Beginning November 5, 2012, heterosexual HIV-1-serodiscordant couples were enrolled in a prospective, open-label, implementation science-driven study of ART and PrEP for HIV-1 prevention (the Partners Demonstration Project, Clinicaltrials.gov NCT02775929). The overall goal was to evaluate a scalable, integrated, and pragmatic delivery approach for ART and time-limited PrEP, in combination with targeted counseling, brief adherence promotion, and frequency of follow-up designed to reflect approaches suitable for public health settings in East Africa. A sample size of 1,000 couples was chosen to provide a robust evaluation of the integrated ART and PrEP delivery strategy, across a diversity of clinical research sites. Couples were recruited using community outreach methods by four clinical care and research sites in Kenya (Kisumu and Thika) and Uganda (Kabwohe and Kampala). Recruitment strategies included working with voluntary counseling and testing centers, antenatal clinics and programs for prevention of mother-to-child HIV-1 transmission, referrals from HIV-1 care providers, including those performing testing of partners of known HIV-1 infected individuals engaged in HIV-1 care, and community promotion activities for couples’ testing.
Eligible couples were ≥18 y of age, sexually active, and intending to remain as a couple. At the time of enrollment, HIV-1 seronegative partners had never used PrEP, had normal renal function (defined as an estimated creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation), were not infected with hepatitis B virus, and were not pregnant or breastfeeding. At enrollment, HIV-1 seropositive partners were not using ART; so as not to have the research process detract from immediate clinical need for ART, couples were excluded if the HIV-1-infected partner had WHO stage III or IV HIV-1 disease conditions. In addition, in order to recruit a population at higher risk for HIV-1 infection, a validated, empiric risk scoring tool was applied, and couples with a score ≥5 (out of a maximum of 12) were eligible for enrollment; in prior studies of HIV-1-serodiscordant couples, a score ≥5 was associated with an HIV-1 incidence in excess of 3%–4% per year [11 (link)]. For calculating the score, characteristics assessed at the time of screening included age of the HIV-1-uninfected partner, number of children in the partnership, circumcision status of HIV-1-uninfected men, whether the couple was cohabitating, whether the couple had had sex unprotected by a condom in the prior month, and the plasma HIV-1 RNA level in the HIV-1-infected partner. There was no obligation for couples to commit to initiating ART or PrEP as part of study eligibility. Ineligible couples were referred for standard of care HIV-1 prevention and treatment services.
Eligible couples were ≥18 y of age, sexually active, and intending to remain as a couple. At the time of enrollment, HIV-1 seronegative partners had never used PrEP, had normal renal function (defined as an estimated creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation), were not infected with hepatitis B virus, and were not pregnant or breastfeeding. At enrollment, HIV-1 seropositive partners were not using ART; so as not to have the research process detract from immediate clinical need for ART, couples were excluded if the HIV-1-infected partner had WHO stage III or IV HIV-1 disease conditions. In addition, in order to recruit a population at higher risk for HIV-1 infection, a validated, empiric risk scoring tool was applied, and couples with a score ≥5 (out of a maximum of 12) were eligible for enrollment; in prior studies of HIV-1-serodiscordant couples, a score ≥5 was associated with an HIV-1 incidence in excess of 3%–4% per year [11 (link)]. For calculating the score, characteristics assessed at the time of screening included age of the HIV-1-uninfected partner, number of children in the partnership, circumcision status of HIV-1-uninfected men, whether the couple was cohabitating, whether the couple had had sex unprotected by a condom in the prior month, and the plasma HIV-1 RNA level in the HIV-1-infected partner. There was no obligation for couples to commit to initiating ART or PrEP as part of study eligibility. Ineligible couples were referred for standard of care HIV-1 prevention and treatment services.
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