Actively Recruiting
HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics: The HIV Testing Services PrEP Integration (HTS PrEP) Project
Led by University of Washington · Updated on 2026-05-18
30000
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new way to provide HIV prevention care by training HIV testing services (HTS) counselors to deliver pre-exposure prophylaxis (PrEP) in public family planning clinics in Kenya. The study aims to understand how integrating PrEP delivery with HIV testing by existing clinic staff affects the use of HIV prevention services over time. This implementation study uses a cluster randomized, stepped wedge design to gradually introduce the intervention across clinics. During the study, clinics will first operate under usual care for a baseline period of three months and additional control times when the standard model is maintained. In the intervention period, HTS counselors will provide all key parts of PrEP delivery, including HIV testing, assessing eligibility, dispensing the medicine, counseling on adherence, and providing refills as part of routine care. This approach is designed to integrate PrEP more fully into existing health services. Participants will be users of the public health clinics who are 15 years or older and not known to be living with HIV. Researchers will track outcomes such as how many people are screened for PrEP, how many start using it, and how many continue over a period of up to 42 months. The study will monitor these measures to evaluate the impact of the HTS counselor-led care model on HIV prevention efforts.
CONDITIONS
Brief Title
HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 15 years of age or older
- 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
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 42 months
Participants receive PrEP delivery including HIV testing, eligibility assessment, dispensing, adherence counseling, and provision of refills led by an HIV Testing Services counselor as part of standard care.
Visits as needed for PrEP delivery and follow-up
Trial Site Locations
Total: 1 location
1
Kenyatta National Hospital
Kisumu, Kenya
Actively Recruiting
Research Team
C
Clare Brown, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here