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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Unsafe Drinking in HIV Primary Care

Resource links provided by NLM:


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
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00371969     History of Changes
Other Study ID Numbers: NIAAA-HAS-14323, NIH Grant R01 AA14323-01A1
Study First Received: August 31, 2006
Last Updated: November 20, 2009
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 01, 2014