Game Plan for PrEP

Game Plan for PrEP: A Pilot Trial of a Web-based Intervention to Help High-risk Men on PrEP Adhere to Their Medication, Reduce Alcohol Use, and Encourage Safe Sex

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.

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.

Participants will be randomly assigned 1:1 to one of two conditions: (1) Game Plan for PrEP and (2) an attention-matched control consisting of videos encouraging healthy lifestyle habits.

Investigators will be blinded to study condition. Staff collecting dried blood spot samples will also be blinded to condition. Participants will be encouraged to complete online surveys using an automated email system, so outcomes assessors will not be present.

Participants will be asked to use Game Plan for PrEP for however long they wish. Game Plan for PrEP is a web-based intervention that provides users with feedback about how much their risk for HIV is reduced on PrEP, their risk for bacterial STIs, and helps them make a plan to take their medication regularly and reduce their risk for STIs. Game Plan for PrEP also providers users with feedback about their alcohol use compared to others in their age group and encourages them to make a plan to reduce it.

Participants in this condition will view several videos that encourage them to adopt sleep hygiene and healthy diet behaviors. The videos were selected to last as long as the average time users engage with Game Plan for PrEP in its initial modules.

Whether or not participants were diagnosed with any bacterial STI (genital, oral, or rectal Chlamydia or Gonorrhea or Syphilis) at 3- and 6-months

The average number of standard alcoholic drinks consumed when participants reported drinking over the past 30 days

The total number of days on which participants reported drinking 5+ drinks in a single day over the past 30 days

The quantity of phosphatidylethanol detected in dried blood spot samples collected at 3- and 6-months

The quantity of tenofovir diphosphate detected in dried blood spot samples collected at 3- and 6-months

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