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

Alcohol; Harmful Use Clinical Trial

— MI&TXT4MSM  

Official title:

Alcohol and Implicit Process in Sexual Risk Behavior in MSM Supplement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755661
• Other study ID #: 3468a
• Secondary ID: 3R01AA022301-02S
• Status: Completed
• Phase: N/A
• Start date: October 9, 2018
• Est. completion date: March 9, 2020

Study information

• Verified date: March 2021
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol; Harmful Use
• Sex, Unsafe

Intervention

Behavioral:
• MI&TXT4MSM
brief in-person intervention followed by text messaging

Locations

Country	Name	City	State
United States	Boston University Department of Psychological and Brain Science	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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	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