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

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 and Susan H Eshleman

PLOS ONE, 2013, vol. 8, issue 7, 1-9

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

Date: 2013
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0068349

DOI: 10.1371/journal.pone.0068349

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