TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- University of Kentucky
- Study ID
- NCT05576350
- Status
- Recruiting
Conditions
- Alcohol Use Disorder
- HIV Infections
- Risk Behavior
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 35 Years
- Healthy Volunteers
- Accepted
Interventions
- Smartphone Based Alcohol Monitoring (SAM) — BEHAVIORALSmartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.
- Tracking and Reducing Alcohol Consumption (TRAC) — BEHAVIORALThe 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 — BEHAVIORALEcological 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.
Study Details
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.
Key Dates
- Start date
- Dec 9, 2024
- Status verified
- Mar 2025
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 405 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SAM-Only Comparison GroupParticipants in this group will engage only in smartphone-based alcohol monitoring.
- Experimental: TRAC plus SAMParticipants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention and smartphone-based alcohol monitoring.
- Experimental: TRAC-ER plus SAMParticipants 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.
Primary Outcome Measure
Number of drinking days [ Time Frame: Measured daily for 30 day periods during months 1, 2, 3, 6, and 9 ]
Central Contacts
- Carolyn Lauckner, PhD859-562-3335
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | Trace Kershaw, Ph.D. (PRINCIPAL_INVESTIGATOR) |
| University of Kentucky | Lexington | Kentucky | 40536 | Carolyn Lauckner, Ph.D. (PRINCIPAL_INVESTIGATOR) |
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