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Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS (TRAC)

Primary Purpose

Acquired Immunodeficiency Syndrome, HIV/AIDS, Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project TRAC: Tracking and Reducing Alcohol Consumption
Sponsored by
Carolyn Lauckner
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Immunodeficiency Syndrome focused on measuring HIV/AIDS, Alcohol Drinking, Medication Adherence

Eligibility Criteria

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

Inclusion Criteria:

  • HIV-positive
  • 18 years or older
  • At-risk drinker
  • Currently prescribed HIV medication
  • Current patient at the study recruitment site(s)

Exclusion Criteria:

  • Less than 18 years old
  • Non-English Speaking

Sites / Locations

  • Atlanta Veterans Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate Intervention Group

Waitlist Control Group

Arm Description

Receives the eight-week intervention, "Project TRAC: Tracking and Reducing Alcohol Consumption," immediately upon enrollment. This intervention focuses on skill building and motivational enhancement for reducing alcohol consumption.

Receives the "Project TRAC: Tracking and Reducing Alcohol Consumption" alcohol reduction intervention after an 8-week, assessment-only period. This 8-wek intervention focuses on skill building and motivational enhancement for reducing alcohol consumption.

Outcomes

Primary Outcome Measures

Change in Problematic Alcohol Use
(Alcohol Use Disorders Identification Test (AUDIT score). For this 10-item scale, scores range from 0-40. Higher values represent greater alcohol dependence.
Change in daily alcohol consumption
Self-reported # of drinks consumed
Change in Average Blood Alcohol Content
Reading obtained by BACTrack mobile breathalyzer

Secondary Outcome Measures

Change in HIV/AIDS Medication adherence
Reported % adherence over previous month (participants self-report on a single item scale of 0-100% how much of their medication they have taken in the previous month)
Change in CD4 count
CD4 cell count as determined by medical chart
Change in Viral load
Level of HIV virus in the month as determined by medical chart
Change in Daily HIV/AIDS Medication adherence
Self-reported intake of HIV/AIDS medication

Full Information

First Posted
September 24, 2018
Last Updated
July 12, 2023
Sponsor
Carolyn Lauckner
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03746600
Brief Title
Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS
Acronym
TRAC
Official Title
A Telemedicine and mHealth Intervention for Reducing Alcohol Consumption Among People Living With HIV/AIDS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
June 7, 2023 (Actual)
Study Completion Date
June 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carolyn Lauckner
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
While advances in medication have led to greatly improved outcomes for people living with HIV/AIDS, less than one-third of all people living with the disease are adherent enough to their medication to achieve viral suppression. Alcohol consumption has been shown to have a significant effect on HIV medication adherence, so the proposed research will aim to reduce alcohol use among people living with HIV/AIDS through a technology-driven intervention. This eight-session intervention will be delivered using a combination of videoconferencing, smart phones, and Bluetooth-enabled breathalyzers for monitoring of alcohol consumption, with an overall goal of reducing alcohol use, mitigating adherence issues, and achieving optimal prevention and treatment responses for people living with HIV/AIDS.
Detailed Description
The TRAC intervention focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage drinking. It requires eight 30-minute sessions with a counselor using videoconferencing and mobile phones. In addition to receiving the eight sessions of intervention content, participants will complete smartphone-based self-monitoring of medication adherence and alcohol consumption, which will be discussed during intervention sessions. Each day, they will be texted at two random times to complete a breathalyzer reading using a BACtrack Mobile Pro, which is sold by a company with FDA clearance and utilizes law enforcement-grade sensors for determining blood alcohol level. It connects wirelessly to phones via Bluetooth, automatically uploads readings, allows the user to view their current and past readings with a mobile app, and allows them to share their readings with counselors. At the time of the breathalyzer reading, participants will also be asked to indicate via survey how many drinks they have consumed and their medication use for the day. The surveys will be programmed using Qualtrics and accessible via a link in the reminder text message. Data analytic methods will be focused on examining effects on alcohol intake, HAART adherence, and HIV-related medical outcomes (CD4 count and viral load).If shown to be feasible, acceptable, and potentially efficacious, this intervention could have a significant impact on improving the accessibility of alcohol reduction counseling among PLWHA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome, HIV/AIDS, Alcohol Drinking
Keywords
HIV/AIDS, Alcohol Drinking, Medication Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized waitlist-controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention Group
Arm Type
Experimental
Arm Description
Receives the eight-week intervention, "Project TRAC: Tracking and Reducing Alcohol Consumption," immediately upon enrollment. This intervention focuses on skill building and motivational enhancement for reducing alcohol consumption.
Arm Title
Waitlist Control Group
Arm Type
Other
Arm Description
Receives the "Project TRAC: Tracking and Reducing Alcohol Consumption" alcohol reduction intervention after an 8-week, assessment-only period. This 8-wek intervention focuses on skill building and motivational enhancement for reducing alcohol consumption.
Intervention Type
Behavioral
Intervention Name(s)
Project TRAC: Tracking and Reducing Alcohol Consumption
Intervention Description
The TRAC intervention for people living with HIV/AIDS focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage alcohol consumption. It requires eight 30-minute sessions with a counselor using videoconferencing and mobile phones. In addition to receiving the eight sessions of intervention content, participants will complete smart phone-based self-monitoring of medication adherence and alcohol consumption, which will be discussed during intervention sessions.
Primary Outcome Measure Information:
Title
Change in Problematic Alcohol Use
Description
(Alcohol Use Disorders Identification Test (AUDIT score). For this 10-item scale, scores range from 0-40. Higher values represent greater alcohol dependence.
Time Frame
Baseline, 8-week post-test, 16-week follow-up
Title
Change in daily alcohol consumption
Description
Self-reported # of drinks consumed
Time Frame
Two times/day for 8 weeks
Title
Change in Average Blood Alcohol Content
Description
Reading obtained by BACTrack mobile breathalyzer
Time Frame
Two times/day for 8 weeks
Secondary Outcome Measure Information:
Title
Change in HIV/AIDS Medication adherence
Description
Reported % adherence over previous month (participants self-report on a single item scale of 0-100% how much of their medication they have taken in the previous month)
Time Frame
Baseline, 8-week post-test, 16-week follow up
Title
Change in CD4 count
Description
CD4 cell count as determined by medical chart
Time Frame
Baseline, 8-week post-test, 16-week follow-up
Title
Change in Viral load
Description
Level of HIV virus in the month as determined by medical chart
Time Frame
Baseline, 8-week post-test, 16-week follow-up
Title
Change in Daily HIV/AIDS Medication adherence
Description
Self-reported intake of HIV/AIDS medication
Time Frame
Daily for 8 weeks
Other Pre-specified Outcome Measures:
Title
Change in Depressive Symptomology
Description
Patient Health Questionnaire-9 (PHQ-9). For this 9-item scale, scores range from 0-27. Higher scores indicate greater depressive symptomology.
Time Frame
Baseline, 8-week post-test, 16-week follow-up
Title
Change in Anxiety Symptoms
Description
Beck Anxiety Inventory. For this 21-item scale, scores range from 0-63. Higher score indicates greater anxiety symptoms.
Time Frame
Baseline, 8-week post-test, 16-week follow-up
Title
Change in Self-Reported Quality of Life
Description
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). For this 16-item scale, raw scores range from 14-70. Scores are then converted to percentages, with higher percentages equaling greater quality of life.
Time Frame
Baseline, 8-week post-test, 16-week follow-up
Title
Change in Stress
Description
Perceived Stress Scale-10. For this 10-item scale, scores range from 0-40. A higher score suggests higher perceived stress levels.
Time Frame
Baseline, 8-week post-test, 16-week follow-up
Title
Change in Social Support
Description
Medical Outcomes Study Social Support Survey-12 (MOS-SSS-12). For this 12-item scale, scores range from 12-60. Higher scores suggest greater levels of social support.
Time Frame
Baseline, 8-week post-test, 16-week follow-up
Title
Change in Coping Behaviors
Description
Brief COPE. This 28-item scale measures use of multiple forms of coping strategies, reflected in several subscales: Self-distraction, Active coping, Denial, Substance use, Use of emotional support, Use of instrumental support, Behavioral disengagement, Venting, Positive reframing, Planning, Humor, Acceptance, Religion, and Self-blame. Scores for each subscale range from 2-8, with higher values indicating greater use of that coping strategy.
Time Frame
Baseline, 8-week post-test, 16-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-positive 18 years or older At-risk drinker Currently prescribed HIV medication Current patient at the study recruitment site(s) Exclusion Criteria: Less than 18 years old Non-English Speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Lauckner, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta Veterans Health Care System
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not share data due to: 1) the sensitive nature of the data (small sample size and information about HIV status of participants) and 2) the fact that these preliminary data will be used to inform a larger randomized controlled trial.

Learn more about this trial

Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS

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