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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections, Contraception, STI

Intervention / Treatment
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* Drug: PrEP


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: This a programmatic stepped-Wedge cluster randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PrEP for HIV-1 uninfected for women accessing family planning<br>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. | Drug: PrEP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women accessing family planning services who are screened for HIV risk | Measure HIV risk screening completion among women receiving family planning services | 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 | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP adherence quantified by tenofovir drug levels in blood | Measure PrEP adherence among women who initiate PrEP | up to 24 months | 
| Proportion of women who remain HIV-negative | Assess HIV status of women receiving family planning services | up to 24 months | 
| Proportion of family planning clinics that implement PrEP provision | Measure number of clinics that provide PrEP | 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 | up to 24 months | 
| Proportion of core PrEP delivery components delivered per protocol | Measure fidelity to PrEP delivery procedures in family planning clinics | up to 24 months | 
| Facilitators and barriers to PrEP implementation | Mixed methods assessment of clinic readiness and ability to implement PrEP per protocol | 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 | 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 | up to 24 months |