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Completed

NCT Number: NCT04552171

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Brown University School of Public Health

Providence, Rhode Island, 02901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of alcohol drinking days in the past 30 days

    Time frame: 3 months, 6 months, 9 months, 12 months

    Total number of days in which participants reported drinking over the 30 days preceding each follow-up

  2. Number of heavy (5+ standard drinks) alcohol drinking days in the past 30 days

    Time frame: 3 months, 6 months, 9 months, 12 months

    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. Average number of standard drinks consumed on a drinking day in the past 30 days

    Time frame: 3 months, 6 months, 9 months, 12 months

    The average number of standard drinks participants reported consuming when they drank over the 30 days preceding each follow-up

  4. Any new bacterial sexually-transmitted infection diagnosis

    Time frame: 6 months, 12 months

    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

  5. Number of sex events that pose risk for sexually-transmitted infections in the past 30 days

    Time frame: 3 months, 6 months, 9 months, 12 months

    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

  6. Receiving a prescription for pre-exposure prophylaxis

    Time frame: 6 months, 12 months

    Whether or not participants reported receiving a prescription for pre-exposure prophylaxis in the 6 months prior to each follow-up

Secondary outcomes

  1. HIV diagnosis

    Time frame: 6 months, 12 months

    Whether or not participants were diagnosed with HIV at any time during the 12-month study period

  2. Phosphatidylethanol quantity

    Time frame: 6 months, 12 months

    The quantity of phosphatidylethanol detected in dried blood spots collected at 6- and 12-months

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2020
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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