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

NCT04666792 | Completed Phase 4 DMC

• 2 other identifiers: STUDY00009583R01MH123267
• Study Type: interventional
• Target: 25,457
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• PrEP adherence quantified by tenofovir drug levels in blood

  up to 24 months

• Proportion of women who remain HIV-negative

  up to 24 months

• Proportion of family planning clinics that implement PrEP provision

  up to 36 months

• Proportion of targeted providers who are trained and provide PrEP

  up to 24 months

• Proportion of core PrEP delivery components delivered per protocol

  up to 24 months

Study Arms (1)

PrEP for HIV-1 uninfected for women accessing family planning

OTHER

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

Interventions

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.

PrEP for HIV-1 uninfected for women accessing family planning

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Kenyatta National Hospital

Kisumu, Kenya

Location

Related Publications (1)

• Mugwanya KK, Matemo D, Scoville CW, Beima-Sofie KM, Meisner A, Onyango D, Mugambi M, Feutz E, Grabow C, Barnabas R, Weiner B, Baeten JM, Kinuthia J; FP Plus Team. Integrating PrEP delivery in public health family planning clinics: a protocol for a pragmatic stepped wedge cluster randomized trial in Kenya. Implement Sci Commun. 2021 Dec 11;2(1):135. doi: 10.1186/s43058-021-00228-4.

  PMID: 34895357 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Kenneth Mugwanya, MBChB, MS, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Global Health, School of Medicine and School of Public Health,

Model Details: This a programmatic stepped-Wedge cluster randomized trial

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 14, 2020
• Study Start: March 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)