Trial reportClinical and vaccine immunology : CVI2011
Performance of a rapid and simple HIV testing algorithm in a multicenter phase III microbicide clinical trial.
Trial report in Clinical and vaccine immunology : CVI, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.
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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
25 citing papers in PubMed, 1 synthesis or guideline pooled it.
- To err is human, to correct is public health: a systematic review examining poor quality testing and misdiagnosis of HIV status.Journal of the International AIDS Society · 2017Pooled it
- Repeat HIV testing of individuals with discrepant HIV self-test results in Central Uganda.AIDS research and therapy · 2019Trial
- Identification of misdiagnosed HIV clients in an Early Access to ART for All implementation study in Swaziland.Journal of the International AIDS Society · 2017Trial
- Trial
- HIV surveillance in a large, community-based study: results from the pilot study of Project Accept (HIV Prevention Trials Network 043).BMC infectious diseases · 2011Trial
- The Performance of the Current Algorithm of HIV Diagnosis.Iranian journal of public health · 2024Article
- Assessment of HIV Rapid Test Kits Inventory Management Practice and Challenges in Public Health Facilities of Addis Ababa, Ethiopia.Integrated pharmacy research & practice · 2022Article
- Rapid point-of-care (POC) testing for Hepatitis C antibodies in a very high prevalence setting: persons injecting drugs in Tallinn, Estonia.Harm reduction journal · 2021Article
- False reactive HIV-1 diagnostic test results in an individual from Kenya on multiple testing platforms-A case report.IDCases · 2021Article
- Prevalence and risk factors associated with HIV-1 infection among people who inject drugs in Dar es Salaam, Tanzania: a sign of successful intervention?Harm reduction journal · 2020Article
- Article
- Designing HIV Testing Algorithms Based on 2015 WHO Guidelines Using Data from Six Sites in Sub-Saharan Africa.Journal of clinical microbiology · 2017Article
- A public health approach to addressing and preventing misdiagnosis in the scale-up of HIV rapid testing programmes.Journal of the International AIDS Society · 2017Article
- HIV misdiagnosis in sub-Saharan Africa: performance of diagnostic algorithms at six testing sites.Journal of the International AIDS Society · 2017Review
- Alert, but not alarmed - a comment on "Towards more accurate HIV testing in sub-Saharan Africa: a multi-site evaluation of HIV RDTs and risk factors for false positives (Kosack et al. 2017)".Journal of the International AIDS Society · 2017Article
- Spectrum of false positivity for the fourth generation human immunodeficiency virus diagnostic tests.AIDS research and therapy · 2016Article
- Initial Accuracy of HIV Rapid Test Kits Stored in Suboptimal Conditions and Validity of Delayed Reading of Oral Fluid Tests.PloS one · 2016Article
- Explaining racial disparities in HIV incidence in black and white men who have sex with men in Atlanta, GA: a prospective observational cohort study.Annals of epidemiology · 2015Observational
- The Effect of High Rates of Bacterial Sexually Transmitted Infections on HIV Incidence in a Cohort of Black and White Men Who Have Sex with Men in Atlanta, Georgia.AIDS research and human retroviruses · 2015Article
- Understanding racial HIV/STI disparities in black and white men who have sex with men: a multilevel approach.PloS one · 2014Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A multitest sequential algorithm based on rapid and simple (R/S) assays was applied for the diagnosis of HIV infection among participants in a phase 3 microbicide effectiveness trial. HIV testing was performed on finger-prick blood samples obtained from patients after their enrollment in the trial. The specimens were tested in a serial procedure using three different rapid tests (Determine HIV-1/2 [Abbott], SD Bioline HIV-1/2 3.0 [Standard Diagnostics], and Uni-Gold HIV [Trinity Biotech]). In the event of discordant results between the Determine HIV-1/2 and SD Bioline HIV-1/2 3.0 tests, the third assay (Uni-Gold HIV) determined the final outcome. When the final outcome was positive, a second specimen was collected and tested with the same algorithm, only if a positive result was obtained with this sample the participant was informed of her positive serostatus. A total of 5,734 postenrollment specimens obtained from 1,398 women were tested. Forty-six women tested positive according to the testing algorithm performed on the first collected specimen. Confirmatory testing results obtained at the ITM confirmed that 42 women were truly infected. Two of four initial false positives tested negative upon analysis of a second blood specimen. The other two tested false positive twice using specimens collected the same day. A high percentage of specimens reactive with the Determine HIV-1/2 assay was only observed at the study site in Kampala. This result did not appear to be associated with pregnancy or malaria infection. We conclude that HIV testing algorithms, including only R/S assays, are suitable for use in clinical trials, provided that adequate quality assurance procedures are in place.
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