Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya (NCT04982250) | Clinical Trial Compass
CompletedNot Applicable
Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya
Kenya211 participantsStarted 2022-02-24
Plain-language summary
Few young women at risk of HIV infection are initiating pre-exposure prophylaxis (PrEP) for HIV prevention in Kenya, thus we propose refining and testing a new model to increase PrEP initiation among young women at high HIV risk that has never been explored: enhanced peer PrEP referral with HIV self-test (HIVST) delivery. We conducted formative research to design of a model that is acceptable to young women and feasible to implement in Kenya. In this study, we will refine this model where young (≥16 to 24 years) female PrEP users refer their peers to PrEP and deliver HIVSTs in a pilot study and then test the refined model in a hybrid effectiveness-implementation trial. We hypothesize that relative to standard informal word-of-month peer PrEP referral (currently ongoing in Kenya), enhanced peer PrEP referral with HIVST delivery will increase PrEP initiation, continuation, and adherence among peers; have high fidelity; and be low cost.
Who can participate
Age range
16 Years – 24 Years
Sex
FEMALE
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:
For peer providers (qualitative data, pilot):
* Age ≥16 to 24 years\*
* Female
* Have been on PrEP for a minimum of three months
* Good adherence to PrEP (i.e., self-report take PrEP all the time)
* Willing to disclose PrEP use to their peers
* Able to identify up to 4 peers at risk of HIV infection
* Willing to participate in training with study counselors on PrEP referral and HIVST use
* Willing to refer peers to PrEP and deliver HIVSTs
* Able and willing to provide written informed consent
* Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home in the context of PrEP delivery
For peer providers (cRCT):
* Age ≥16 to 24 years\*
* Female
* Must have refilled or initiated PrEP (i.e., been dispensed PrEP)
* Not currently enrolled in an HIV study
* Able to identify up to 4 peers with recent self-reported behaviors associated with risk of HIV acquisition
* Willing to participate in training with study counselors on PrEP referral and HIVST use
* Willing to refer peers to PrEP and deliver HIVSTs
* Able and willing to provide written informed consent
* Willing to provide contact information for follow-up
* Willing to engage in all research activities including completion of questionnaires
* Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home in the context of PrEP delivery
For peer clients (pilot, R…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
cRCT: PrEP Initiation
Timeframe: 3 months
2
Pilot: PrEP Initiation, as Reported by Index Peers
Timeframe: 1 month
3
Pilot: PrEP Initiation, as Reported by Referred Peers