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Completed

NCT Number: NCT03052010

The Partners Scale-Up Project

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.

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

KEMRI, Kisumu, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

PrEP

Drug

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.

ART

Drug

ART medications will be provided according to Kenya national ART policies and will come from clinic stocks.

Primary outcomes

  1. 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

  2. PrEP initiation

    Time frame: up to 36 months

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

  3. 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

  4. HIV-1 uninfected partners staying HIV-1 uninfected.

    Time frame: up to 36 months

  5. ART initiation

    Time frame: up to 36 months

    Number of HIV-1 infected partners newly initiating ART

  6. 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.

  7. 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

  8. 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.

  9. 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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Official study title

Delivery of Integrated PrEP and ART for Couples in Kenya

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Feb 14, 2017
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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