NCT03052010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,898

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

3.9 years

First QC Date

February 5, 2017

Last Update Submit

October 17, 2021

Conditions

HIV-1-infection

Keywords

HIV-1 serodiscordant couplesPrEP as Bridge to ART

Outcome Measures

Primary Outcomes (9)

  • 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

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

    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

    up to 6 months

  • HIV-1 uninfected partners staying HIV-1 uninfected.

    up to 36 months

  • ART initiation

    Number of HIV-1 infected partners newly initiating ART

    up to 36 months

  • ART adherence

    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

    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

    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 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

Study Arms (1)

PrEP for HIV-1 uninfected partners and ART for HIV-1 infected

OTHER

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

Other: Integrated PrEP as a bridge to ART HIV-1 prevention strategyDrug: PrEPDrug: ART

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

PrEP for HIV-1 uninfected partners and ART for HIV-1 infected
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.

PrEP for HIV-1 uninfected partners and ART for HIV-1 infected
ARTDRUG

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

PrEP for HIV-1 uninfected partners and ART for HIV-1 infected

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KEMRI

Kisumu, Kenya

Location

Partners in Health Research and Development

Thika, Kenya

Location

Related Publications (5)

  • Irungu EM, Mugwanya KK, Mugo NR, Bukusi EA, Donnell D, Odoyo J, Wamoni E, Peacock S, Morton JF, Ngure K, Mugambi M, Mukui I, O'Malley G, Baeten JM; Partners Scale-Up Project Team. Integration of pre-exposure prophylaxis services into public HIV care clinics in Kenya: a pragmatic stepped-wedge randomised trial. Lancet Glob Health. 2021 Dec;9(12):e1730-e1739. doi: 10.1016/S2214-109X(21)00391-0.

    PMID: 34798031DERIVED

  • Irungu EM, Odoyo J, Wamoni E, Bukusi EA, Mugo NR, Ngure K, Morton JF, Mugwanya KK, Baeten JM, O'Malley G; Partners Scale-Up Project Team. Process evaluation of PrEP implementation in Kenya: adaptation of practices and contextual modifications in public HIV care clinics. J Int AIDS Soc. 2021 Sep;24(9):e25799. doi: 10.1002/jia2.25799.

    PMID: 34496148DERIVED

  • Peebles K, Mugwanya KK, Irungu E, Odoyo J, Wamoni E, Morton JF, Ngure K, Bukusi EA, Mugo NR, Masyuko S, Mukui I, Baeten JM, Barnabas RV; Partners Scale-Up Project Team. Low costs and opportunities for efficiency: a cost analysis of the first year of programmatic PrEP delivery in Kenya's public sector. BMC Health Serv Res. 2021 Aug 16;21(1):823. doi: 10.1186/s12913-021-06832-3.

    PMID: 34399736DERIVED

  • Irungu EM, Ngure K, Mugwanya K, Mugo N, Bukusi E, Wamoni E, Odoyo J, Morton JF, Bernabee G, Mambo B, Masyuko S, Mukui I, O'Malley G, Baeten JM. Training health care providers to provide PrEP for HIV serodiscordant couples attending public health facilities in Kenya. Glob Public Health. 2019 Oct;14(10):1524-1534. doi: 10.1080/17441692.2019.1588908. Epub 2019 Mar 14.

    PMID: 30871413DERIVED

  • Mugwanya KK, Irungu E, Bukusi E, Mugo NR, Odoyo J, Wamoni E, Ngure K, Morton JF, Peebles K, Masyuko S, Barnabee G, Donnell D, Barnabas R, Haberer J, O'Malley G, Baeten JM; Partners Scale Up Team. Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya. Implement Sci. 2018 Sep 4;13(1):118. doi: 10.1186/s13012-018-0809-7.

    PMID: 30180860DERIVED

Study Officials

  • Jared Baeten, MD, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Kenneth K. Mugwanya, MBChB, MS, PhD

    University of Washington

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Global Health, Medicine, & Epidemiology

Study Record Dates

First Submitted

February 5, 2017

First Posted

February 14, 2017

Study Start

February 6, 2017

Primary Completion

December 15, 2020

Study Completion

April 30, 2021

Last Updated

October 19, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

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)

Locations

KE(2)