The Partners Scale-Up Project

HIV-1-infection Clinical Trial

Official title:

Delivery of Integrated PrEP and ART for Couples in Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052010
• Other study ID #: STUDY00002183
• Secondary ID: 2R01MH095507
• Status: Completed
• Phase: Phase 4
• Start date: February 6, 2017
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4898
• Est. completion date: April 30, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

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

Locations

Country	Name	City	State
Kenya	KEMRI	Kisumu
Kenya	Partners in Health Research and Development	Thika

Sponsors (5)

Lead Sponsor	Collaborator
University of Washington	Bill and Melinda Gates Foundation, Kenya Medical Research Institute, Kenya National AIDS & STI Control Programme, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	PrEP initiation	Measure the number of HIV-1 uninfected partners initiating PrEP.	up to 36 months
Primary	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
Primary	HIV-1 uninfected partners staying HIV-1 uninfected.		up to 36 months
Primary	ART initiation	Number of HIV-1 infected partners newly initiating ART	up to 36 months
Primary	ART adherence	Adherence measured by plasma RNA viral load. Viral load will be abstract from the HIV-infected partners records.	up to 6 months
Primary	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
Primary	PrEP delivery operational tools	Training manual on deliver of integrated PrEP and ART HIV prevention strategy for couples will be developed.	24 months
Primary	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