Clinical trial NCT03755661: MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM
Official title: Alcohol and Implicit Process in Sexual Risk Behavior in MSM Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol; Harmful Use
Sex, Unsafe
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-11-28
Enrollment: 24
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two groups
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)
timeFrame: 30 days
measure: 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]
timeFrame: 90 days
measure: Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month
timeFrame: 30 days
Secondary outcomes:
measure: Young Adult Alcohol Consequences Questionnaire [Alcohol]
timeFrame: 30 days
Other outcomes:
measure: Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above.
timeFrame: 6 -weeks
Locations:
city: Boston
country: United States
facility: Boston University Department of Psychological and Brain Science
state: Massachusetts
Study officials:
References: