The Partners Scale-Up Project

October 17, 2021 updated by: Jared Baeten, University of Washington

Delivery of Integrated PrEP and ART for Couples in Kenya

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4898

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya
        • KEMRI
      • Thika, Kenya
        • Partners in Health Research and Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PrEP for HIV-1 uninfected partners and ART for HIV-1 infected
Integrated PrEP as a bridge to ART HIV-1 prevention strategy
Drug: PrEP
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.
Other: Integrated PrEP as a bridge to ART HIV-1 prevention strategy
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
Drug: ART
ART medications will be provided according to Kenya national ART policies and will come from clinic stocks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 36 months
PrEP initiation
Time Frame: up to 36 months
Measure the number of HIV-1 uninfected partners initiating PrEP.
up to 36 months
PrEP adherence
Time Frame: 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
up to 6 months
HIV-1 uninfected partners staying HIV-1 uninfected.
Time Frame: up to 36 months
up to 36 months
ART initiation
Time Frame: up to 36 months
Number of HIV-1 infected partners newly initiating ART
up to 36 months
ART adherence
Time Frame: up to 6 months
Adherence measured by plasma RNA viral load. Viral load will be abstract from the HIV-infected partners records.
up to 6 months
Facilitators and barriers to implementation of integrated PrEP and ART
Time Frame: 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
up to 36 months
PrEP delivery operational tools
Time Frame: 24 months
Training manual on deliver of integrated PrEP and ART HIV prevention strategy for couples will be developed.
24 months
Cost and cost-effectiveness of the integrated PrEP and ART when delivered in public health clinics.
Time Frame: 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
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)
Bill and Melinda Gates Foundation
Kenya Medical Research Institute
Kenya National AIDS & STI Control Programme

Investigators

  • Study Director: Kenneth K. Mugwanya, MBChB, MS, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2017

Primary Completion (Actual)

December 15, 2020

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

February 5, 2017

First Submitted That Met QC Criteria

February 9, 2017

First Posted (Actual)

February 14, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 17, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00002183
  • 2R01MH095507 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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