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Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons (REACH)

Primary Purpose

HIV, Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Brief Advice
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring Alcohol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Butler Hospital
  • Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Brief Advice

MI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Alcohol Use questionnaire
participants will be asked how many drinks/week they have

Secondary Outcome Measures

Full Information

First Posted
December 10, 2014
Last Updated
November 1, 2022
Sponsor
Butler Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02316184
Brief Title
Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons
Acronym
REACH
Official Title
Comparing Brief Alcohol Interventions For HIV-HCV Co-infected Persons
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
February 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Hepatitis C
Keywords
Alcohol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief Advice
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
MI
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Advice
Primary Outcome Measure Information:
Title
Alcohol Use questionnaire
Description
participants will be asked how many drinks/week they have
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stein, MD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33047258
Citation
Stein MD, Herman DS, Kim HN, Howell A, Lambert A, Madden S, Moitra E, Blevins CE, Anderson BJ, Taylor LE, Pinkston MM. A Randomized Trial Comparing Brief Advice and Motivational Interviewing for Persons with HIV-HCV Co-infection Who Drink Alcohol. AIDS Behav. 2021 Apr;25(4):1013-1025. doi: 10.1007/s10461-020-03062-2. Epub 2020 Oct 12.
Results Reference
derived

Learn more about this trial

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

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