Phase 4
N=240
Parrying the Pitfalls of PrEP: Project PEACH
HIV · STI
Bottom Line
View on ClinicalTrials.gov: NCT05072093 ↗Enrolled (actual)
240
Serious AEs
0.8%
Results posted
Apr 2026
Primary outcome: Primary: Number of Men Who Discontinue Daily Oral PrEP — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- PrEP discontinuation intervention (Behavioral); Offering of on-demand oral PrEP (Drug); Offering of STI PEP (Drug); Injectable PrEP (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Emory University
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Men Who Discontinue Daily Oral PrEP |
18 | — |
| PRIMARY Number of Men Who Initiate On-demand Oral PrEP |
59 | — |
| PRIMARY Number of Men Who Initiate Long-acting Injectable PrEP |
12 | — |
| PRIMARY Number of STI Diagnoses |
77; 33; 21 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT05072093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.