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NCT04899024 · ClinicalTrials.gov registry record · NA
PrEP Affect Regulation Treatment Innovation
A NA study of Medication Adherence and HIV Prevention, sponsored by Florida International University.
- Active
- Registry status
- NA
- Development phase
- 239
- Enrollment target
- 2
- Study locations
NCT04899024: Active NA study of Medication Adherence and HIV Prevention, sponsored by Florida International University.
NCT04899024 is a NA study of Medication Adherence and HIV Prevention that is active but no longer recruiting, run by Florida International University. The registered enrollment target is 239 participants, below the 1,652-participant average among 52 other Medication Adherence trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04899024, a NA study of Medication Adherence and HIV Prevention, is active but no longer recruiting, sponsored by Florida International University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 239 participants
- Enrollment target
- 2
- Study locations
Study Summary
This multi-site randomized controlled trial enrolling sexual minority men who use stimulants and are currently taking pre-exposure prophylaxis (PrEP). This randomized controlled trial will test the efficacy of a PrEP Affect Regulation Treatment Innovation (PARTI) condition comprised of a 5-session positive affect intervention delivered during smartphone-based Contingency Management (CM) for directly observed PrEP doses (PARTI+CM) compared to an attention-control condition delivered during CM. The primary outcome is HIV acquisition risk measured using a combination of tenofovir-diphosphate levels in dried blood spots that are indicative of sub-optimal adherence to PrEP and recent condomless anal sex.
Primary Outcome
Percentage of participants engaging in HIV acquisition risk (i.e., defined as tenofovir - diphosphate levels from dried blood spots that are indicative of less than four oral PrEP doses per week AND any self-reported recent condomless anal sex)
Conditions Studied
Interventions
- BEHAVIORAL PARTI
- BEHAVIORAL Attention-Control
- BEHAVIORAL Contingency Management for PrEP Adherence
Study Locations (2)
California
- University of California, San Francisco - San Francisco
Florida
- University of Miami Miller School of Medicine - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2022-01-31 |
| Est. Completion | 2026-12-01 |
| Phase | NA |
What the registry record for NCT04899024 still lists
NCT04899024 is an interventional study that assigns participants to a tested intervention. The registered 239 participants enrollment target is mid-sized for trials with a published cap, below the 1,652-participant average among 52 other Medication Adherence trials with a reported enrollment target (86% lower).
The record links to 3 conditions, with Medication Adherence appearing as the primary indexed condition, and to 3 interventions - of which PARTI is the first listed.
NCT04899024 reports a single indexed study location in California, Florida.
Frequently Asked Questions
What is clinical trial NCT04899024 about?
NCT04899024 is a clinical study titled "PrEP Affect Regulation Treatment Innovation". This multi-site randomized controlled trial enrolling sexual minority men who use stimulants and are currently taking pre-exposure prophylaxis (PrEP). This randomized controlled trial will test the efficacy of a PrEP Affect Regulation Treatment Innovation (PARTI) condition comprised of a 5-session p...
What is the current status of trial NCT04899024?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 239 participants. The study started on 2022-01-31. Estimated completion is 2026-12-01.
What conditions does trial NCT04899024 study?
This clinical trial studies the following conditions: Medication Adherence, HIV Prevention, Stimulant Use.
What interventions are being tested in trial NCT04899024?
The interventions under investigation include: PARTI (BEHAVIORAL), Attention-Control (BEHAVIORAL), Contingency Management for PrEP Adherence (BEHAVIORAL).
Who is sponsoring clinical trial NCT04899024?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04899024 being conducted?
This trial has 2 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04899024's enrollment target sits among peer trials
239 17th of 52 higher than 36 of 52 other Medication Adherence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Medication Adherence 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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