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

Completed · Not applicable

Conditions studied: Sexually Transmitted Diseases, Bacterial, Alcohol; Harmful Use

In brief

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.

Key facts

Study ID

NCT04552171

Run by

Brown University

People needed

314

Starts

2021-08-13

Expected to finish

2025-09-30

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Brown University School of Public Health — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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