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

NCT04666792 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25457

Last updated 2025-09-04

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections
  • Contraception
  • STI

Interventions

DRUG

PrEP

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Kenyatta National Hospital

    collaborator OTHER_GOV

  • Kenya National AIDS & STI Control Programme

    collaborator OTHER

  • Kisumu County Government

    collaborator UNKNOWN

  • University of Washington

    lead OTHER

Principal Investigators

  • Kenneth Mugwanya, MBChB, MS, PhD · University of Washington

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04666792 on ClinicalTrials.gov