Clinical trial NCT05576350: TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk
Official title: Evaluation of a Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Risky Alcohol Use Among Individuals Vulnerable to HIV/AIDS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Risk Behavior
Alcohol Use Disorder
HIV Infections
Keywords: motivational interviewing
behavior
ecological momentary intervention
EMI
TRAC
mobile
GPS
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Yale University
First posted: 2022-10-12
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of drinking days
timeFrame: Measured daily for 30 day periods during months 1, 2, 3, 6, and 9
Secondary outcomes:
measure: Number of binge drinking episodes
timeFrame: Measured daily for 30 day periods during months 1, 2, 3, 6, and 9
measure: Number of drinks/drinking day
timeFrame: Measured daily for 30 day periods during months 1, 2, 3, 6, and 9
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Carolyn Lauckner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Trace Kershaw, PhD
role: PRINCIPAL_INVESTIGATOR
References: