NCT04666792

PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25,457 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

This a prospective, open-label implementation project to catalyze integration of HIV prevention and PrEP care services for adolescent girls and young women in family planning clinics in Kenya.

Detailed 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 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.

Conditions

• HIV Infections
• Contraception
• STI

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-12-14
• Last updated: 2025-09-04

Locations

1 site across 1 country: Kenya