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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Risk Behavior, Alcohol Use Disorder, HIV Infections

Intervention / Treatment
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* Behavioral: Smartphone Based Alcohol Monitoring (SAM)
* Behavioral: Tracking and Reducing Alcohol Consumption (TRAC)
* Behavioral: TRAC-ER


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAM-Only Comparison Group<br>Participants in this group will engage only in smartphone-based alcohol monitoring. | Behavioral: Smartphone Based Alcohol Monitoring (SAM)<br>* Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.<br>|
| Experimental: TRAC plus SAM<br>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)<br>* Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.<br>Behavioral: Tracking and Reducing Alcohol Consumption (TRAC)<br>* 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.<br>|
| Experimental: TRAC-ER plus SAM<br>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)<br>* Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.<br>Behavioral: Tracking and Reducing Alcohol Consumption (TRAC)<br>* 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.<br>Behavioral: TRAC-ER<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sexual minority, transgender, motivational interviewing, behavior, ecological momentary intervention, EMI, TRAC, mobile, GPS