Game Plan: Efficacy of a Brief, Web-based Intervention on Alcohol Use and Sexually-transmitted Infections

Alcohol; Harmful Use Clinical Trial

Official title:

Game Plan: Testing the Efficacy of a Brief, Web-based Intervention in Reducing Heavy Drinking and Reducing Sexually-transmitted Infections Among High-risk Men Completing Self-testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04552171
• Other study ID #: 2003002671
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2022
• Source: Brown University
• Contact: Tyler B Wray, PhD
• Phone: 4018636659
• Email: tyler_wray[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study involves conducting a larger-scale study exploring Game Plan's effects among MSM in the real-world, alongside innovative approaches for expanding HIV testing. Using a hybrid 1 effectiveness-implementation approach, the investigators will recruit up to 360 high-risk, heavy drinking MSM online from several high-incidence areas in the US to participate in a program providing home-based HIV/STI self-tests in the mail at regular intervals over a year (baseline, 6 months, 12 months). Participants will be randomly assigned to receive access to either (1) a 24-hour helpline for counseling/referrals, or (2) the helpline plus Game Plan. Investigators will test whether those who use Game Plan show lower rates of heavy drinking, any STIs, and high-risk CAS events compared to those receiving access to the helpline alone.

Description:

This is a hybrid 1 effectiveness-implementation, mixed methods study that involves conducting a longitudinal randomized controlled trial in which high-risk, heavy drinking MSM (N = 360) will be recruited online from several high-incidence US cities: Atlanta, Los Angeles, Miami, New Orleans, Washington DC/Baltimore. Participants will be sent HIV and STI self-testing kits at baseline, 6 mo., and 12 mo. Along with their test kits, they will be randomized to receive access to either: (1) a 24-hour helpline providing free standard post-test counseling and referral, or (2) the 24-hour helpline plus the Game Plan app. Test kits will provide testing and results for HIV, Syphilis, and genital, rectal, and pharyngeal Gonorrhea and Chlamydia, as well as phosphatidylethanol (PEth). Participants will also be asked to complete an online follow-up survey every three months that assess drinking, sexual behavior, and use of prevention methods over the 12-month study period. At 12 mo., 30 participants and 12 HST stakeholders will be recruited to participate in qualitative interviews to issues relevant to implementing Game Plan alongside HIV testing programs. Specifically, this study aims to: (1) test whether using a brief, MI-inspired, web-based intervention (Game Plan) after HST reduces (a) binge drinking, (b) the average number of drinks per drinking day over 12 months among heavy-drinking and high-risk, HIV-negative MSM, compared to providing access to a 24h helpline providing risk-reduction counseling alone, (2) test whether using Game Plan results in lower rates of (a) bacterial STIs, (b) high-risk CAS, and (c) higher rates of PrEP uptake over 12 months, and (3) to assess Game Plan's potential for implementation into self-testing programs by examining indicators of adoption, engagement, appropriateness and satisfaction among MSM assigned to have access to the site. Investigators will use site metrics and responses, survey data, and in-depth qualitative interview data from users and virtual focus groups with stakeholders to help address key implementation questions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Assigned male sex at birth
• Currently male gender
• 18+ years old
• HIV-negative or unknown status
• Able to speak and read English or Spanish fluently
• Report drinking heavily within the past month, defined according to NIAAA guidelines as having drank >5 drinks on a single occasion at least once or an average of >14 drinks in a given week
• Not being currently prescribed or taking PrEP
• Having met at least one of three HIV-risk-related PrEP eligibility criteria in the last 6 months: (a) having been diagnosed with an STI, (b) currently having regular anal sex with a man who is HIV-positive, or (c) having had anal sex without a condom with a man outside of the context of a sexually exclusive relationship with a single partner who has been recently tested and is HIV-negative.

Exclusion Criteria:

• Injection drug use in the past year
• Screened positive for drug use disorder
• Report history or risk of complicated alcohol withdrawal
• Report currently receiving medications or counseling for an alcohol or drug use disorder

Related Conditions & MeSH terms

• Alcohol; Harmful Use
• Sexually Transmitted Diseases
• Sexually Transmitted Diseases, Bacterial

Intervention

Behavioral:
• Access to Game Plan app and 24-hour helpline
Game Plan is a web-based application that helps users reflect on their risk for HIV and level of alcohol use, and if interested, make a plan for reducing their sexual risk or drinking.

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of alcohol drinking days in the past 30 days	Total number of days in which participants reported drinking over the 30 days preceding each follow-up	3 months, 6 months, 9 months, 12 months
Primary	Number of heavy (5+ standard drinks) alcohol drinking days in the past 30 days	Total number of days on which participants reported consuming 5+ standard drinks in a given day over the 30 days preceding each follow-up	3 months, 6 months, 9 months, 12 months
Primary	Average number of standard drinks consumed on a drinking day in the past 30 days	The average number of standard drinks participants reported consuming when they drank over the 30 days preceding each follow-up	3 months, 6 months, 9 months, 12 months
Primary	Any new bacterial sexually-transmitted infection diagnosis	Whether or not participants were diagnosed with a bacterial sexually-transmitted infection (Chlamydia or Gonorrhea at genital, oral, or rectal sites, or Syphilis) in the past 6 months	6 months, 12 months
Primary	Number of sex events that pose risk for sexually-transmitted infections in the past 30 days	The total number of sex events in which participants reported engaging in insertive or receptive anal sex with a non-exclusive partner or partner whose HIV status is uncertain without using a condom, or for those who have started PrEP, without reporting having taken a dose within 2 days of sex occurring, in the 30 days preceding each follow-up	3 months, 6 months, 9 months, 12 months
Primary	Receiving a prescription for pre-exposure prophylaxis	Whether or not participants reported receiving a prescription for pre-exposure prophylaxis in the 6 months prior to each follow-up	6 months, 12 months
Secondary	HIV diagnosis	Whether or not participants were diagnosed with HIV at any time during the 12-month study period	6 months, 12 months
Secondary	Phosphatidylethanol quantity	The quantity of phosphatidylethanol detected in dried blood spots collected at 6- and 12-months	6 months, 12 months