Reducing Unsafe Alcohol Use in HIV-Positive Individuals

Alcohol Abuse Clinical Trial

Official title:

Reducing Unsafe Drinking in HIV Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371969
• Other study ID #: NIAAA-HAS-14323
• Secondary ID: NIH Grant R01 AA
• Status: Completed
• Phase: N/A
• First received: August 31, 2006
• Last updated: October 28, 2015
• Start date: October 2006
• Est. completion date: October 2011

Study information

• Verified date: October 2015
• Source: Research Foundation for Mental Hygiene, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse

Intervention

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).
• Standard Motivational Interview or viewing DVD
Brief motivational interview, viewing a DVD on HIV self-care.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute/ St. Vincent's Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.	As measured by number of drinks per drinking day and percentage of days abstinent.	Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months	No