Alcohol and Sex Risk Intervention for MSM Supplement

NCT ID: NCT03522948

Last Updated: 2021-02-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-07

Study Completion Date

2018-05-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heavy Drinking and Sexual Risk Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open pilot study to test feasibility of intervention
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open pilot

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.

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Intervention to reduce heavy drinking and sex risk among MSM

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Boston University Charles River Campus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tibor Palfai

Professor of Psychological and Brain Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tibor Palfai, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston University

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3R01AA022301-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3468

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Social Media Alcohol Intervention
NCT02809586 COMPLETED NA
mHealth Behavior Study
NCT06624514 RECRUITING NA
Multi-Component Breath Alcohol Intervention
NCT06124898 ACTIVE_NOT_RECRUITING NA