PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya
Overview
- Phase
- Phase 4
- Intervention
- PrEP
- Conditions
- HIV Infections
- Sponsor
- University of Washington
- Enrollment
- 25457
- Locations
- 1
- Primary Endpoint
- Proportion of women accessing family planning services who are screened for HIV risk
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief 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.
Investigators
Kenneth K Mugwanya
Assistant Professor, Global Health, School of Medicine and School of Public Health,
University of Washington
Eligibility Criteria
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 STI Control Program
Exclusion Criteria
- •\- Otherwise not eligible based on the above inclusion criteria
Arms & Interventions
PrEP for HIV-1 uninfected for women accessing family planning
Women accessing family planning will be assessed for HIV risk and PrEP eligibility. If eligible and willing to initiate PrEP, they will be provided PrEP in accordance with national guidelines as part of their standard of care at the family planning clinic.
Intervention: PrEP
Outcomes
Primary Outcomes
Proportion of women accessing family planning services who are screened for HIV risk
Time Frame: up to 24 months
Measure HIV risk screening completion among women receiving family planning services
Proportion of women accessing family planning services who uptake PrEP for HIV prevention
Time Frame: up to 24 months
Measure PrEP initiation among women receiving family planning services
Secondary Outcomes
- Develop data tools to expand and support delivery of family planning and HIV prevention services(up to 24 months)
- Proportion of family planning clinics that implement PrEP provision(up to 36 months)
- Proportion of targeted providers who are trained and provide PrEP(up to 24 months)
- Facilitators and barriers to PrEP implementation(up to 24 months)
- Proportion of women who remain HIV-negative(up to 24 months)
- Programmatic costs of providing PrEP in family planning clinics(up to 24 months)
- Proportion of core PrEP delivery components delivered per protocol(up to 24 months)
- PrEP adherence quantified by tenofovir drug levels in blood(up to 24 months)