Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05576350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2022-09-29
Brief Title:
TRAC-ER Intervention to Reduce Risky Alcohol Use Among Sexual Minority Males and Transgender Individuals
Sponsor:
Carolyn Lauckner
Organization:
University of Kentucky
Study Overview
Official Title:
Evaluation of a Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Risky Alcohol Use Among Sexual Minority Males and Transgender Individuals
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAC-ER
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
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 HIVAIDS which has shown promising preliminary results with high feasibility acceptability and encouraging preliminary outcomes
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 HIVAIDS which has shown promising preliminary results with high feasibility acceptability and encouraging preliminary outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AA030487-01 | NIH | None | httpsreporternihgovquickSearch1R01AA030487-01 |