Alcohol and Sex Risk Intervention for M… | Clinical Trial

Key information

Conditions

Heavy Drinking and Sexual Risk Behavior

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Boston University

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Non-monogamous bisexual/gay male with Kinsey score indicating mainly homosexual identification, heavy drinking, UAI in past 3 months.

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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

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Treatment and study plan

Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM

Behavioral

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

Other names: Intervention to reduce heavy drinking and sex risk among MSM

Primary outcomes

Intervention Satisfaction Scale

Time frame: Participants complete the measure 5-6 weeks following baseline.

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

Secondary outcomes

Frequency of Heavy Episodic Drinking Measure From the Alcohol Use Disorders Identification Test

Time frame: 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.

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
Frequency of Condomless Anal Intercourse.

Time frame: 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.

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.

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: May 14, 2018
Registry last updated: Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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