HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics (NCT07089966) | Clinical Trial Compass
RecruitingNot Applicable
HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics
Kenya30,000 participantsStarted 2025-12-01
Plain-language summary
This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is being run through family planning clinics and involves HIV testing counselors guiding PrEP delivery — does that setting make sense for where I'm already getting care, and would participating mean switching or adding a clinic?
2Since this is listed as Phase NA, which often means it's testing a care delivery model rather than a new drug, can you help me understand what's actually being studied here — is it about how PrEP is offered and supported, rather than whether PrEP itself is safe or effective?
3The trial is measuring whether people get screened for PrEP, start it, and keep taking it — does that mean my main role would be going through that counselor-led process, and what would that actually look like in terms of appointments or check-ins for me?
4If I'm already on PrEP or have been thinking about starting it, how does joining this trial compare to just starting PrEP through my current provider — would I get the same medication and monitoring either way?
5Are there any populations this trial is specifically designed for, like people who use family planning services, and based on my situation would you think this is worth pursuing or would a different path to PrEP make more sense for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.