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NCT06631365 · ClinicalTrials.gov registry record · Phase 2
PrEPsmart 2-1-1 Pilot
A Phase 2 study of HIV-1-infection, sponsored by Public Health Foundation Enterprises.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06631365: Recruiting Phase 2 study of HIV-1-infection, sponsored by Public Health Foundation Enterprises.
NCT06631365 is a Phase 2 study of HIV-1-infection that is actively recruiting participants, run by Public Health Foundation Enterprises. The registered enrollment target is 60 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06631365, a Phase 2 study of HIV-1-infection, is actively recruiting participants, sponsored by Public Health Foundation Enterprises.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Acceptability will be measured using the Client Satisfaction Questionnaire (CSQ-8) adapted for use in PrEPsmart pilot. The study team will also assess interest in future use of the app at study completion.
Conditions Studied
Interventions
- DEVICE PrEPsmart mobile app
- DRUG Truvada
Study Locations (1)
California
- Bridge HIV, San Francisco Department of Public Health - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2025-04-01 |
| Phase | Phase 2 |
What NCT06631365 shows while recruiting
NCT06631365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (83% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 2 interventions - of which PrEPsmart mobile app is the first listed.
NCT06631365 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06631365 about?
NCT06631365 is a clinical study titled "PrEPsmart 2-1-1 Pilot". 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 inno...
What is the current status of trial NCT06631365?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-10-02. Estimated completion is 2025-04-01.
What conditions does trial NCT06631365 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT06631365?
The interventions under investigation include: PrEPsmart mobile app (DEVICE), Truvada (DRUG).
Who is sponsoring clinical trial NCT06631365?
This trial is sponsored by Public Health Foundation Enterprises, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06631365 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV-1-infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06631365's enrollment target sits among peer trials
60 45th of 71 higher than 27 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection 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.
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