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Reducing Alcohol Dependence Among HIV-Positive Individuals

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinician's Guide
Enhanced Motivational Interviewing
Enhanced Clinician's Guide
Sponsored by
Research Foundation for Mental Hygiene, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Human Immunodeficiency Virus, Unsafe Drinking, Antiretroviral Therapy (ART)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Clinician's Guide

    Enhanced Motivational Interviewing

    Enhanced Clinician's Guide

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 13, 2015
    Last Updated
    October 7, 2020
    Sponsor
    Research Foundation for Mental Hygiene, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02501057
    Brief Title
    Reducing Alcohol Dependence Among HIV-Positive Individuals
    Official Title
    HealthCall: Enhancing Brief Intervention for HIV Primary Care Alcohol Dependence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (Actual)
    Primary Completion Date
    June 2020 (Actual)
    Study Completion Date
    June 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Research Foundation for Mental Hygiene, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Dependence
    Keywords
    Human Immunodeficiency Virus, Unsafe Drinking, Antiretroviral Therapy (ART)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    133 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinician's Guide
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Enhanced Motivational Interviewing
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Enhanced Clinician's Guide
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Clinician's Guide
    Intervention Description
    An evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhanced Motivational Interviewing
    Intervention Description
    Brief motivational interview plus the use of a smart phone application to monitor alcohol use and health behaviors.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhanced Clinician's Guide
    Intervention Description
    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 Measure Information:
    Title
    Alcohol consumption in the last 30 days, assessed at baseline and repeatedly during follow-up so that change can be analyzed.
    Description
    As measured by number of drinks per drinking day and percentage of days abstinent.
    Time Frame
    Baseline, 30, 60 days (end-of-treatment), 3, 6, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deborah S Hasin, Ph.D.
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Reducing Alcohol Dependence Among HIV-Positive Individuals

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