title: Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043).
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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00203749.
authors.affiliation: Laboratory of Immunoregulation, NIAID, NIH, Baltimore, Maryland, United States of America.
authors.forename: Oliver
authors.initials: O
authors.lastname: Laeyendecker
authors.forename: Estelle
authors.initials: E
authors.lastname: Piwowar-Manning
authors.forename: Agnes
authors.initials: A
authors.lastname: Fiamma
authors.forename: Michal
authors.initials: M
authors.lastname: Kulich
authors.forename: Deborah
authors.initials: D
authors.lastname: Donnell
authors.forename: Deb
authors.initials: D
authors.lastname: Bassuk
authors.forename: Caroline E
authors.initials: CE
authors.lastname: Mullis
authors.forename: Craig
authors.initials: C
authors.lastname: Chin
authors.forename: Priscilla
authors.initials: P
authors.lastname: Swanson
authors.forename: John
authors.initials: J
authors.lastname: Hackett
authors.forename: William
authors.initials: W
authors.lastname: Clarke
authors.forename: Mark
authors.initials: M
authors.lastname: Marzinke
authors.forename: Greg
authors.initials: G
authors.lastname: Szekeres
authors.forename: Glenda
authors.initials: G
authors.lastname: Gray
authors.forename: Linda
authors.initials: L
authors.lastname: Richter
authors.forename: Michel W
authors.initials: MW
authors.lastname: Alexandre
authors.forename: Suwat
authors.initials: S
authors.lastname: Chariyalertsak
authors.forename: Alfred
authors.initials: A
authors.lastname: Chingono
authors.forename: David D
authors.initials: DD
authors.lastname: Celentano
authors.forename: Stephen F
authors.initials: SF
authors.lastname: Morin
authors.forename: Michael
authors.initials: M
authors.lastname: Sweat
authors.forename: Thomas
authors.initials: T
authors.lastname: Coates
authors.forename: Susan H
authors.initials: SH
authors.lastname: Eshleman
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control; D000293:Adolescent; D000328:Adult; D000349:Africa / Q000453:epidemiology; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count / Q000379:methods; D003430:Cross-Sectional Studies; D015658:HIV Infections / Q000188:drug therapy / Q000453:epidemiology* / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D009315:National Institute of Mental Health (U.S.); D015995:Prevalence; D013785:Thailand / Q000453:epidemiology; D014481:United States; D019562:Viral Load / Q000379:methods; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents