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

• Main Authors: 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: Journal
• Published: 2018
• Online Access: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84880063002&origin=inward; http://cmuir.cmu.ac.th/jspui/handle/6653943832/47816
• Institution: Chiang Mai University

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.