TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk
TRAC-ER
Evaluation of a Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Risky Alcohol Use Among Individuals Vulnerable to HIV/AIDS
2 other identifiers
interventional
405
1 country
2
Brief Summary
Ecological momentary interventions (EMI), which use phones to deliver messages to reduce alcohol use and related risk behaviors during or prior to drinking events, can help to address triggers in real-time. 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. A mobile app has been developed that uses GPS tracking to determine when individuals visit "risky" places and then delivers a survey asking what behaviors they engaged in while at the location. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedStudy Start
First participant enrolled
December 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
March 30, 2025
March 1, 2025
2.4 years
September 29, 2022
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of drinking days
Number of days in which alcohol was consumed based on breathalyzer readings greater than 0.00
Measured daily for 30 day periods during months 1, 2, 3, 6, and 9
Secondary Outcomes (2)
Number of binge drinking episodes
Measured daily for 30 day periods during months 1, 2, 3, 6, and 9
Number of drinks/drinking day
Measured daily for 30 day periods during months 1, 2, 3, 6, and 9
Study Arms (3)
SAM-Only Comparison Group
EXPERIMENTALParticipants in this group will engage only in smartphone-based alcohol monitoring.
TRAC plus SAM
EXPERIMENTALParticipants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention and smartphone-based alcohol monitoring.
TRAC-ER plus SAM
EXPERIMENTALParticipants 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.
Interventions
Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.
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.
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
You may qualify if:
- is between the ages of 18-35 at the start of the study
- 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.)
You may not qualify if:
- do not speak English
- are actively detoxifying from substances and need medical supervision
- a score of 20 or greater on the Alcohol Use Disorders Identification Test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kentuckylead
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
- Yale Universitycollaborator
Study Sites (2)
Yale University
New Haven, Connecticut, 06520, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Related Publications (1)
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.
PMID: 38578673DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn Lauckner, PhD
University of Kentucky
- PRINCIPAL INVESTIGATOR
Trace Kershaw, PhD
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 29, 2022
First Posted
October 12, 2022
Study Start
December 9, 2024
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
March 30, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share