title: Characteristics of HIV-1 serodiscordant couples enrolled in a clinical trial of antiretroviral pre-exposure prophylaxis for HIV-1 prevention.
abstract: BACKGROUND
  Stable heterosexual HIV-1 serodiscordant couples in Africa have high HIV-1 transmission rates and are a critical population for evaluation of new HIV-1 prevention strategies. The Partners PrEP Study is a randomized, double-blind, placebo-controlled trial of tenofovir and emtricitabine-tenofovir pre-exposure prophylaxis to decrease HIV-1 acquisition within heterosexual HIV-1 serodiscordant couples. We describe the trial design and characteristics of the study cohort.
  
  
  METHODS
  HIV-1 serodiscordant couples, in which the HIV-1 infected partner did not meet national guidelines for initiation of antiretroviral therapy, were enrolled at 9 research sites in Kenya and Uganda. The HIV-1 susceptible partner was randomized to daily oral tenofovir, emtricitabine-tenofovir, or matching placebo with monthly follow-up for 24-36 months.
  
  
  RESULTS
  From July 2008 to November 2010, 7920 HIV-1 serodiscordant couples were screened and 4758 enrolled. For 62% (2966/4758) of enrolled couples, the HIV-1 susceptible partner was male. Median age was 33 years for HIV-1 susceptible and HIV-1 infected partners [IQR (28-40) and (26-39) respectively]. Most couples (98%) were married, with a median duration of partnership of 7.0 years (IQR 3.0-14.0) and recent knowledge of their serodiscordant status [median 0.4 years (IQR 0.1-2.0)]. During the month prior to enrollment, couples reported a median of 4 sex acts (IQR 2-8); 27% reported unprotected sex and 14% of male and 1% of female HIV-1 susceptible partners reported sex with outside partners. Among HIV-1 infected partners, the median plasma HIV-1 level was 3.94 log(10) copies/mL (IQR 3.31-4.53) and median CD4 count was 496 cells/µL (IQR 375-662); the majority (64%) had WHO stage 1 HIV-1 disease.
  
  
  CONCLUSIONS
  Couples at high risk of HIV-1 transmission were rapidly recruited into the Partners PrEP Study, the largest efficacy trial of oral PrEP. (ClinicalTrials.gov NCT00557245).
authors: Department of Global Health, University of Washington, Seattle, Washington, United States of America.
authors: Andrew
authors: A
authors: Mujugira
authors: Jared M
authors: JM
authors: Baeten
authors: Deborah
authors: D
authors: Donnell
authors: Patrick
authors: P
authors: Ndase
authors: Nelly R
authors: NR
authors: Mugo
authors: Linda
authors: L
authors: Barnes
authors: James D
authors: JD
authors: Campbell
authors: Jonathan
authors: J
authors: Wangisi
authors: Jordan W
authors: JW
authors: Tappero
authors: Elizabeth
authors: E
authors: Bukusi
authors: Craig R
authors: CR
authors: Cohen
authors: Elly
authors: E
authors: Katabira
authors: Allan
authors: A
authors: Ronald
authors: Elioda
authors: E
authors: Tumwesigye
authors: Edwin
authors: E
authors: Were
authors: Kenneth H
authors: KH
authors: Fife
authors: James
authors: J
authors: Kiarie
authors: Carey
authors: C
authors: Farquhar
authors: Grace
authors: G
authors: John-Stewart
authors: Lara
authors: L
authors: Kidoguchi
authors: Dana
authors: D
authors: Panteleeff
authors: Meighan
authors: M
authors: Krows
authors: Heena
authors: H
authors: Shah
authors: Jennifer
authors: J
authors: Revall
authors: Susan
authors: S
authors: Morrison
authors: Lisa
authors: L
authors: Ondrejcek
authors: Charlotte
authors: C
authors: Ingram
authors: Robert W
authors: RW
authors: Coombs
authors: Jairam R
authors: JR
authors: Lingappa
authors: Connie
authors: C
authors: Celum
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000494:pharmacology; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000494:pharmacology*; D015331:Cohort Studies; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000494:pharmacology; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D018023:HIV Seronegativity / Q000187:drug effects*; D006679:HIV Seropositivity / Q000635:transmission*; D015497:HIV-1 / Q000187:drug effects*; D020010:Heterosexuality; D006801:Humans; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000494:pharmacology; D012309:Risk-Taking; D012725:Sexual Behavior / Q000706:statistics & numerical data; D000068698:Tenofovir; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine