TRAC-ER Intervention to Reduce Risky Alcohol Use Among Sexual Minority Males and Transgender Individuals (TRAC-ER)

Evaluation of a Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Risky Alcohol Use Among Sexual Minority Males and Transgender Individuals

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 emerging adult sexual minority male and transgender (SMMTs) persons 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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections; Risk Behavior; Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Smartphone Based Alcohol Monitoring (SAM); Behavioral: Tracking and Reducing Alcohol Consumption (TRAC); Behavioral: TRAC-ER

Detailed Description

For this study, the investigators will enhance an existing mHealth intervention (TRAC) to reduce alcohol use among SMMT individuals 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 that serve SMMT individuals.

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 Type: Interventional
• Enrollment (Estimated): 405
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolyn Lauckner, PhD; Phone Number: 859-562-3335; Email: carolyn.lauckner@uky.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
      • Contact: Trace Kershaw, PhD; Phone Number: 203-785-3441; Email: trace.kershaw@yale.edu
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
      • Contact: Carolyn K Lauckner, PhD; Phone Number: 859-562-3335; Email: carolyn.lauckner@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• self-identify as a sexual minority male (i.e., identifies as male and as a sexual orientation other than heterosexual) or as a transgender individual
• is between the ages of 18-35 at the start of the study
• owns a smartphone
• is HIV-negative (confirmed through a test at baseline)
• screens positively for at-risk alcohol use
• meets CDC PrEP eligibility criteria

Exclusion Criteria:

• do not speak English
• active psychosis or severe mental illness
• are actively detoxifying from substances and need medical supervision
• a score of 23 or greater on the Alcohol Withdrawal Symptom Checklist

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAM-Only Comparison Group; Participants in this group will engage only in smartphone-based alcohol monitoring.	Behavioral: Smartphone Based Alcohol Monitoring (SAM); Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.
Experimental: TRAC plus SAM; Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention and smartphone-based alcohol monitoring.	Behavioral: Smartphone Based Alcohol Monitoring (SAM); Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.; Behavioral: Tracking 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 medication adherence and alcohol consumption, which will be discussed during intervention sessions.
Experimental: TRAC-ER plus 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.	Behavioral: Smartphone Based Alcohol Monitoring (SAM); Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.; Behavioral: Tracking 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 medication adherence and alcohol consumption, which will be discussed during intervention sessions.; Behavioral: TRAC-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of drinking days	Number of days in which alcohol was consumed based on breathalyzer readings greater than 0.00	8 months (measured twice daily)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of binge drinking episodes	Number of binge drinking episodes (occasions when participants had 5+ drinks based on self-reported number of drinks)	8 months (measured daily)
Number of drinks/drinking day	Number of drinks per drinking day	8 months (measured daily)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol withdrawal	Alcohol withdrawal symptom severity on a scale of 0-9, Alcohol Withdrawal Symptom Checklist	8 months (measured daily)
Hazardous/harmful drinking	PROMIS SF Alcohol Use 7a, asks about hazardous/harmful drinking behaviors (e.g., drank too much, drank heavily). Scores range from 7-35, higher scores mean more hazardous/harmful drinking behaviors.	8 months
Rate of alcohol use	Number of self-reported drinking days reported via Timeline Followback	8 months
Alcohol cravings	Individual thinking about alcohol and drinking behavior (Obsessive Compulsive Drinking Scale, scores ranging from 0-56; higher scores indicate higher rates of alcohol cravings)	8 months
Alcohol consequences	Perceived negative consequences of using alcohol (e.g., unreliable, social problems, judgement; PROMIS SF Alcohol Use- Negative Consequences 7a). Scores range from 7-35; higher scores mean more perceived negative consequences. Perceived positive consequences of using alcohol (e.g., self-esteem, confidence, enjoyment; PROMIS SF Alcohol Use- Positive Consequences 7a). Scores range from 7-35; higher scores mean more perceived positive consequences.	8 months
Alcohol expectancies	Negative expectancies of alcohol use (e.g., making bad decisions, rudeness; PROMIS SF Alcohol Use- Negative Expectancies 7a). Scores range from 7-35; higher scores mean more negative expectancies. Positive expectancies of alcohol use (e.g., improves mood, improves sociability; PROMIS SF Alcohol Use- Positive Expectancies 7a). Scores range from 7-35; higher scores mean more positive expectancies.	8 months
Readiness to change drinking	Stage of change toward reducing alcohol use (precontemplation, contemplation, action)- Readiness to Change Questionnaire (scores ranging from -24 to +24; higher positive scores indicate a greater readiness to change drinking habits)	8 months
Drinking refusal self-efficacy	Individuals' belief in their ability to resist alcohol (Drinking Refusal Self-Efficacy Questionnaire-R; 3 subscales: social pressure drinking, emotional relief drinking, opportunistic drinking. Scores range from 0-114; higher scores indicate higher rates of refusal to drink.)	8 months
Condom attitudes	Attitudes towards condoms across 7 factors: reliability and effectiveness, pleasure, identity stigma, embarrassment about purchase, negotiation, and action maintenance (Multidimensional Condom Attitudes Scale; scores range from 16-112; higher scores indicate more positive attitudes about condoms.)	8 months
Perceived HIV risk	Likelihood estimates, intuitive judgements, and salience of HIV risk based on previous behaviors (Perceived Risk of HIV Scale). Scores range from 10-40; higher scores indicate higher risk perception.	8 months
Discrimination due to sexual/gender identity	Harassment, rejection, and family discrimination related to LGBTQ identities (Heterosexist Harassment, Rejection, and Discrimination Scale). Scores range from 12-72; higher scores indicate more frequent occurrences of harassment/rejection/discrimination.	8 months
Sexual activity	Engaged in sexual activity on previous day (percentage of respondents answering yes or no)	8 months (measured daily)
Characteristics of sex partners	If applicable; number, type (percentage of respondents answering primary or non-primary partners), HIV status of partner(s) (percentage of respondents answering positive or negative status)	8 months (measured daily)
PrEP use	Used PrEP on previous day (percentage of respondents answering yes or no)	8 months (measured daily)
Condomless sex	If applicable; frequency of condomless sex for primary/non-primary partners assessed using a 5-point Likert scale ranging from "never" to "always"	8 months
Transactional sex	Engagement in transactional sex (percentage of respondents answering yes or no)	8 months
Concurrent sex and substance use	Engagement in concurrent sex and substance use (percentage of respondents answering yes or no)	8 months
Location characteristics - substances	Substances used by participant at location (check all that apply from list if used yes/no; percentage of "yes" responses for each substance out of all location surveys completed by participant)	8 months (assessed up to 2x daily)
Location characteristics - sexual activity	Sexual activity engaged in at location (yes/no; percentage of "yes" responses out of all location surveys completed by participant)	8 months (assessed up to 2x daily)
Location characteristics - harassment/discrimination	Experienced harassment/discrimination at location (check all that apply from list: physical, emotional, or sexual harassment; percentage of "yes" responses for each type of harassment/discrimination out of all location surveys completed by participant)	8 months (assessed up to 2x daily)

Collaborators and Investigators

• Sponsor: Carolyn Lauckner
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Trace Kershaw, PhD, Yale University; Principal Investigator: Carolyn Lauckner, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: behavior; transgender; motivational interviewing; mobile; GPS; ecological momentary intervention; sexual minority; EMI; TRAC
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: 79109; 1R01AA030487-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No