Clinical Trial

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

Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial completed 2026-07-29
notable Enrollment reduced: 500 -> 314 participants 2026-07-29
minor Completion moved earlier: 2025-12-31 -> 2025-09-30 2026-07-29
Trial Details
NCT Number NCT04552171
Lead Sponsor Brown University
Conditions Sexually Transmitted Diseases, Bacterial, Alcohol; Harmful Use
Enrollment 314 participants
Start Date 2021-08-13
Primary Completion 2025-09-01 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-28