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Reducing Unsafe Alcohol Use in HIV-Positive Individuals

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00371969
First received: August 31, 2006
Last updated: November 20, 2009
Last verified: November 2009

August 31, 2006
November 20, 2009
October 2006
October 2011   (final data collection date for primary outcome measure)
Alcohol Consumption
Same as current
Complete list of historical versions of study NCT00371969 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Reducing Unsafe Alcohol Use in HIV-Positive Individuals
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Alcohol Abuse
  • 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).
  • Behavioral: Standard Motivational Interview or viewing DVD
    Brief motivational interview, viewing a DVD on HIV self-care.
  • Active Comparator: 1 - enhanced MI
    Enhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes)
    Intervention: Behavioral: Enhanced Motivational Interview
  • Active Comparator: 2- standard MI
    The intervention consists of a standard motivational interview or viewing a DVD on HIV self-care.
    Intervention: Behavioral: Standard Motivational Interview or viewing DVD
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
348
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Deborah S. Hasin, PhD 212-543-5035 dsh2@columbia.edu
Contact: Efrat Aharonovich, PhD 212-543-5035 dsh2@columbia.edu
United States
 
NCT00371969
NIAAA-HAS-14323, NIH Grant R01 AA14323-01A1
Not Provided
Not Provided
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Not Provided
Study Director: Selvija G. Marovic, PhD New York State Psychiatric Institute (NYSPI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP