Clinical trial Recruiting at 1 site Interventional Ages 15 and up

PrEP delivery led by HIV testing counselors in Kenyan clinics

Official title: HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics: The HIV Testing Services PrEP Integration (HTS PrEP) Project

Run by University of Washington · NCT07089966 · Data updated 2026-11-12

A counselor-led approach is being tested to see if it helps deliver PrEP in public health clinics for people in Kenya who may be at risk for HIV.

Quick facts

Study typeInterventional
Ages15 Years and up
SexAll
Enrollment30000 (estimated)
SponsorUniversity of Washington
Academic / other
Locations1 site (Kisumu)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 31, 2028
Study endsJune 30, 2029
Registry record updatedJune 18, 2026
Trial IDNCT07089966 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 15 and older who visit participating public health facilities and are not known to be living with HIV.

Probably not a fit

People who are already on a stable PrEP regimen or who do not engage with HTS counselor-led care may not experience additional benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a cluster-randomized, stepped-wedge implementation study conducted in public health clinics in Kenya to introduce HIV testing services (HTS) counselor-led PrEP care. The study evaluates how a PrEP care model led by HTS counselors integrates with existing clinic workflows. Eligible participants are individuals aged 15 years or older who access services at participating facilities and are not known to have HIV at the time their data are first abstracted. The lead sponsor is the University of Washington, with collaborators from NIMH, and the clinics include Kenyatta National Hospital sites in Kisumu.

Why it matters

Potential benefit: If successful, the model could streamline PrEP delivery in busy clinics and improve HIV prevention for at-risk populations.

How similar studies have gone: Prior implementation efforts with HTS-guided PrEP delivery have shown potential in improving access and uptake in some settings, but results vary by context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* ≥15 years of age
* Accessing health services at participating public health facilities.
* Not known to be living with HIV prior to the visit when their clinical data is first abstracted

Where it's running

  • Kenyatta National Hospital
    Kisumu, Kenya
    Recruiting

Study contacts

  • Principal investigator: Kenneth Mugwanya, MBChB, MS, PhD — University of Washington
  • Study coordinator: Clare Brown, PhD
  • Email: brownce@uw.edu
  • Phone: 206-543-8225

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.