Clinical trial NCT03052010: The Partners Scale-Up Project
Official title: Delivery of Integrated PrEP and ART for Couples in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV-1-infection
Keywords: HIV-1 serodiscordant couples
PrEP as Bridge to ART
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: Kenya National AIDS & STI Control Programme
name: National Institute of Mental Health (NIMH)
name: Bill and Melinda Gates Foundation
First posted: 2017-02-14
Enrollment: 4898
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of HIV-1 infected persons whose partners are tested for HIV-1 before/after PrEP as a bridge to ART is implemented
timeFrame: up to 36 months
measure: PrEP initiation
timeFrame: up to 36 months
measure: PrEP adherence
timeFrame: up to 6 months
measure: HIV-1 uninfected partners staying HIV-1 uninfected.
timeFrame: up to 36 months
measure: ART initiation
timeFrame: up to 36 months
measure: ART adherence
timeFrame: up to 6 months
measure: Facilitators and barriers to implementation of integrated PrEP and ART
timeFrame: up to 36 months
measure: PrEP delivery operational tools
timeFrame: 24 months
measure: Cost and cost-effectiveness of the integrated PrEP and ART when delivered in public health clinics.
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: KEMRI
city: Thika
country: Kenya
facility: Partners in Health Research and Development
Study officials:
affiliation: University of Washington
name: Jared Baeten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Kenneth K. Mugwanya, MBChB, MS, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.