Parrying the Pitfalls of PrEP: Project PEACH (NCT05072093) | Clinical Trial Compass
CompletedPhase 4
Parrying the Pitfalls of PrEP: Project PEACH
United States240 participantsStarted 2021-11-20
Plain-language summary
The study is a prospective cohort of young MSM who are followed for 2 years either in-person at the PRISM Health Research Clinic and/or virtually with telehealth study visits. Follow-up visits occur as frequently as every 3 months, or as appropriate to clinical needs of HIV PrEP or STI PEP. The investigators will enroll men who may decide to start or stop PrEP, change from daily oral PrEP to on-demand oral PrEP or from on-demand oral PrEP to daily PrEP, to start or stop STI PEP at any point in the study period, or injectable PrEP as an alternative to daily oral PrEP or on-demand oral PrEP. All men will be provided with the study's mobile smart phone app to support early identification of risks for PrEP discontinuation, to provide information about STI PEP and document usage patterns of on-demand oral PrEP and STI PEP, and to support easy linkage to support services for PrEP counseling and addressing concerns or questions about STI PEP and injectable PrEP.
Who can participate
Age range
18 Years – 45 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 at birth
* Self-identify as Cisgender Male
* Ages 18-45 years
* ≥1 male anal sex partner in the 12 months before the baseline interview
* Live in the Atlanta MSA
* Owns cell phone with data service
* Willing to download a health-related app to their cell phone as part of the research study
* Able to provide ≥ 2 means of contact
* Not currently enrolled in another HIV prevention clinical trial
* Confirmed HIV-negative at baseline visit
Exclusion Criteria:
* Female at birth
* Do not self-identify as Cisgender Male
* Individuals \< 18 years of age or \> 45 years of age
* HIV positive status
* No male anal sex partner in the 12 months before the baseline interview
* Does not own mobile phone with data service
* Not willing to download a health-related app to their cell phone as part of the research study
* Live outside the metro Atlanta MSA and/or planning to move from Atlanta area in the next 2 years
* Currently enrolled in an HIV prevention or treatment clinical trial
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
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 Men Who Discontinue Daily Oral PrEP
Timeframe: 24 month post intervention
2
Number of Men Who Initiate On-demand Oral PrEP
Timeframe: 24 month post intervention
3
Number of Men Who Initiate Long-acting Injectable PrEP
Timeframe: 24 month post intervention
4
Number of STI Diagnoses
Timeframe: Baseline, 12 and 24 months post intervention