- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02316184
Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons (REACH)
November 1, 2022 updated by: Michael Stein, MD, Butler Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- Butler Hospital
-
Providence, Rhode Island, United States
- Miriam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Brief Advice
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.
|
|
Active Comparator: MI
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Use questionnaire
Time Frame: up to 24 months
|
participants will be asked how many drinks/week they have
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Stein, MD, Butler Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
February 1, 2022
Study Registration Dates
First Submitted
December 10, 2014
First Submitted That Met QC Criteria
December 11, 2014
First Posted (Estimate)
December 12, 2014
Study Record Updates
Last Update Posted (Actual)
November 3, 2022
Last Update Submitted That Met QC Criteria
November 1, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA023726
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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