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

Evaluation of a Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Risky Alcohol Use Among Individuals Vulnerable to HIV/AIDS

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05576350
Acronym
TRAC-ER
Enrollment
405
Registered
2022-10-12
Start date
2024-12-09
Completion date
2027-05-31
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, HIV Infections, Risk Behavior

Keywords

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

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.

Interventions

BEHAVIORALSmartphone Based Alcohol Monitoring (SAM)

Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.

BEHAVIORALTracking 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.

BEHAVIORALTRAC-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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Yale University
CollaboratorOTHER
University of Kentucky
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Number of binge drinking episodesMeasured daily for 30 day periods during months 1, 2, 3, 6, and 9Number of binge drinking episodes (occasions when participants had 5+ drinks based on self-reported number of drinks)
Number of drinks/drinking dayMeasured daily for 30 day periods during months 1, 2, 3, 6, and 93 items: alcohol consumed (yes or no), number of drinks, and time spent drinking

Countries

United States

Contacts

Primary ContactCarolyn Lauckner, PhD
carolyn.lauckner@uky.edu859-562-3335

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026