Game Plan Intervention for Alcohol Abuse and STIs

Overseen By Tyler B Wray, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Brown University

Must not be taking: PrEP

Disqualifiers: Injection drug use, Drug use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Game Plan, designed to reduce alcohol use and sexually transmitted infections (STIs) among men who have sex with men (MSM). Participants will receive home-based HIV/STI self-tests and will be divided into two groups: one with access to a 24-hour helpline, and the other with access to both the helpline and the Game Plan app, a web-based intervention. The study aims to determine if the Game Plan app reduces heavy drinking and risky behaviors more effectively than the helpline alone. The trial seeks HIV-negative or unknown status MSM who have recently engaged in heavy drinking and risky sexual activities. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve community health outcomes.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but you cannot participate if you are currently receiving medications or counseling for an alcohol or drug use disorder.

What prior data suggests that the Game Plan intervention is safe for participants?

Research shows that the Game Plan program is generally safe for users. This online tool aims to reduce alcohol use and promote HIV prevention methods. Being digital, Game Plan involves no medication or medical procedures, eliminating the risk of physical side effects associated with drugs. Studies have tested Game Plan in various settings, and no harmful effects have been reported. This suggests good user tolerance. Prospective trial participants can feel confident that past research indicates its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Game Plan intervention because it offers a fresh approach to tackling alcohol abuse and sexually transmitted infections (STIs). Unlike the standard of care, which typically involves access to a 24-hour helpline for counseling, Game Plan incorporates a unique app that encourages self-assessment and proactive management of these issues. This app not only empowers individuals with interactive tools but also provides continuous support through a 24-hour helpline, potentially enhancing user engagement and effectiveness. The combination of digital self-help with traditional counseling could lead to more personalized and immediate support, setting it apart from existing options.

What evidence suggests that the Game Plan intervention is effective for reducing alcohol abuse and STIs among MSM?

Research has shown that the Game Plan app, available to participants in this trial, might help reduce heavy drinking and sexually transmitted infections (STIs) among men who have sex with men (MSM). Early results suggest that Game Plan, a short online program, effectively lowers alcohol use and risky sexual behaviors. In a small study, participants using Game Plan had fewer instances of sex without a condom and drank less alcohol. These findings indicate that Game Plan could be a useful tool for managing alcohol use and reducing STI risks. Another group in this trial will have access only to a 24-hour helpline, serving as a comparison to evaluate the added benefits of the Game Plan app. ^{2 3 6 7 8}

Who Is on the Research Team?

Tyler B Wray, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

This trial is for men who have sex with men (MSM), are over 18, HIV-negative or unsure about their status, and meet certain risk criteria like recent STI diagnosis or unprotected anal sex. They must not be on PrEP, should drink heavily by NIAAA standards, speak English/Spanish fluently, and were assigned male at birth. Those with complicated alcohol withdrawal history or current substance abuse treatment are excluded.

Inclusion Criteria

I am not currently taking medication to prevent HIV.

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

HIV-negative or unknown status

Exclusion Criteria

You have used injection drugs within the last year.

You have a history of severe symptoms when withdrawing from alcohol or are at risk of experiencing severe symptoms.

You are currently taking medication or getting counseling for a drug or alcohol addiction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment and Initial Testing

Participants complete baseline assessments and receive initial HIV/STI self-testing kits

4 weeks

1 visit (virtual)

Intervention and Monitoring

Participants are randomly assigned to receive either the Game Plan app and helpline or helpline only, with follow-up surveys every 3 months

12 months

4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with qualitative interviews conducted at 12 months

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Game Plan

Trial Overview The study tests the Game Plan app's effectiveness in reducing heavy drinking and sexually transmitted infections among MSM. Participants will receive home-based HIV/STI self-tests regularly and either access to a helpline or both the helpline and Game Plan app to see if there's a difference in outcomes.

How Is the Trial Designed?

Group I: Access to Game Plan app and 24-hour helpline Experimental Treatment 1 Intervention

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.

Group II: Access to a 24-hour helpline Active Control 1 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 Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

Published Research Related to This Trial

A smartphone game designed to reduce sexual risk behavior in urban Black adolescent girls was developed using a comprehensive framework that incorporates trauma-informed care and social cognitive theory.

The study identified that Arnab's IM + LM-GM framework effectively guided the game's development and the selection of measurable health outcomes, ensuring the game is well-aligned with educational and health objectives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Evaluation Frameworks for Design of a Sexual Risk Prevention Game for Black Adolescent Girls. Sockolow, P., Joppa, M., Zhu, J.[2022]

The gamified web application 'sjekkdeg.no' was developed to engage North-Norwegian youngsters in sexual health education and STD prevention, utilizing features like avatars and achievement rewards.

Preliminary results suggest that this interactive approach may effectively encourage users to learn about sexual health and STDs, potentially leading to changes in risky behaviors and a reduction in STD rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamification strategy on prevention of STDs for youth. Gabarron, E., Schopf, T., Serrano, JA., et al.[2022]

A study involving 87 health professionals in Mongolia revealed that 'gaming' strategies, such as concealing hospital-acquired infections (HAIs) through overprescribing antibiotics or early patient discharges, are widespread and linked to punitive evaluations from health authorities.

The findings suggest that the current performance indicators, particularly the focus on HAI rates, contribute to this underreporting, indicating a need for revised evaluation methods and increased funding for infection control to improve transparency and accuracy in reporting HAIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaming in infection control: a qualitative study exploring the perceptions and experiences of health professionals in Mongolia. Ider, BE., Adams, J., Morton, A., et al.[2011]

The Internet quiz game intervention significantly reduced underage drinking among adolescents, with a 21% decrease at 1-month follow-up and a 14% decrease at 3-month follow-up compared to conventional health education.

In the intervention group, fewer students reported drinking alcohol, and those who did consumed less, indicating that engaging educational methods can be more effective in changing drinking behaviors among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet Quiz Game Intervention for Adolescent Alcohol Drinking: A Clustered RCT. Ho, FK., Tung, KTS., Wong, RS., et al.[2021]

In a study of 142 patients with alcohol addiction, three distinct patterns of A-CHESS mobile health intervention use were identified: inactive, passive, and active users, with active users engaging more in online social activities and using the app more frequently.

Despite active users showing more engagement with A-CHESS, the likelihood of experiencing an initial lapse after discharge from detoxification was not statistically different among the user profiles, suggesting that engagement alone may not prevent relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the use patterns of a mobile health application for alcohol addiction before the initial lapse after detoxification. Chih, MY.[2022]

In a study involving 885 open-access users and 156 participants from a randomized controlled trial, the completion rates for a web-based alcohol treatment program were 35% and 45%, respectively, indicating that structured trials may yield better adherence than open-access formats.

Key predictors of treatment completion included factors like treatment readiness, gender, and baseline alcohol consumption, while common reasons for dropping out were personal issues and dissatisfaction with the program, suggesting that enhancing engagement strategies could improve retention rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attrition in web-based treatment for problem drinkers. Postel, MG., de Haan, HA., ter Huurne, ED., et al.[2022]

The serious game training 'The Fling' was developed to help adolescents improve their behavioral control regarding alcohol use, and it was tested with 185 participants aged around 15 years in a randomized controlled trial.

While the game showed promise in motivating adolescents and improving behavioral control over time, the effects on actual drinking behavior were not significant, indicating that further research is needed to determine its effectiveness as a cognitive training tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Behavioral Control in Adolescents Using a Serious Game. Boendermaker, WJ., Veltkamp, RC., Peeters, M.[2018]

Participation in drinking games (DGs) is linked to increased alcohol use, with medium effect sizes indicating higher frequency of drinking (r = .47) and binge drinking (r = .50) among players, based on a meta-analysis of 48 studies involving 31 independent samples.

The study found that both men and women who participate in DGs are at equal risk for experiencing negative alcohol-related consequences, suggesting that interventions should address the risks associated with DGs for all genders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of drinking game participation and alcohol-related outcomes. Zamboanga, BL., Newins, AR., Cook, MA.[2021]

Computer-based drinking assessment and intervention programs have been evaluated in the general public, revealing that users are typically young males in their early 30s who are at risk for alcohol-related issues.

While dropout rates from these online interventions are high, those who complete the programs generally show improvements in their drinking behaviors, indicating potential efficacy for those who engage fully.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of computer-based alcohol problem services designed for the general public. Vernon, ML.[2022]

A study with 140 participants found that a cognitive behavioral game design (CBGD) mobile game effectively decreased participants' intent to use alcohol and increased their knowledge about alcohol use.

While the mobile game was better at improving knowledge, watching a video documentary was more effective in reducing actual alcohol use, suggesting different strengths in the two intervention methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Cognitive-Behavioral Game Design-Based Mobile Game on Alcohol Use for Adolescents. Yap, AGH., Roy, RED., Lasala, JRS., et al.[2021]

In a study involving 41 male veterans with alcohol use disorders, participants who played a simulation video game showed significant reductions in obsessive-compulsive drinking behaviors and increased self-efficacy in relapse prevention after 8 weeks.

Although there was no difference in relapse rates between the video game group and those who viewed educational slides, the positive changes in self-efficacy suggest that the simulation could be a beneficial addition to traditional treatment methods for AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer simulation games as an adjunct for treatment in male veterans with alcohol use disorder. Verduin, ML., LaRowe, SD., Myrick, H., et al.[2015]

Game-facilitated interventions can effectively address the specific challenges of nightlife well-being, providing a tailored approach to improve health in this context.

User tests conducted in real nightlife settings demonstrate the potential effectiveness of the developed game, suggesting it could be a valuable tool for promoting well-being in nightlife environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing a serious game for in-field interventions to promote nightlife well-being. Gamberini, L., Zamboni, L., Privitera, A., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04552171

Game Plan: Efficacy of a Brief, Web-based Intervention on ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04973267

Study Details | NCT04973267 | Game Plan for PrEP Game Plan for PrEP is a web-based intervention that provides users with ... National Institute on Alcohol Abuse and Alcoholism (NIAAA). Investigators.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10947926/

Pilot randomized controlled trial of Game Plan for PrEP Game Plan—a brief web-based intervention to improve uptake and use ... National Institute on Alcohol Abuse and Alcoholism. Helping patients ...

4. withpower.com withpower.com/trial/phase-sexually-transmitted-diseases-bacterial-7-2021-8bd0f

Game Plan Intervention for Alcohol Abuse and STIs Trial Overview The study tests the Game Plan app's effectiveness in reducing heavy drinking and sexually transmitted infections among MSM. Participants will ...

5. researchgate.net researchgate.net/publication/375695475_Pilot_Randomized_Controlled_Trial_of_Game_Plan_for_PrEP_A_Brief_Web_and_Text_Message_Intervention_to_Help_Sexual_Minority_Men_Adhere_to_PrEP_and_Reduce_Their_Alcohol_Use

Pilot Randomized Controlled Trial of Game Plan for PrEP messaging intervention, helped promote PrEP persistence and adherence and reduced condomless sex and alcohol use. Seventy-three heavy-drinking ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8771347/

Game Plan—a Brief Web-Based Intervention to Improve ... Users' overall level of drinking is first classified as moderate or hazardous according to the National Institute on Alcohol Abuse and Alcoholism guidelines [90] ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34989679/

Game Plan-a Brief Web-Based Intervention to Improve Uptake ... Game Plan-a Brief Web-Based Intervention to Improve Uptake and Use of HIV Pre-exposure Prophylaxis (PrEP) and Reduce Alcohol Use Among Gay and ...

8. formative.jmir.org formative.jmir.org/2021/11/e31843/

Game Plan, a Web-Based Intervention to Improve Adherence ... AUDIT: Alcohol Use Disorders Identification Test. cDAST: Drug Abuse Screening Test. dPrEP: pre-exposure prophylaxis.