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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 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.

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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.

Conditions Studied

Alcohol; Harmful Use Human Immunodeficiency Virus Exposure

Interventions

  • BEHAVIORAL Game Plan for PrEP
  • BEHAVIORAL Attention-Matched Control Lifestyle Habits Videos

Study Locations (1)

Rhode Island

  • Brown University - Providence

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2021-07-01
Est. Completion 2023-02-28
Phase NA

Sponsor

Brown University

231 total trials

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What the Registry Record Tells You About NCT04973267

The ClinicalTrials.gov registry entry for NCT04973267 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 372-participant average among 9 other Alcohol; Harmful Use trials with a reported enrollment target (80% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.