Clinical Trials Logo

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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05533554 - Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students N/A
Not yet recruiting NCT06337721 - Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults N/A
Active, not recruiting NCT04090723 - Using CBPR to Engage Hazardous Drinking Women in the HIV Prevention and Care Continuum N/A
Completed NCT03488927 - Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking N/A
Completed NCT03755661 - MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM N/A
Enrolling by invitation NCT04147520 - Reducing Hazardous Alcohol Use in Social Networks Using Targeted Intervention: 21 Rising N/A
Recruiting NCT04164940 - Patient Trajectories for Older Adults Admitted to Hospital for Alcohol-related Problems
Completed NCT01125371 - Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women N/A
Completed NCT03483389 - Alcohol and Immune Response N/A
Completed NCT03449095 - Understanding Alcohol Reward in Social Context N/A
Completed NCT04494633 - Summative Assessment of the BurntOut 3D Simulation With Medical Students N/A
Not yet recruiting NCT06286774 - Sleep as a Mechanism of Change in Alcohol Use N/A
Completed NCT04229550 - Metabolic Effects of One-weak Heavy Drinking N/A
Completed NCT03589508 - Testing A Couple-based Program for Alcohol Risk Reduction in the National Guard N/A
Completed NCT04263259 - Efficacy and Mechanisms of Mobile-Delivered Alcohol Attentional Bias Modification N/A
Active, not recruiting NCT06022107 - Social Support Intervention for Addiction Recovery N/A
Completed NCT03116282 - E-alcohol Therapy - an Evaluation of Alcohol Therapy Delivered Via Video Conference N/A
Recruiting NCT04594304 - Screening While You Wait 2: Alcohol and Tobacco Use N/A
Completed NCT03884478 - A Gamified, Social Media Inspired Personalized Normative Feedback Alcohol Intervention for Sexual Minority Women N/A
Active, not recruiting NCT03467191 - Behavioral Alcohol Responses (BAR) Study Early Phase 1