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

June 2, 2023 updated by: Kenneth K Mugwanya, University of Washington
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.

Study Overview

Status

Recruiting

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

3600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zarna Marfatia
  • Phone Number: +12065203866
  • Email: zarnam@uw.edu

Study Contact Backup

  • Name: John Kinuthia, PhD
  • Phone Number: +254-722-799-052

Study Locations

      • Kisumu, Kenya
        • Recruiting
        • Kenyatta National Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PrEP for HIV-1 uninfected for women accessing family planning
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24 months
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
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP adherence quantified by tenofovir drug levels in blood
Time Frame: up to 24 months
Measure PrEP adherence among women who initiate PrEP
up to 24 months
Proportion of women who remain HIV-negative
Time Frame: up to 24 months
Assess HIV status of women receiving family planning services
up to 24 months
Proportion of family planning clinics that implement PrEP provision
Time Frame: up to 36 months
Measure number of clinics that provide PrEP
up to 36 months
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
up to 24 months
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
up to 24 months
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
up to 24 months
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
up to 24 months
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
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kenneth Mugwanya, MBChB, MS, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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