TY - JOUR
T1 - Estimation of HIV Incidence in a Large, Community-Based, Randomized Clinical Trial
T2 - NIMH Project Accept (HIV Prevention Trials Network 043)
AU - Laeyendecker, Oliver
AU - Piwowar-Manning, Estelle
AU - Fiamma, Agnes
AU - Kulich, Michal
AU - Donnell, Deborah
AU - Bassuk, Deb
AU - Mullis, Caroline E.
AU - Chin, Craig
AU - Swanson, Priscilla
AU - Hackett, John
AU - Clarke, William
AU - Marzinke, Mark
AU - Szekeres, Greg
AU - Gray, Glenda
AU - Richter, Linda
AU - Alexandre, Michel W.
AU - Chariyalertsak, Suwat
AU - Chingono, Alfred
AU - Celentano, David D.
AU - Morin, Stephen F.
AU - Sweat, Michael
AU - Coates, Thomas
AU - Eshleman, Susan H.
PY - 2013/7/11
Y1 - 2013/7/11
N2 - 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.
AB - 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.
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U2 - 10.1371/journal.pone.0068349
DO - 10.1371/journal.pone.0068349
M3 - Article
C2 - 23874597
AN - SCOPUS:84880063002
VL - 8
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 7
M1 - e68349
ER -