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NCT Number: NCT05576350

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

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.

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Key information

Conditions

Risk Behavior Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Risk-Taking Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone Based Alcohol Monitoring (SAM)

Behavioral

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

Tracking and Reducing Alcohol Consumption (TRAC)

Behavioral

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

Behavioral

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 outcomes

  1. Number of drinking days

    Time frame: 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 outcomes

  1. Number of binge drinking episodes

    Time frame: 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)

  2. Number of drinks/drinking day

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyn Lauckner, PhD

CONTACT

[email protected]

859-562-3335

Sponsors and collaborators

Lead sponsor

University of Kentucky

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Yale University

Registry information

Official study title

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

Acronym: TRAC-ER

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 12, 2022
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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