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Completed

NCT Number: NCT04666792

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Contraception Disease Attributes Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections STI Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kenyatta National Hospital

Kisumu, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PrEP

Drug

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.

Primary outcomes

  1. 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

  2. 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

  1. PrEP adherence quantified by tenofovir drug levels in blood

    Time frame: up to 24 months

    Measure PrEP adherence among women who initiate PrEP

  2. Proportion of women who remain HIV-negative

    Time frame: up to 24 months

    Assess HIV status of women receiving family planning services

  3. Proportion of family planning clinics that implement PrEP provision

    Time frame: up to 36 months

    Measure number of clinics that provide PrEP

  4. Proportion of targeted providers who are trained and provide PrEP

    Time frame: up to 24 months

    Measure number of providers in family planning clinics who implement PrEP

  5. Proportion of core PrEP delivery components delivered per protocol

    Time frame: up to 24 months

    Measure fidelity to PrEP delivery procedures in family planning clinics

  6. Facilitators and barriers to PrEP implementation

    Time frame: up to 24 months

    Mixed methods assessment of clinic readiness and ability to implement PrEP per protocol

  7. Programmatic costs of providing PrEP in family planning clinics

    Time frame: 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

  8. Develop data tools to expand and support delivery of family planning and HIV prevention services

    Time frame: up to 24 months

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 14, 2020
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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