Clinical trial NCT04973267: Game Plan for PrEP
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus Exposure
Alcohol; Harmful Use
Keywords: PrEP
Alcohol Use
HIV
STIs
LGBTQ
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-07-22
Enrollment: 73
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Pre-exposure Prophylaxis (PrEP) Lapse Days
timeFrame: 6 months
measure: Persistence With Pre-exposure Prophylaxis (PrEP)
timeFrame: Past 6 months
measure: Number of Alcohol Drinking Days
timeFrame: Month 1, Month 3, and Month 6
measure: Average Number of Drinks Consumed Per Drinking Day
timeFrame: Month 1, Month 3, and Month 6
measure: Number of Heavy Drinking Days (5+ Drinks on a Single Occasion)
timeFrame: Month 1, Month 3, and Month 6
Secondary outcomes:
measure: Phosphatidylethanol Level
timeFrame: Month 3 and Month 6
measure: Tenofovir Diphosphate Adherence
timeFrame: Month 3 and Month 6
measure: Any Sexually-transmitted Infection (STI) Diagnosis
timeFrame: 6 Months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Tyler Wray, PhD
role: PRINCIPAL_INVESTIGATOR
References: