The Partners Scale-Up Project

Phase 4CompletedNCT03052010

University of Washington4,898 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

4,898

Conditions

HIV-1-infection

Interventions

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

The PrEP as a bridge to ART intervention will be introduced into clinics according to Kenya national guidelines using a stepped wedge design, stratified by region. The components of the intervention are: a) Couples' HIV-1 counseling and testing; 2) PrEP as a bridge to ART: PrEP offered prior to ART initiation in couples in which the HIV-1 infected partner is not on ART due to refusal/delay, during the first 6 months after ART start during viral decline, and then discontinuation; 3) ART at any CD4 count, offered to all HIV-1 infected partners, with ongoing promotion/counseling for those delaying/declining;4) Standard of care HIV-1 prevention services

PrEPDRUG

A fixed-dose, oral co-formulation of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is the approved and preferred regimen for HIV-1 prevention in Kenya and the United States. The World Health Organization (WHO) recommends TDF-containing medications as PrEP, which includes TDF combined with FTC as well as potentially TDF alone and TDF combined with lamivudine (or 3TC, a medication closely related to FTC). Any TDF-containing medications that align with WHO and Kenya national guidelines for PrEP will be used. PrEP medication will come from clinic stocks.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

KEMRI

Kisumu, Kenya

Partners in Health Research and Development

Thika, Kenya

Outcomes

Primary Outcomes

Number of HIV-1 infected persons whose partners are tested for HIV-1 before/after PrEP as a bridge to ART is implemented

Time frame: up to 36 months

PrEP initiation

Measure the number of HIV-1 uninfected partners initiating PrEP.

Time frame: up to 36 months

PrEP adherence

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

Time frame: up to 6 months

HIV-1 uninfected partners staying HIV-1 uninfected.

Time frame: up to 36 months

ART initiation

Number of HIV-1 infected partners newly initiating ART

Time frame: up to 36 months

ART adherence

Adherence measured by plasma RNA viral load. Viral load will be abstract from the HIV-infected partners records.

Time frame: up to 6 months

Facilitators and barriers to implementation of integrated PrEP and ART

Mixed methods assessment of how integrated PrEP and ART is implemented at the level of provider, health center, and health systems

Time frame: up to 36 months

PrEP delivery operational tools

Training manual on deliver of integrated PrEP and ART HIV prevention strategy for couples will be developed.

Time frame: 24 months

Cost and cost-effectiveness of the integrated PrEP and ART when delivered in public health clinics.

Data from ClinicalTrials.gov

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