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

Not Applicable

Recruiting

• Conditions: Risk Behavior; HIV Infections; Alcohol Use Disorder
• Interventions: Behavioral: Smartphone Based Alcohol Monitoring (SAM); Behavioral: Tracking and Reducing Alcohol Consumption (TRAC); Behavioral: TRAC-ER

• Registration Number: NCT05576350
• Lead Sponsor: University of Kentucky

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-12
• Study Start: 2024-12-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 405

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRAC-ER plus SAM	Smartphone Based Alcohol Monitoring (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.
SAM-Only Comparison Group	Smartphone Based Alcohol Monitoring (SAM)	Participants in this group will engage only in smartphone-based alcohol monitoring.
TRAC plus SAM	Smartphone Based Alcohol Monitoring (SAM)	Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention and smartphone-based alcohol monitoring.
TRAC plus SAM	Tracking and Reducing Alcohol Consumption (TRAC)	Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention and smartphone-based alcohol monitoring.
TRAC-ER plus SAM	Tracking and Reducing Alcohol Consumption (TRAC)	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.
TRAC-ER plus SAM	TRAC-ER	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.

Primary Outcome Measures

Name	Time	Method
Number of drinking days	Measured daily for 30 day periods during months 1, 2, 3, 6, and 9	Number of days in which alcohol was consumed based on breathalyzer readings greater than 0.00

Secondary Outcome Measures

Name	Time	Method
Number of binge drinking episodes	Measured daily for 30 day periods during months 1, 2, 3, 6, and 9	Number of binge drinking episodes (occasions when participants had 5+ drinks based on self-reported number of drinks)
Number of drinks/drinking day	Measured daily for 30 day periods during months 1, 2, 3, 6, and 9	3 items: alcohol consumed (yes or no), number of drinks, and time spent drinking

Trial Locations

Locations (2)

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States