Reducing Unsafe Alcohol Use in HIV-Positive Individuals

NCT ID: NCT00371969

Last Updated: 2015-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2011-10-31

Brief Summary

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.

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.

Conditions

Alcohol Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 - enhanced MI

Enhanced brief motivational interview (including an IVR component for alcohol self-monitoring purposes)

Group Type: ACTIVE_COMPARATOR

Enhanced Motivational Interview

Intervention Type: BEHAVIORAL

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

The intervention consists of a standard motivational interview or viewing a DVD on HIV self-care.

Group Type: ACTIVE_COMPARATOR

Standard Motivational Interview or viewing DVD

Intervention Type: BEHAVIORAL

Brief motivational interview, viewing a DVD on HIV self-care.

Interventions

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).

Intervention Type: BEHAVIORAL

Standard Motivational Interview or viewing DVD

Brief motivational interview, viewing a DVD on HIV self-care.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Deborah Hasin

Professor of Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selvija G. Marovic, PhD

Role: STUDY_DIRECTOR

New York State Psychiatric Institute (NYSPI)

Locations

New York State Psychiatric Institute/ St. Vincent's Hospital

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23432593 (View on PubMed)

Other Identifiers

NIH Grant R01 AA14323-01A1

Identifier Type: -

Identifier Source: secondary_id

NIAAA-HAS-14323

Identifier Type: -

Identifier Source: org_study_id