Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alcohol and Sex Risk Intervention for MSM Supplement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03522948
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Tibor Palfai, Boston University Charles River Campus

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

Condition or disease Intervention/treatment Phase
Heavy Drinking and Sexual Risk Behavior Behavioral: Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open pilot study to test feasibility of intervention
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Alcohol and Implicit Process in Sexual Risk Behavior in MSM- Supplement
Actual Study Start Date : November 7, 2017
Actual Primary Completion Date : May 17, 2018
Actual Study Completion Date : May 17, 2018

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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
Other Name: Intervention to reduce heavy drinking and sex risk among MSM




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 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

  2. Frequency of unprotected anal intercourse. [ Time Frame: Participants rate frequency of unprotected anal intercourse over the past 3 months at baseline and rate frequency of unprotected 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 0-90 for baseline and range is 0-30 for follow-up. Higher scores reflect a worse outcome.

  3. Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for behavior goal of "Using condoms every time you have sex with a partner of unknown HIV status". [ Time Frame: This measure was taken at baseline and at follow-up. There is no specific timeframe indicated on the questions as the measure indicates current goal cognitions. The measure is completed at baseline and 5 to 6 weeks following baseline. ]
    This GSAB battery consists of 4 subscales comprised of 4 Likert scale items each ranging from 0-4. The subscales indicate value, self-efficacy, planning, and monitoring related to the behavior change goal. The mean subscale range is from 0-4. Higher scores reflect better self-regulatory outcomes

  4. Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for behavior goal of "Reducing alcohol use". [ Time Frame: This measure was taken at baseline and at follow-up. There is no specific timeframe indicated in the measure as it is used to indicate current goal cognitions. The measure is completed at baseline and 5 to 6 weeks following baseline. ]
    This GSAB battery consists of 4 subscales comprised of 4 Likert scale items each ranging from 0-4. The subscales indicate value, self-efficacy, planning, and monitoring related to the behavior change goal. The mean subscale range is from 0-4. Higher scores reflect better self-regulatory outcomes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522948


Locations
Layout table for location information
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston University Charles River Campus
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Layout table for investigator information
Principal Investigator: Tibor Palfai, PhD Boston University

Layout table for additonal information
Responsible Party: Tibor Palfai, Professor of Psychological and Brain Sciences, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT03522948     History of Changes
Other Study ID Numbers: 3468
3R01AA022301-02S1 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: under discussion

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tibor Palfai, Boston University Charles River Campus:
heavy drinking
sexual risk behavior