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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
25,457
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.
Kenyatta National Hospital
Kisumu, Kenya
Proportion of women accessing family planning services who are screened for HIV risk
Measure HIV risk screening completion among women receiving family planning services
Time frame: up to 24 months
Proportion of women accessing family planning services who uptake PrEP for HIV prevention
Measure PrEP initiation among women receiving family planning services
Time frame: up to 24 months
PrEP adherence quantified by tenofovir drug levels in blood
Measure PrEP adherence among women who initiate PrEP
Time frame: up to 24 months
Proportion of women who remain HIV-negative
Assess HIV status of women receiving family planning services
Time frame: up to 24 months
Proportion of family planning clinics that implement PrEP provision
Measure number of clinics that provide PrEP
Time frame: up to 36 months
Proportion of targeted providers who are trained and provide PrEP
Measure number of providers in family planning clinics who implement PrEP
Time frame: up to 24 months
Proportion of core PrEP delivery components delivered per protocol
Measure fidelity to PrEP delivery procedures in family planning clinics
Time frame: up to 24 months
Facilitators and barriers to PrEP implementation
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Mixed methods assessment of clinic readiness and ability to implement PrEP per protocol
Time frame: up to 24 months
Programmatic costs of providing PrEP in family planning clinics
Conduct micro-costing, cost-effectiveness, and budget impact analyses to estimate the programmatic costs of providing PrEP in family planning clinics
Time frame: up to 24 months
Develop data tools to expand and support delivery of family planning and HIV prevention services
Coordinate with key stakeholders to develop and refine data tools and clinical delivery products during project implementation
Time frame: up to 24 months