Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS
TRAC
A Telemedicine and mHealth Intervention for Reducing Alcohol Consumption Among People Living With HIV/AIDS
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2018
CompletedFirst Posted
Study publicly available on registry
November 19, 2018
CompletedStudy Start
First participant enrolled
May 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2023
CompletedResults Posted
Study results publicly available
August 9, 2024
CompletedAugust 9, 2024
August 1, 2024
3 years
September 24, 2018
June 5, 2024
August 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Problematic Alcohol Use
Alcohol Use Disorders Identification Test-C (AUDIT-C): A validated, self-report instrument assessing problematic alcohol use. For this 3-item scale, scores range from 0-12. Higher values represent greater problematic alcohol use. Change= Week 8 score - Baseline score
Baseline, 8-week post-test
Change in Daily Alcohol Consumption
Single item asking how many days in the past month participants consumed alcohol. Responses range from 0-31. Change= Days reported at 8 weeks - Days reported at baseline
Baseline (T1), Immediate follow-up at 8 weeks (T2)
Average Percent Change in Positive Breathalyzer Readings
Participants completed up to 14 breathalyzer readings/week obtained by BACTrack mobile breathalyzer. This outcome compares average % of positive breathalyzer readings (breathalyzer values \> 0.00) per participant at Week 1 to Week 8. Numbers should be converted to percentages to aid in interpretation (e.g., -0.10 corresponds to a 10% decrease).
Week 1 and Week 8 of the active intervention period
Secondary Outcomes (4)
Percent Change in HIV/AIDS Medication Adherence
Baseline, 8-week post-test
Change in CD4 Count
Baseline, 8-week post-test, 16-week follow-up
Change in Viral Load
Baseline, 8-week post-test, 16-week follow-up
Percent Change in Daily HIV/AIDS Medication Adherence
Week 1 and Week 8 of the active intervention period
Other Outcomes (6)
Change in Depressive Symptomology
Baseline, 8-week post-test, 16-week follow-up
Change in Anxiety Symptoms
Baseline, 8-week post-test, 16-week follow-up
Change in Self-Reported Quality of Life
Baseline, 8-week post-test, 16-week follow-up
- +3 more other outcomes
Study Arms (2)
Immediate Intervention Group
EXPERIMENTALReceives 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.
Waitlist Control Group
OTHERReceives 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- HIV-positive
- years or older
- At-risk drinker
- Currently prescribed HIV medication
- Current patient at the study recruitment site(s)
You may not qualify if:
- Less than 18 years old
- Non-English Speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atlanta Veterans Health Care System
Decatur, Georgia, 30033, United States
Related Publications (1)
Lauckner C, Adatorwovor R, Taylor E, Sesenu F, Tanner T, Whitmire A, Marconi V, Kershaw T, Hansen N. The tracking and reducing alcohol consumption (TRAC) intervention for veterans living with HIV/AIDS: results from a pilot randomized waitlist-controlled trial. Addict Sci Clin Pract. 2025 Dec 3;21(1):1. doi: 10.1186/s13722-025-00631-5.
PMID: 41339902DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carolyn Lauckner, PhD
- Organization
- University of Kentucky College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn Lauckner, PhD
University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 24, 2018
First Posted
November 19, 2018
Study Start
May 23, 2020
Primary Completion
June 7, 2023
Study Completion
June 7, 2023
Last Updated
August 9, 2024
Results First Posted
August 9, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share
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.