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The Partners Scale-Up Project

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ClinicalTrials.gov Identifier: NCT03052010
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
Kenya Medical Research Institute
Kenya National AIDS & STI Control Programme
National Institute of Mental Health (NIMH)
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Jared Baeten, 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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Other: Integrated PrEP as a bridge to ART HIV-1 prevention strategy Drug: PrEP Drug: ART Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Delivery of Integrated PrEP and ART for Couples in Kenya
Actual Study Start Date : February 6, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
PrEP for HIV-1 uninfected partners and ART for HIV-1 infected
Integrated PrEP as a bridge to ART HIV-1 prevention strategy
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: 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.

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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052010


Contacts
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Contact: Kenneth Mugwanya, MBChB, MS, PhD 2065203806 mugwanya@uw.edu
Contact: Jared Baeten, MD, PhD 2065203808 jbaeten@uw.edu

Locations
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Kenya
KEMRI Recruiting
Kisumu, Kenya
Contact: Elizabeth Bukusi, MBChB, MMed, MPH, PhD         
Partners in Health Research and Development Recruiting
Thika, Kenya
Contact: Nelly R Mugo, MBChB, MMed, MPH         
Contact: Elizabeth Irungu, MBChB, MPH         
Sponsors and Collaborators
University of Washington
Kenya Medical Research Institute
Kenya National AIDS & STI Control Programme
National Institute of Mental Health (NIMH)
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Jared Baeten, MD, PhD University of Washington
Study Director: Kenneth K. Mugwanya, MBChB, MS, PhD University of Washington

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jared Baeten, Professor, Global Health, Medicine, & Epidemiology, University of Washington
ClinicalTrials.gov Identifier: NCT03052010     History of Changes
Other Study ID Numbers: STUDY00002183
2R01MH095507 ( U.S. NIH Grant/Contract )
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jared Baeten, University of Washington:
HIV-1 serodiscordant couples
PrEP as Bridge to ART