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

Primary Purpose

Risk Behavior, Alcohol Use Disorder, HIV Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone Based Alcohol Monitoring (SAM)
Tracking and Reducing Alcohol Consumption (TRAC)
TRAC-ER
Sponsored by
Carolyn Lauckner
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Risk Behavior focused on measuring sexual minority, transgender, motivational interviewing, behavior, ecological momentary intervention, EMI, TRAC, mobile, GPS

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale University
  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SAM-Only Comparison Group

TRAC plus SAM

TRAC-ER plus SAM

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Number of drinking days
Number of days in which alcohol was consumed based on breathalyzer readings greater than 0.00

Secondary Outcome Measures

Number of binge drinking episodes
Number of binge drinking episodes (occasions when participants had 5+ drinks based on self-reported number of drinks)
Number of drinks/drinking day
Number of drinks per drinking day

Full Information

First Posted
September 29, 2022
Last Updated
October 5, 2023
Sponsor
Carolyn Lauckner
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05576350
Brief Title
TRAC-ER Intervention to Reduce Risky Alcohol Use Among Sexual Minority Males and Transgender Individuals
Acronym
TRAC-ER
Official Title
Evaluation of a Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Risky Alcohol Use Among Sexual Minority Males and Transgender Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carolyn Lauckner
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Risk Behavior, Alcohol Use Disorder, HIV Infections
Keywords
sexual minority, transgender, motivational interviewing, behavior, ecological momentary intervention, EMI, TRAC, mobile, GPS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAM-Only Comparison Group
Arm Type
Experimental
Arm Description
Participants in this group will engage only in smartphone-based alcohol monitoring.
Arm Title
TRAC plus SAM
Arm Type
Experimental
Arm Description
Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention and smartphone-based alcohol monitoring.
Arm Title
TRAC-ER plus SAM
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone Based Alcohol Monitoring (SAM)
Intervention Description
Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.
Intervention Type
Behavioral
Intervention Name(s)
Tracking and Reducing Alcohol Consumption (TRAC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TRAC-ER
Intervention Description
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 Outcome Measure Information:
Title
Number of drinking days
Description
Number of days in which alcohol was consumed based on breathalyzer readings greater than 0.00
Time Frame
8 months (measured twice daily)
Secondary Outcome Measure Information:
Title
Number of binge drinking episodes
Description
Number of binge drinking episodes (occasions when participants had 5+ drinks based on self-reported number of drinks)
Time Frame
8 months (measured daily)
Title
Number of drinks/drinking day
Description
Number of drinks per drinking day
Time Frame
8 months (measured daily)
Other Pre-specified Outcome Measures:
Title
Alcohol withdrawal
Description
Alcohol withdrawal symptom severity on a scale of 0-9, Alcohol Withdrawal Symptom Checklist
Time Frame
8 months (measured daily)
Title
Hazardous/harmful drinking
Description
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.
Time Frame
8 months
Title
Rate of alcohol use
Description
Number of self-reported drinking days reported via Timeline Followback
Time Frame
8 months
Title
Alcohol cravings
Description
Individual thinking about alcohol and drinking behavior (Obsessive Compulsive Drinking Scale, scores ranging from 0-56; higher scores indicate higher rates of alcohol cravings)
Time Frame
8 months
Title
Alcohol consequences
Description
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.
Time Frame
8 months
Title
Alcohol expectancies
Description
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.
Time Frame
8 months
Title
Readiness to change drinking
Description
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)
Time Frame
8 months
Title
Drinking refusal self-efficacy
Description
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.)
Time Frame
8 months
Title
Condom attitudes
Description
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.)
Time Frame
8 months
Title
Perceived HIV risk
Description
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.
Time Frame
8 months
Title
Discrimination due to sexual/gender identity
Description
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.
Time Frame
8 months
Title
Sexual activity
Description
Engaged in sexual activity on previous day (percentage of respondents answering yes or no)
Time Frame
8 months (measured daily)
Title
Characteristics of sex partners
Description
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)
Time Frame
8 months (measured daily)
Title
PrEP use
Description
Used PrEP on previous day (percentage of respondents answering yes or no)
Time Frame
8 months (measured daily)
Title
Condomless sex
Description
If applicable; frequency of condomless sex for primary/non-primary partners assessed using a 5-point Likert scale ranging from "never" to "always"
Time Frame
8 months
Title
Transactional sex
Description
Engagement in transactional sex (percentage of respondents answering yes or no)
Time Frame
8 months
Title
Concurrent sex and substance use
Description
Engagement in concurrent sex and substance use (percentage of respondents answering yes or no)
Time Frame
8 months
Title
Location characteristics - substances
Description
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)
Time Frame
8 months (assessed up to 2x daily)
Title
Location characteristics - sexual activity
Description
Sexual activity engaged in at location (yes/no; percentage of "yes" responses out of all location surveys completed by participant)
Time Frame
8 months (assessed up to 2x daily)
Title
Location characteristics - harassment/discrimination
Description
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)
Time Frame
8 months (assessed up to 2x daily)

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolyn Lauckner, PhD
Phone
859-562-3335
Email
carolyn.lauckner@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Lauckner, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trace Kershaw, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trace Kershaw, PhD
Phone
203-785-3441
Email
trace.kershaw@yale.edu
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn K Lauckner, PhD
Phone
859-562-3335
Email
carolyn.lauckner@uky.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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