TRAC-ER Intervention to Reduce Risky Alcohol Use Among Sexual Minority Males and Transgender Individuals
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Number of drinking days [8 months (measured twice daily)]
Number of days in which alcohol was consumed based on breathalyzer readings greater than 0.00
Secondary Outcome Measures
- Number of binge drinking episodes [8 months (measured daily)]
Number of binge drinking episodes (occasions when participants had 5+ drinks based on self-reported number of drinks)
- Number of drinks/drinking day [8 months (measured daily)]
Number of drinks per drinking day
Other Outcome Measures
- Alcohol withdrawal [8 months (measured daily)]
Alcohol withdrawal symptom severity on a scale of 0-9, Alcohol Withdrawal Symptom Checklist
- Hazardous/harmful drinking [8 months]
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.
- Rate of alcohol use [8 months]
Number of self-reported drinking days reported via Timeline Followback
- Alcohol cravings [8 months]
Individual thinking about alcohol and drinking behavior (Obsessive Compulsive Drinking Scale, scores ranging from 0-56; higher scores indicate higher rates of alcohol cravings)
- Alcohol consequences [8 months]
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.
- Alcohol expectancies [8 months]
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.
- Readiness to change drinking [8 months]
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)
- Drinking refusal self-efficacy [8 months]
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.)
- Condom attitudes [8 months]
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.)
- Perceived HIV risk [8 months]
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.
- Discrimination due to sexual/gender identity [8 months]
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.
- Sexual activity [8 months (measured daily)]
Engaged in sexual activity on previous day (percentage of respondents answering yes or no)
- Characteristics of sex partners [8 months (measured daily)]
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)
- PrEP use [8 months (measured daily)]
Used PrEP on previous day (percentage of respondents answering yes or no)
- Condomless sex [8 months]
If applicable; frequency of condomless sex for primary/non-primary partners assessed using a 5-point Likert scale ranging from "never" to "always"
- Transactional sex [8 months]
Engagement in transactional sex (percentage of respondents answering yes or no)
- Concurrent sex and substance use [8 months]
Engagement in concurrent sex and substance use (percentage of respondents answering yes or no)
- Location characteristics - substances [8 months (assessed up to 2x daily)]
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)
- Location characteristics - sexual activity [8 months (assessed up to 2x daily)]
Sexual activity engaged in at location (yes/no; percentage of "yes" responses out of all location surveys completed by participant)
- Location characteristics - harassment/discrimination [8 months (assessed up to 2x daily)]
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)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale University | New Haven | Connecticut | United States | 06520 |
| 2 | University of Kentucky | Lexington | Kentucky | United States | 40536 |
Sponsors and Collaborators
- Carolyn Lauckner
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Carolyn Lauckner, PhD, University of Kentucky
- Principal Investigator: Trace Kershaw, PhD, Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 79109
- 1R01AA030487-01