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Reducing Alcohol Dependence Among HIV-Positive Individuals

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ClinicalTrials.gov Identifier: NCT02501057
Recruitment Status : Enrolling by invitation
First Posted : July 17, 2015
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Deborah Hasin, Columbia University

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Behavioral: Clinician's Guide Behavioral: Enhanced Motivational Interviewing Behavioral: Enhanced Clinician's Guide Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HealthCall: Enhancing Brief Intervention for HIV Primary Care Alcohol Dependence
Study Start Date : August 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clinician's Guide
The Baseline intervention includes a brief meeting (20 minutes or less) with a clinic staff member to discuss drinking and HIV medication adherence. The clinic staff member provides feedback on the participant's drinking, helps the participant set a drinking goal, and make suggestions to help the participant reduce their drinking. Participant receives a booklet called "Rethinking Drinking" that includes information about alcohol and tips for cutting down on alcohol use or quitting drinking. 30- and 60-day visits last about 10 minutes each, and include a meeting with the clinic staff member again to discuss drinking and HIV medication adherence, and to get additional feedback.
Behavioral: Clinician's Guide
An evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings.

Active Comparator: Enhanced Motivational Interviewing
Participants meet with a counselor to discuss their alcohol use, the impact it has on their health, and the possibility of reducing their drinking. The first counseling session is intended to help participants reduce their alcohol use. They are asked to describe the pros and cons of their alcohol use and whether it might be important to reduce or quit drinking. After, they are given a study smartphone and asked to use HealthCall-S daily to help keep track of their drinking. At 30 days, participants review a graph showing the results of HealthCall-S use and discuss it with the counselor. They also have a brief discussion about drinking patterns and goals for reduction. They are then asked to continue using HealthCall-S for the next 30 days, after which the counselor meets with the participant for another brief interview to go over the updated graph, and to discuss their experience with HealthCall-S. They will also have a brief discussion about drinking patterns and goals for reduction.
Behavioral: Enhanced Motivational Interviewing
Brief motivational interview plus the use of a smart phone application to monitor alcohol use and health behaviors.

Experimental: Enhanced Clinician's Guide
Participants in this group receive the Clinician's Guide intervention paired with daily use of HealthCall-S, which includes two cycles of daily use of HealthCall for 30 days, followed by personalized feedback in the form of a graph with a clinic staff member.
Behavioral: 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.




Primary Outcome Measures :
  1. Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed. [ Time Frame: Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months ]
    As measured by number of drinks per drinking day and percentage of days abstinent.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501057


Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
Investigators
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Principal Investigator: Deborah S Hasin, Ph.D. Columbia University

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Responsible Party: Deborah Hasin, Professor of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT02501057     History of Changes
Other Study ID Numbers: R01AA023163-01 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Keywords provided by Deborah Hasin, Columbia University:
Human Immunodeficiency Virus
Unsafe Drinking
Antiretroviral Therapy (ART)
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs