Clinical trial NCT00371969: Reducing Unsafe Alcohol Use in HIV-Positive Individuals
Official title: Reducing Unsafe Drinking in HIV Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Keywords: Unsafe drinking
Human Immunodeficiency Virus
Motivational Interviewing
Lead sponsor: Research Foundation for Mental Hygiene, Inc.
Sponsor class: OTHER
First posted: 2006-09-04
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.
timeFrame: Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute/ St. Vincent's Hospital
state: New York
Study officials:
affiliation: New York State Psychiatric Institute (NYSPI)
name: Selvija G. Marovic, PhD
role: STUDY_DIRECTOR
References:
citation: 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.