PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya
- Conditions
- HIV InfectionsContraceptionSTI
- Interventions
- Drug: PrEP
- Registration Number
- NCT04666792
- Lead Sponsor
- University of Washington
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 3600
- 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
- Otherwise not eligible based on the above inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PrEP for HIV-1 uninfected for women accessing family planning PrEP 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.
- Primary Outcome Measures
Name Time Method Proportion of women accessing family planning services who are screened for HIV risk 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 up to 24 months Measure PrEP initiation among women receiving family planning services
- Secondary Outcome Measures
Name Time Method Develop data tools to expand and support delivery of family planning and HIV prevention services up to 24 months Coordinate with key stakeholders to develop and refine data tools and clinical delivery products during project implementation
Proportion of family planning clinics that implement PrEP provision up to 36 months Measure number of clinics that provide PrEP
Proportion of targeted providers who are trained and provide PrEP up to 24 months Measure number of providers in family planning clinics who implement PrEP
Facilitators and barriers to PrEP implementation up to 24 months Mixed methods assessment of clinic readiness and ability to implement PrEP per protocol
Proportion of women who remain HIV-negative up to 24 months Assess HIV status of women receiving family planning services
Programmatic costs of providing PrEP in family planning clinics up to 24 months Conduct micro-costing, cost-effectiveness, and budget impact analyses to estimate the programmatic costs of providing PrEP in family planning clinics
Proportion of core PrEP delivery components delivered per protocol up to 24 months Measure fidelity to PrEP delivery procedures in family planning clinics
PrEP adherence quantified by tenofovir drug levels in blood up to 24 months Measure PrEP adherence among women who initiate PrEP
Trial Locations
- Locations (1)
Kenyatta National Hospital
🇰🇪Kisumu, Kenya