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.
Integrated ART and PrEP Delivery for HIV Prevention
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.
Corresponding Organization : University of Washington
Other organizations : Kenya Medical Research Institute, Makerere University, Joint Clinical Research Centre, Massachusetts General Hospital, Jomo Kenyatta University of Agriculture and Technology, Johns Hopkins Medicine, Johns Hopkins University, Harvard Global Health Institute, Harvard University, Fred Hutch Cancer Center
Protocol cited in 25 other protocols
Variable analysis
- Time-limited PrEP
- Targeted counseling
- Brief adherence promotion
- Frequency of follow-up
- Evaluation of the integrated ART and PrEP delivery strategy
- HIV-1 incidence
- 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
- Plasma HIV-1 RNA level in the HIV-1-infected partner
- Positive controls: None specified
- Negative controls: None specified
Annotations
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