MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM (MI&TXT4MSM)

Alcohol and Implicit Process in Sexual Risk Behavior in MSM Supplement

This is a small pilot study to provide effect size estimates for a brief intervention designed to reduce hazardous drinking and sexual risk behavior among men who have sex with men. The intervention consists of an "in-person" brief motivational intervention followed by a series of text messages related to alcohol and sexual risk reduction. The primary outcome is heavy drinking episodes and frequency of condomless anal intercourse at 3 months.

Study Overview

• Status: Completed
• Conditions: Alcohol; Harmful Use; Sex, Unsafe
• Intervention / Treatment: Behavioral: MI&TXT4MSM

Detailed Description

This is a pilot study designed to provide initial effect size estimates for an intervention addressing hazardous drinking and sexual risk behavior among men who have sex with men. In this study, 24 participants initially recruited through advertisements in the community will be randomly assigned to either Assessment Only or Intervention Condition. Those in the Assessment Only condition will complete baseline, 6-week, 3-month and 6-month assessments. Those in the intervention condition will receive a 50-min brief intervention in person followed by 6 weeks of tailored app-based messaging to support the intervention content, then another 6-weeks of goal setting text-based messages. Data will be analyzed to determine effect sizes of the intervention on key alcohol use and sex risk outcomes. The primary outcome will be 3-month outcomes, controlling for corresponding baseline outcomes.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University Department of Psychological and Brain Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• At least 1 heavy drinking episode or consumption of more than 14 drinks per week over the past month
• At least 1 condomless anal sex episode in past 3 months
• Score of 3 or greater on the Kinsey Scale (Kinsey et al., 1948) indicating at least "equally heterosexual and homosexual". Scale ranges from 0 (exclusively heterosexual) to 6 (exclusively homosexual)

Exclusion Criteria:

• Alcohol treatment currently or in past 3 years
• Bipolar disorder or schizophrenia treatment
• Exclusive monogamous relationship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; This intervention arm is a combined in-person text messaging intervention	Behavioral: MI&TXT4MSM; brief in-person intervention followed by text messaging
No Intervention: Assessment Only Control; The is the assessment only comparison condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)	Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion [no scale]. Higher score is a worse outcome, range 0-30	30 days
Number of Condomless Anal Intercourse Episodes (CAI) From the Sexual Behaviors Survey (Gordon et al., 2007) is Used to Measure Sexual Risk [Main Time Point at 3 Month Follow-up]	Frequency of CAI in past 90 days. This is an open ended question where the Participant report the frequency of condomless anal intercourse episodes over a period of 90 days [no scale] Range from 0-90	90 days
Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month	Average quantity of alcohol use per week in the past 30 days. Participants complete a seven day calendar which reflects the typical number of standard drinks that they have consumed for each day of the week over the past 30 days. The number of drinks can range from 0 to an unlimited high number. A higher number of drinks listed in the week is reflective of a worse outcome	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Young Adult Alcohol Consequences Questionnaire [Alcohol]	Number of alcohol-related consequences in the past month. This is the 48-item Yes/No version of the YAACQ. The range for the score is 0-48. Higher score is a worse outcome	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above.	The number of condomless anal intercourse episodes (CAI) in the 6 weeks following the baseline as an additional outcome	6 -weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Actual): March 9, 2020
• Study Completion (Actual): March 9, 2020

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 3468a; 3R01AA022301-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared following release within one year of the trial end to investigators who make specific requests in writing regarding analysis plans. Plans will be reviewed with co-investigators to ensure that there is no overlap with planned analyses. Specific de-identified data set will be provided to other researchers after this review
• IPD Sharing Time Frame: Data will be available one year after the trial end. They will be available for investigators to request up to 5 years following their release
• IPD Sharing Access Criteria: Researcher with specified analytic request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No