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Completed

NCT Number: NCT04973267

Game Plan for PrEP

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.

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Key information

Conditions

Human Immunodeficiency Virus Exposure Alcohol Drinking Alcohol; Harmful Use Behavior Communicable Diseases Disease Attributes Drinking Behavior Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Game Plan for PrEP

Behavioral

See arm description.

Attention-Matched Control Lifestyle Habits Videos

Behavioral

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

Primary outcomes

  1. Pre-exposure Prophylaxis (PrEP) Lapse Days

    Time frame: 6 months

    Number of participants who reported missing 4+ consecutive days of PrEP doses

  2. Persistence With Pre-exposure Prophylaxis (PrEP)

    Time frame: Past 6 months

    Whether or not participants explicitly stopped taking PrEP at some point during the 6-month study period

  3. Number of Alcohol Drinking Days

    Time frame: Month 1, Month 3, and Month 6

    The total number of days in which participants reported drinking alcohol in the past 30 days

  4. Average Number of Drinks Consumed Per Drinking Day

    Time frame: Month 1, Month 3, and Month 6

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

  5. Number of Heavy Drinking Days (5+ Drinks on a Single Occasion)

    Time frame: Month 1, Month 3, and Month 6

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

Secondary outcomes

  1. Phosphatidylethanol Level

    Time frame: Month 3 and Month 6

    The quantity of phosphatidylethanol (PEth) detected in dried blood spot samples collected at 3- and 6-months, ng/mL

  2. Tenofovir Diphosphate Adherence

    Time frame: Month 3 and Month 6

    The predicted probability of tenofovir diphosphate adherence (>= 4 doses/week) detected in dried blood spot samples collected at 3- and 6-months

  3. Any Sexually-transmitted Infection (STI) Diagnosis

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2021
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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