Sexually Transmitted Diseases, BacterialNCT04552171
Game Plan: Efficacy of a Brief, Web-based Intervention on Alcohol Use and Sexually-transmitted Infections
A study testing Access to Game Plan app and 24-hour helpline in people with Sexually Transmitted Diseases, Bacterial and Alcohol; Harmful Use, run by Brown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, Bacterial, Alcohol; Harmful Use
- What is being tested?
- Access to Game Plan app and 24-hour helpline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Public Health
Providence, Rhode Island, 02901
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Access to Game Plan app and 24-hour helpline
- Medical subject headings
- Sexually Transmitted Diseases, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to Game Plan app and 24-hour helplineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months, 12 months
Secondary outcomes (2)
HIV diagnosis
Whether or not participants were diagnosed with HIV at any time during the 12-month study period
Measured: 6 months, 12 months
Phosphatidylethanol quantity
The quantity of phosphatidylethanol detected in dried blood spots collected at 6- and 12-months
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start13 Aug 2021
- Primary completion1 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted Diseases, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tyler B Wray, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552171
- Sponsor's protocol ID
- 2003002671
- Status last verified
- May 2026
- First submitted
- 28 Aug 2020
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be uploaded to the National Institute on Alcohol Abuse and Alcoholism data archive (NIAAA-DA) every 6 months while the trial is actively recruiting and collecting data, with a final dataset planned for upload within 6 months of the final follow-ups being conducted, as per NIAAA policy. The dataset will be formatted, structured, and curated to align with NIAAA policy.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04552171
- Acronym / sponsor ID
- 2003002671
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Access to Game Plan app and 24-hour helpline | Experimental | Behavioral: Access to Game Plan app and 24-hour helplineParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to Game Plan app and 24-hour helplineGame 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. | Behavioural | Access to Game Plan app and 24-hour helpline |
Primary outcome
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
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
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
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
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
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
2 secondary outcomes
HIV diagnosis
Time frame: 6 months, 12 months
Phosphatidylethanol quantity
Time frame: 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be uploaded to the National Institute on Alcohol Abuse and Alcoholism data archive (NIAAA-DA) every 6 months while the trial is actively recruiting and collecting data, with a final dataset planned for upload within 6 months of the final follow-ups being conducted, as per NIAAA policy. The dataset will be formatted, structured, and curated to align with NIAAA policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler B Wray, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to Game Plan app and 24-hour helpline in people with Sexually Transmitted Diseases, Bacterial and Alcohol; Harmful Use, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of alcohol drinking days in the past 30 days (time frame: 3 months, 6 months, 9 months, 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.