Game Plan for PrEP

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    100
  • sponsor
    Brown University
Updated on 10 September 2021

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.

Description

This small, pilot randomized controlled trial will explore preliminary evidence for the efficacy of Game Plan for PrEP, a brief, web-based intervention inspired by brief motivational interventions. The study will test whether Game Plan for PrEP is efficacious in reducing heavy drinking and sexually-transmitted infection (STI) incidence, and improving PrEP adherence/persistence, among heavy drinking MSM who are on PrEP, but who report a recent history of missing 3 or more consecutive doses in the past month. In this study, we will randomize 50 gay and bisexual men to receive either (1) Game Plan for PrEP (GP4PrEP) or (2) an attention-matched control at the same PrEP care/monitoring visit that they reported meeting eligibility criteria. We will use self-report measures of alcohol use collected at 1-, 3-, and 6-months and changes in a biomarker of alcohol use collected at baseline, 3-, and 6-months to explore whether Game Plan for PrEP reduces binge drinking compared with control. We will also use data from a biomarker of PrEP adherence to explore whether Game Plan for PrEP improves PrEP adherence versus control.

Details
Condition Human Immunodeficiency Virus Exposure, Alcohol; Harmful Use
Treatment Game Plan for PrEP, Attention-Matched Control Lifestyle Habits Videos
Clinical Study IdentifierNCT04973267
SponsorBrown University
Last Modified on10 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Current male gender
+ years old
Fluent in English
Heavy alcohol use in the past month (>5 drinks on a single occasion or >14 drinks in a week)
Currently prescribed and actively taking PrEP
Report missing > 3 PrEP doses in a row at least once in the past 3 months

Exclusion Criteria

Reporting a history or risk of complicated alcohol withdrawal
Reporting currently receiving medications or counseling for an alcohol or drug use disorder
Injection drug use in the past year
Positive screen for drug-related disorders
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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