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Clinical Trials/NCT05576350
NCT05576350
Recruiting
Not Applicable

Evaluation of a Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Risky Alcohol Use Among Individuals Vulnerable to HIV/AIDS

University of Kentucky2 sites in 1 country405 target enrollmentDecember 9, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Risk Behavior
Sponsor
University of Kentucky
Enrollment
405
Locations
2
Primary Endpoint
Number of drinking days
Status
Recruiting
Last Updated
last year

Overview

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 individuals 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 young adults at risk for HIV 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. 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.

Registry
clinicaltrials.gov
Start Date
December 9, 2024
End Date
May 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carolyn Lauckner

Associate Professor

University of Kentucky

Eligibility Criteria

Inclusion Criteria

  • is between the ages of 18-35 at the start of the study
  • owns a smartphone
  • has not been diagnosed with HIV
  • screens positively for at-risk alcohol use (score of 4 or higher on the AUDIT-C, OR report engaging in binge drinking at least once over the past 12 months).
  • meets criteria for pre-exposure prophylaxis (PrEP) OR is identified as being at high risk for HIV (i.e., reports history of using PrEP/PEP, reports unprotected sex, etc.)

Exclusion Criteria

  • do not speak English
  • are actively detoxifying from substances and need medical supervision
  • a score of 20 or greater on the Alcohol Use Disorders Identification Test

Outcomes

Primary Outcomes

Number of drinking days

Time Frame: Measured daily for 30 day periods during months 1, 2, 3, 6, and 9

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

Secondary Outcomes

  • Number of binge drinking episodes(Measured daily for 30 day periods during months 1, 2, 3, 6, and 9)
  • Number of drinks/drinking day(Measured daily for 30 day periods during months 1, 2, 3, 6, and 9)

Study Sites (2)

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