Clinical trial NCT03522948: Alcohol and Sex Risk Intervention for MSM Supplement
Official title: Alcohol and Implicit Process in Sexual Risk Behavior in MSM- Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Drinking and Sexual Risk Behavior
Keywords: heavy drinking
sexual risk behavior
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-05-14
Enrollment: 8
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open pilot study to test feasibility of intervention
Primary purpose: PREVENTION

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.

Eligibility criteria: 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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Primary outcomes:
measure: Intervention Satisfaction Scale
timeFrame: Participants complete the measure 5-6 weeks following baseline.
Secondary outcomes:
measure: Frequency of Heavy Episodic Drinking Measure From the Alcohol Use Disorders Identification Test
timeFrame: 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.
measure: Frequency of Condomless Anal Intercourse.
timeFrame: 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.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Tibor Palfai, PhD
role: PRINCIPAL_INVESTIGATOR
References: