Game Plan Intervention for Alcohol Abuse and STIs

Overseen by Tyler B Wray, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brown University

Must not be taking: PrEP

Disqualifiers: Injection drug use, Drug use disorder, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Game Plan Web-Based Intervention treatment for alcohol abuse and STIs?

Research shows that computer simulation games can help people with alcohol use disorders improve their confidence in avoiding relapse, even if they don't reduce relapse rates. Additionally, mobile health applications have been found to increase knowledge and reduce the intent to use alcohol, suggesting that web-based interventions can be effective in changing behavior and increasing awareness. ^{1 2 3 4 5}

Is the Game Plan Intervention for Alcohol Abuse and STIs safe for humans?

There is no specific safety data available for the Game Plan Intervention for Alcohol Abuse and STIs in the provided research articles. ^{4 6 7 8 9}

How is the Game Plan Web-Based Intervention different from other treatments for alcohol abuse and STIs?

The Game Plan Web-Based Intervention is unique because it uses a web-based platform to deliver its treatment, which can increase accessibility and engagement compared to traditional in-person therapies. This approach is similar to other interventions that use games or online tools to influence behavior and knowledge, making it a novel option for addressing alcohol abuse and STIs. ^{2 7 10 11 12}

Research Team

Tyler B Wray, PhD

Principal Investigator

Brown University

Eligibility Criteria

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.

I am 18 years old or older.

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

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.

Trial Timeline

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)

Treatment Details

Interventions

• Game Plan (Behavioral Intervention)

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.

Participant Groups

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+

Mukesh Jain

Brown University

Chief Medical Officer since 2022

MD from Harvard Medical School

Christina H. Paxson

Brown University

Chief Executive Officer since 2012

PhD in Economics from Columbia University

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Cognitive-Behavioral Game Design-Based Mobile Game on Alcohol Use for Adolescents. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Attrition in web-based treatment for problem drinkers. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Assessment of Evaluation Frameworks for Design of a Sexual Risk Prevention Game for Black Adolescent Girls. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Computer simulation games as an adjunct for treatment in male veterans with alcohol use disorder. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Gaming in infection control: a qualitative study exploring the perceptions and experiences of health professionals in Mongolia. [2011]

7. United States pubmed.ncbi.nlm.nih.gov

An Internet Quiz Game Intervention for Adolescent Alcohol Drinking: A Clustered RCT. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Gamification strategy on prevention of STDs for youth. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A meta-analysis of drinking game participation and alcohol-related outcomes. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Designing a serious game for in-field interventions to promote nightlife well-being. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. United States pubmed.ncbi.nlm.nih.gov

Training Behavioral Control in Adolescents Using a Serious Game. [2018]