Reducing Unsafe Alcohol Use in HIV-Positive Individuals

October 28, 2015 updated by: Deborah Hasin, Research Foundation for Mental Hygiene, Inc.

Reducing Unsafe Drinking in HIV Primary Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

254

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

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute/ St. Vincent's 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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 - enhanced MI
Enhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes)
Behavioral: Enhanced Motivational Interview
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).
Active Comparator: 2- standard MI
The intervention consists of a standard motivational interview or viewing a DVD on HIV self-care.
Behavioral: Standard Motivational Interview or viewing DVD
Brief motivational interview, viewing a DVD on HIV self-care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.
Time Frame: Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months
As measured by number of drinks per drinking day and percentage of days abstinent.
Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Foundation for Mental Hygiene, Inc.

Investigators

  • Study Director: Selvija G. Marovic, PhD, New York State Psychiatric Institute (NYSPI)

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.

General Publications

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

October 1, 2006

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

August 31, 2006

First Submitted That Met QC Criteria

August 31, 2006

First Posted (Estimate)

September 4, 2006

Study Record Updates

Last Update Posted (Estimate)

October 30, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAA-HAS-14323
  • NIH Grant R01 AA14323-01A1

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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