Trial reportHIV clinical trials
Failure to identify HIV-infected individuals in a clinical trial using a single HIV rapid test for screening.
Trial report in HIV clinical trials. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- Influence of Combination Antiretroviral Therapy on HIV-1 Serological Responses and Their Implications: A Systematic Review and Meta-Analysis.Frontiers in immunology · 2022Pooled it
- Detection of HIV-1 Transmission Clusters from Dried Blood Spots within a Universal Test-and-Treat Trial in East Africa.Viruses · 2022Trial
- Brief Report: Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays.Journal of acquired immune deficiency syndromes (1999) · 2017Trial
- Assessing the Effectiveness of the Human Immunodeficiency Virus Point-of-Care Proficiency Testing Scheme: Analysis of the Data From 2021 to 2022 in South Africa.Health science reports · 2026Article
- Update on HIV prevention and management in pregnancy Number 10 - 2025.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2025Article
- Article
- Does antiretroviral therapy use affect the accuracy of HIV rapid diagnostic assays? Experience from a demographic health and surveillance site in rural South Africa.Diagnostic microbiology and infectious disease · 2020Article
- Rapid Serological Tests Ineffectively Screen for HIV Exposure in HIV-Positive Infants.Journal of acquired immune deficiency syndromes (1999) · 2018Article
- The validity of self-reported antiretroviral use in persons living with HIV: a population-based study.AIDS (London, England) · 2018Article
- Sources of racial disparities in HIV prevalence in men who have sex with men in Atlanta, GA, USA: a modelling study.The lancet. HIV · 2017Article
- Evaluation of Performance of Two Rapid Tests for Detection of HIV-1 and -2 in High- and Low-Prevalence Populations in Nigeria.Journal of clinical microbiology · 2015Article
- Determination of HIV Status in African Adults With Discordant HIV Rapid Tests.Journal of acquired immune deficiency syndromes (1999) · 2015Article
- Performance of the fourth-generation Bio-Rad GS HIV Combo Ag/Ab enzyme immunoassay for diagnosis of HIV infection in Southern Africa.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2015Article
- Low-level Viremia early in HIV infection.Journal of acquired immune deficiency syndromes (1999) · 2014Article
- Infrequent HIV testing and late HIV diagnosis are common among a cohort of black men who have sex with men in 6 US cities.Journal of acquired immune deficiency syndromes (1999) · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 11 institutions in 1 country.
Funding
Abstract
backgroundIn the HIV Prevention Trials Network (HPTN) 061 study, 8 (2.3%) of 348 HIV-infected participants identified as HIV uninfected at study enrollment using a single HIV rapid test for screening were found to be HIV infected after additional testing.
objectivesTo evaluate the performance of different HIV assays for detection of HIV infection in HPTN 061 participants with missed infection and individuals with viral suppression.
methodsPlasma samples from 8 HPTN 061 participants, 17 elite controllers, and 101 individuals on antiretroviral treatment (ART) were tested for HIV with 3 rapid tests, 2 laboratory-based immunoassays, and a Western blot assay. The HPTN 061 samples were also tested with 2 HIV RNA assays and an antiretroviral drug assay.
resultsOf the 8 HPTN 061 participants with missed infection, 1 was an elite controller, 1 was taking ART, 2 were missed because of testing or clerical errors, 1 had recent HIV infection (identified using a multi-assay algorithm), and 3 had acute HIV infection. Two (1.7%) of 118 individuals with viral suppression (both taking ART) had at least 1 false-negative test.
conclusionsIn clinical trials, HIV infections can be missed for a variety of reasons. Using more than one assay to screen for HIV infection may reduce the number of missed infections.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.