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Clinical Trials/NCT04821427
NCT04821427
Unknown
Not Applicable

Feasibility of an mHealth + Brief Intervention for Heavy Drinking African American and Latino MSM: A Pilot Study

Boston University Charles River Campus1 site in 1 country24 target enrollmentApril 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heavy Drinking and Sexual Risk Behavior
Sponsor
Boston University Charles River Campus
Enrollment
24
Locations
1
Primary Endpoint
Modified Daily Drinking Questionnaire - Heavy Drinking Episodes
Last Updated
5 years ago

Overview

Brief Summary

Randomized controlled pilot trial to test the feasibility and efficacy of a brief intervention with app-based messaging to reduce sexual risk behavior and heavy drinking among Black/African American and Hispanic/Latino MSM.

Detailed Description

This study seeks to develop and provide an initial test of a brief intervention to reduce alcohol use and sex risk behavior among Black and Latino men who have sex with men \[BLMSM\]. The study seeks to recruit BLMSM who are non-monogamous, not currently on pre-exposure prophylaxis \[PrEP\], have engaged in condomless anal intercourse over the past 6 months, who have engaged in heavy drinking defined as \>14 drinks per week or at least 1 heavy drinking episode (5+ drinks on a single occasion) in the past month. All participants will complete baseline measures about past month behavior and if eligible will be assigned to the intervention condition or an assessment only condition. The intervention consists of a single brief video-conferencing intervention coupled with 4 weeks of mobile-messaging related to individualized goals about alcohol use and sexual behavior. Follow-up assessments are scheduled for 4 weeks after baseline (upon completion of the mobile-messaging component of the intervention) and 2 months after baseline. Primary outcomes are feasibility and acceptability of the intervention and mobile-messaging components. Secondary outcomes are changes in frequency of condomless anal intercourse and heavy drinking episodes.

Registry
clinicaltrials.gov
Start Date
April 2021
End Date
July 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Boston University Charles River Campus
Responsible Party
Principal Investigator
Principal Investigator

Kathryn Chavez

Clinical Psychology Doctoral Candidate, Department of Psychological and Brain Sciences

Boston University Charles River Campus

Eligibility Criteria

Inclusion Criteria

  • Black/African American or Latino/Hispanic
  • At least one heavy drinking episode in past month
  • At least one episode of condomless anal intercourse with another man in the past 6 months
  • Own a smartphone
  • English speaking

Exclusion Criteria

  • Currently on PrEP
  • Monogamous/exclusive relationship
  • Past or current treatment for alcohol (past 3 years)
  • Current or past psychiatric treatment (past 3 months)
  • Diagnosis of Bipolar Disorder or Schizophrenia
  • Brief Michigan Alcoholism Screening Test score \>5
  • Lifetime diagnosis of substance use disorder
  • ASSIST score of \>/=27 for any individual substance

Outcomes

Primary Outcomes

Modified Daily Drinking Questionnaire - Heavy Drinking Episodes

Time Frame: Past 30 days

Number of heavy drinking episodes NIAAA criteria (5+ drinks)

Sexual Behavior - Extended Survey - Condomless Anal Intercourse

Time Frame: Past 30 days

Frequency of condomless anal intercourse. This is an open ended question where the Participant reports the frequency of condomless anal intercourse over the past 30 days.

Secondary Outcomes

  • Goal Systems Assessment Battery - Alcohol(Past 30 days)
  • Goal Systems Assessment Battery - Condom Use(Past 30 days)
  • Intervention Acceptability Ratings(2 months post-baseline)
  • Client Satisfaction Questionnaire(2 months post-baseline)

Study Sites (1)

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