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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4800 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
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 medications will be provided according to Kenya national ART policies and will come from clinic stocks.
- 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 ]
- PrEP initiation [ Time Frame: up to 36 months ]Measure the number of HIV-1 uninfected partners initiating PrEP.
- 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
- HIV-1 uninfected partners staying HIV-1 uninfected. [ Time Frame: up to 36 months ]
- ART initiation [ Time Frame: up to 36 months ]Number of HIV-1 infected partners newly initiating ART
- 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.
- 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
- 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.
- 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
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
|Contact: Kenneth Mugwanya, MBChB, MS, PhDfirstname.lastname@example.org|
|Contact: Jared Baeten, MD, PhDemail@example.com|
|Contact: Elizabeth Bukusi, MBChB, MMed, MPH, PhD|
|Partners in Health Research and Development||Recruiting|
|Contact: Nelly R Mugo, MBChB, MMed, MPH|
|Contact: Elizabeth Irungu, MBChB, MPH|
|Principal Investigator:||Jared Baeten, MD, PhD||University of Washington|
|Study Director:||Kenneth K. Mugwanya, MBChB, MS, PhD||University of Washington|