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NCT04973267 · ClinicalTrials.gov registry record · NA
Game Plan for PrEP
A NA study of Alcohol; Harmful Use and Human Immunodeficiency Virus Exposure, sponsored by Brown University.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
- 1
- Study location
NCT04973267: Completed NA study of Alcohol; Harmful Use and Human Immunodeficiency Virus Exposure, sponsored by Brown University.
NCT04973267 is a NA study of Alcohol; Harmful Use and Human Immunodeficiency Virus Exposure that has completed, run by Brown University. The registered enrollment target is 73 participants, below the 372-participant average among 9 other Alcohol; Harmful Use trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04973267, a NA study of Alcohol; Harmful Use and Human Immunodeficiency Virus Exposure, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
- 1
- Study location
Study Summary
This small pilot randomized controlled trial will test whether a brief, web-based intervention inspired by the principles of motivational interviewing helps high-risk men who take pre-exposure prophylaxis (PrEP) moderate their alcohol use, and improve key outcomes of PrEP care, including adherence, persistence, and STI rates. Men with a history of "lapses" in PrEP adherence will be randomly assigned to either (1) use the web-based intervention, called Game Plan for PrEP, or (2) watch video clips encouraging healthy lifestyles (e.g., sleep hygiene, balanced diet; attention-matched control). Participants will complete STI testing and submit dried blood spot (DBS) samples to facilitate analyses of alcohol use and PrEP adherence biomarkers at baseline, 3-months, and 6-months during the study period. Participants will also complete online surveys at baseline, 1-month, 3-months, and 6-months during the study period.
Primary Outcome
Number of participants who reported missing 4+ consecutive days of PrEP doses
Conditions Studied
Interventions
- BEHAVIORAL Game Plan for PrEP
- BEHAVIORAL Attention-Matched Control Lifestyle Habits Videos
Study Locations (1)
Rhode Island
- Brown University - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2023-02-28 |
| Phase | NA |
What the finished NCT04973267 record still lists
NCT04973267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 372-participant average among 9 other Alcohol; Harmful Use trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Alcohol; Harmful Use appearing as the primary indexed condition, and to 2 interventions - of which Game Plan for PrEP is the first listed.
NCT04973267 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT04973267 about?
NCT04973267 is a clinical study titled "Game Plan for PrEP". This small pilot randomized controlled trial will test whether a brief, web-based intervention inspired by the principles of motivational interviewing helps high-risk men who take pre-exposure prophylaxis (PrEP) moderate their alcohol use, and improve key outcomes of PrEP care, including adherence, ...
What is the current status of trial NCT04973267?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2021-07-01. Estimated completion is 2023-02-28.
What conditions does trial NCT04973267 study?
This clinical trial studies the following conditions: Alcohol; Harmful Use, Human Immunodeficiency Virus Exposure.
What interventions are being tested in trial NCT04973267?
The interventions under investigation include: Game Plan for PrEP (BEHAVIORAL), Attention-Matched Control Lifestyle Habits Videos (BEHAVIORAL).
Who is sponsoring clinical trial NCT04973267?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04973267 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04973267's enrollment target sits among peer trials
73 7th of 9 higher than 3 of 9 other Alcohol; Harmful Use trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol; Harmful 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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