Game Plan for PrEP

Not Applicable

Completed

Brief 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.

Detailed 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 men who have sex with men 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.

Recruitment & Eligibility

Inclusion Criteria

Current male gender
18+ 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

Primary Outcome Measures

Name	Time	Method
Persistence With Pre-exposure Prophylaxis (PrEP)	Past 6 months	Whether or not participants explicitly stopped taking PrEP at some point during the 6-month study period
Number of Alcohol Drinking Days	Month 1, Month 3, and Month 6	The total number of days in which participants reported drinking alcohol in the past 30 days
Average Number of Drinks Consumed Per Drinking Day	Month 1, Month 3, and Month 6	The average number of standard alcoholic drinks consumed when participants reported drinking over the past 30 days
Number of Heavy Drinking Days (5+ Drinks on a Single Occasion)	Month 1, Month 3, and Month 6	The total number of days on which participants reported drinking 5+ drinks in a single day over the past 30 days
Pre-exposure Prophylaxis (PrEP) Lapse Days	6 months	Number of participants who reported missing 4+ consecutive days of PrEP doses

Secondary Outcome Measures

Name	Time	Method
Tenofovir Diphosphate Adherence	Month 3 and Month 6	The predicted probability of tenofovir diphosphate adherence (\>= 4 doses/week) detected in dried blood spot samples collected at 3- and 6-months
Any Sexually-transmitted Infection (STI) Diagnosis	6 Months
Phosphatidylethanol Level	Month 3 and Month 6	The quantity of phosphatidylethanol (PEth) detected in dried blood spot samples collected at 3- and 6-months, ng/mL