The Partners Scale-Up Project

Phase 4

Completed

• Conditions: HIV-1-infection
• Interventions: Other: Integrated PrEP as a bridge to ART HIV-1 prevention strategy; Drug: PrEP; Drug: ART

• Registration Number: NCT03052010
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-02-05
• Study Start: 2017-02-06
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Primary Completion: 2020-12-15
• Study Completion: 2021-04-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-17
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4898

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PrEP for HIV-1 uninfected partners and ART for HIV-1 infected	PrEP	Integrated PrEP as a bridge to ART HIV-1 prevention strategy
PrEP for HIV-1 uninfected partners and ART for HIV-1 infected	Integrated PrEP as a bridge to ART HIV-1 prevention strategy	Integrated PrEP as a bridge to ART HIV-1 prevention strategy
PrEP for HIV-1 uninfected partners and ART for HIV-1 infected	ART	Integrated PrEP as a bridge to ART HIV-1 prevention strategy

Primary Outcome Measures

Name	Time	Method
Number of HIV-1 infected persons whose partners are tested for HIV-1 before/after PrEP as a bridge to ART is implemented	up to 36 months
PrEP initiation	up to 36 months	Measure the number of HIV-1 uninfected partners initiating PrEP.
PrEP adherence	up to 6 months	Adherence by HIV-1 uninfected partners until their HIV-1 infected partners initiate ART and sustain use for six months. Adherence will be measured by self reported and random dry blood spot for tenofovir levels
HIV-1 uninfected partners staying HIV-1 uninfected.	up to 36 months
ART initiation	up to 36 months	Number of HIV-1 infected partners newly initiating ART
PrEP delivery operational tools	24 months	Training manual on deliver of integrated PrEP and ART HIV prevention strategy for couples will be developed.
ART adherence	up to 6 months	Adherence measured by plasma RNA viral load. Viral load will be abstract from the HIV-infected partners records.
Facilitators and barriers to implementation of integrated PrEP and ART	up to 36 months	Mixed methods assessment of how integrated PrEP and ART is implemented at the level of provider, health center, and health systems
Cost and cost-effectiveness of the integrated PrEP and ART when delivered in public health clinics.	up to 36 months	Time and motions to define the cost and cost-effectiveness of intervention summarized in terms of HIV infections averted, disability-adjusted life years saved, and incremental cost-effectiveness over routine HIV-1 care

Trial Locations

Locations (2)

KEMRI; 🇰🇪 Kisumu, Kenya

Partners in Health Research and Development; 🇰🇪 Thika, Kenya