Reducing Alcohol Dependence Among HIV-Positive Individuals

Alcohol Dependence Clinical Trial

Official title:

HealthCall: Enhancing Brief Intervention for HIV Primary Care Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501057
• Other study ID #: R01AA023163-01
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: June 2020

Study information

• Verified date: October 2020
• Source: Research Foundation for Mental Hygiene, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of interventions for drinking-reduction and antiretroviral therapy (ART) adherence among HIV-positive primary care patients. The interventions consist of brief meetings to discuss drinking and ART adherence enhanced with daily self-monitoring through the use of a smart phone application that tracks drinking and other aspects of health. These meetings will either be based on the Clinician's Guide, a brief intervention for heavy drinking in primary care settings advocated by the National Institute on Alcohol Abuse and Alcoholism, or Motivational Interviewing. Participants will be assessed at baseline, 30, 60, 90 days, 6 and 12 months after baseline. By the end of treatment (60 days) and throughout the follow-up period, alcohol use is expected to highest among participants who receive the Clinician's Guide alone, intermediate among participants who receive the enhanced Clinician's Guide, and lowest among participants who receive enhanced Motivational Interviewing.

Description:

HIV infection is a widespread health problem in the U.S. Antiretroviral (ART) therapy 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. This study aims to evaluate two evidence-based approaches when combined with an innovative smart phone application designed to help users track drinking and other aspects of health. An effective, easily implemented alcohol-reduction intervention could be incorporated into standard care in HIV clinics to help 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and older

• Patient had 4 or more drinks on any day in prior 30 days

• Patient meets criteria for DSM-IV current alcohol dependence

• HIV+

Exclusion Criteria:

• Patient is psychotic, suicidal, or homicidal

• Patient has gross cognitive impairment

• Patient does not speak English or Spanish

• Patient has plans to leave the greater New York metropolitan area within the study period

• Patient has vision/hearing impairment that would preclude participation

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Behavioral:
• Clinician's Guide
An evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings.
• Enhanced Motivational Interviewing
Brief motivational interview plus the use of a smart phone application to monitor alcohol use and health behaviors.
• Enhanced Clinician's Guide
An evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings plus the use of a smart phone application to monitor alcohol use and health behaviors.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Research Foundation for Mental Hygiene, Inc.

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