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

NCT ID: NCT03755661

Last Updated: 2021-05-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-09

Study Completion Date

2020-03-09

Brief Summary

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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

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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.

Conditions

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Alcohol; Harmful Use Sex, Unsafe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to one of two groups
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The outcomes assessor is not provided with randomization information for the subjects

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

MI&TXT4MSM

Intervention Type BEHAVIORAL

brief in-person intervention followed by text messaging

Assessment Only Control

The is the assessment only comparison condition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MI&TXT4MSM

brief in-person intervention followed by text messaging

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Boston University Charles River Campus

OTHER

Sponsor Role lead

Responsible Party

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Tibor Palfai

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston University Department of Psychological and Brain Science

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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3R01AA022301-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3468a

Identifier Type: -

Identifier Source: org_study_id

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