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

Phase

Condition

Contraception

Hiv Infections

Treatment

PrEP

Clinical Study ID

NCT04666792

STUDY00009583

R01MH123267

Female
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Female of reproductive age
Sexually active
Able and willing to provide informed consent
HIV negative, according to national HIV testing algorithm
Has at least one risk factor for HIV as defined by the Kenya National AIDS and STIControl Program

Exclusion

Exclusion Criteria:

Otherwise not eligible based on the above inclusion criteria

Study Design

PrEP

March 01, 2021

December 31, 2024

Study 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.

Connect with a study center

Kenyatta National Hospital
Kisumu,
Kenya
Site Not Available
Kenyatta National Hospital
Kisumu 191245,
Kenya
Site Not Available

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