Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
4800

Summary

Conditions
HIV -1 Infection
Type
Interventional
Phase
Phase 4
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 cost...

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.

Tracking Information

NCT #
NCT03052010
Collaborators
  • Kenya Medical Research Institute
  • Kenya National AIDS & STI Control Programme
  • National Institute of Mental Health (NIMH)
  • Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Jared Baeten, MD, PhD University of Washington Study Director: Kenneth K. Mugwanya, MBChB, MS, PhD University of Washington