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Reducing Unsafe Alcohol Use in HIV-Positive Individuals

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Motivational Interview
Standard Motivational Interview or viewing DVD
Sponsored by
Research Foundation for Mental Hygiene, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Unsafe drinking, Human Immunodeficiency Virus, Motivational Interviewing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and females 18 years of age or older.
  • Participants have had 4 or more drinks on any day in the prior 30 days assessed via standardized questions.
  • Participants are referred to a study MI counselor by clinic staff as needing an intervention for drinking
  • Participants agree to random assignment and provide informed consent

Exclusion Criteria:

  • Participants who are currently psychotic, suicidal or homicidal.
  • Participants who have definite plans to leave the greater New York metropolitan area within the study period.
  • Participants who demonstrate gross cognitive impairment as evidenced on the Halstead-Reitain Trails (A).
  • Participants who do not speak English or Spanish, or have hearing impairments that preclude use of the telephone.

Sites / Locations

  • New York State Psychiatric Institute/ St. Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 - enhanced MI

2- standard MI

Arm Description

Enhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes)

The intervention consists of a standard motivational interview or viewing a DVD on HIV self-care.

Outcomes

Primary Outcome Measures

Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.
As measured by number of drinks per drinking day and percentage of days abstinent.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2006
Last Updated
October 28, 2015
Sponsor
Research Foundation for Mental Hygiene, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00371969
Brief Title
Reducing Unsafe Alcohol Use in HIV-Positive Individuals
Official Title
Reducing Unsafe Drinking in HIV Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Foundation for Mental Hygiene, Inc.

4. Oversight

5. Study Description

Brief Summary
The main aim of this study is to test an intervention to reduce unsafe drinking among HIV-positive primary care patients. The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system). Subjects who receive the enhanced motivational interview are expected to show greater improvements in drinking than individuals who receive the standard motivational interview or view a DVD on HIV self-care.
Detailed Description
HIV infection is a widespread health problem in the U.S. Antiretroviral treatment has increased longevity and changed the nature of risk factors for morbidity and mortality. Alcohol consumption has become an increasingly serious health issue among HIV primary care patients. Drinking is a key factor in progression to severe liver damage (especially those co-infected with hepatitis), and liver disease is now one of the most common causes of death among those with HIV. Excess drinking is also associated with medication noncompliance, reduces the effect of antiretroviral treatment, and is linked to other health problems. Therefore, helping HIV patients reduce unsafe drinking is crucial to their long-term health. The intervention combines the brief MI, an established, evidence-based counseling approach, with an innovative procedure designed to strengthen the effects of the MI. An effective, easily implemented alcohol-reduction intervention could be incorporated into standard care in HIV clinics helping prevent or slow the progress of some medical problems in HIV-infected individuals, improve medication compliance, prolong lifespan and decrease risk behavior associated with alcohol use. Comparison(s): Enhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes), brief motivational interview, viewing a DVD on HIV self-care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
Unsafe drinking, Human Immunodeficiency Virus, Motivational Interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - enhanced MI
Arm Type
Active Comparator
Arm Description
Enhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes)
Arm Title
2- standard MI
Arm Type
Active Comparator
Arm Description
The intervention consists of a standard motivational interview or viewing a DVD on HIV self-care.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Motivational Interview
Intervention Description
The intervention consists of a brief motivational interview, which is combined with daily alcohol monitoring through the use of an interactive voice response system IVR (automated telephone system).
Intervention Type
Behavioral
Intervention Name(s)
Standard Motivational Interview or viewing DVD
Intervention Description
Brief motivational interview, viewing a DVD on HIV self-care.
Primary Outcome Measure Information:
Title
Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.
Description
As measured by number of drinks per drinking day and percentage of days abstinent.
Time Frame
Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and females 18 years of age or older. Participants have had 4 or more drinks on any day in the prior 30 days assessed via standardized questions. Participants are referred to a study MI counselor by clinic staff as needing an intervention for drinking Participants agree to random assignment and provide informed consent Exclusion Criteria: Participants who are currently psychotic, suicidal or homicidal. Participants who have definite plans to leave the greater New York metropolitan area within the study period. Participants who demonstrate gross cognitive impairment as evidenced on the Halstead-Reitain Trails (A). Participants who do not speak English or Spanish, or have hearing impairments that preclude use of the telephone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selvija G. Marovic, PhD
Organizational Affiliation
New York State Psychiatric Institute (NYSPI)
Official's Role
Study Director
Facility Information:
Facility Name
New York State Psychiatric Institute/ St. Vincent's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23432593
Citation
Hasin DS, Aharonovich E, O'Leary A, Greenstein E, Pavlicova M, Arunajadai S, Waxman R, Wainberg M, Helzer J, Johnston B. Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Addiction. 2013 Jul;108(7):1230-40. doi: 10.1111/add.12127. Epub 2013 Apr 17.
Results Reference
derived

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Reducing Unsafe Alcohol Use in HIV-Positive Individuals

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