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Completed

NCT Number: NCT03755661

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

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.

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Key information

Conditions

Alcohol; Harmful Use Behavior Sex, Unsafe Sexual Behavior Unsafe Sex

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Department of Psychological and Brain Science

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MI&TXT4MSM

Behavioral

brief in-person intervention followed by text messaging

Primary outcomes

  1. Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)

    Time frame: 30 days

    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

  2. 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]

    Time frame: 90 days

    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

  3. Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month

    Time frame: 30 days

    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

Secondary outcomes

  1. Young Adult Alcohol Consequences Questionnaire [Alcohol]

    Time frame: 30 days

    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

Other outcomes

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

    Time frame: 6 -weeks

    The number of condomless anal intercourse episodes (CAI) in the 6 weeks following the baseline as an additional outcome

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Alcohol and Implicit Process in Sexual Risk Behavior in MSM Supplement

Acronym: MI&TXT4MSM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 28, 2018
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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