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Title: Estimation of HIV Incidence in a Large, Community-Based, Randomized Clinical Trial: NIMH Project Accept (HIV Prevention Trials Network 043)
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
Keywords: Agricultural and Biological Sciences
Biochemistry, Genetics and Molecular Biology
Issue Date: 11-Jul-2013
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 NCT00203749.
ISSN: 19326203
Appears in Collections:CMUL: Journal Articles

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