MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM

Study Overview
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Brief Summary
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This is a small pilot study to provide effect size estimates for a brief intervention designed to reduce hazardous drinking and sexual risk behavior among men who have sex with men. The intervention consists of an in-person brief motivational intervention followed by a series of text messages related to alcohol and sexual risk reduction. The primary outcome is heavy drinking episodes and frequency of condomless anal intercourse at 3 months.

Detailed Description
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This is a pilot study designed to provide initial effect size estimates for an intervention addressing hazardous drinking and sexual risk behavior among men who have sex with men. In this study, 24 participants initially recruited through advertisements in the community will be randomly assigned to either Assessment Only or Intervention Condition. Those in the Assessment Only condition will complete baseline, 6-week, 3-month and 6-month assessments. Those in the intervention condition will receive a 50-min brief intervention in person followed by 6 weeks of tailored app-based messaging to support the intervention content, then another 6-weeks of goal setting text-based messages. Data will be analyzed to determine effect sizes of the intervention on key alcohol use and sex risk outcomes. The primary outcome will be 3-month outcomes, controlling for corresponding baseline outcomes.

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

Conditions
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Alcohol; Harmful Use, Sex, Unsafe

Intervention / Treatment
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* Behavioral: MI&TXT4MSM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 1 heavy drinking episode or consumption of more than 14 drinks per week over the past month At least 1 condomless anal sex episode in past 3 months Score of 3 or greater on the Kinsey Scale (Kinsey et al., 1948) indicating at least equally heterosexual and homosexual. Scale ranges from 0 (exclusively heterosexual) to 6 (exclusively homosexual) Exclusion Criteria: Alcohol treatment currently or in past 3 years Bipolar disorder or schizophrenia treatment Exclusive monogamous relationship

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to one of two groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This intervention arm is a combined in-person text messaging intervention | Behavioral: MI&TXT4MSM<br>* brief in-person intervention followed by text messaging<br>|
| No Intervention: Assessment Only Control<br>The is the assessment only comparison condition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion) | Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion [no scale]. Higher score is a worse outcome, range 0-30 | 30 days | 
| Number of Condomless Anal Intercourse Episodes (CAI) From the Sexual Behaviors Survey (Gordon et al., 2007) is Used to Measure Sexual Risk [Main Time Point at 3 Month Follow-up] | Frequency of CAI in past 90 days. This is an open ended question where the Participant report the frequency of condomless anal intercourse episodes over a period of 90 days [no scale] Range from 0-90 | 90 days | 
| Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month | Average quantity of alcohol use per week in the past 30 days. Participants complete a seven day calendar which reflects the typical number of standard drinks that they have consumed for each day of the week over the past 30 days. The number of drinks can range from 0 to an unlimited high number. A higher number of drinks listed in the week is reflective of a worse outcome | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young Adult Alcohol Consequences Questionnaire [Alcohol] | Number of alcohol-related consequences in the past month. This is the 48-item Yes/No version of the YAACQ. The range for the score is 0-48. Higher score is a worse outcome | 30 days |