The Partners Scale-Up Project

PHASE4CompletedINTERVENTIONAL
Enrollment

4,898

Participants

Timeline

Start Date

February 6, 2017

Primary Completion Date

December 15, 2020

Study Completion Date

April 30, 2021

Conditions
HIV-1-infection
Interventions
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.

DRUG

ART

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

Trial Locations (2)

Unknown

KEMRI, Kisumu

Partners in Health Research and Development, Thika

Sponsors
All Listed Sponsors
collaborator

Kenya Medical Research Institute

OTHER

collaborator

Kenya National AIDS & STI Control Programme

OTHER

collaborator

National Institute of Mental Health (NIMH)

NIH

collaborator

Bill and Melinda Gates Foundation

OTHER

lead

University of Washington

OTHER