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Characteristics of HIV-1 serodiscordant couples enrolled in a clinical trial of antiretroviral pre-exposure prophylaxis for HIV-1 prevention.

  • Author(s): Mujugira, Andrew
  • Baeten, Jared M
  • Donnell, Deborah
  • Ndase, Patrick
  • Mugo, Nelly R
  • Barnes, Linda
  • Campbell, James D
  • Wangisi, Jonathan
  • Tappero, Jordan W
  • Bukusi, Elizabeth
  • Cohen, Craig R
  • Katabira, Elly
  • Ronald, Allan
  • Tumwesigye, Elioda
  • Were, Edwin
  • Fife, Kenneth H
  • Kiarie, James
  • Farquhar, Carey
  • John-Stewart, Grace
  • Kidoguchi, Lara
  • Panteleeff, Dana
  • Krows, Meighan
  • Shah, Heena
  • Revall, Jennifer
  • Morrison, Susan
  • Ondrejcek, Lisa
  • Ingram, Charlotte
  • Coombs, Robert W
  • Lingappa, Jairam R
  • Celum, Connie
  • Partners PrEP Study Team
  • et al.
Abstract

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.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.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.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).

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