Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
4898 participants
INTERVENTIONAL
2017-02-06
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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PrEP for HIV-1 uninfected partners and ART for HIV-1 infected
Integrated PrEP as a bridge to ART HIV-1 prevention strategy
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
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.
ART
ART medications will be provided according to Kenya national ART policies and will come from clinic stocks.
Interventions
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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
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.
ART
ART medications will be provided according to Kenya national ART policies and will come from clinic stocks.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Kenya Medical Research Institute
OTHER
Kenya National AIDS & STI Control Programme
OTHER
National Institute of Mental Health (NIMH)
NIH
Bill and Melinda Gates Foundation
OTHER
University of Washington
OTHER
Responsible Party
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Jared Baeten
Professor, Global Health, Medicine, & Epidemiology
Principal Investigators
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Jared Baeten, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Kenneth K. Mugwanya, MBChB, MS, PhD
Role: STUDY_DIRECTOR
University of Washington
Locations
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KEMRI
Kisumu, , Kenya
Partners in Health Research and Development
Thika, , Kenya
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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STUDY00002183
Identifier Type: -
Identifier Source: org_study_id