TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk
NCT ID: NCT05576350
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
405 participants
INTERVENTIONAL
2024-12-09
2027-05-31
Brief Summary
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The goal of the proposed study is to use this app to enhance the Tracking and Reducing Alcohol Consumption (TRAC) intervention by delivering messages that encourage participants to employ strategies discussed during TRAC sessions when arriving at risky places. When they leave these places, they will complete a survey and breathalyzer reading in order to collect event-level self-report and biological data on alcohol use and HIV risk. If their breathalyzer result indicates alcohol use, they will receive harm reduction messaging. It is expected that combining TRAC with EMI ("TRAC-ER") will increase effectiveness by reinforcing topics discussed during these sessions, providing in-the-moment messaging to address triggers, and collecting real-time alcohol use data.
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Detailed Description
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Participants will be recruited from Kentucky and Connecticut through community-based recruitment and health clinics.
Preliminary data used for this study were collected from a study (PI: Lauckner, K01AA02530) testing the TRAC intervention with people living with HIV/AIDS, which has shown promising preliminary results, with high feasibility, acceptability, and encouraging preliminary outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SAM-Only Comparison Group
Participants in this group will engage only in smartphone-based alcohol monitoring.
Smartphone Based Alcohol Monitoring (SAM)
Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.
TRAC plus SAM
Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention and smartphone-based alcohol monitoring.
Smartphone Based Alcohol Monitoring (SAM)
Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.
Tracking and Reducing Alcohol Consumption (TRAC)
The TRAC intervention focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage drinking. It requires four 30-minute sessions with a counselor using videoconferencing and mobile phones. In addition to receiving the four sessions of intervention content, participants will complete smartphone-based self-monitoring of alcohol consumption, which will be discussed during intervention sessions.
TRAC-ER plus SAM
Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention combined with GPS-based ecological momentary interventions (EMI) and smartphone-based alcohol monitoring.
Smartphone Based Alcohol Monitoring (SAM)
Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.
Tracking and Reducing Alcohol Consumption (TRAC)
The TRAC intervention focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage drinking. It requires four 30-minute sessions with a counselor using videoconferencing and mobile phones. In addition to receiving the four sessions of intervention content, participants will complete smartphone-based self-monitoring of alcohol consumption, which will be discussed during intervention sessions.
TRAC-ER
Ecological momentary interventions (EMI) use phones to deliver messages to reduce alcohol use and related risk behaviors during or prior to drinking events. GPS tracking can determine when individuals visit places they have previously reported drinking or triggers to drink and then EMI messages can be delivered upon arrival to prevent risky alcohol use.
Interventions
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Smartphone Based Alcohol Monitoring (SAM)
Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.
Tracking and Reducing Alcohol Consumption (TRAC)
The TRAC intervention focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage drinking. It requires four 30-minute sessions with a counselor using videoconferencing and mobile phones. In addition to receiving the four sessions of intervention content, participants will complete smartphone-based self-monitoring of alcohol consumption, which will be discussed during intervention sessions.
TRAC-ER
Ecological momentary interventions (EMI) use phones to deliver messages to reduce alcohol use and related risk behaviors during or prior to drinking events. GPS tracking can determine when individuals visit places they have previously reported drinking or triggers to drink and then EMI messages can be delivered upon arrival to prevent risky alcohol use.
Eligibility Criteria
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Inclusion Criteria
* owns a smartphone
* has not been diagnosed with HIV
* screens positively for at-risk alcohol use (score of 4 or higher on the AUDIT-C, OR report engaging in binge drinking at least once over the past 12 months).
* meets criteria for pre-exposure prophylaxis (PrEP) OR is identified as being at high risk for HIV (i.e., reports history of using PrEP/PEP, reports unprotected sex, etc.)
Exclusion Criteria
* are actively detoxifying from substances and need medical supervision
* a score of 20 or greater on the Alcohol Use Disorders Identification Test
18 Years
35 Years
ALL
Yes
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Yale University
OTHER
University of Kentucky
OTHER
Responsible Party
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Carolyn Lauckner
Associate Professor
Principal Investigators
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Carolyn Lauckner, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Trace Kershaw, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
University of Kentucky
Lexington, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Lauckner C, Takenaka BP, Sesenu F, Brown JS, Kirklewski SJ, Nicholson E, Haney K, Adatorwovor R, Boyd DT, Fallin-Bennett K, Restar AJ, Kershaw T. Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Hazardous Alcohol Use Among Sexual Minority Cisgender Men and Transgender Individuals: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 5;13:e55166. doi: 10.2196/55166.
Other Identifiers
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79109
Identifier Type: -
Identifier Source: org_study_id
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