Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043).

Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043).

<h4>Background</h4>National Institute of Mental Health Project Accept (HIV Prevention Trials Network [HPTN] 043) is a large, Phase III, community-randomized, HIV prevention trial conducted in 48 matched communities in Africa and Thailand. The study intervention included enhanced communit...

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Auteurs principaux: Oliver Laeyendecker, Estelle Piwowar-Manning, Agnes Fiamma, Michal Kulich, Deborah Donnell, Deb Bassuk, Caroline E Mullis, Craig Chin, Priscilla Swanson, John Hackett, William Clarke, Mark Marzinke, Greg Szekeres, Glenda Gray, Linda Richter, Michel W Alexandre, Suwat Chariyalertsak, Alfred Chingono, David D Celentano, Stephen F Morin, Michael Sweat, Thomas Coates, Susan H Eshleman
Format: article
Langue:EN
Publié: Public Library of Science (PLoS) 2013
Sujets:
Medicine
R
Science
Q
Accès en ligne:https://doaj.org/article/fe8f9227f4ab405085832b59c3b4eef8
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Résumé:<h4>Background</h4>National Institute of Mental Health Project Accept (HIV Prevention Trials Network [HPTN] 043) is a large, Phase III, community-randomized, HIV prevention trial conducted in 48 matched communities in Africa and Thailand. The study intervention included enhanced community-based voluntary counseling and testing. The primary endpoint was HIV incidence, assessed in a single, cross-sectional, post-intervention survey of >50,000 participants.<h4>Methods</h4>HIV rapid tests were performed in-country. HIV status was confirmed at a central laboratory in the United States. HIV incidence was estimated using a multi-assay algorithm (MAA) that included the BED capture immunoassay, an avidity assay, CD4 cell count, and HIV viral load.<h4>Results</h4>Data from Thailand was not used in the endpoint analysis because HIV prevalence was low. Overall, 7,361 HIV infections were identified (4 acute, 3 early, and 7,354 established infections). Samples from established infections were analyzed using the MAA; 467 MAA positive samples were identified; 29 of those samples were excluded because they contained antiretroviral drugs. HIV prevalence was 16.5% (range at study sites: 5.93% to 30.8%). HIV incidence was 1.60% (range at study sites: 0.78% to 3.90%).<h4>Conclusions</h4>In this community-randomized trial, a MAA was used to estimate HIV incidence in a single, cross-sectional post-intervention survey. Results from this analysis were subsequently used to compare HIV incidence in the control and intervention communities.<h4>Trial registration</h4>ClinicalTrials.gov NCT00203749.

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