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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00371969 |
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 |
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Alcohol Abuse |
Behavioral: Enhanced Motivational Interview Behavioral: Standard Motivational Interview or viewing DVD |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Reducing Unsafe Drinking in HIV Primary Care |
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 |
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1 - enhanced MI: Active Comparator
Enhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes)
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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.
|
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Deborah S. Hasin, PhD | 212-543-5035 | dsh2@columbia.edu |
Contact: Efrat Aharonovich, PhD | 212-543-5035 | dsh2@columbia.edu |
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 |
Study Director: | Selvija G. Marovic, PhD | New York State Psychiatric Institute (NYSPI) |
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 |
Unsafe drinking Human Immunodeficiency Virus Motivational Interviewing |
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 |
Mental Disorders Alcoholism Substance-Related Disorders Disorders of Environmental Origin Alcohol-Related Disorders |