Alcohol and Sex Risk Intervention for MSM Supplement

NCT03522948 | Completed Results

• 2 other identifiers: 34683R01AA022301-02S1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Heavy Drinking and Sexual Risk Behavior

Keywords

heavy drinking; sexual risk behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (1)

Open pilot

EXPERIMENTAL

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

Interventions

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

Also known as: Intervention to reduce heavy drinking and sex risk among MSM

Open pilot

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Crisis Intervention

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The focus of the intervention was feasibility and acceptability, not results of inferential statistical analysis as this is a small sample in an open pilot

Results Point of Contact

• Title: Tibor Palfai
• Organization: Boston University

palfai@bu.edu

617-353-9345

Study Officials

• Tibor Palfai, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychological and Brain Sciences

Model Details: Open pilot study to test feasibility of intervention

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 14, 2018
• Study Start: November 7, 2017
• Primary Completion: May 17, 2018
• Study Completion: May 17, 2018
• Last Updated: February 11, 2021
• Results First Posted: February 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)