The Partners Scale-Up Project

University of Washington

Status and phase: Completed; Phase 4

Conditions: HIV-1-infection

Treatments: Drug: ART; Drug: PrEP; Other: Integrated PrEP as a bridge to ART HIV-1 prevention strategy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03052010

2R01MH095507 (U.S. NIH Grant/Contract)

STUDY00002183

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4,898 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4,898 participants in 1 patient group

PrEP for HIV-1 uninfected partners and ART for HIV-1 infected

Other group

Description:

Integrated PrEP as a bridge to ART HIV-1 prevention strategy

Treatment:

Drug: ART

Drug: PrEP

Other: Integrated PrEP as a bridge to ART HIV-1 prevention strategy