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Acquired Immunodeficiency SyndromeTRACNCT03746600

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

A study testing Project TRAC: Tracking and Reducing Alcohol Consumption in people with Acquired Immunodeficiency Syndrome and HIV/AIDS, run by Carolyn Lauckner at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Project TRAC: Tracking and Reducing Alcohol Consumption
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
23 May 2020to 7 Jun 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Less than 18 years old
  • Non-English Speaking

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Atlanta Veterans Health Care System

    Decatur, Georgia, 30033

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Project TRAC: Tracking and Reducing Alcohol Consumption
Keywords
HIV/AIDS, Alcohol Drinking, Medication Adherence
Medical subject headings
Acquired Immunodeficiency Syndrome, Alcohol Drinking, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Project TRAC: Tracking and Reducing Alcohol ConsumptionBehavioural

    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.

Study groups in NCT03746600
Study groupRoleWhat they receive
Immediate Intervention GroupExperimentalReceives 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: Behavioral: Project TRAC: Tracking and Reducing Alcohol Consumption
Waitlist Control GroupOtherReceives 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.
Receives: Behavioral: Project TRAC: Tracking and Reducing Alcohol Consumption

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 8-week post-test

  2. 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

    Measured: Baseline (T1), Immediate follow-up at 8 weeks (T2)

  3. 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).

    Measured: Week 1 and Week 8 of the active intervention period

Secondary outcomes (4)

  1. Percent Change in HIV/AIDS Medication Adherence

    Single item: Participants self-report on a scale of 0-100% how much of their HIV/AIDS medication they have taken in the previous month. Scores range from 0-100. Change = Week 8 score - Baseline score.

    Measured: Baseline, 8-week post-test

  2. Change in CD4 Count

    CD4 cell count as determined by medical chart

    Measured: Baseline, 8-week post-test, 16-week follow-up

  3. Change in Viral Load

    Level of HIV virus in the month as determined by medical chart

    Measured: Baseline, 8-week post-test, 16-week follow-up

  4. Percent Change in Daily HIV/AIDS Medication Adherence

    % change in self-reported HIV/AIDS medication as measured via daily surveys, comparing percent of days HIV/AIDS medication was taken in Week 1 to Week 8. Numbers should be converted to percentages (i.e., a decrease of -0.01 is equivalent to a 1% decrease).

    Measured: Week 1 and Week 8 of the active intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2018
  2. Study start23 May 2020
  3. Primary completion7 Jun 2023
  4. Study completion7 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized waitlist-controlled trial
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03746600
Sponsor's protocol ID
FP00008294
Other IDs
1K01AA025305-01A1
Acronym
TRAC
Status last verified
Aug 2024
First submitted
24 Sep 2018
Last updated
9 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 41339902

Questions about this trial

What is this clinical trial studying?

A study testing Project TRAC: Tracking and Reducing Alcohol Consumption in people with Acquired Immunodeficiency Syndrome and HIV/AIDS, run by Carolyn Lauckner at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Problematic Alcohol Use (time frame: Baseline, 8-week post-test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03746600, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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