Reducing Alcohol Dependence Among HIV-Positive Individuals
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02501057|
Recruitment Status : Enrolling by invitation
First Posted : July 17, 2015
Last Update Posted : September 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Behavioral: Clinician's Guide Behavioral: Enhanced Motivational Interviewing Behavioral: Enhanced Clinician's Guide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|Principal Investigator:||Deborah S Hasin, Ph.D.||Columbia University|