Clinical trial NCT04552171: Game Plan: Efficacy of a Brief, Web-based Intervention on Alcohol Use and Sexually-transmitted Infections
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sexually Transmitted Diseases, Bacterial
Alcohol; Harmful Use
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of alcohol drinking days in the past 30 days
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Number of heavy (5+ standard drinks) alcohol drinking days in the past 30 days
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Average number of standard drinks consumed on a drinking day in the past 30 days
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Any new bacterial sexually-transmitted infection diagnosis
timeFrame: 6 months, 12 months
measure: Number of sex events that pose risk for sexually-transmitted infections in the past 30 days
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Receiving a prescription for pre-exposure prophylaxis
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: HIV diagnosis
timeFrame: 6 months, 12 months
measure: Phosphatidylethanol quantity
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
affiliation: Brown University
name: Tyler B Wray, PhD
role: PRINCIPAL_INVESTIGATOR
References: