PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men (NCT05353283) | Clinical Trial Compass
CompletedNot Applicable
PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men
United States63 participantsStarted 2023-09-01
Plain-language summary
Despite advances in HIV prevention, the HIV incidence among young men who have sex with men (YMSM) is increasing, threatening to derail achievement of the United States End the HIV Epidemic goals. Although, pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method, adherence was sufficiently low to comprise efficacy among a high proportion of YMSM in multiple clinical trials and demonstration projects. In this study, the investigators will leverage a novel urine point-of-care drug-level test for PrEP adherence, to both enhance and target motivational-interviewing-based adherence counseling among YMSM, with the goal of preventing HIV infections among this critically at-risk group.
Who can participate
Age range
18 Years – 30 Years
Sex
MALE
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:
* Male sex at birth who has sex with men
* Age 18-30 years-old
* Currently receiving tenofovir-based oral PrEP
* Plans to continue taking daily PrEP over the upcoming 3 months
Exclusion Criteria:
* Participant living with HIV
* Age \> 30 years
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
Number of Participants Indicating the Intervention Was Acceptable