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Clinical Trials/NCT03522948
NCT03522948
Completed
Not Applicable

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

Boston University Charles River Campus1 site in 1 country8 target enrollmentNovember 7, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heavy Drinking and Sexual Risk Behavior
Sponsor
Boston University Charles River Campus
Enrollment
8
Locations
1
Primary Endpoint
Intervention Satisfaction Scale
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 7, 2017
End Date
May 17, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Boston University Charles River Campus
Responsible Party
Principal Investigator
Principal Investigator

Tibor Palfai

Professor of Psychological and Brain Sciences

Boston University Charles River Campus

Eligibility Criteria

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

Outcomes

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(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.(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.)

Study Sites (1)

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