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

Not Applicable

Completed

• Conditions: Hepatitis C; HIV

• Registration Number: NCT02316184
• Lead Sponsor: Butler Hospital

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.

Study Timeline

• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-12
• Study Start: 2015-01
• Primary Completion: 2020-06
• Study Completion: 2022-02
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• HIV+
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Alcohol Use questionnaire	up to 24 months	participants will be asked how many drinks/week they have

Trial Locations

Locations (2)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States

Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States