NCT05576350 TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk
| NCT ID | NCT05576350 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Kentucky |
| Condition | Risk Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 405 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 405 participants in total. It began in 2024-12-09 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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.) Exclusion Criteria: * 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 & Investigator
Carolyn Lauckner, PhD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT05576350 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Risk Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05576350 currently recruiting?
Yes, NCT05576350 is actively recruiting participants. Contact the research team at carolyn.lauckner@uky.edu for enrollment information.
Where is the NCT05576350 trial being conducted?
This trial is being conducted at New Haven, United States, Lexington, United States.
Who is sponsoring the NCT05576350 clinical trial?
NCT05576350 is sponsored by University of Kentucky. The principal investigator is Carolyn Lauckner, PhD at University of Kentucky. The trial plans to enroll 405 participants.