PrEPsmart 2-1-1 Pilot (NCT06631365) | Clinical Trial Compass
RecruitingPhase 2
PrEPsmart 2-1-1 Pilot
United States60 participantsStarted 2023-10-02
Plain-language summary
This is a pilot study to assess the feasibility, acceptability, and preliminary effectiveness of pre-exposure prophylaxis (PrEP)smart among cisgender sexual minority males (SMM) taking on-demand PrEP over a 6-month period.
Upon project completion, the investigators will have developed a highly innovative tool to support men who have sex with men (MSM) using on-demand PrEP ready for testing in a larger efficacy trial
Who can participate
Age range
18 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:
* Age 18 years or older
* Cisgender-male who reports sex with persons assigned male at birth
* Willing and able to provide written informed consent
* HIV-uninfected by negative 4th generation HIV test during screening (prescribed group)
* Documentation of negative HIV test within the last 3 months by outside laboratory OR evidence of PrEP prescription within the last 6 months based on medical records or pharmacy/provider communication
* Owns an iOS or Android mobile phone with a camera and has private access to the internet
* Able to understand, read, and speak English
* Able to attend study visits at a local research site in San Francisco (Bridge HIV) (prescribed and non-prescribed groups) or virtual visits via a HIPAA-compliant teleconferencing platform (non-prescribed group)
* Interested in starting or currently taking on-demand PrEP with TDF/FTC
* Report having anal sex at least once a month and expecting to maintain at least this frequency of anal sex during study participation by self-report
* Creatinine clearance ≥60 mL/min based on testing done during screening (prescribed group)
* Have PrEP clinical and laboratory monitoring by another provider or clinic by self-report (non-prescribed group)
* No contraindications to TDF/FTC use
* No evidence of chronic HBV infection based on testing done during screening (prescribed group)
* Willing to self-collect urine samples weekly
Exclusion Criteria:
* Repeatedly reactive HIV test at screening or enrollme…
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.