Partners PrEP Program (PPP)

University of Washington

Status: Completed

Conditions: HIV Infections

Treatments: Drug: ART; Drug: PrEP

Study type: Observational

Funder types: Other

Identifiers

NCT03586128

STUDY00000320

Details and patient eligibility

About

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.

Enrollment: 1,381 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Otherwise not eligible based on the above inclusion criteria

Trial design

1,381 participants in 1 patient group

HIV serodiscordant couples

Treatment:

Drug: ART

Drug: PrEP