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

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

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

National Institute of Mental Health (NIMH), Kenyatta National Hospital, Kenya National AIDS & STI Control Programme, Kisumu County Government

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.

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.

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.

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.

Conduct micro-costing, cost-effectiveness, and budget impact analyses to estimate the programmatic costs of providing PrEP in family planning clinics

Coordinate with key stakeholders to develop and refine data tools and clinical delivery products during project implementation

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

Mugwanya KK, Matemo D, Scoville CW, Beima-Sofie KM, Meisner A, Onyango D, Mugambi M, Feutz E, Grabow C, Barnabas R, Weiner B, Baeten JM, Kinuthia J; FP Plus Team. Integrating PrEP delivery in public health family planning clinics: a protocol for a pragmatic stepped wedge cluster randomized trial in Kenya. Implement Sci Commun. 2021 Dec 11;2(1):135. doi: 10.1186/s43058-021-00228-4.