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Clinical Trials/NCT02316184
NCT02316184
Completed
Not Applicable

Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons

Butler Hospital2 sites in 1 country300 target enrollmentJanuary 2015
ConditionsHIVHepatitis C

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
Butler Hospital
Enrollment
300
Locations
2
Primary Endpoint
Alcohol Use questionnaire
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Two types of brief intervention, Brief Advice (BA) and Motivational Interviewing (MI), have been shown to be efficacious in reducing drinking in non-HIV samples. Our goal is to determine whether offering counseling beyond Brief Advice, namely MI, has greater alcohol reduction effects. In the proposed randomized trial, all 300 HIV-HCV co-infected participants will receive BA delivered by their HIV PCP during a regular HIV visit and will then be randomized to either a 30-minute Motivational Interviewing Intervention with a Behavioral Counselor (MI) or to HIV clinic treatment-as-usual. After this initial meeting, drinking "check-in" (MI or BA) sessions will then be provided telephonically every three months for 18 months, with a final assessment at 24 months. Our primary outcome is drinks per week.

Detailed Description

Two types of brief intervention, Brief Advice (BA) and Motivational Interviewing (MI), have been shown to be efficacious in reducing drinking in non-HIV samples. Our goal is to determine whether offering counseling beyond Brief Advice, namely MI, has greater alcohol reduction effects. In the proposed randomized trial, all 300 HIV-HCV co-infected participants will receive BA delivered by their HIV PCP during a regular HIV visit and will then be randomized to either a 30-minute Motivational Interviewing Intervention with a Behavioral Counselor (MI) or to HIV clinic treatment-as-usual. After this initial meeting, drinking "check-in" (MI or BA) sessions will then be provided telephonically every three months for 18 months. Research assessments will also be done every three months, with a final assessment at 24 months. Our primary outcome is drinks per week.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
February 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Stein, MD

Principal Investigator (MPI)

Butler Hospital

Eligibility Criteria

Inclusion Criteria

  • HCV RNA positive
  • consuming on average at least 4 alcoholic drinks per week in the last month
  • 18 years or older

Exclusion Criteria

  • current, severe psychiatric symptoms requiring immediate clinical attention (e.g., suicidal ideation, current mania, psychosis)
  • inability to understand English
  • cognitive impairment severe enough to interfere with ability to actively participate
  • hepatocellular carcinoma or life expectancy less than 24 months
  • plan to move from Providence area in the next 24 months

Outcomes

Primary Outcomes

Alcohol Use questionnaire

Time Frame: up to 24 months

participants will be asked how many drinks/week they have

Study Sites (2)

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