Alcohol and Sex Risk Intervention for MSM Supplement

Study Overview
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Brief Summary
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Open pilot trial to test the feasibility and efficacy of a brief intervention with text messaging to reduce sexual risk behavior and heavy drinking among MSM

Detailed Description
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This study seeks to develop and provide an initial test of a brief intervention to reduce alcohol use and sex risk behavior among among men who have sex with men. The study seeks to recruit MSM who are non-monogamous, have engaged in unprotected anal intercourse over the past 3 months, and who have engaged in heavy drinking defined as > 14 drinks per week or at least 1 heavy drinking episode (5+ drinks on a single occasion) in the past month. All participants will complete baseline measures about past month behavior and if eligible will be assigned to the intervention condition. This intervention consists of a single brief in-person intervention coupled with 4 weeks of text messaging related to individualized goals about alcohol use and sexual behavior. Follow-up assessments are scheduled for within 1 week of completion of the text messaging component of the intervention. Primary outcomes are feasibility and acceptability of the intervention and message components. Secondary outcomes are changes in frequency of unprotected intercourse and heavy drinking episodes.

Official Title
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Alcohol and Implicit Process in Sexual Risk Behavior in MSM- Supplement

Conditions
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Heavy Drinking and Sexual Risk Behavior

Intervention / Treatment
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* Behavioral: Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-monogamous bisexual/gay male with Kinsey score indicating mainly homosexual identification, heavy drinking, UAI in past 3 months. - Exclusion Criteria: HIV+ Past or current tx for alcohol use (past 3 years), bipolar disorder or schizophrenia Current psychiatric treatment Medications contraindicated by alcohol Medical conditions contraindicated by alcohol Substance specific ASSIST scores of 27 or greater -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Open pilot study to test feasibility of intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open pilot<br>The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men. | Behavioral: Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM<br>* Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use<br>* Other names: Intervention to reduce heavy drinking and sex risk among MSM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Satisfaction Scale | 3-item modification of Client Satisfaction Questionnaire. Three 5-point Likert scale is used to assess intervention satisfaction [very dissatisfied - very satisfied]; degree to which intervention helped alcohol use [no effect to helped a great deal], and intervention helped sexual behavior decisions [no effect - helped a great deal]. Mean scale range is 1-5. Higher scores reflect a better outcome | Participants complete the measure 5-6 weeks following baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Heavy Episodic Drinking Measure From the Alcohol Use Disorders Identification Test | This measure is a 5-point Likert scale item which asks participants to report How often do you have six or more drinks on one occasion? Response options range from never to daily or almost daily. This measure is completed at baseline and 5 to 6 weeks after baseline. Higher scores reflect worse outcomes. Responses reflect current perceptions of past drinking. Range 0-4 | Participants report frequency of heavy drinking episodes as part of the AUDIT-C questionnaire. The question is presented at baseline and at follow-up which occurs 5-6 weeks following baseline. There is no timeframe specified in the question itself. | 
| Frequency of Condomless Anal Intercourse. | Single item measure of number of times that individual engaged in unprotected intercourse. Range is 0-30 for baseline (reflecting 0-90 range for past 3 months divided by 3) and range is 0-30 for follow-up. Higher scores reflect a worse outcome. | Frequency of condomless anal intercourse (CAI) over the past 3 months at baseline (divided by 3 for monthly CAI) and rate frequency of condomless anal intercourse over the past month at follow-up assessment that occurs 5-6 weeks following baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heavy drinking, sexual risk behavior