Combatting HIV Or Other STIs Early (CHOOSE) (NCT07510048) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Combatting HIV Or Other STIs Early (CHOOSE)
United States200 participantsStarted 2026-04
Plain-language summary
The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people. It is hypothesized that PrEP Choice will improve HIV PrEP uptake and adherence among young people and will be cost-effective to deliver to young people in the United States (U.S.). This study will also assess the uptake, adherence, and acceptability of DoxyPEP among young people.
Who can participate
Age range
13 Years – 24 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 13-24 years, inclusive;
* Self-reports being at increased likelihood for HIV acquisition, defined as having anal sex with a male in their lifetime;
* Owns an iOS or Android Smartphone and able to access all elements of the PrEP Choice package;
* Not currently on PrEP and interested in learning more about PrEP;
* Is not living with HIV;
* Weighs at least 35 kg;
* Willing to receive PrEP care from a provider at a participating ATN SC;
* Able to understand, read, and speak English;
* Able to participate at the study site; and
* Willing and able to provide written informed consent.
* If of legal age or otherwise able to provide independent informed consent as determined by local law and consistent with IRB policies: Willing and able to provide written informed consent for study participation.
* If not of legal age or otherwise not able to provide independent informed consent as determined by local law and consistent with IRB policies: Parent or legal guardian is willing and able to provide written informed consent for study participation and potential participant is willing and able to provide written assent for study participation.
Exclusion Criteria:
* Female;
* In a mutually monogamous sexual relationship with a partner not living with HIV for the past 12 months;
* Currently participating in an interventional trial of PrEP agents, or prior enrollment in HPTN 083, HPTN 083-01, or any other study of long-acting PrEP (including PURPOSE- 2 lenacapavir s…
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
PrEP Uptake; proportion of participants receiving PrEP from the study site within 9 months of study follow-up
Timeframe: first 9 months of follow up
2
PrEP Adherence; rate at which participants who received PrEP on study adhere to selected PrEP regimen as measured by dried blood spot for oral regimen and by the on-time CAB-LA and LEN injections for injectable PrEP
Timeframe: first 9 months of follow-up
3
DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site
Timeframe: 18 months of follow up
4
DoxyPEP Adherence; the rate at which participants are adherent to DoxyPEP coverage of condomless sexual exposures as measured by self-report
Timeframe: 18 months of follow up
5
DoxyPEP Acceptability; assessed by Likert scale every 3 months of study follow-up