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A smartphone app takes on heavy drinking and STIs in high-risk men

NCT ID NCT04552171

Disease control Sponsor: Brown University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial tests whether a web-based app called Game Plan can help men who have sex with men reduce heavy drinking and sexually transmitted infections. Participants receive home HIV/STI self-testing kits and are randomly assigned to either a 24-hour helpline alone or the helpline plus the Game Plan app. The app helps users reflect on their alcohol use and sexual risk and make a personalized plan to cut back. The study tracks drinking patterns, STI diagnoses, and risky sexual behavior over a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a web-based app called Game Plan that helps users reflect on their HIV risk and alcohol use and make a plan to reduce risky behaviors, plus a 24-hour helpline
What this could lead to
If effective, Game Plan could offer a scalable, low-cost way to reduce heavy drinking and STI risk among men who have sex with men, especially those not yet on PrEP.
What could go wrong
This is a behavioral intervention, so effects may be modest or short-lived. The trial relies on self-reported drinking and sexual behavior, which can be unreliable. Results may not generalize beyond the specific online-recruited population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

314 people

The number who actually took part.

Started

Aug 2021

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

alcohol abuse bacterial sexually transmitted disease chlamydia trachomatis infectious disease prevention target gonorrhea prevention target HIV infectious disease prevention target syphilis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol; harmful use Sexually transmitted diseases, bacterial

Contacts and locations

Locations

  • Brown University School of Public Health

    Providence, Rhode Island, 02901, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.