Partners PrEP Program
- Conditions
- HIV Infections
- Interventions
- Drug: PrEPDrug: ART
- Registration Number
- NCT03586128
- Lead Sponsor
- University of Washington
- Brief Summary
Through close collaboration with the Ugandan Ministry of Health, the investigators plan to provide PrEP for HIV-negative members of HIV serodiscordant couples by launching PrEP delivery within 12 public ART clinics in Kampala, Uganda. Intervention delivery will be launched in a staggered fashion among clinics through a stepped wedge cluster randomized trial providing a rigorous research opportunity to measure the effect of the intervention on PrEP and ART initiation and adherence. To measure these outcomes using clinic records and biomarkers, the program will enroll approximately 1440 HIV serodiscordant couples. Additionally, the program will collect qualitative and quantitative data to determine if PrEP-taking is a modeled behavior that facilitates ART use and characterize the way that PrEP and ART use interact within couples and estimate the programmatic costs of the integrated PrEP and ART strategy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1381
For both members of the couple
- Age ≥18 years
- Able and willing to provide informed consent
- Sexually active with each other
- Willing to engage with the clinic system as a couple
For HIV-positive members of the couples (index participants)
- HIV-positive, according to national HIV testing algorithm
- Recent diagnosis as a member in an HIV serodiscordant couple
- Not currently enrolled in an HIV treatment clinical trial
For HIV-negative members of the couples (partner participants)
- HIV-negative, according to national HIV testing algorithm
- Recent diagnosis as a member in an HIV serodiscordant couple
- Not currently enrolled in an HIV treatment clinical trial
- Not currently using PrEP
- Eligible for PrEP, according to WHO or Ugandan national guidelines
- Otherwise not eligible based on the above inclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HIV serodiscordant couples PrEP - HIV serodiscordant couples ART -
- Primary Outcome Measures
Name Time Method Number of HIV-positive members of a discordant partnership who initiate ART Up to 24 months Measure ART initiation of the HIV-positive member of the couple
HIV viral load suppression of HIV-positive members of a discordant partnership Up to 24 months ART adherence by measuring HIV viral load of the HIV-positive member of the couple
Number of HIV-negative members of a discordant partnership who initiate PrEP Up to 24 months Measure PrEP initiation of the HIV-negative member of the couple
PrEP adherence of HIV-negative members of a discordant partnership Up to 24 months Measure PrEP adherence, among HIV-negative members of a discordant partnership who initiated PrEP, by self-report and tenofovir drug level testing.
- Secondary Outcome Measures
Name Time Method PrEP-taking as a modeled behavior Up to 24 months Measure the degree to which PrEP-taking behavior is modeled by HIV-negative partners and the degree to which it is witnessed by HIV-positive partners using questionnaires developed for this purpose.
Facilitators and barriers to use of ART and PrEP Up to 24 months Mixed methods assessment of how integrated PrEP and ART is 1) used among couples and 2) implemented by health care providers using qualitative interviews and questionnaires. These data will be aggregated to understand the facilitators and barriers to use of ART and PrEP.
Programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples Up to 24 months Conduct micro-costing, cost-effectiveness, and budget impact analyses to estimate the programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples.
Trial Locations
- Locations (1)
Makerere University
🇺🇬Kampala, Uganda