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HIV InfectionsPhase 4NCT04666792

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

A Phase 4 study testing PrEP in people with HIV Infections and Contraception, run by University of Washington at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections, Contraception, STI
What is being tested?
PrEP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25,457 participants
Where
1 siteKenya
Study dates
1 Mar 2021to 31 Dec 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Otherwise not eligible based on the above inclusion criteria

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Kenyatta National Hospital

    Kisumu

Other trials in Kenya

About this study

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.

Read the 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.

Being tested
PrEP
Medical subject headings
HIV Infections, Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrEPDrug

    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.

Study groups in NCT04666792
Study groupRoleWhat they receive
PrEP for HIV-1 uninfected for women accessing family planningOtherWomen 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.
Receives: Drug: PrEP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of women accessing family planning services who are screened for HIV risk

    Measure HIV risk screening completion among women receiving family planning services

    Measured: up to 24 months

  2. Proportion of women accessing family planning services who uptake PrEP for HIV prevention

    Measure PrEP initiation among women receiving family planning services

    Measured: up to 24 months

Secondary outcomes (8)

  1. PrEP adherence quantified by tenofovir drug levels in blood

    Measure PrEP adherence among women who initiate PrEP

    Measured: up to 24 months

  2. Proportion of women who remain HIV-negative

    Assess HIV status of women receiving family planning services

    Measured: up to 24 months

  3. Proportion of family planning clinics that implement PrEP provision

    Measure number of clinics that provide PrEP

    Measured: up to 36 months

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

    Measure number of providers in family planning clinics who implement PrEP

    Measured: up to 24 months

  5. Proportion of core PrEP delivery components delivered per protocol

    Measure fidelity to PrEP delivery procedures in family planning clinics

    Measured: up to 24 months

  6. Facilitators and barriers to PrEP implementation

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

    Measured: up to 24 months

  7. 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

    Measured: up to 24 months

  8. 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

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2020
  2. Study start1 Mar 2021
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
This a programmatic stepped-Wedge cluster randomized trial
Masking
None (open label)
Enrolment
25,457 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04666792
Sponsor's protocol ID
STUDY00009583
Other IDs
R01MH123267
Status last verified
Aug 2025
First submitted
8 Dec 2020
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mukui IN, Urusaro S, Kinuthia J, Matemo D, Morton JF, Mugwanya KK; FP Plus Project. Fidelity of Implementation of Oral Pre-Exposure Prophylaxis for HIV in Public Family Planning Clinics in Kenya: Results From a Stepped-Wedge Cluster Randomized Trial. J Int AIDS Soc. 2026 Oct;29 Suppl 5(Suppl 5):e70189. doi: 10.1002/jia2.70189.

    PubMed 42850961

  • Mugwanya KK, Matemo D, Meisner A, Schaafsma T, Morton J, Wandera C, Kemunto V, Cherotich I, Odhiambo S, Bii M, Oduor B, Achieng E, Oyombra T, Owaga D, Beima-Sofie KM, Baeten JM, Kinuthia J. Integrating oral pre-exposure prophylaxis delivery in primary care family planning clinics: a pragmatic, stepped-wedge, cluster-randomised trial. Lancet Prim Care. 2025 Nov;1(5):100057. doi: 10.1016/j.lanprc.2025.100057. Epub 2025 Nov 21.

    PubMed 42232582

  • Mukasa D, Kinuthia J, Meisner A, Matemo D, Schaafsma T, Morton J, Wandera C, Budiawan E, Kemuto V, Irine C, Odhiambo S, Bii M, Oduor B, Achieng E, Oyombra T, Ukah UV, Mugwanya KK; FP Plus Project Team. Oral preexposure prophylaxis use and the risk of bacterial sexually transmitted infections and HIV among African women: A prospective observational cohort study. PLoS Med. 2026 Mar 9;23(3):e1004962. doi: 10.1371/journal.pmed.1004962. eCollection 2026 Mar.

    PubMed 41802176

  • 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.

    PubMed 34895357

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PrEP in people with HIV Infections and Contraception, run by University of Washington at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of women accessing family planning services who are screened for HIV risk (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04666792, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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