- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03746600
Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS (TRAC)
July 12, 2023 updated by: Carolyn Lauckner
A Telemedicine and mHealth Intervention for Reducing Alcohol Consumption Among People Living With HIV/AIDS
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Decatur, Georgia, United States, 30033
- Atlanta Veterans Health Care System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Intervention Group
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.
|
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.
|
Other: Waitlist Control Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Problematic Alcohol Use
Time Frame: Baseline, 8-week post-test, 16-week follow-up
|
(Alcohol Use Disorders Identification Test (AUDIT score).
For this 10-item scale, scores range from 0-40.
Higher values represent greater alcohol dependence.
|
Baseline, 8-week post-test, 16-week follow-up
|
Change in daily alcohol consumption
Time Frame: Two times/day for 8 weeks
|
Self-reported # of drinks consumed
|
Two times/day for 8 weeks
|
Change in Average Blood Alcohol Content
Time Frame: Two times/day for 8 weeks
|
Reading obtained by BACTrack mobile breathalyzer
|
Two times/day for 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HIV/AIDS Medication adherence
Time Frame: Baseline, 8-week post-test, 16-week follow up
|
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)
|
Baseline, 8-week post-test, 16-week follow up
|
Change in CD4 count
Time Frame: Baseline, 8-week post-test, 16-week follow-up
|
CD4 cell count as determined by medical chart
|
Baseline, 8-week post-test, 16-week follow-up
|
Change in Viral load
Time Frame: Baseline, 8-week post-test, 16-week follow-up
|
Level of HIV virus in the month as determined by medical chart
|
Baseline, 8-week post-test, 16-week follow-up
|
Change in Daily HIV/AIDS Medication adherence
Time Frame: Daily for 8 weeks
|
Self-reported intake of HIV/AIDS medication
|
Daily for 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depressive Symptomology
Time Frame: Baseline, 8-week post-test, 16-week follow-up
|
Patient Health Questionnaire-9 (PHQ-9).
For this 9-item scale, scores range from 0-27.
Higher scores indicate greater depressive symptomology.
|
Baseline, 8-week post-test, 16-week follow-up
|
Change in Anxiety Symptoms
Time Frame: Baseline, 8-week post-test, 16-week follow-up
|
Beck Anxiety Inventory.
For this 21-item scale, scores range from 0-63.
Higher score indicates greater anxiety symptoms.
|
Baseline, 8-week post-test, 16-week follow-up
|
Change in Self-Reported Quality of Life
Time Frame: Baseline, 8-week post-test, 16-week follow-up
|
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.
|
Baseline, 8-week post-test, 16-week follow-up
|
Change in Stress
Time Frame: Baseline, 8-week post-test, 16-week follow-up
|
Perceived Stress Scale-10.
For this 10-item scale, scores range from 0-40.
A higher score suggests higher perceived stress levels.
|
Baseline, 8-week post-test, 16-week follow-up
|
Change in Social Support
Time Frame: Baseline, 8-week post-test, 16-week follow-up
|
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.
|
Baseline, 8-week post-test, 16-week follow-up
|
Change in Coping Behaviors
Time Frame: Baseline, 8-week post-test, 16-week follow-up
|
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.
|
Baseline, 8-week post-test, 16-week follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carolyn Lauckner, PhD, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2019
Primary Completion (Actual)
June 7, 2023
Study Completion (Actual)
June 7, 2023
Study Registration Dates
First Submitted
September 24, 2018
First Submitted That Met QC Criteria
November 15, 2018
First Posted (Actual)
November 19, 2018
Study Record Updates
Last Update Posted (Actual)
July 14, 2023
Last Update Submitted That Met QC Criteria
July 12, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Drinking Behavior
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- Alcohol Drinking
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- FP00008294
- 1K01AA025305-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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