Game Plan for PrEP

Alcohol; Harmful Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04973267
• Other study ID #: 2105002999
• Secondary ID: 5R34AA027195
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: July 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Alcohol; Harmful Use
• HIV Infections

Intervention

Behavioral:
• Game Plan for PrEP
See arm description.
• Attention-Matched Control Lifestyle Habits Videos
Web-based videos providing information on sleep hygiene and proper diet.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-exposure prophylaxis (PrEP) lapse days	Number of days that were part of a period of 3+ days of missed PrEP doses, past 30 days	Past 30 days
Primary	Persistence with pre-exposure prophylaxis (PrEP)	Whether or not participants were taking any prescribed PrEP throughout the 6-month study period	Past 6 months
Primary	Any sexually-transmitted infection (STI) diagnosis	Whether or not participants were diagnosed with any bacterial STI (genital, oral, or rectal Chlamydia or Gonorrhea or Syphilis) at 3- and 6-months	Past 3 months
Primary	Number of alcohol drinking days	The total number of days in which participants reported drinking alcohol in the past 30 days	Past 30 days
Primary	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	Past 30 days
Primary	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	Past 30 days
Secondary	Phosphatidylethanol level	The quantity of phosphatidylethanol detected in dried blood spot samples collected at 3- and 6-months	Past 3 months
Secondary	Tenofovir diphosphate level	The quantity of tenofovir diphosphate detected in dried blood spot samples collected at 3- and 6-months	Past 3 months