Game Plan for PrEP

NCT04973267 | Completed Results

• 2 other identifiers: 21050029995R34AA027195
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus Exposure; Alcohol; Harmful Use

Keywords

PrEP; Alcohol Use; HIV; STIs; LGBTQ

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Phosphatidylethanol Level

  Month 3 and Month 6

• Tenofovir Diphosphate Adherence

  Month 3 and Month 6

• Any Sexually-transmitted Infection (STI) Diagnosis

  6 Months

Study Arms (2)

Game Plan for PrEP

EXPERIMENTAL

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

Lifestyle Habits Videos

SHAM COMPARATOR

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

Interventions

Game Plan for PrEP BEHAVIORAL

See arm description.

Game Plan for PrEP

Attention-Matched Control Lifestyle Habits Videos BEHAVIORAL

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

Lifestyle Habits Videos

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligible participants will be assigned male sex at birth and report current male gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current male gender
• + 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Tyler Wray, PhD
• Organization: Brown University - SPH

tyler_wray@brown.edu

4018636659

Study Officials

• Tyler Wray, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: July 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)