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.

Study Overview

• Status: Completed
• Conditions: Alcohol; Harmful Use; Human Immunodeficiency Virus Exposure
• Intervention / Treatment: Behavioral: Game Plan for PrEP; Behavioral: Attention-Matched Control Lifestyle Habits Videos

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Game Plan for PrEP; 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.	Behavioral: Game Plan for PrEP; See arm description.
Sham Comparator: Lifestyle Habits Videos; 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.	Behavioral: Attention-Matched Control Lifestyle Habits Videos; Web-based videos providing information on sleep hygiene and proper diet.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Tyler Wray, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: HIV; PrEP; STIs; Alcohol Use; LGBTQ
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 2105002999; 5R34AA027195 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No