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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
500
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.
Brown University School of Public Health
Providence, Rhode Island, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months, 12 months
HIV diagnosis
Whether or not participants were diagnosed with HIV at any time during the 12-month study period
Time frame: 6 months, 12 months
Phosphatidylethanol quantity
The quantity of phosphatidylethanol detected in dried blood spots collected at 6- and 12-months
Time frame: 6 months, 12 months
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