Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
5000

Summary

Conditions
  • Contraception
  • HIV Infections
  • STI
Type
Interventional
Phase
Phase 4
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This a programmatic stepped-Wedge cluster randomized trialMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Younger than 125 years
Gender
Only males

Description

Investigators will conduct a stepped-wedge cluster-randomized programmatic project to integrate PrEP provision within a combination HIV prevention package in 12 family planning clinics in Kisumu, Kenya- a region with an HIV prevalence of up to 28% among young women. The project will optimize and sus...

Investigators will conduct a stepped-wedge cluster-randomized programmatic project to integrate PrEP provision within a combination HIV prevention package in 12 family planning clinics in Kisumu, Kenya- a region with an HIV prevalence of up to 28% among young women. The project will optimize and sustain PrEP delivery with existing family planning staff, supported through training and ongoing technical assistance. The investigators will rigorously evaluate program reach, effectiveness, adoption, implementation, maintenance, and impact using validated implementation science frameworks and how clinics build new efficient delivery systems.

Tracking Information

NCT #
NCT04666792
Collaborators
  • National Institute of Mental Health (NIMH)
  • Kenyatta National Hospital
  • Kenya National AIDS & STI Control Programme
  • Kisumu County Government
Investigators
Principal Investigator: Kenneth Mugwanya, MBChB, MS, PhD University of Washington