MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM

NCT03755661 | Completed Results

• 2 other identifiers: 3468a3R01AA022301-02S1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol; Harmful Use; Sex, Unsafe

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Young Adult Alcohol Consequences Questionnaire [Alcohol]

  30 days

Other Outcomes (1)

• Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above.

  6 -weeks

Study Arms (2)

Intervention

EXPERIMENTAL

This intervention arm is a combined in-person text messaging intervention

Behavioral: MI&TXT4MSM

Assessment Only Control

NO INTERVENTION

The is the assessment only comparison condition

Interventions

MI&TXT4MSM BEHAVIORAL

brief in-person intervention followed by text messaging

Intervention

Eligibility Criteria

• Age: 21 Years - 50 Years
• Gender Eligibility Details: identify as male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Boston University Department of Psychological and Brain Science

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Unsafe Sex

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Results Point of Contact

• Title: LaNeia Thomas
• Organization: Boston University

laneia@bu.edu

617-358-6346

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor is not provided with randomization information for the subjects
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are randomly assigned to one of two groups

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: October 9, 2018
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: May 6, 2021
• Results First Posted: May 6, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• 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
• Access Criteria: Researcher with specified analytic request.

Locations

US (1)