TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk

Last updated: March 25, 2025
Sponsor: University of Kentucky
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alcohol Dependence

Addictions

Alcohol Use Disorder

Treatment

Smartphone Based Alcohol Monitoring (SAM)

TRAC-ER

Tracking and Reducing Alcohol Consumption (TRAC)

Clinical Study ID

NCT05576350
79109
1R01AA030487-01
  • Ages 18-35
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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, ORreport 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 highrisk for HIV (i.e., reports history of using PrEP/PEP, reports unprotected sex,etc.)

Exclusion

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

Total Participants: 405
Treatment Group(s): 3
Primary Treatment: Smartphone Based Alcohol Monitoring (SAM)
Phase:
Study Start date:
December 09, 2024
Estimated Completion Date:
May 31, 2027

Study Description

For this study, the investigators will enhance an existing mHealth intervention (TRAC) to reduce alcohol use among young adults at risk for HIV by combining the intervention with an app which delivers EMI messages in real-time. Upon enrollment, participants will be randomized into one of 3 arms: TRAC-ER (EMI messaging, TRAC intervention, and smartphone-based alcohol monitoring), TRAC (TRAC intervention and smartphone-based alcohol monitoring), or a comparison group (smartphone-based alcohol monitoring only).

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.

Connect with a study center

  • Yale University

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

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