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

Details

• Alternative Title:
  PLoS One
• Personal Author:
  Laeyendecker, Oliver ; Piwowar-Manning, Estelle ; Fiamma, Agnes ; Kulich, Michal ; Donnell, Deborah ; Bassuk, Deb ; Mullis, Caroline E. ; Chin, Craig ; Swanson, Priscilla ; Hackett, John ; Clarke, William ; Marzinke, Mark ; Szekeres, Greg ; Gray, Glenda ; Richter, Linda ; Alexandre, Michel W. ; Chariyalertsak, Suwat ; Chingono, Alfred ; Celentano, David D. ; Morin, Stephen F. ; Sweat, Michael ; Coates, Thomas ; Eshleman, Susan H.
  More +
• Description:
  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
• Subjects:
  • Research Article
  • Biology
  • Computer Science
  • Mathematics
  • Medicine
• Source:
  PLoS One. 2013; 8(7).
• Document Type:
  Journal Article
• Volume:
  8
• Issue:
  7
• Download URL:
  https://stacks.cdc.gov/view/cdc/19602/cdc_19602_DS1.pdf
• File Type:
  [PDF - 412.12 KB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:b3498050f1cf17ba6ce99025a2422b2740d8f0fb96fb2cca8ab4d7a9af53ac9f