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

University of Kentucky

Status: Enrolling

Conditions: Risk Behavior; HIV Infections; Alcohol Use Disorder

Treatments: Behavioral: Smartphone Based Alcohol Monitoring (SAM); Behavioral: TRAC-ER; Behavioral: Tracking and Reducing Alcohol Consumption (TRAC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05576350

79109

1R01AA030487-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 405 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

405 participants in 3 patient groups

SAM-Only Comparison Group

Experimental group

Description:

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

Treatment:

Behavioral: Smartphone Based Alcohol Monitoring (SAM)

TRAC plus SAM

Experimental group

Description:

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

Treatment:

Behavioral: Tracking and Reducing Alcohol Consumption (TRAC)

Behavioral: Smartphone Based Alcohol Monitoring (SAM)

TRAC-ER plus SAM

Experimental group

Description:

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.

Treatment:

Behavioral: Tracking and Reducing Alcohol Consumption (TRAC)

Behavioral: TRAC-ER

Behavioral: Smartphone Based Alcohol Monitoring (SAM)