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

HIV Infections Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05576350
• Other study ID #: 79109
• Secondary ID: 1R01AA030487-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2027

Study information

• Verified date: March 2024
• Source: University of Kentucky
• Contact: Carolyn Lauckner, PhD
• Phone: 859-562-3335
• Email: carolyn.lauckner[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 405
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• HIV Infections
• Risk Behavior

Intervention

Behavioral:
• Smartphone Based Alcohol Monitoring (SAM)
Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Carolyn Lauckner	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Alcohol withdrawal	Alcohol withdrawal symptom severity on a scale of 0-9, Alcohol Withdrawal Symptom Checklist	8 months (measured daily)
Other	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
Other	Rate of alcohol use	Number of self-reported drinking days reported via Timeline Followback	8 months
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Sexual activity	Engaged in sexual activity on previous day (percentage of respondents answering yes or no)	8 months (measured daily)
Other	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)
Other	PrEP use	Used PrEP on previous day (percentage of respondents answering yes or no)	8 months (measured daily)
Other	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
Other	Transactional sex	Engagement in transactional sex (percentage of respondents answering yes or no)	8 months
Other	Concurrent sex and substance use	Engagement in concurrent sex and substance use (percentage of respondents answering yes or no)	8 months
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	Number of drinks/drinking day	Number of drinks per drinking day	8 months (measured daily)