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Game Plan Intervention for Alcohol Abuse and STIs

N/A

Recruiting

Led By Tyler B Wray, PhD

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not being currently prescribed or taking PrEP

18+ years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 9 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether the "Game Plan" intervention can help reduce heavy drinking, STIs, and risky sexual behaviors among 360 high-risk men who have sex with men (MSM) in the US. Participants will be randomly assigned to either receive access to a 24-hour counseling/referral helpline, or the helpline plus the Game Plan intervention.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves an app and helpline rather than medication, traditional side effects aren't expected. However, participants may experience emotional distress related to discussions around personal health behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not currently taking medication to prevent HIV.

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I am 18 years old or older.

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I meet one of the HIV-risk criteria for PrEP in the last 6 months.

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I was assigned male at birth.

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I am fluent in English or Spanish.

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I am currently male.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 9 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 9 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 9 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Any new bacterial sexually-transmitted infection diagnosis

Average number of standard drinks consumed on a drinking day in the past 30 days

Number of alcohol drinking days in the past 30 days

+3 more

Secondary study objectives

HIV diagnosis

Phosphatidylethanol quantity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Access to Game Plan app and 24-hour helplineExperimental Treatment1 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 helplineActive Control1 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.

0 / 6Eligibility criteria met