Game Plan for PrEP

NCT ID: NCT04973267

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-02-28

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.

Conditions

Human Immunodeficiency Virus Exposure; Alcohol; Harmful Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Game Plan for PrEP

Intervention Type: BEHAVIORAL

See arm description.

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.

Group Type: SHAM_COMPARATOR

Attention-Matched Control Lifestyle Habits Videos

Intervention Type: BEHAVIORAL

Web-based videos providing information on sleep hygiene and proper diet.

Interventions

Game Plan for PrEP

See arm description.

Intervention Type: BEHAVIORAL

Attention-Matched Control Lifestyle Habits Videos

Web-based videos providing information on sleep hygiene and proper diet.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tyler Wray, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R34AA027195

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2105002999

Identifier Type: -

Identifier Source: org_study_id