The Partners Scale-Up Project

HIV-1-infection Clinical Trial

Official title: Delivery of Integrated PrEP and ART for Couples in Kenya

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• HIV-1-infection

• NCT number: NCT03052010
• Study type: Interventional
• Source: University of Washington
• Status: Completed
• Phase: Phase 4
• Start date: February 6, 2017
• Completion date: April 30, 2021