D; Schilsky Mneimneh, Allison; Farirai, Thato; Wamai, Nafuna; Ntiro, Marylad; Sabatier, Jennifer; Makhunga-Ramfolo, Nondumiso; Mwanasalli, Salli; Awor, Anna; Moore, Jan

2015-12-01

To determine which of 3 HIV testing and counseling (HTC) models in outpatient departments (OPDs) increases HIV testing and entry of newly identified HIV-infected patients into care. Randomized trial of HTC interventions. Thirty-six OPDs in South Africa, Tanzania, and Uganda were randomly assigned to 3 different HTC models: (A) health care providers referred eligible patients (aged 18-49, not tested in the past year, not known HIV positive) to on-site voluntary counseling and testing for HTC offered and provided by voluntary counseling and testing counselors after clinical consultation; (B) health care providers offered and provided HTC to eligible patients during clinical consultation; and (C) nurse or lay counselors offered and provided HTC to eligible patients before clinical consultation. Data were collected from October 2011 to September 2012. We describe testing eligibility and acceptance, HIV prevalence, and referral and entry into care. Chi-square analyses were conducted to examine differences by model. Of 79,910 patients, 45% were age eligible and 16,099 (45%) age eligibles were tested. Ten percent tested HIV positive. Significant differences were found in percent tested by model. The proportion of age eligible patients tested by Project STATUS was highest for model C (54.1%, 95% confidence interval [CI]: 42.4 to 65.9), followed by model A (41.7%, 95% CI: 30.7 to 52.8), and then model B (33.9%, 95% CI: 25.7 to 42.1). Of the 1596 newly identified HIV positive patients, 94% were referred to care (96.1% in model A, 94.7% in model B, and 94.9% in model C), and 58% entered on-site care (74.4% in model A, 54.8% in model B, and 55.6% in model C) with no significant differences in referrals or care entry by model. Model C resulted in the highest proportion of all age-eligible patients receiving a test. Although 94% of STATUS patients with a positive test result were referred to care, only 58% entered care. We found no differences in patients entering care by HTC

Curcumin derivatives as HIV-1 protease inhibitors

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sui, Z.; Li, J.; Craik, C.S.

1993-12-31

Curcumin, a non-toxic natural compound from Curcuma longa, has been found to be an HIV-1 protease inhibitor. Some of its derivatives were synthesized and their inhibitory activity against the HIV-1 protease was tested. Curcumin analogues containing boron enhanced the inhibitory activity. At least of the the synthesized compounds irreversibly inhibits the HIV-1 protease.

Determinants of HIV testing and receipt of test results among adolescent girls in Nigeria: the role of assets and decision-making.

PubMed

Iwelunmor, Juliet; Blackstone, Sarah; Jennings, Larissa; Converse, Donaldson; Ehiri, John; Curley, Jami

2018-04-09

Purpose Many adolescent girls in Nigeria do not test for HIV despite being at high risk. While the influence of psychosocial factors on HIV testing has been examined, there is less evidence regarding the impact of assets and control of assets on HIV testing. This study investigated the protective effects of specific adolescent girls' assets on decision-making regarding HIV testing. Methods Cross-sectional data from the 2013 Nigeria Demographic and Health Survey was analyzed. The main outcome variables were self-reports of having been tested for HIV and knowledge of a place that offers HIV testing. Binary logistic regression was used with employment, education, wealth index, home ownership, land ownership and decision making as potential predictors. Demographic characteristics were controlled in the analysis. Results Age [odds ratio (OR = 1.49)], employment (OR = 3.38), education (OR = 3.16), wealth index (OR = 1.33) and decision making (OR = 3.16) were positively associated with HIV testing. Age (OR = 1.20), employment (OR = 1.33), education (OR = 1.38), wealth (OR = 1.64), land ownership (OR = 1.42), and decision making (OR = 1.26) were positively associated with knowledge of an HIV testing location. Conclusion Our findings suggest that assets play an important role with HIV testing decisions for adolescent girls. Further research to elucidate the specific asset-based needs of adolescent girls will be needed to enhance decisions surrounding uptake of HIV testing and receipt of test results in Nigeria.

HIV-1 viral load measurement in venous blood and fingerprick blood using Abbott RealTime HIV-1 DBS assay.

PubMed

Tang, Ning; Pahalawatta, Vihanga; Frank, Andrea; Bagley, Zowie; Viana, Raquel; Lampinen, John; Leckie, Gregor; Huang, Shihai; Abravaya, Klara; Wallis, Carole L

2017-07-01

HIV RNA suppression is a key indicator for monitoring success of antiretroviral therapy. From a logistical perspective, viral load (VL) testing using Dried Blood Spots (DBS) is a promising alternative to plasma based VL testing in resource-limited settings. To evaluate the analytical and clinical performance of the Abbott RealTime HIV-1 assay using a fully automated one-spot DBS sample protocol. Limit of detection (LOD), linearity, lower limit of quantitation (LLQ), upper limit of quantitation (ULQ), and precision were determined using serial dilutions of HIV-1 Virology Quality Assurance stock (VQA Rush University), or HIV-1-containing armored RNA, made in venous blood. To evaluate correlation, bias, and agreement, 497 HIV-1 positive adult clinical samples were collected from Ivory Coast, Uganda and South Africa. For each HIV-1 participant, DBS-fingerprick, DBS-venous and plasma sample results were compared. Correlation and bias values were obtained. The sensitivity and specificity were analyzed at a threshold of 1000 HIV-1 copies/mL generated using the standard plasma protocol. The Abbott HIV-1 DBS protocol had an LOD of 839 copies/mL, a linear range from 500 to 1×10 7 copies/mL, an LLQ of 839 copies/mL, a ULQ of 1×10 7 copies/mL, and an inter-assay SD of ≤0.30 log copies/mL for all tested levels within this range. With clinical samples, the correlation coefficient (r value) was 0.896 between DBS-fingerprick and plasma and 0.901 between DBS-venous and plasma, and the bias was -0.07 log copies/mL between DBS-fingerprick and plasma and -0.02 log copies/mL between DBS-venous and plasma. The sensitivity of DBS-fingerprick and DBS-venous was 93%, while the specificity of both DBS methods was 95%. The results demonstrated that the Abbott RealTime HIV-1 assay with DBS sample protocol is highly sensitive, specific and precise across a wide dynamic range and correlates well with plasma values. The Abbott RealTime HIV-1 assay with DBS sample protocol provides an

Video as an Effective Method to Deliver Pre-Test Information for Rapid HIV Testing

PubMed Central

Clark, Melissa A.; Mayer, Kenneth H.; Seage, George R.; DeGruttola, Victor G.; Becker, Bruce M.

2008-01-01

Objectives Video-based delivery of HIV pre-test information might assist in streamlining HIV screening and testing efforts in the emergency department (ED). The objectives of this study were to determine if the video “Do you know about rapid HIV testing?” is an acceptable alternative to an in-person information session on rapid HIV pre-test information, in regards to comprehension of rapid HIV pre-test fundamentals; and to identify patients who might have difficulties in comprehending pre-test information. Methods This was a non-inferiority trial of 574 participants in an ED opt-in rapid HIV screening program who were randomly assigned to receive identical pre-test information from either an animated and live-action 9.5-minute video, or an in-person information session. Pre-test information comprehension was assessed using a questionnaire. The video would be accepted as not inferior to the in-person information session if the 95% confidence interval (CI) of the difference (Δ) in mean scores on the questionnaire between the two information groups was less than a 10% decrease in the in-person information session arm's mean score. Linear regression models were constructed to identify patients with lower mean scores based upon study arm assignment, demographic characteristics, and history of prior HIV testing. Results The questionnaire mean scores were 20.1 (95% CI = 19.7 to 20.5) for the video arm and 20.8 (95% CI = 20.4 to 21.2) for the in-person information session arm. The difference in mean scores compared to the mean score for the in-person information session met the non-inferiority criterion for this investigation (Δ = 0.68; 95% CI = 0.18 to 1.26). In a multivariable linear regression model, Blacks/African Americans, Hispanics, and those with Medicare and Medicaid insurance exhibited slightly lower mean scores, regardless of the pre-test information delivery format. There was a strong relationship between fewer years of formal education and lower mean

Clinical validation of a novel diagnostic HIV-2 total nucleic acid qualitative assay using the Abbott m2000 platform: Implications for complementary HIV-2 nucleic acid testing for the CDC 4th generation HIV diagnostic testing algorithm.

PubMed

Chang, Ming; Wong, Audrey J S; Raugi, Dana N; Smith, Robert A; Seilie, Annette M; Ortega, Jose P; Bogusz, Kyle M; Sall, Fatima; Ba, Selly; Seydi, Moussa; Gottlieb, Geoffrey S; Coombs, Robert W

2017-01-01

The 2014 CDC 4th generation HIV screening algorithm includes an orthogonal immunoassay to confirm and discriminate HIV-1 and HIV-2 antibodies. Additional nucleic acid testing (NAT) is recommended to resolve indeterminate or undifferentiated HIV seroreactivity. HIV-2 NAT requires a second-line assay to detect HIV-2 total nucleic acid (TNA) in patients' blood cells, as a third of untreated patients have undetectable plasma HIV-2 RNA. To validate a qualitative HIV-2 TNA assay using peripheral blood mononuclear cells (PBMC) from HIV-2-infected Senegalese study participants. We evaluated the assay precision, sensitivity, specificity, and diagnostic performance of an HIV-2 TNA assay. Matched plasma and PBMC samples were collected from 25 HIV-1, 30 HIV-2, 8 HIV-1/-2 dual-seropositive and 25 HIV seronegative individuals. Diagnostic performance was evaluated by comparing the outcome of the TNA assay to the results obtained by the 4th generation HIV screening and confirmatory immunoassays. All PBMC from 30 HIV-2 seropositive participants tested positive for HIV-2 TNA including 23 patients with undetectable plasma RNA. Of the 30 matched plasma specimens, one was HIV non-reactive. Samples from 50 non-HIV-2 infected individuals were confirmed as non-reactive for HIV-2 Ab and negative for HIV-2 TNA. The agreement between HIV-2 TNA and the combined immunoassay results was 98.8% (79/80). Furthermore, HIV-2 TNA was detected in 7 of 8 PBMC specimens from HIV-1/HIV-2 dual-seropositive participants. Our TNA assay detected HIV-2 DNA/RNA in PBMC from serologically HIV-2 reactive, HIV indeterminate or HIV undifferentiated individuals with undetectable plasma RNA, and is suitable for confirming HIV-2 infection in the HIV testing algorithm. Copyright © 2016 Elsevier B.V. All rights reserved.

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.

HIV health literacy, sexual behaviour and self-reports of having tested for HIV among students.

PubMed

Naidoo, Saloshni; Taylor, Myra

2015-01-01

The HIV prevalence among young South African adults makes it important to understand their HIV knowledge, sexual behaviour and HIV counselling and testing (HCT) behaviour in this group. This paper presents the demographics, knowledge, sexual behaviour and cues to action as reported by sexually active students' who had HCT. A cross-sectional study conducted in 10 high schools in the eThekwini and Ugu districts, KwaZulu-Natal, surveyed students' HIV knowledge, sexual behaviour and HCT behaviour. Complete information was available from 1 114 (97.9%) students who participated in the survey. Of these, 378 (33.9%) were sexually active and were included in this analysis. Logistic regression models tested for significant associations between the independent and the dependent variables under study, nesting the students within schools and controlling for age, sex, grade and school location (urban/rural).The median age of students was 17 years (range: 14-23 years) with most being male (n=287; 75.9%). The lifetime median number of sexual partners of students was 3 (range: 1-27). Students who used condoms with their regular partners were more likely to have had counselling for HIV (OR :1.79; 95% CI: 1.06-3.01). Those students who were more likely to have been tested for HIV were female (OR: 44.90; 95% CI: 7.77-259.38), those who had always used a condom with their non-regular partner (OR: 2.75; 95% CI: 1.01-7.47), and those who knew a person who had tested for HIV (OR: 15.28; 95% CI: 5.16-45.23). Targeting students, especially males early in adolescence and reinforcing safe sex behaviour messages through their high school years, can encourage HCT among students.

HIV counseling and testing practices among clients presenting at a market HIV clinic in Kampala, Uganda: a cross-sectional study.

PubMed

Matovu, Joseph Kb; Bukuluki, Paul W; Mafigiri, David K; Mudondo, Harriet

2017-09-01

Uptake of HIV counseling and testing (HCT) among informal sector workers is not well documented. To assess HCT practices among clients presenting for HIV services at a market HIV clinic in Kampala, Uganda. Between August 1 and September 15, 2009, clients presenting for HIV services at a market HIV clinic were invited to participate in the study. Socio-demographic and HCT data were collected from consenting adults aged 16+ years. Descriptive statistics were performed using STATA version 14.1. Of 224 individuals who consented to the interview, n=139 62 % were market vendors while n=85 38 % were engaged in other market-related activities. Majority of the respondents, n=165, 73.7 %, had ever tested for HIV; of these, n=148,89.7 % had ever tested for 2+ times. The main reasons for repeat testing were the need to confirm previous HIV test results, n=126, 85.1% and the belief that the previous HIV test results were false, n=35, 23.6 %. Uptake of couples' HCT was low, n=63, 38.2 %, despite the fact that n=200, 89 % had ever heard of couples' HCT. These findings indicate high rates of repeat testing but low rates of couples' HCT uptake in this population.

A Randomized Study of Incentivizing HIV Testing for Parolees in Community Aftercare.

PubMed

Saxena, Preeta; Hall, Elizabeth A; Prendergast, Michael

2016-04-01

HIV risk-behaviors are high in criminal justice populations and more efforts are necessary to address them among criminal justice-involved substance abusers. This study examines the role of incentives in promoting HIV testing among parolees. Participants were randomly assigned to either an incentive (n = 104) or education group (control; n = 98), where the incentive group received a voucher for testing for HIV. Bivariate comparisons showed that a larger proportion of those in the incentive group received HIV testing (59% versus 47%), but this was not statistically significant (p = .09). However, in a multivariate logistic regression model controlling for covariates likely to influence HIV-testing behavior, those in the incentive group had increased odds of HIV testing in comparison to those in the education group (OR = 1.99, p < .05, CI [1.05, 3.78]). As a first of its kind, this study provides a foundation for further research on the utility of incentives in promoting HIV testing and other healthy behaviors in criminal justice populations.

HIV testing in dermatology - a national audit.

PubMed

Esson, Gavin A; Holme, S A

2018-05-01

Forty percent of individuals have late-stage HIV at the time of diagnosis, resulting in increased morbidity. Identifying key diseases which may indicate HIV infection can prompt clinicians to trigger testing, which may result in more timely diagnosis. The British HIV Association has published guidelines on such indicator diseases in dermatology. We audited the practice of HIV testing in UK dermatologists and General Practitioners (GPs) and compared results with the national guidelines. This audit showed that HIV testing in key indicator diseases remains below the standard set out by the national guidelines, and that GPs with special interest in dermatology have a lower likelihood for testing, and lower confidence when compared to consultants, registrars and associate specialists. Large proportions of respondents believed further training in HIV testing would be beneficial.

A Cross-Sectional Survey of HIV Testing and Prevalence in Twelve Brazilian Correctional Facilities

PubMed Central

Sgarbi, Renata Viebrantz Enne; Carbone, Andrea da Silva Santos; Paião, Dayse Sanchez Guimarães; Lemos, Everton Ferreira; Simionatto, Simone; Puga, Marco Antonio Moreira; Motta-Castro, Ana Rita Coimbra; Pompilio, Mauricio Antonio; Urrego, Juliana; Ko, Albert I.; Andrews, Jason R.; Croda, Julio

2015-01-01

Background Prior studies have reported higher HIV prevalence among prisoners than the general population in Brazil, but data have been derived from single prisons. The aim of this study was to evaluate HIV testing practices, prevalence and linkage to care among inmates in a network of 12 prisons. Methods We administered a questionnaire to a population-based sample of inmates from 12 prisons in Central-West Brazil and collected sera for HIV and syphilis testing from January to December 2013. We evaluated factors associated with HIV testing and infection using multivariable logistic regression models. Six months after HIV testing, we assessed whether each HIV-infected prisoner was engaged in clinical care and whether they had started antiretroviral therapy. Results We recruited 3,362 inmates, of whom 2,843 (85%) were men from 8 prisons, and 519 (15%) were women from 4 prisons. Forty-five percent of participants reported never having been tested for HIV previously. In multivariable analysis, the variables associated with previous HIV testing were lack of a stable partner (adjusted odds ratio [AOR]: 1.38; 95% CI: 1.18–1.60), completed more than four years of schooling (AOR 1.40; 95% CI: 1.20–1.64), history of previous incarceration (AOR: 1.68; 95% CI: 1.43–1.98), history of mental illness (AOR 1.52; 95% CI: 1.31–1.78) and previous surgery (AOR 1.31; 95% CI: 1.12–1.52). Fifty-four (1.6%) of all participants tested positive for HIV; this included 44 (1.54%) men and 10 (1.92%) women. Among male inmates, HIV infection was associated with homosexuality (AOR 6.20, 95% CI: 1.73–22.22), self-report of mental illness (AOR 2.18, 95% CI: 1.13–4.18), history of sexually transmitted infections (AOR 3.28, 95% CI: 1.64–6.56), and syphilis sero-positivity (AOR 2.54, 95% CI: 1.20–5.39). Among HIV-infected individuals, 34 (63%) were unaware of their HIV status; only 23 of these 34 (68%) newly diagnosed participants could be reached at six month follow-up, and 21 of 23

Structural inequalities drive late HIV diagnosis: The role of black racial concentration, income inequality, socioeconomic deprivation, and HIV testing

PubMed Central

Ransome, Yusuf; Kawachi, Ichiro; Braunstein, Sarah; Nash, Denis

2017-01-01

In the United States, research is limited on the mechanisms that link socioeconomic and structural factors to HIV diagnosis outcomes. We tested whether neighborhood income inequality, socioeconomic deprivation, and black racial concentration were associated with gender-specific rates of HIV in the advanced stages of AIDS (i.e., late HIV diagnosis). We then examined whether HIV testing prevalence and accessibility mediated any of the associations above. Neighborhoods with highest (relative to lowest) black racial concentration had higher relative risk of late HIV diagnosis among men (RR=1.86; 95%CI=1.15, 3.00) and women (RR=5.37; 95% CI=3.16, 10.43) independent of income inequality and socioeconomic deprivation. HIV testing prevalence and accessibility did not significantly mediate the associations above. Research should focus on mechanisms that link black racial concentration to HIV diagnosis outcomes. PMID:27770671

Evaluation of 9 rapid diagnostic tests for screening HIV infection, in Lomé, Togo.

PubMed

Dagnra, A Y; Dossim, S; Salou, M; Nyasenu, T; Ali-Edje, K; Ouro-Médeli, A; Doufan, M; Ehlan, A; Prince-David, M

2014-12-01

HIV rapid diagnostic tests (RDT) could be greatly contributive for a universal access to HIV diagnosis. However, according to the WHO, these tests need to be assessed before they can be used in routine. We assessed 9 RDT in routine clinical use between 2009 and 2013. The sensitivity and specificity observed for 7 tests were≥99% and≥98%, respectively: FIRST RESPONSE HIV1-2-O PMC Medical, India, GENIE Fast HIV 1-2 and GENIE™ III HIV(1/2) Bio-Rad, France, HIV TRI-DOT+Ag;J. Mitra, INDIA; SD BIOLINE HIV(1/2) 3.0 and SD BIOLINE HIV/SYPHILIS DUO Standard Diagnostic, Korea; and VIKIA HIV(1/2); BioMérieux, France. Two tests had performances inferior to WHO recommendations: INSTI HIV1/2 Biolytical Canada; sensitivity=97.8% and HEXAGON HIV HUMAN GmbH Germany; specificity=94.8%. Seven of 9 RDT had excellent performances. Nevertheless, they can be used only after training staff, and taking into account national algorithm for their safe use. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Evaluation of performance across the dynamic range of the Abbott RealTime HIV-1 assay as compared to VERSANT HIV-1 RNA 3.0 and AMPLICOR HIV-1 MONITOR v1.5 using serial dilutions of 39 group M and O viruses.

PubMed

Swanson, Priscilla; Huang, Shihai; Abravaya, Klara; de Mendoza, Carmen; Soriano, Vincent; Devare, Sushil G; Hackett, John

2007-04-01

Performance of the Abbott m2000 instrument system and the Abbott RealTime HIV-1 assay was evaluated using a panel of 37 group M (subtypes A-D, F, G, CRF01_AE, CRF02_AG and unique recombinant forms) and 2 group O virus isolates. Testing was performed on 273 sample dilutions and compared to VERSANT HIV-1 RNA 3.0 (bDNA) and AMPLICOR HIV-1 MONITOR v1.5 (Monitor v1.5) test results. RealTime HIV-1, bDNA, and Monitor v1.5 tests quantified 87%, 78%, and 81% of samples, respectively. RealTime HIV-1 detected an additional 31 samples at < 40 copies/mL. For group M, RealTime HIV-1 dilution profiles and viral loads were highly correlated with bDNA and Monitor v1.5 values; 87% and 89% of values were within 0.5 log(10) copies/mL. In contrast, the group O viruses were not detected by Monitor v1.5 and were substantially underquantified by approximately 2 log(10) copies/mL in bDNA relative to the RealTime HIV-1 assay. Sequence analysis revealed that RealTime HIV-1 primer/probe binding sites are highly conserved and exhibit fewer nucleotide mismatches relative to Monitor v1.5. The automated m2000 system and RealTime HIV-1 assay offer the advantages of efficient sample processing and throughput with reduced "hands-on" time while providing improved sensitivity, expanded dynamic range and reliable quantification of genetically diverse HIV-1 strains.

Zambian Peer Educators for HIV Self-Testing (ZEST) study: rationale and design of a cluster randomised trial of HIV self-testing among female sex workers in Zambia.

PubMed

Oldenburg, Catherine E; Ortblad, Katrina F; Chanda, Michael M; Mwanda, Kalasa; Nicodemus, Wendy; Sikaundi, Rebecca; Fullem, Andrew; Barresi, Leah G; Harling, Guy; Bärnighausen, Till

2017-04-20

HIV testing and knowledge of status are starting points for HIV treatment and prevention interventions. Among female sex workers (FSWs), HIV testing and status knowledge remain far from universal. HIV self-testing (HIVST) is an alternative to existing testing services for FSWs, but little evidence exists how it can be effectively and safely implemented. Here, we describe the rationale and design of a cluster randomised trial designed to inform implementation and scale-up of HIVST programmes for FSWs in Zambia. The Zambian Peer Educators for HIV Self-Testing (ZEST) study is a 3-arm cluster randomised trial taking place in 3 towns in Zambia. Participants (N=900) are eligible if they are women who have exchanged sex for money or goods in the previous 1 month, are HIV negative or status unknown, have not tested for HIV in the previous 3 months, and are at least 18 years old. Participants are recruited by peer educators working in their communities. Participants are randomised to 1 of 3 arms: (1) direct distribution (in which they receive an HIVST from the peer educator directly); (2) fixed distribution (in which they receive a coupon with which to collect the HIVST from a drug store or health post) or (3) standard of care (referral to existing HIV testing services only, without any offer of HIVST). Participants are followed at 1 and 4 months following distribution of the first HIVST. The primary end point is HIV testing in the past month measured at the 1-month and 4-month visits. This study was approved by the Institutional Review Boards at the Harvard T.H. Chan School of Public Health in Boston, USA and ERES Converge in Lusaka, Zambia. The findings of this trial will be presented at local, regional and international meetings and submitted to peer-reviewed journals for publication. Pre-results; NCT02827240. 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/.

HIV prevalence among high school learners - opportunities for school-based HIV testing programmes and sexual reproductive health services.

PubMed

Kharsany, Ayesha B M; Mlotshwa, Mukelisiwe; Frohlich, Janet A; Zuma, Nonhlanhla Yende; Samsunder, Natasha; Karim, Salim S Abdool; Karim, Quarraisha Abdool

2012-01-01

Young girls in sub Saharan Africa are reported to have higher rates of human immunodeficiency virus (HIV) infection compared to boys in the same age group. Knowledge of HIV status amongst high schools learners provides an important gateway to prevention and treatment services. This study aimed at determining the HIV prevalence and explored the feasibility of HIV testing among high school learners. Between September 2010 and February 2011, a linked, anonymous cross-sectional survey was conducted in two public sector high schools in the rural KwaZulu-Natal midlands. Following written informed consent, dried blood spot samples (DBS) were collected and tested for HIV. The overall and age-specific HIV prevalence were compared with select demographic variables. The HIV prevalence in learners aged 12 to 25 in school A was 4.7% (95% CI 2.8-6.5) compared to 2.5% (95% CI 1.6-3.5) in school B, (p=0.04). Whilst the HIV prevalence was similar for boys at 1.3% (95% CI 0-2.8) in school A and 1.7% (95% CI 0.5-2.8) in school B, the prevalence in girls was consistently higher and was 7.7% (95% CI 4.5-10.9) in school A and 3.2% (95% CI 1.8-4.6) in school B. The age-specific HIV prevalence in girls increased 1.5 to 2 fold for each two year age category, while for boys the prevalence was stable across all age groups. The high HIV prevalence in female learners underscores the importance of sexual reproductive health and schools-based HIV testing programs as an important gateway to prevention and treatment services.

HIV prevalence among high school learners - opportunities for schools-based HIV testing programmes and sexual reproductive health services.

PubMed

Kharsany, Ayesha B M; Mlotshwa, Mukelisiwe; Frohlich, Janet A; Yende Zuma, Nonhlanhla; Samsunder, Natasha; Abdool Karim, Salim S; Abdool Karim, Quarraisha

2012-03-22

Young girls in sub Saharan Africa are reported to have higher rates of human immunodeficiency virus (HIV) infection compared to boys in the same age group. Knowledge of HIV status amongst high schools learners provides an important gateway to prevention and treatment services. This study aimed at determining the HIV prevalence and explored the feasibility of HIV testing among high school learners. Between September 2010 and February 2011, a linked, anonymous cross-sectional survey was conducted in two public sector high schools in the rural KwaZulu-Natal midlands. Following written informed consent, dried blood spot samples (DBS) were collected and tested for HIV. The overall and age-specific HIV prevalence were compared with select demographic variables. The HIV prevalence in learners aged 12 to 25 in school A was 4.7% (95% CI 2.8-6.5) compared to 2.5% (95% CI 1.6-3.5) in school B, (p = 0.04). Whilst the HIV prevalence was similar for boys at 1.3% (95% CI 0-2.8) in school A and 1.7% (95% CI 0.5-2.8) in school B, the prevalence in girls was consistently higher and was 7.7% (95% CI 4.5-10.9) in school A and 3.2% (95% CI 1.8-4.6) in school B. The age-specific HIV prevalence in girls increased 1.5 to 2 fold for each two year age category, while for boys the prevalence was stable across all age groups. The high HIV prevalence in female learners underscores the importance of sexual reproductive health and schools-based HIV testing programs as an important gateway to prevention and treatment services.

Crowdsourcing HIV Test Promotion Videos: A Noninferiority Randomized Controlled Trial in China.

PubMed

Tang, Weiming; Han, Larry; Best, John; Zhang, Ye; Mollan, Katie; Kim, Julie; Liu, Fengying; Hudgens, Michael; Bayus, Barry; Terris-Prestholt, Fern; Galler, Sam; Yang, Ligang; Peeling, Rosanna; Volberding, Paul; Ma, Baoli; Xu, Huifang; Yang, Bin; Huang, Shujie; Fenton, Kevin; Wei, Chongyi; Tucker, Joseph D

2016-06-01

Crowdsourcing, the process of shifting individual tasks to a large group, may enhance human immunodeficiency virus (HIV) testing interventions. We conducted a noninferiority, randomized controlled trial to compare first-time HIV testing rates among men who have sex with men (MSM) and transgender individuals who received a crowdsourced or a health marketing HIV test promotion video. Seven hundred twenty-one MSM and transgender participants (≥16 years old, never before tested for HIV) were recruited through 3 Chinese MSM Web portals and randomly assigned to 1 of 2 videos. The crowdsourced video was developed using an open contest and formal transparent judging while the evidence-based health marketing video was designed by experts. Study objectives were to measure HIV test uptake within 3 weeks of watching either HIV test promotion video and cost per new HIV test and diagnosis. Overall, 624 of 721 (87%) participants from 31 provinces in 217 Chinese cities completed the study. HIV test uptake was similar between the crowdsourced arm (37% [114/307]) and the health marketing arm (35% [111/317]). The estimated difference between the interventions was 2.1% (95% confidence interval, -5.4% to 9.7%). Among those tested, 31% (69/225) reported a new HIV diagnosis. The crowdsourced intervention cost substantially less than the health marketing intervention per first-time HIV test (US$131 vs US$238 per person) and per new HIV diagnosis (US$415 vs US$799 per person). Our nationwide study demonstrates that crowdsourcing may be an effective tool for improving HIV testing messaging campaigns and could increase community engagement in health campaigns. NCT02248558. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Crowdsourcing HIV Test Promotion Videos: A Noninferiority Randomized Controlled Trial in China

PubMed Central

Tang, Weiming; Han, Larry; Best, John; Zhang, Ye; Mollan, Katie; Kim, Julie; Liu, Fengying; Hudgens, Michael; Bayus, Barry; Terris-Prestholt, Fern; Galler, Sam; Yang, Ligang; Peeling, Rosanna; Volberding, Paul; Ma, Baoli; Xu, Huifang; Yang, Bin; Huang, Shujie; Fenton, Kevin; Wei, Chongyi; Tucker, Joseph D.

2016-01-01

Background. Crowdsourcing, the process of shifting individual tasks to a large group, may enhance human immunodeficiency virus (HIV) testing interventions. We conducted a noninferiority, randomized controlled trial to compare first-time HIV testing rates among men who have sex with men (MSM) and transgender individuals who received a crowdsourced or a health marketing HIV test promotion video. Methods. Seven hundred twenty-one MSM and transgender participants (≥16 years old, never before tested for HIV) were recruited through 3 Chinese MSM Web portals and randomly assigned to 1 of 2 videos. The crowdsourced video was developed using an open contest and formal transparent judging while the evidence-based health marketing video was designed by experts. Study objectives were to measure HIV test uptake within 3 weeks of watching either HIV test promotion video and cost per new HIV test and diagnosis. Results. Overall, 624 of 721 (87%) participants from 31 provinces in 217 Chinese cities completed the study. HIV test uptake was similar between the crowdsourced arm (37% [114/307]) and the health marketing arm (35% [111/317]). The estimated difference between the interventions was 2.1% (95% confidence interval, −5.4% to 9.7%). Among those tested, 31% (69/225) reported a new HIV diagnosis. The crowdsourced intervention cost substantially less than the health marketing intervention per first-time HIV test (US$131 vs US$238 per person) and per new HIV diagnosis (US$415 vs US$799 per person). Conclusions. Our nationwide study demonstrates that crowdsourcing may be an effective tool for improving HIV testing messaging campaigns and could increase community engagement in health campaigns. Clinical Trials Registration. NCT02248558. PMID:27129465

Quantifying Ongoing HIV-1 Exposure in HIV-1–Serodiscordant Couples to Identify Individuals With Potential Host Resistance to HIV-1

PubMed Central

Mackelprang, Romel D.; Baeten, Jared M.; Donnell, Deborah; Celum, Connie; Farquhar, Carey; de Bruyn, Guy; Essex, Max; McElrath, M. Juliana; Nakku-Joloba, Edith; Lingappa, Jairam R.

2012-01-01

Background. Immunogenetic correlates of resistance to HIV-1 in HIV-1–exposed seronegative (HESN) individuals with consistently high exposure may inform HIV-1 prevention strategies. We developed a novel approach for quantifying HIV-1 exposure to identify individuals remaining HIV-1 uninfected despite persistent high exposure. Methods. We used longitudinal predictors of HIV-1 transmission in HIV-1 serodiscordant couples to score HIV-1 exposure and define HESN clusters with persistently high, low, and decreasing risk trajectories. The model was validated in an independent cohort of serodiscordant couples. We describe a statistical tool that can be applied to other HESN cohorts to identify individuals with high exposure to HIV-1. Results. HIV-1 exposure was best quantified by frequency of unprotected sex with, plasma HIV-1 RNA levels among, and presence of genital ulcer disease among HIV-1–infected partners and by age, pregnancy status, herpes simplex virus 2 serostatus, and male circumcision status among HESN participants. Overall, 14% of HESN individuals persistently had high HIV-1 exposure and exhibited a declining incidence of HIV-1 infection over time. Conclusions. A minority of HESN individuals from HIV-1–discordant couples had persistent high HIV-1 exposure over time. Decreasing incidence of infection in this group suggests these individuals were selected for resistance to HIV-1 and may be most appropriate for identifying biological correlates of natural host resistance to HIV-1 infection. PMID:22926009

Costs of voluntary rapid HIV testing and counseling in jails in 4 states--advancing HIV Prevention Demonstration Project, 2003-2006.

PubMed

Shrestha, Ram K; Sansom, Stephanie L; Richardson-Moore, April; French, P Tyler; Scalco, Beth; Lalota, Marlene; Llanas, Michelle; Stodola, James; Macgowan, Robin; Margolis, Andrew

2009-02-01

To assess the costs of rapid human immunodeficiency virus (HIV) testing and counseling to identify new diagnoses of HIV infection among jail inmates. We obtained program costs and testing outcomes from rapid HIV testing and counseling services provided in jails from March 1, 2004, through February 28, 2005, in Florida, Louisiana, New York, and Wisconsin. We obtained annual program delivery costs-fixed and variable costs-from each project area. We estimated the average cost of providing counseling and testing to HIV-negative and HIV-infected inmates and estimated the cost per newly diagnosed HIV infection. In the 4 project areas, 17,433 inmates (range, 2185-6463) were tested: HIV infection was diagnosed for 152 inmates (range, 4-81). The average cost of testing ranged from $29.46 to $44.98 for an HIV-negative inmate and from $71.37 to $137.72 for an HIV-infected inmate. The average cost per newly diagnosed HIV infection ranged from $2,451 to $25,288. Variable costs were 61% to 86% of total costs. The cost of identifying jail inmates with newly diagnosed HIV infection by using rapid HIV testing varied according to the prevalence of undiagnosed HIV infection among inmates tested in project areas. Variations in the cost of testing HIV-negative and HIV-infected inmates were because of the differences in wages, travel to the jails, and the amount of time spent on counseling and testing. Program managers can use these data to gauge the cost of initiating counseling and testing programs in jails or to streamline current programs.

Spillover effects of HIV testing policies: changes in HIV testing guidelines and HCV testing practices in drug treatment programs in the United States.

PubMed

Frimpong, Jemima A; D'Aunno, Thomas; Helleringer, Stéphane; Metsch, Lisa R

2016-07-29

To examine the extent to which state adoption of the Centers for Disease Control and Prevention (CDC) 2006 revisions to adult and adolescent HIV testing guidelines is associated with availability of other important prevention and medical services. We hypothesized that in states where the pretest counseling requirement for HIV testing was dropped from state legislation, substance use disorder treatment programs would have higher availability of HCV testing services than in states that had maintained this requirement. We analyzed a nationally representative sample of 383 opioid treatment programs from the 2005 and 2011 National Drug Abuse Treatment System Survey (NDATSS). Data were collected from program directors and clinical supervisors through telephone surveys. Multivariate logistic regression models were used to measure associations between state adoption of CDC recommended guidelines for HIV pretest counseling and availability of HCV testing services. The effects of HIV testing legislative changes on HCV testing practices varied by type of opioid treatment program. In states that had removed the requirement for HIV pretest counseling, buprenorphine-only programs were more likely to offer HCV testing to their patients. The positive spillover effect of HIV pretest counseling policies, however, did not extend to methadone programs and did not translate into increased availability of on-site HCV testing in either program type. Our findings highlight potential positive spillover effects of HIV testing policies on HCV testing practices. They also suggest that maximizing the benefits of HIV policies may require other initiatives, including resources and programmatic efforts that support systematic integration with other services and effective implementation.

Structural inequalities drive late HIV diagnosis: The role of black racial concentration, income inequality, socioeconomic deprivation, and HIV testing.

PubMed

Ransome, Yusuf; Kawachi, Ichiro; Braunstein, Sarah; Nash, Denis

2016-11-01

In the United States, research is limited on the mechanisms that link socioeconomic and structural factors to HIV diagnosis outcomes. We tested whether neighborhood income inequality, socioeconomic deprivation, and black racial concentration were associated with gender-specific rates of HIV in the advanced stages of AIDS (i.e., late HIV diagnosis). We then examined whether HIV testing prevalence and accessibility mediated any of the associations above. Neighborhoods with highest (relative to lowest) black racial concentration had higher relative risk of late HIV diagnosis among men (RR=1.86; 95%CI=1.15, 3.00) and women (RR=5.37; 95%CI=3.16, 10.43) independent of income inequality and socioeconomic deprivation. HIV testing prevalence and accessibility did not significantly mediate the associations above. Research should focus on mechanisms that link black racial concentration to HIV diagnosis outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

Efficacy of an HIV/AIDS and HIV testing video for Spanish-speaking Latinos in healthcare and non-healthcare settings

PubMed Central

Merchant, Roland C.; Clark, Melissa A.; Santelices, Claudia A.; Liu, Tao; Cortés, Dharma E.

2014-01-01

We assessed the efficacy of a Spanish-language HIV/AIDS and HIV testing video as a substitute for comparable orally-delivered information in healthcare and non-health care settings for Spanish-speakers regardless of health literacy level. In a non-inferiority clinical trial, Spanish-speaking Latinos from an emergency department, a clinic, and community-based organizations were randomly assigned to receive HIV/AIDS and HIV testing information orally or from a video. Comprehension of the information was measured using a questionnaire. Of the 150 participants, 39% met criteria for lower health literacy and 75% previously had been tested for HIV. Mean scores on the questionnaire for the video (20.4; 95% CI: 19.5∼21.3) and the orally-delivered information arms (20.6; 95% CI: 19.7∼21.5) were similar (Δ = -0.15; 95% CI: -1.4∼1.1). Mean scores among lower health literacy participants also were similar (18.3 (video) vs. 19.6 (in-person); p<0.30). This Spanish-language video is a viable substitute for orally-delivered HIV/AIDS and HIV testing information. PMID:25179540

The Impact of Homophobia and HIV Stigma on HIV Testing Uptake among Chinese Men Who Have Sex with Men: A Mediation Analysis

PubMed Central

Wei, Chongyi; Cheung, Doug H.; Yan, Hongjing; Li, Jianjun; Shi, Ling-en; Raymond, H. Fisher

2015-01-01

BACKGROUND Gay and HIV-related stigma and discrimination are major barriers to accessing HIV prevention services among MSM worldwide. We aimed to identify modifiable factors that mediate the relationships between gay and HIV-related stigma and discrimination and HIV testing uptake among Chinese MSM. METHODS We conducted a cross-sectional survey study of 523 HIV-uninfected or unknown MSM in Jiangsu Province, China between November 2013 and January 2014. Multivariable analyses were conducted to examine the associations among experienced homophobia, HIV stigma, and recent HIV testing. Causal mediation parametric analyses were conducted to assess whether depression and social norms mediated hypothesized associations. RESULTS Stronger subjective norms toward testing was associated with higher odds of recent HIV testing (AOR: 1.10, 95% CI: 1.01, 1.21) while increasing levels of depression and HIV stigma were both associated with lower odds of recent testing (AOR: 0.96, 95% CI: 0.92, 0.99; and AOR: 0.91, 95% CI: 0.84, 0.99, respectively). There was an indirect relationship (natural indirect effect) of experienced homophobia on recent testing (ORNIE: 0.96, 95% CI: 0.93, 0.98) mediated (35.0%) through depression. Furthermore, there was an indirect relationship of HIV stigma on recent testing (ORNIE: 0.98, 95% CI: 0.95, 0.99) mediated (19.2%) through subjective norms. CONCLUSIONS Depression and social norms are important mediators of HIV testing uptake among stigmatized Chinese MSM. Therefore, in addition to advocacy efforts and policies that address social-level stigma and discrimination, HIV prevention programs should also address mental health issues and incorporate community-based approaches to changing social norms toward HIV testing. PMID:26334742

Interval Since Last HIV Test for Men and Women with Recent Risk for HIV Infection - United States, 2006-2016.

PubMed

Pitasi, Marc A; Delaney, Kevin P; Oraka, Emeka; Bradley, Heather; DiNenno, Elizabeth A; Brooks, John T; Prejean, Joseph

2018-06-22

Since 2006, CDC has recommended routine screening of all persons aged 13-64 years for human immunodeficiency virus (HIV) and at least annual rescreening of persons at higher risk (1). However, national surveillance data indicate that many persons at higher risk for HIV infection are not screened annually, and delays in diagnosis persist (2). CDC analyzed 2006-2016 data from the General Social Survey (GSS)* and estimated that only 39.6% of noninstitutionalized U.S. adults had ever tested for HIV. Among persons ever tested, the estimated median interval since last test was 1,080 days or almost 3 years. Only 62.2% of persons who reported HIV-related risk behaviors in the past 12 months were ever tested for HIV, and the median interval since last test in this group was 512 days (1.4 years). The percentage of persons ever tested and the interval since last test remained largely unchanged during 2006-2016. More frequent screening of persons with ongoing HIV risk is needed to achieve full implementation of CDC's screening recommendations and to prevent new infections. Integration of routine screening as standard clinical practice through existing strategies, such as electronic medical record prompts (3), or through new, innovative strategies might be needed to increase repeat screening of persons with ongoing risk.

Knowledge and Concern about STIs/HIV and Sociodemographic Variables Associated with Getting Tested for HIV Among the General Population in Spain.

PubMed

Teva, Inmaculada; de Araújo, Ludgleydson Fernandes; de la Paz Bermúdez, María

2018-07-04

HIV testing is important in terms of prevention and treatment. However, HIV testing rates in the Spanish general population remains low. Therefore, HIV testing promotion constitutes a key issue. A high level of knowledge about HIV/AIDS is associated with having been tested for HIV. The general aim of this study was to determine the prevalence of people who had ever been tested for HIV in Spain. The sample consisted of 1,106 participants from the general population - 60.0% females and 40.0% males - aged between 17 and 55 years old. The assessment instruments were a questionnaire on sociodemographic data and HIV testing, a scale of knowledge about STIs and HIV/AIDS, and a scale of concern about STIs/HIV. Results showed that greater knowledge about STIs and HIV was associated with a greater likelihood of being tested for HIV (OR = .77; 95.0% CI = .73-.82; p < .05). In addition, higher concern about HIV/AIDS decreased the likelihood of not having been tested for HIV (OR = .87; 95.0% CI = .83-.92; p < .05). In fact, the higher participants concern about STIs was, the lower their likelihood of not having been tested for HIV was (OR = .87; 95.0% CI = .83-.91; p < .05). It is necessary to promote HIV testing in the general population as well as to consider their socio-demographic and psychological characteristics.

Diagnostic Value of Culture and Serological Tests in the Diagnosis of Histoplasmosis in HIV and non-HIV Colombian Patients

PubMed Central

Arango-Bustamante, Karen; Restrepo, Angela; Cano, Luz Elena; de Bedout, Catalina; Tobón, Angela Maria; González, Angel

2013-01-01

We determined the value of culture and serological tests used to diagnose histoplasmosis. The medical records of 391 histoplasmosis patients were analyzed. Diagnosis of the mycosis was assessed by culture, complement fixation, and immunodiffusion tests; 310 patients (79.5%) were male, and 184 patients (47.1%) were infected with human immunodeficiency virus (HIV). Positivity value for cultures was 35.7% (74/207), reactivity of serological tests was 95.2% (160/168), and a combination of both methodologies was 16.9% (35/207) for non-HIV patients. Positivity value for cultures was 75.0% (138/184), reactivity of serological tests was 92.4% (85/92), and a combination of both methodologies was 26.0% (48/184) for HIV/acquired immunodeficiency syndrome (AIDS) patients; 48.1% (102/212) of extrapulmonary samples from HIV/AIDS patients yielded positive cultures compared with 23.1% (49/212) in non-HIV patients. Lymphocyte counts made for 33.1% (61/184) of HIV/AIDS patients showed a trend to low CD4+ numbers and higher proportion of positive cultures. These results indicate that culture is the most reliable fungal diagnostic method for HIV/AIDS patients, and contrary to what is generally believed, serological assays are useful for diagnosing histoplasmosis in these patients. PMID:24043688

The Impact of Homophobia and HIV Stigma on HIV Testing Uptake Among Chinese Men Who Have Sex With Men: a Mediation Analysis.

PubMed

Wei, Chongyi; Cheung, Doug H; Yan, Hongjing; Li, Jianjun; Shi, Ling-en; Raymond, Henry F

2016-01-01

Gay and HIV-related stigma and discrimination are major barriers to accessing HIV prevention services among Men Who Have Sex with Men (MSM) worldwide. We aimed to identify modifiable factors that mediate the relationships between gay and HIV-related stigma and discrimination and HIV testing uptake among Chinese MSM. We conducted a cross-sectional survey study of 523 HIV-uninfected or unknown HIV status MSM in Jiangsu Province, China between November 2013 and January 2014. Multivariable analyses were conducted to examine the associations among experienced homophobia, HIV stigma, and recent HIV testing. Causal mediation parametric analyses were conducted to assess whether depression and social norms mediated hypothesized associations. Stronger subjective norms toward testing was associated with higher odds of recent HIV testing (adjusted odds ratio [AOR]: 1.10, 95% confidence interval [CI]: 1.01 to 1.21), whereas increasing levels of depression and HIV stigma were both associated with lower odds of recent testing (AOR: 0.96, 95% CI: 0.92 to 0.99; and AOR: 0.91, 95% CI: 0.84 to 0.99, respectively). There was an indirect relationship (natural indirect effect [NIE]) of experienced homophobia on recent testing (ORNIE: 0.96, 95% CI: 0.93 to 0.98) mediated (35.0%) through depression. Furthermore, there was an indirect relationship of HIV stigma on recent testing (ORNIE: 0.98, 95% CI: 0.95 to 0.99) mediated (19.2%) through subjective norms. Depression and social norms are important mediators of HIV testing uptake among stigmatized Chinese MSM. Therefore, in addition to advocacy efforts and policies that address social-level stigma and discrimination, HIV prevention programs should also address mental health issues and incorporate community-based approaches to changing social norms toward HIV testing.

Cost-effectiveness of HIV counseling and testing in US prisons.

PubMed

Varghese, B; Peterman, T A

2001-06-01

The prevalence of human immunodeficiency virus (HIV) in correctional facilities is much higher than in the general population. However, HIV prevention resources are limited, making it important to evaluate different prevention programs in prison settings. Our study presents the cost-effectiveness of offering HIV counseling and testing (CT) to soon-to-be-released inmates in US prisons. A decision model was used to estimate the costs and benefits (averted HIV cases) of HIV testing and counseling compared to no CT from a societal perspective. Model parameters were HIV prevalence among otherwise untested inmates (1%); acceptance of CT (50%); risk for HIV transmission from infected individuals (7%); risk of HIV acquisition for uninfected individuals (0.3%); and reduction of risk after counseling for those infected (25%) and uninfected (20%). Marginal costs of testing and counseling per person were used (no fixed costs). If infected, the cost was $78.17; if uninfected, it was $24.63. A lifetime treatment cost of $186,900 was used to estimate the benefits of prevented HIV infections. Sensitivity and threshold analysis were done to test the robustness of these parameters. Our baseline model shows that, compared to no CT, offering CT to 10,000 inmates detects 50 new or previously undiagnosed infections and averts 4 future cases of HIV at a cost of $125,000 to prison systems. However, this will save society over $550,000. Increase in HIV prevalence, risk of transmission, or effectiveness of counseling increased societal savings. As prevalence increases, focusing on HIV-infected inmates prevents additional future infections; however, when HIV prevalence is less than 5%, testing and counseling of both infected and uninfected inmates are important for HIV prevention.

Expanding HIV testing efforts in concentrated epidemic settings: a population-based survey from rural Vietnam.

PubMed

Pharris, Anastasia; Nguyen, Thi Kim Chuc; Tishelman, Carol; Brugha, Ruairí; Nguyen, Phuong Hoa; Thorson, Anna

2011-01-11

To improve HIV prevention and care programs, it is important to understand the uptake of HIV testing and to identify population segments in need of increased HIV testing. This is particularly crucial in countries with concentrated HIV epidemics, where HIV prevalence continues to rise in the general population. This study analyzes determinants of HIV testing in a rural Vietnamese population in order to identify potential access barriers and areas for promoting HIV testing services. A population-based cross-sectional survey of 1874 randomly sampled adults was linked to pregnancy, migration and economic cohort data from a demographic surveillance site (DSS). Multivariate logistic regression analysis was used to determine which factors were associated with having tested for HIV. The age-adjusted prevalence of ever-testing for HIV was 7.6%; however 79% of those who reported feeling at-risk of contracting HIV had never tested. In multivariate analysis, younger age (aOR 1.85, 95% CI 1.14-3.01), higher economic status (aOR 3.4, 95% CI 2.21-5.22), and semi-urban residence (aOR 2.37, 95% CI 1.53-3.66) were associated with having been tested for HIV. HIV testing rates did not differ between women of reproductive age who had recently been pregnant and those who had not. We found low testing uptake (6%) among pregnant women despite an existing prevention of mother-to-child HIV testing policy, and lower-than-expected testing among persons who felt that they were at-risk of HIV. Poverty and residence in a more geographically remote location were associated with less HIV testing. In addition to current HIV testing strategies focusing on high-risk groups, we recommend targeting HIV testing in concentrated HIV epidemic settings to focus on a scaled-up provision of antenatal testing. Additional recommendations include removing financial and geographic access barriers to client-initiated testing, and encouraging provider-initiated testing of those who believe that they are at-risk of

Missed opportunities for concurrent HIV-STD testing in an academic emergency department.

PubMed

Klein, Pamela W; Martin, Ian B K; Quinlivan, Evelyn B; Gay, Cynthia L; Leone, Peter A

2014-01-01

We evaluated emergency department (ED) provider adherence to guidelines for concurrent HIV-sexually transmitted disease (STD) testing within an expanded HIV testing program and assessed demographic and clinical factors associated with concurrent HIV-STD testing. We examined concurrent HIV-STD testing in a suburban academic ED with a targeted, expanded HIV testing program. Patients aged 18-64 years who were tested for syphilis, gonorrhea, or chlamydia in 2009 were evaluated for concurrent HIV testing. We analyzed demographic and clinical factors associated with concurrent HIV-STD testing using multivariate logistic regression with a robust variance estimator or, where applicable, exact logistic regression. Only 28.3% of patients tested for syphilis, 3.8% tested for gonorrhea, and 3.8% tested for chlamydia were concurrently tested for HIV during an ED visit. Concurrent HIV-syphilis testing was more likely among younger patients aged 25-34 years (adjusted odds ratio [AOR] = 0.36, 95% confidence interval [CI] 0.78, 2.10) and patients with STD-related chief complaints at triage (AOR=11.47, 95% CI 5.49, 25.06). Concurrent HIV-gonorrhea/chlamydia testing was more likely among men (gonorrhea: AOR=3.98, 95% CI 2.25, 7.02; chlamydia: AOR=3.25, 95% CI 1.80, 5.86) and less likely among patients with STD-related chief complaints at triage (gonorrhea: AOR=0.31, 95% CI 0.13, 0.82; chlamydia: AOR=0.21, 95% CI 0.09, 0.50). Concurrent HIV-STD testing in an academic ED remains low. Systematic interventions that remove the decision-making burden of ordering an HIV test from providers may increase HIV testing in this high-risk population of suspected STD patients.

HIV Testing, HIV Positivity, and Linkage and Referral Services in Correctional Facilities in the United States, 2009–2013

PubMed Central

Seth, Puja; Figueroa, Argelia; Wang, Guoshen; Reid, Laurie; Belcher, Lisa

2016-01-01

Background Because of health disparities, incarcerated persons are at higher risk for multiple health issues, including HIV. Correctional facilities have an opportunity to provide HIV services to an underserved population. This article describes Centers for Disease Control and Prevention (CDC)–funded HIV testing and service delivery in correctional facilities. Methods Data on HIV testing and service delivery were submitted to CDC by 61 health department jurisdictions in 2013. HIV testing, HIV positivity, receipt of test results, linkage, and referral services were described, and differences across demographic characteristics for linkage and referral services were assessed. Finally, trends were examined for HIV testing, HIV positivity, and linkage from 2009 to 2013. Results Of CDC-funded tests in 2013 among persons 18 years and older, 254,719 (7.9%) were conducted in correctional facilities. HIV positivity was 0.9%, and HIV positivity for newly diagnosed persons was 0.3%. Blacks accounted for the highest percentage of HIV-infected persons (1.3%) and newly diagnosed persons (0.5%). Only 37.9% of newly diagnosed persons were linked within 90 days; 67.5% were linked within any time frame; 49.7% were referred to partner services; and 45.2% were referred to HIV prevention services. There was a significant percent increase in HIV testing, overall HIV positivity, and linkage from 2009 to 2013. However, trends were stable for newly diagnosed persons. Conclusions Identification of newly diagnosed persons in correctional facilities has remained stable from 2009 to 2013. Correctional facilities seem to be reaching blacks, likely due to higher incarceration rates. The current findings indicate that improvements are needed in HIV testing strategies, service delivery during incarceration, and linkage to care postrelease. PMID:26462190

A defucosylated bispecific multivalent molecule exhibits broad HIV-1 neutralizing activity and enhanced ADCC against reactivated HIV-1 latently infected cells.

PubMed

Kong, Desheng; Wang, Yan; Ji, Ping; Li, Wei; Ying, Tianlei; Huang, Jinghe; Wang, Chen; Wu, Yanling; Wang, Yanping; Chen, Weizao; Hao, Yanling; Hong, Kunxue; Shao, Yiming; Dimitrov, Dimiter S; Jiang, Shibo; Ma, Liying

2018-05-11

Current treatments cannot completely eradicate HIV-1 owing to the presence of latently infected cells which harbor transcriptionally silent HIV-1. However, defucosylated antibodies can readily kill latently infected cells after their activation to express envelope glycoprotein (Env) through antibody-dependent cellular cytotoxicity (ADCC). We herein aimed to test a defucosylated bispecific multivalent molecule consisting of domain-antibody and single-domain CD4, LSEVh-LS-F, for its HIV-1 neutralizing activity and ADCC against the reactivated latently infected cells, compared with the non-defucosylated molecule LSEVh-LS. LSEVh-LS-F's neutralizing activity against a panel of newly characterized Chinese HIV-1 clinical isolates was assessed by using TZM-bl- and PBMC-based assays. LSEVh-LS-F-mediated ADCC in the presence of NK cells against cell lines that stably express Env proteins, HIV-1-infected cells and LRA-reactivated HIV-1 latent cells, was measured using a lactate dehydrogenase (LDH) cytotoxicity assay or flow cytometry. LSEVh-LS-F and LSEVh-LS were equally effective in neutralized infection of all HIV-1 isolates tested with IC50 and IC90 values 3∼4-fold lower than those of VRC01. LSEVh-LS-F was more effective in NK-mediated killing of HIV-1 Env-expressing cell lines, HIV-1-infected cells, latency reactivation agents-reactivated ACH2 cells, and reactivated latently infected resting CD4 T cell line as well as resting CD4 T lymphocytes isolated from patients receiving highly active anti-retroviral therapy (HAART). LSEVh-LS-F exhibits broad HIV-1 neutralizing activity and enhanced ADCC against HIV-1-infected cells, reactivated latently infected cell lines and primary CD4 T cells, thus being a promising candidate therapeutic for eradicating the HIV-1 reservoir.

Knowledge of HIV/AIDS and predictors of uptake of HIV counseling and testing among undergraduate students of a privately owned university in Nigeria.

PubMed

Abiodun, Olumide; Sotunsa, John; Ani, Franklin; Jaiyesimi, Ebunoluwa

2014-09-12

The spread of HIV/AIDS among the reproductive age group particularly young adults is a major public health concern in Nigeria. Lifestyles of students on university campuses put them at increased risk of contracting the HIV. The aim of this study was to assess the level of HIV/AIDS knowledge and to investigate the factors that were correlated with the uptake of and willingness to take up HIV counseling and testing. A cross-sectional study of 1,250 university students selected by 2-stage random sampling technique using self-administered questionnaire. The participants consisted of 57.7% females and 42.3% males with ages ranging from 15 to 32 years and a mean of 19.13 ± 2.32 years. The awareness of HIV was universal. The knowledge about HIV/AIDS was very high with a mean score of 8.18 ± 1.60 out of 10; and 97.1% of participants having good knowledge of HIV/AIDS. The major source of HIV/AIDS information was the mass media. There was a significant difference in knowledge of HIV/AIDS by gender where male students had better knowledge about HIV/AIDS than females [t (1225) = 3.179, p = 0.002]. While 95% of the participants knew where to get an HIV test done, only 30.4% had tested for HIV within the six months preceding the study. However, 72.2% of them were willing to test for HIV. There was no significant association between demographic characteristics and having tested for HIV in the preceding six months but there was significant association between willingness to have an HIV test and the participants' age groups, sex, marital status and their knowledge of HIV/AIDS. Participants who were aged 21 years and above and had good knowledge about HIV were more willing to take an HIV test. Females were more willing to take an HIV test than males. The participants' knowledge about HIV /AIDS was quite good, the willingness to have HIV test done was high and the knowledge of a place where test can be done was nearly universal yet HIV testing was low. Innovative

Rapid HIV testing at gay pride events to reach previously untested MSM: U.S., 2009-2010.

PubMed

Mdodo, Rennatus; Thomas, Peter E; Walker, Anissa; Chavez, Pollyanna; Ethridge, Steven; Oraka, Emeka; Sutton, Madeline Y

2014-01-01

We offered rapid HIV testing at social events frequented by young men who have sex with men (MSM), a group disproportionately affected by the HIV epidemic. We tested 1,312 MSM; of those MSM, 1,072 (81.7%) reported HIV testing history. Of those reporting HIV testing history, 550 (51.3%) were non-Hispanic black and 404 (37.7%) were aged <25 years. One hundred twenty-eight (11.9%) had never tested for HIV; 77 (7.2%) were preliminarily positive, with 15 (19.5%) being first-time testers. Factors associated with no previous HIV test included young age (13-24 years) (adjusted odds ratio [AOR] = 3.5, 95% confidence interval [CI] 1.9, 6.5) and non-Hispanic black (AOR=3.2, 95% CI 1.6, 6.4) or Hispanic (AOR=2.8, 95% CI 1.2, 6.3) race/ethnicity. HIV testing at Gay Pride events reaches young, previously untested MSM. This venue-based HIV testing approach at nonclinical sociocultural events is an additional strategy for HIV prevention goals to increase the number of people aware of their HIV infection with subsequent linkage to HIV care.

Investigating Barriers in HIV-Testing Oncology Patients: The IBITOP Study, Phase I.

PubMed

Merz, Laurent; Zimmermann, Stefan; Peters, Solange; Cavassini, Matthias; Darling, Katharine E A

2016-10-01

Although the prevalence of non-AIDS-defining cancers (non-ADCs) among people living with HIV is rising, we observed HIV testing rates below 5% at our oncology center, against a regional HIV prevalence of 0.2%-0.4%. We performed the Investigating Barriers in HIV-Testing Oncology Patients (IBITOP) study among oncology physicians and patients. Between July 1 and October 31, 2013, patients of unknown HIV status newly diagnosed with solid-organ non-ADCs referred to Lausanne University Hospital Oncology Service, Switzerland, were offered free HIV testing as part of their oncology work-up. The primary endpoints were (a) physician willingness to offer and patient acceptance of HIV testing and (b) physicians' reasons for not offering testing. Of 239 patients of unknown HIV status with a new non-ADC diagnosis, 43 (18%) were offered HIV testing, of whom 4 declined (acceptance rate: 39 of 43; 91%). Except for 21 patients tested prior to oncology consultation, 175 patients (of 239; 73%) were not offered testing. Testing rate declined among patients who were >70 years old (12% versus 30%; p = .04); no non-European patients were tested. Physicians gave reasons for not testing in 16% of cases, the main reason being patient follow-up elsewhere (10 patients; 5.7%). HIV testing during the IBITOP study increased the HIV testing rate to 18%. Although the IBITOP study increased HIV testing rates, most patients were not tested. Testing was low or nonexistent among individuals at risk of late HIV presentation (older patients and migrants). Barriers to testing appear to be physician-led, because patient acceptance of testing offered was very high (91%). In November 2013, the Swiss HIV testing recommendations were updated to propose testing in cancer patients. Phase II of the IBITOP study is examining the effect of these recommendations on HIV testing rates and focusing on physician-led testing barriers. Patients of unknown HIV status newly diagnosed with solid-organ non

Investigating Barriers in HIV-Testing Oncology Patients: The IBITOP Study, Phase I

PubMed Central

Merz, Laurent; Zimmermann, Stefan; Peters, Solange; Cavassini, Matthias

2016-01-01

Background. Although the prevalence of non-AIDS-defining cancers (non-ADCs) among people living with HIV is rising, we observed HIV testing rates below 5% at our oncology center, against a regional HIV prevalence of 0.2%–0.4%. We performed the Investigating Barriers in HIV-Testing Oncology Patients (IBITOP) study among oncology physicians and patients. Methods. Between July 1 and October 31, 2013, patients of unknown HIV status newly diagnosed with solid-organ non-ADCs referred to Lausanne University Hospital Oncology Service, Switzerland, were offered free HIV testing as part of their oncology work-up. The primary endpoints were (a) physician willingness to offer and patient acceptance of HIV testing and (b) physicians’ reasons for not offering testing. Results. Of 239 patients of unknown HIV status with a new non-ADC diagnosis, 43 (18%) were offered HIV testing, of whom 4 declined (acceptance rate: 39 of 43; 91%). Except for 21 patients tested prior to oncology consultation, 175 patients (of 239; 73%) were not offered testing. Testing rate declined among patients who were >70 years old (12% versus 30%; p = .04); no non-European patients were tested. Physicians gave reasons for not testing in 16% of cases, the main reason being patient follow-up elsewhere (10 patients; 5.7%). HIV testing during the IBITOP study increased the HIV testing rate to 18%. Conclusion. Although the IBITOP study increased HIV testing rates, most patients were not tested. Testing was low or nonexistent among individuals at risk of late HIV presentation (older patients and migrants). Barriers to testing appear to be physician-led, because patient acceptance of testing offered was very high (91%). In November 2013, the Swiss HIV testing recommendations were updated to propose testing in cancer patients. Phase II of the IBITOP study is examining the effect of these recommendations on HIV testing rates and focusing on physician-led testing barriers. Implications for Practice: Patients of

[Analysis on willingness to pay for HIV antibody saliva rapid test and related factors].

PubMed

Li, Junjie; Huo, Junli; Cui, Wenqing; Zhang, Xiujie; Hu, Yi; Su, Xingfang; Zhang, Wanyue; Li, Youfang; Shi, Yuhua; Jia, Manhong

2015-02-01

To understand the willingness to pay for HIV antibody saliva rapid test and its influential factors among people seeking counsel and HIV test, STD clinic patients, university students, migrant people, female sex workers (FSWs), men who have sex with men (MSM) and injecting drug users (IDUs). An anonymous questionnaire survey was conducted among 511 subjects in the 7 groups selected by different sampling methods, and 509 valid questionnaires were collected. The majority of subjects were males (54.8%) and aged 20-29 years (41.5%). Among the subjects, 60.3% had education level of high school or above, 55.4% were unmarried, 37.3% were unemployed, 73.3% had monthly expenditure <2 000 Yuan RMB, 44.2% had received HIV test, 28.3% knew HIV saliva test, 21.0% were willing to receive HIV saliva test, 2.0% had received HIV saliva test, only 1.0% had bought HIV test kit for self-test, and 84.1% were willing to pay for HIV antibody saliva rapid test. Univariate logistic regression analysis indicated that subject group, age, education level, employment status, monthly expenditure level, HIV test experience and willingness to receive HIV saliva test were correlated statistically with willingness to pay for HIV antibody saliva rapid test. Multivariate logistic regression analysis showed that subject group and monthly expenditure level were statistically correlated with willingness to pay for HIV antibody saliva rapid test. The willingness to pay for HIV antibody saliva rapid test and acceptable price of HIV antibody saliva rapid test varied in different areas and populations. Different populations may have different willingness to pay for HIV antibody saliva rapid test;the affordability of the test could influence the willingness to pay for the test.

Implementation and Operational Research: Cost and Efficiency of a Hybrid Mobile Multidisease Testing Approach With High HIV Testing Coverage in East Africa.

PubMed

Chang, Wei; Chamie, Gabriel; Mwai, Daniel; Clark, Tamara D; Thirumurthy, Harsha; Charlebois, Edwin D; Petersen, Maya; Kabami, Jane; Ssemmondo, Emmanuel; Kadede, Kevin; Kwarisiima, Dalsone; Sang, Norton; Bukusi, Elizabeth A; Cohen, Craig R; Kamya, Moses; Havlir, Diane V; Kahn, James G

2016-11-01

In 2013-2014, we achieved 89% adult HIV testing coverage using a hybrid testing approach in 32 communities in Uganda and Kenya (SEARCH: NCT01864603). To inform scalability, we sought to determine: (1) overall cost and efficiency of this approach; and (2) costs associated with point-of-care (POC) CD4 testing, multidisease services, and community mobilization. We applied microcosting methods to estimate costs of population-wide HIV testing in 12 SEARCH trial communities. Main intervention components of the hybrid approach are census, multidisease community health campaigns (CHC), and home-based testing for CHC nonattendees. POC CD4 tests were provided for all HIV-infected participants. Data were extracted from expenditure records, activity registers, staff interviews, and time and motion logs. The mean cost per adult tested for HIV was $20.5 (range: $17.1-$32.1) (2014 US$), including a POC CD4 test at $16 per HIV+ person identified. Cost per adult tested for HIV was $13.8 at CHC vs. $31.7 by home-based testing. The cost per HIV+ adult identified was $231 ($87-$1245), with variability due mainly to HIV prevalence among persons tested (ie, HIV positivity rate). The marginal costs of multidisease testing at CHCs were $1.16/person for hypertension and diabetes, and $0.90 for malaria. Community mobilization constituted 15.3% of total costs. The hybrid testing approach achieved very high HIV testing coverage, with POC CD4, at costs similar to previously reported mobile, home-based, or venue-based HIV testing approaches in sub-Saharan Africa. By leveraging HIV infrastructure, multidisease services were offered at low marginal costs.

HIV prevalence among high school learners - opportunities for schools-based HIV testing programmes and sexual reproductive health services

PubMed Central

2012-01-01

Background Young girls in sub Saharan Africa are reported to have higher rates of human immunodeficiency virus (HIV) infection compared to boys in the same age group. Knowledge of HIV status amongst high schools learners provides an important gateway to prevention and treatment services. This study aimed at determining the HIV prevalence and explored the feasibility of HIV testing among high school learners. Methods Between September 2010 and February 2011, a linked, anonymous cross-sectional survey was conducted in two public sector high schools in the rural KwaZulu-Natal midlands. Following written informed consent, dried blood spot samples (DBS) were collected and tested for HIV. The overall and age-specific HIV prevalence were compared with select demographic variables. Results The HIV prevalence in learners aged 12 to 25 in school A was 4.7% (95% CI 2.8-6.5) compared to 2.5% (95% CI 1.6-3.5) in school B, (p = 0.04). Whilst the HIV prevalence was similar for boys at 1.3% (95% CI 0-2.8) in school A and 1.7% (95% CI 0.5-2.8) in school B, the prevalence in girls was consistently higher and was 7.7% (95% CI 4.5-10.9) in school A and 3.2% (95% CI 1.8-4.6) in school B. The age-specific HIV prevalence in girls increased 1.5 to 2 fold for each two year age category, while for boys the prevalence was stable across all age groups. Conclusions The high HIV prevalence in female learners underscores the importance of sexual reproductive health and schools-based HIV testing programs as an important gateway to prevention and treatment services. PMID:22439635

Optimizing Infant HIV Diagnosis in Resource-Limited Settings: Modeling the Impact of HIV DNA PCR Testing at Birth.

PubMed

Chiu, Alexander; Modi, Surbhi; Rivadeneira, Emilia D; Koumans, Emilia H

2016-12-01

Early antiretroviral therapy (ART) initiation in HIV-infected infants significantly improves survival but is often delayed in resource-limited settings. Adding HIV testing of infants at birth to the current recommendation of testing at age 4-6 weeks may improve testing rates and decrease time to ART initiation. We modeled the benefit of adding HIV testing at birth to the current 6-week testing algorithm. Microsoft Excel was used to create a decision-tree model of the care continuum for the estimated 1,400,000 HIV-infected women and their infants in sub-Saharan Africa in 2012. The model assumed average published rates for facility births (42.9%), prevention of mother-to-child HIV transmission utilization (63%), mother-to-child-transmission rates based on prevention of mother-to-child HIV transmission regimen (5%-40%), return of test results (41%), enrollment in HIV care (52%), and ART initiation (54%). We conducted sensitivity analyses to model the impact of key variables and applied the model to specific country examples. Adding HIV testing at birth would increase the number of infants on ART by 204% by age 18 months. The greatest increase is seen in early ART initiations (543% by age 3 months). The increase would lead to a corresponding increase in survival at 12 months of age, with 5108 fewer infant deaths (44,550, versus 49,658). Adding HIV testing at birth has the potential to improve the number and timing of ART initiation of HIV-infected infants, leading to a decrease in infant mortality. Using this model, countries should investigate a combination of HIV testing at birth and during the early infant period.

Expanded HIV Testing Strategy Leveraging the Electronic Medical Record Uncovers Undiagnosed Infection Among Hospitalized Patients.

PubMed

Felsen, Uriel R; Cunningham, Chinazo O; Heo, Moonseong; Futterman, Donna C; Weiss, Jeffrey M; Zingman, Barry S

2017-05-01

Routine HIV testing of hospitalized patients is recommended, but few strategies to expand testing in the hospital setting have been described. We assessed the impact of an electronic medical record (EMR) prompt on HIV testing for hospitalized patients. We performed a pre-post study at 3 hospitals in the Bronx, NY. We compared the proportion of admissions of patients 21-64 years old with an HIV test performed, characteristics of patients tested, and rate of new HIV diagnoses made by screening while an EMR prompt recommending HIV testing was inactive vs. active. The prompt appeared for patients with no previous HIV test or a high-risk diagnosis after their last HIV test. Among 36,610 admissions while the prompt was inactive, 9.5% had an HIV test performed. Among 18,943 admissions while the prompt was active, 21.8% had an HIV test performed. Admission while the prompt was active was associated with increased HIV testing among total admissions [adjusted odds ratio (aOR) 2.78, 95% confidence interval (CI): 2.62 to 2.96], those without a previous HIV test (aOR 4.03, 95% CI: 3.70 to 4.40), and those with a previous negative test (aOR 1.52, 95% CI: 1.37 to 1.68) (P < 0.0001 for all). Although the prompt was active, testing increased across all patient characteristics. New HIV diagnoses made by screening increased from 8.2/100,000 admissions to 37.0/100,000 admissions while the prompt was inactive and active, respectively (OR 4.51 95% CI: 1.17 to 17.45, P = 0.03). An EMR prompt for hospitalized patients was associated with a large increase in HIV testing, a diversification of patients tested, and an increase in diagnoses made by screening.

HIV care-seeking behaviour after HIV self-testing among men who have sex with men in Beijing, China: a cross-sectional study.

PubMed

Ren, Xian-Long; Wu, Zun-You; Mi, Guo-Dong; McGoogan, Jennifer M; Rou, Ke-Ming; Zhao, Yan; Zhang, Nanci

2017-06-28

Men who have sex with men (MSM) has become the group with the fastest growing HIV epidemic in China. Since many Chinese MSM are conducting HIV self-testing, we aimed to determine the rate of HIV care seeking after self-testing, examine characteristics of "seekers" compared to "non-seekers," and explore factors associated with HIV care-seeking behaviour. A cross-sectional study design was used and an online survey was conducted in Beijing, China in 2016, among users of a popular Chinese gay networking smart phone application. Chi-square test was used to compare characteristics of those who sought HIV care ("seekers") and those who did not ("non-seekers"). Univariate and multivariate logistic regression analyses were conducted to assess factors associated with HIV care seeking. Among 21,785 screened, 2383 participants (10.9%) were included in the study. A total of 380 participants (15.9%) reported seeking HIV care after HIV self-testing while 2003 (84.1%) did not. Lack of knowledge of the "window period" (adjusted odds ratio [AOR] = 0.68, 95% confidence interval [95% CI] = 0.47-0.97, P = 0.04) was associated with reduced odds of seeking HIV care, while lower monthly income (AOR = 1.29, 95% CI = 1.03-1.62, P = 0.03) and obtaining HIV self-testing kits from health facilities (AOR = 2.40, 95% CI = 1.81-3.17, P < 0.001), and non-governmental organizations (AOR = 2.44, 95% CI = 1.79-3.34, P < 0.001) was associated with increased odds of seeking HIV care. Among those who sought HIV care, a large majority (92.4%) had non-reactive HIV self-testing results. Only 29 out of 265 with reactive, uncertain, or unknown results sought HIV care. We found a very low rate of HIV care seeking among our sample of urban Chinese MSM. The observation that most with reactive, uncertain, or unknown results did not seek HIV care is a cause for concern. These people should be paid more attention and helped to enter the care cascade. Our findings highlight that

The Cobas AmpliPrep/Cobas TaqMan HCV test, version 2.0, real-time PCR assay accurately quantifies hepatitis C virus genotype 4 RNA.

PubMed

Chevaliez, Stéphane; Bouvier-Alias, Magali; Rodriguez, Christophe; Soulier, Alexandre; Poveda, Jean-Dominique; Pawlotsky, Jean-Michel

2013-04-01

Accurate hepatitis C virus (HCV) RNA quantification is mandatory for the management of chronic hepatitis C therapy. The first-generation Cobas AmpliPrep/Cobas TaqMan HCV test (CAP/CTM HCV) underestimated HCV RNA levels by >1-log10 international units/ml in a number of patients infected with HCV genotype 4 and occasionally failed to detect it. The aim of this study was to evaluate the ability of the Cobas AmpliPrep/Cobas TaqMan HCV test, version 2.0 (CAP/CTM HCV v2.0), to accurately quantify HCV RNA in a large series of patients infected with different subtypes of HCV genotype 4. Group A comprised 122 patients with chronic HCV genotype 4 infection, and group B comprised 4 patients with HCV genotype 4 in whom HCV RNA was undetectable using the CAP/CTM HCV. Each specimen was tested with the third-generation branched DNA (bDNA) assay, CAP/CTM HCV, and CAP/CTM HCV v2.0. The HCV RNA level was lower in CAP/CTM HCV than in bDNA in 76.2% of cases, regardless of the HCV genotype 4 subtype. In contrast, the correlation between bDNA and CAP/CTM HCV v2.0 values was excellent. CAP/CTM HCV v2.0 accurately quantified HCV RNA levels in the presence of an A-to-T substitution at position 165 alone or combined with a G-to-A substitution at position 145 of the 5' untranslated region of HCV genome. In conclusion, CAP/CTM HCV v2.0 accurately quantifies HCV RNA in genotype 4 clinical specimens, regardless of the subtype, and can be confidently used in clinical trials and clinical practice with this genotype.

Centers for Disease Control and Prevention Funding for HIV Testing Associated With Higher State Percentage of Persons Tested.

PubMed

Hayek, Samah; Dietz, Patricia M; Van Handel, Michelle; Zhang, Jun; Shrestha, Ram K; Huang, Ya-Lin A; Wan, Choi; Mermin, Jonathan

2015-01-01

To assess the association between state per capita allocations of Centers for Disease Control and Prevention (CDC) funding for HIV testing and the percentage of persons tested for HIV. We examined data from 2 sources: 2011 Behavioral Risk Factor Surveillance System and 2010-2011 State HIV Budget Allocations Reports. Behavioral Risk Factor Surveillance System data were used to estimate the percentage of persons aged 18 to 64 years who had reported testing for HIV in the last 2 years in the United States by state. State HIV Budget Allocations Reports were used to calculate the state mean annual per capita allocations for CDC-funded HIV testing reported by state and local health departments in the United States. The association between the state fixed-effect per capita allocations for CDC-funded HIV testing and self-reported HIV testing in the last 2 years among persons aged 18 to 64 years was assessed with a hierarchical logistic regression model adjusting for individual-level characteristics. The percentage of persons tested for HIV in the last 2 years. In 2011, 18.7% (95% confidence interval = 18.4-19.0) of persons reported being tested for HIV in last 2 years (state range, 9.7%-28.2%). During 2010-2011, the state mean annual per capita allocation for CDC-funded HIV testing was $0.34 (state range, $0.04-$1.04). A $0.30 increase in per capita allocation for CDC-funded HIV testing was associated with an increase of 2.4 percentage points (14.0% vs 16.4%) in the percentage of persons tested for HIV per state. Providing HIV testing resources to health departments was associated with an increased percentage of state residents tested for HIV.

The role of social support on HIV testing and treatment adherence: A qualitative study of HIV-infected refugees in southwestern Uganda.

PubMed

Rouhani, Shada A; O'Laughlin, Kelli N; Faustin, Zikama M; Tsai, Alexander C; Kasozi, Julius; Ware, Norma C

2017-08-01

Little is known about the factors that encourage or discourage refugees to test for HIV, or to access and adhere to HIV care. In non-refugee populations, social support has been shown to influence HIV testing and utilisation of services. The present study enrolled HIV-infected refugees on anti-retroviral therapy (ART) in Uganda, who participated in qualitative interviews on HIV testing, treatment, and adherence. Interviews were analysed for themes about four types of social support: emotional, informational, instrumental, and appraisal support. A total of 61 interviews were analysed. Four roles for these types of social support were identified: (1) informational support encouraged refugees to test for HIV; (2) emotional support helped refugees cope with a diagnosis of HIV; (3) instrumental support facilitated adherence to ART and (4) after diagnosis, HIV-infected refugees provided informational and emotional support to encourage other refugees to test for HIV. These results suggest that social support influences HIV testing and treatment among refugees. Future interventions should capitalise on social support within a refugee settlement to facilitate testing and treatment.

HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.

PubMed

Chanda, Michael M; Ortblad, Katrina F; Mwale, Magdalene; Chongo, Steven; Kanchele, Catherine; Kamungoma, Nyambe; Fullem, Andrew; Dunn, Caitlin; Barresi, Leah G; Harling, Guy; Bärnighausen, Till; Oldenburg, Catherine E

2017-11-01

HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia. Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use

Comparative evaluation of new TaqMan real-time assays for the detection of hepatitis A virus.

PubMed

Houde, Alain; Guévremont, Evelyne; Poitras, Elyse; Leblanc, Danielle; Ward, Pierre; Simard, Carole; Trottier, Yvon-Louis

2007-03-01

Three novel real-time TaqMan RT-PCR assays targeting the 5'-UTR, the viral protease and the viral polymerase regions of the hepatitis A virus (HAV) were developed, evaluated and compared against a new published 5'-UTR TaqMan assay (JN) and a widely used conventional RT-PCR assay (HAVc). All conventional RT-PCR (HAV, SH-Prot and SH-Poly systems) and TaqMan (SH-Prot, SH-Poly, JN and SH-5U systems) assays evaluated were consistent for the detection of the three different HAV strains (HM-175, HAS-15 and LSH/S) used and reproducible for both RNA duplicates with the exception of two reproducibility discrepancies observed with both 5'-UTR real-time systems (JN and SH-5U). Limits of detection for conventional HAV, SH-Prot and SH-Poly RT-PCR systems were found to be equivalent when tested with serially diluted suspensions of the HM-175 strain. Although the four real-time RT-PCR TaqMan assays evaluated herein produced similar and consistent quantification data down to the level of one genomic equivalent copy with their respectively cloned amplicons, significant and important differences were observed for the detection of HAV genomic RNA. Results showed that the new real-time TaqMan SH-Poly and SH-Prot primer and probe systems were more consistent and sensitive by 5 logs as compared to both 5'-UTR designs (JN and SH-5U) used for the detection of HAV genomic RNA as well as for the detection in cell culture by cytopathic effect. Considering their higher analytical sensitivity, the proposed SH-Poly and SH-Prot amplification systems could therefore represent valuable tools for the detection of HAV in clinical, environmental and food samples.

Evaluating community pharmacists' HIV testing knowledge: A cross-sectional survey.

PubMed

Pineda, Larry J; Mercier, Renee-Claude; Dilworth, Thomas; Iandiorio, Michelle; Rankin, Shannon; Jakeman, Bernadette

2015-01-01

To assess community pharmacists' knowledge of human immunodeficiency virus (HIV), antiretroviral therapy, and new in-home oral fluid HIV test. A cross-sectional questionnaire administered to pharmacists, student pharmacists, and technicians before an education program at the New Mexico Pharmacists Association 2013 Mid-Winter Meeting in Albuquerque, NM. The main outcome measure was community pharmacists' correct response rate of 75% or more. Overall survey response rate of attendees was 89% (173/194 attendees). Among them 87 participants were community pharmacists; 87% of community pharmacists responded correctly when asked how HIV antiretroviral medications work and 84.3% correctly identified known sources of HIV infection. The 75% predefined adequate knowledge threshold was not met on any HIV screening or in-home HIV test knowledge items. Only 65.1% of community pharmacists correctly identified the minimum number of antiretroviral drugs that should be included in an ideal HIV treatment regimen. The only variable that positively influenced pharmacists' knowledge was age. An inverse relationship between pharmacist age and HIV knowledge was observed among study participants. Community pharmacists from urban and rural areas in New Mexico possessed adequate basic HIV knowledge, but did not demonstrate adequate HIV screening or in-home HIV test knowledge. Future educational interventions aimed at improving pharmacist knowledge in this area are warranted.

Comparison of Simplexa HSV 1 & 2 PCR with culture, immunofluorescence, and laboratory-developed TaqMan PCR for detection of herpes simplex virus in swab specimens.

PubMed

Gitman, Melissa R; Ferguson, David; Landry, Marie L

2013-11-01

The Simplexa HSV 1 & 2 direct PCR assay was compared with conventional cell culture, cytospin-enhanced direct fluorescent antibody (DFA), and a laboratory-developed real-time TaqMan PCR (LDT HSV PCR) using extracted nucleic acid for the detection of herpes simplex virus (HSV) in dermal, genital, mouth, ocular, and other swab samples. One hundred seventy-one swabs were tested prospectively, and 58 were positive for HSV (34 HSV-1 and 24 HSV-2). Cytospin-DFA detected 50 (86.2%), conventional cell culture 51 (87.9%), Simplexa direct 55 (94.8%), and LDT HSV PCR 57 (98.3%) of 58 true positives. Simplexa direct detected more positives than DFA and culture, but the differences were not significant (P = 0.0736 and P = 0.3711, respectively, by the McNemar test). Samples that were positive by all methods (n = 48) were strong positives (LDT cycle threshold [CT] value, 14.4 to 26.1). One strongly positive sample was falsely negative by LDT HSV PCR due to a failure of TaqMan probe binding. Three samples falsely negative by Simplexa direct had high CT values by LDT HSV PCR (LDT CT, 35.8 to 38.2). Omission of the DNA extraction step by Simplexa direct led to a drop in sensitivity compared to the sensitivity of LDT HSV PCR using extracted samples (94.8% versus 98.3%, respectively), but the difference was not significant (P = 0.6171). Simplexa HSV 1 & 2 direct PCR was the most expensive but required the least training of the assays used, had the lowest hands-on time and fastest assay time (75 min, versus 3 h by LDT HSV PCR), and provided the HSV type.

Monitoring the quality of HIV-1 viral load testing through a proficiency testing program using dried tube specimens in resource-limited settings.

PubMed

Nguyen, Shon; Ramos, Artur; Chang, Joy; Li, Bin; Shanmugam, Vedapuri; Boeras, Debrah; Nkengasong, John N; Yang, Chunfu; Ellenberger, Dennis

2015-04-01

HIV-1 viral load (VL) levels are used for monitoring disease progression and antiretroviral therapy outcomes in HIV-infected patients. To assess the performance of laboratories conducting HIV-1 VL testing in resource-limited settings, the U.S. Centers for Disease Control and Prevention implemented a voluntary, free-of-charge, external quality assurance program using dried tube specimens (DTSs). Between 2010 and 2012, DTS proficiency testing (PT) panels consisting of 5 specimens were distributed at ambient temperature to participants. The results from the participants (n≥6) using the same assay were grouped, analyzed, and graded as acceptable within a group mean±3 standard deviations. Mean proficiency scores were calculated by dividing the combined PT scores by the number of testing cycles using a linear regression model. Between 2010 and 2012, the number of participants enrolled increased from 32 in 16 countries to 114 in 44 countries. A total of 78.2% of the participants reported results using 10 different VL assays. The rates of reporting of acceptable results by the participants were 96.6% for the Abbott assay, 96.3% for the Roche Cobas assay, 94.5% for the Roche Amplicor assay, 93.0% for the Biocentric assay, and 89.3% for the NucliSens assay. The overall mean proficiency scores improved over time (P=0.024). DTSs are a good alternative specimen type to plasma specimens for VL PT programs, as they do not require cold chain transportation and can be used on PCR-based assays. Our data suggest that the CDC HIV-1 VL PT program using DTSs positively impacts the testing performance of the participants, which might translate into better and more accurate VL testing services for patients. Copyright © 2015, American Society for Microbiology. All Rights Reserved.