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

NCT04552171 | Active Not Recruiting

• 1 other identifier: 2003002671
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sexually Transmitted Diseases, Bacterial; Alcohol; Harmful Use

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• HIV diagnosis

  6 months, 12 months

• Phosphatidylethanol quantity

  6 months, 12 months

Study Arms (2)

Access to Game Plan app and 24-hour helpline

EXPERIMENTAL

Participants in this condition will be provided access to the Game Plan app and encouraged to use it after they complete their baseline assessments and STI testing has been completed. These participants will also be provided with access to a 24-hour helpline that provides free HIV/STI test counseling, which they can elect to use or not.

Behavioral: Access to Game Plan app and 24-hour helpline

Access to a 24-hour helpline

NO INTERVENTION

Participants in this condition will be provided access to a 24-hour helpline that provides free HIV/STI test counseling, which they can elect to use or not. Use of this comparison condition is intended to provide a real-world test of the added benefit of using Game Plan, above and beyond the current "standard of care" for HIV/STI self-testing, which involves providing users with access to a 24-hour helpline.

Interventions

Access to Game Plan app and 24-hour helpline BEHAVIORAL

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.

Access to Game Plan app and 24-hour helpline

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants who are (1) assigned male sex at birth, and (2) currently male gender are eligible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Assigned male sex at birth
• Currently male gender
• + 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

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02901, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tyler B Wray, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All key study personnel will be blinded to participants' condition assignments. Since participants are encouraged to complete both STI self-testing and follow-up online surveys via automated emails linking to a web-based survey system, no members of the study staff will be serving as outcomes assessors. As such, outcomes assessment is also blinded to study condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned 1:1 to one of two conditions: (1) a 24-hour helpline providing free standard post-test counseling and referral, or (2) the 24-hour helpline plus the Game Plan app. In both conditions, participants will be encouraged to use these services via a large postcard included in each test kit and via email, and so, can use them after each test.

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 17, 2020
• Study Start: August 13, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Full datasets of participants agreeing to share their data with the NIAAA-DA will be uploaded once every 6 months while the trial is ongoing, with a final dataset uploaded within 6 months of completing the final follow-ups. Data will be made available from the NIAAA-DA for registered researchers after an embargo period of 2 years after the final dataset is uploaded.
• Access Criteria: Researchers who have registered with the NIAAA-DA are eligible to access data from this trial.

Locations

US (1)