The Partners Scale-Up Project

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.

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.

Sponsors & Collaborators

• Kenya Medical Research Institute

  collaborator OTHER

• Kenya National AIDS & STI Control Programme

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Bill and Melinda Gates Foundation

  collaborator OTHER

• University of Washington

  lead OTHER

Principal Investigators

• Jared Baeten, MD, PhD · University of Washington

• Kenneth K. Mugwanya, MBChB, MS, PhD · University of Washington

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-02-06

Primary Completion

2020-12-15

Completion

2021-04-30

Countries

• Kenya

Study Locations