An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will be introduced into 24 public HIV-1 care centers in central and western Kenya according to national guidelines using a stepped wedge design, stratified by region.

PrEP as a bridge to ART strategy will be introduced into 24 Kenyan public HIV-1 care centers according to national guidelines, in staged fashion, stratified by region (a stepped wedge design). Monitoring and evaluation activities will identify implementation barriers and solutions, characterize costs, and provide best practices for further scale-up. A research component will establish prospective open cohorts of couples at each clinic (up to 200) to study how the program is effectively implemented. Follow-up in the cohorts will be for up to 36 months at each care center and will evaluate impact, costs, and facilitators and barriers to implementation at patient, provider and health system levels.

Inclusion Criteria:

• For HIV-1 uninfected members of the couple
• Age ≥18
• Able and willing to provide consent for follow-up in the cohort
• HIV-1 uninfected based on negative HIV-1 tests, per Kenya national guidelines
• Not currently using PrEP

For HIV-1 infected members of the couple

• Age ≥18
• Able and willing to provide consent for follow-up in the cohort
• HIV-1 infected based on positive HIV-1 tests, per Kenya national guidelines
• Not currently using ART

For both members of the couple - Meet criteria for initiating PrEP as per Kenya national guidelines, including:

• HIV-1 infected member not currently using ART, on ART <6 months, or on ART but not virally suppressed based on a viral load test done at the clinic as per Kenya national guidelines or
• Trying to conceive

For key delivery informants

- Able and willing to provide consent

Exclusion Criteria:

• Otherwise not eligible based on the above inclusion criteria

Data from the Partners Scale-Up Project will be available at end of the Project by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu)