Reducing Alcohol Dependence Among HIV-Positive Individuals

NCT02501057 | Completed DMC

• 1 other identifier: R01AA023163-01
• Study Type: interventional
• Target: 133
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcohol Dependence

Keywords

Human Immunodeficiency Virus; Unsafe Drinking; Antiretroviral Therapy (ART)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Clinician's Guide

ACTIVE COMPARATOR

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

Enhanced Motivational Interviewing

ACTIVE COMPARATOR

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

Enhanced Clinician's Guide

EXPERIMENTAL

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

Interventions

Clinician's Guide BEHAVIORAL

An evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings.

Clinician's Guide

Enhanced Motivational Interviewing BEHAVIORAL

Brief motivational interview plus the use of a smart phone application to monitor alcohol use and health behaviors.

Enhanced Motivational Interviewing

Enhanced Clinician's Guide BEHAVIORAL

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.

Enhanced Clinician's Guide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+

You may not qualify if:

• 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

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead

MeSH Terms

Conditions

Alcoholism; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Deborah S Hasin, Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 17, 2015
• Study Start: August 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10