Recruiting

TRAC-ER

Sponsor:

University of Kentucky

Code:

NCT05576350

Conditions

Risk Behavior

Alcohol Use Disorder

HIV Infections

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Smartphone Based Alcohol Monitoring (SAM)

Tracking and Reducing Alcohol Consumption (TRAC)

TRAC-ER

Study Details

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.

Conditions

Risk Behavior

Alcohol Use Disorder

HIV Infections

Study ID

NCT05576350

Start date

Dec 9, 2024

Status verified date

Mar, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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

Study Design

Enrollment

405 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAM-Only Comparison Group

Participants in this group will engage only in smartphone-based alcohol monitoring.

experimental: TRAC plus SAM

Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention and smartphone-based alcohol monitoring.

experimental: 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.

Interventions

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.

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 and Locations

Central contacts

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Principal Investigator:

Trace Kershaw, Ph.D.

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Principal Investigator:

Carolyn Lauckner, Ph.D.

More Information

Sponsor

University of Kentucky

Last update posted

Mar 30, 2025

Last verified

Mar, 2025

Keywords

  • motivational interviewing
  • behavior
  • ecological momentary intervention
  • EMI
  • TRAC
  • mobile
  • GPS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kentucky on 2025-03-30.