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Reducing Unsafe Alcohol Use in HIV-Positive Individuals
This study is currently recruiting participants.
Verified by National Institute on Alcohol Abuse and Alcoholism (NIAAA), December 2008
First Received: August 31, 2006   Last Updated: December 8, 2008   History of Changes
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00371969
  Purpose

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.


Condition Intervention
Alcohol Abuse
Behavioral: Enhanced Motivational Interview
Behavioral: Standard Motivational Interview or viewing DVD

MedlinePlus related topics: AIDS Alcohol Alcoholism
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Reducing Unsafe Drinking in HIV Primary Care

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • Alcohol Consumption

Secondary Outcome Measures:
  • HIV Medication adherence
  • HIV risk behavior
  • HIV viral load (CD4 count)
  • Liver enzymes/liver status (ALT, AST)
  • Liver diseases (ALT, AST control variables)
  • Depression (BDI score)
  • Drug use
  • Alcohol dependence
  • Start of alcohol treatment/AA
  • Start of hepatitis treatment if infected

Estimated Enrollment: 348
Study Start Date: October 2006
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 - enhanced MI: Active Comparator
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).
2- standard MI: Active Comparator
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371969

Contacts
Contact: Deborah S. Hasin, PhD 212-543-5035 dsh2@columbia.edu
Contact: Efrat Aharonovich, PhD 212-543-5035 dsh2@columbia.edu

Locations
United States, New York
New York State Psychiatric Institute/ St. Vincent's Hospital Recruiting
New York, New York, United States, 10032
Contact: Deborah S. Hasin, PhD     212-543-5035     dsh2@columbia.edu    
Contact: Efrat Aharonovich, PhD     212-740-7257     ea2017@columbia.edu    
Principal Investigator: Deborah S. Hasin, PhD            
Sub-Investigator: Barbara E. Johnston, MD            
Sub-Investigator: David L. Kaufman, MD            
Sponsors and Collaborators
Investigators
Study Director: Selvija G. Marovic, PhD New York State Psychiatric Institute (NYSPI)
  More Information

No publications provided

Study ID Numbers: NIAAA-HAS-14323, NIH Grant R01 AA14323-01A1
Study First Received: August 31, 2006
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00371969     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Unsafe drinking
Human Immunodeficiency Virus
Motivational Interviewing

Study placed in the following topic categories:
Virus Diseases
HIV Seropositivity
Mental Disorders
HIV Infections
Alcoholism
Acquired Immunodeficiency Syndrome
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Alcohol Drinking
Immunologic Deficiency Syndromes
Ethanol

Additional relevant MeSH terms:
Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on May 07, 2009