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NCT05072093 · ClinicalTrials.gov registry record · Phase 4
Parrying the Pitfalls of PrEP: Project PEACH
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 240
- Enrollment target
NCT05072093: Completed Phase 4 study, sponsored by Emory University.
NCT05072093 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 240 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05072093, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 240 participants
- Enrollment target
Study 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.
Primary Outcome
MSM taking daily oral PrEP will complete monthly screener surveys delivered through study app to assess for PrEP stop intentions. After early identification, they will receive Motivational Interviewing (MI) to avoid discontinuation. Participants that discontinue PrEP will be measured.
Interventions
- BEHAVIORAL PrEP discontinuation intervention
- DRUG Offering of on-demand oral PrEP
- DRUG Offering of STI PEP
- DRUG Injectable PrEP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2021-11-20 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 4 |
What the finished NCT05072093 record still lists
NCT05072093 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 4 interventions - of which PrEP discontinuation intervention is the first listed.
NCT05072093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05072093 about?
NCT05072093 is a clinical study titled "Parrying the Pitfalls of PrEP: Project PEACH". 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 inve...
What is the current status of trial NCT05072093?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 240 participants. The study started on 2021-11-20. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT05072093?
The interventions under investigation include: PrEP discontinuation intervention (BEHAVIORAL), Offering of on-demand oral PrEP (DRUG), Offering of STI PEP (DRUG), Injectable PrEP (DRUG).
Who is sponsoring clinical trial NCT05072093?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05072093's enrollment target sits among peer trials
240 360th of 2000 higher than 1,635 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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