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NCT04331704 · ClinicalTrials.gov registry record · Phase 4
ANCHORS Alcohol & Sexual Health Study: UH3 Project
A Phase 4 study of Substance Use and Alcohol Use, Unspecified, sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 88
- Enrollment target
- 1
- Study location
NCT04331704: Recruiting Phase 4 study of Substance Use and Alcohol Use, Unspecified, sponsored by University of Florida.
NCT04331704 is a Phase 4 study of Substance Use and Alcohol Use, Unspecified that is actively recruiting participants, run by University of Florida. The registered enrollment target is 88 participants, below the 1,259-participant average among 88 other Substance Use trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04331704, a Phase 4 study of Substance Use and Alcohol Use, Unspecified, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 88 participants
- Enrollment target
- 1
- Study location
Study Summary
80 young adult men will complete an initial survey and receive 1 of 2 types of alcohol and sexual health education and information to encourage prevention of alcohol-related problems, HIV and other sexually transmitted infections (STIs). Participants will then take pre-exposure prophylaxis (PrEP) for HIV prevention and complete a daily 5-minute, telephone-based interactive voice response (IVR) assessment of alcohol/substance use, sexual behavior and PrEP taking for 30 days. Medication will all be active PrEP. There is no placebo control in this study. Follow-up will occur after 30-days and 6-months later.
Primary Outcome
Change in self-reported number of alcoholic drinks per week
Conditions Studied
Interventions
- DRUG PrEP acronym (pre-exposure prophylaxis)
- BEHAVIORAL Initial Web Survey
- BEHAVIORAL Interactive Voice Response (IVR) monitoring
- BEHAVIORAL Educational material on alcohol and sexual health behavior
- BEHAVIORAL Interactive Voice Response (IVR) assessment with personalized information
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2021-01-12 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 4 |
What NCT04331704 shows while recruiting
NCT04331704 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 1,259-participant average among 88 other Substance Use trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Substance Use appearing as the primary indexed condition, and to 5 interventions - of which PrEP acronym (pre-exposure prophylaxis) is the first listed.
NCT04331704 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04331704 about?
NCT04331704 is a clinical study titled "ANCHORS Alcohol & Sexual Health Study: UH3 Project". 80 young adult men will complete an initial survey and receive 1 of 2 types of alcohol and sexual health education and information to encourage prevention of alcohol-related problems, HIV and other sexually transmitted infections (STIs). Participants will then take pre-exposure prophylaxis (PrEP) fo...
What is the current status of trial NCT04331704?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2021-01-12. Estimated completion is 2026-06-30.
What conditions does trial NCT04331704 study?
This clinical trial studies the following conditions: Substance Use, Alcohol Use, Unspecified, Sex Behavior.
What interventions are being tested in trial NCT04331704?
The interventions under investigation include: PrEP acronym (pre-exposure prophylaxis) (DRUG), Initial Web Survey (BEHAVIORAL), Interactive Voice Response (IVR) monitoring (BEHAVIORAL), Educational material on alcohol and sexual health behavior (BEHAVIORAL), Interactive Voice Response (IVR) assessment with personalized information (BEHAVIORAL).
Who is sponsoring clinical trial NCT04331704?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04331704 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04331704's enrollment target sits among peer trials
88 64th of 88 higher than 25 of 88 other Substance Use trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Substance Use 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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