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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV, Hepatitis C

Intervention / Treatment
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* Behavioral: Motivational Interviewing
* Behavioral: Brief Advice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Brief Advice<br>Participants in this arm will receive brief advice about alcohol use. Sessions will occur at the baseline interview and every three months for 18 months. | Behavioral: Brief Advice<br> <br> |
| Active Comparator: MI<br>Participants in this arm will receive a talking intervention designed to explore their interest in reducing/eliminating alcohol use. Sessions will occur at the baseline interview and every three months for 18 months. | Behavioral: Motivational Interviewing<br>* Motivational Interviewing is a client-centered method of exploring individual's interest in making behavioral changes. In this study, the targeted behavior is alcohol use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Use questionnaire | participants will be asked how many drinks/week they have | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol