NCT05576350Recruiting
TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk
Evaluation of a Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Risky Alcohol Use Among Individuals Vulnerable to HIV/AIDS
Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 405 (estimated)
- First submitted
- 29 Sept 2022
- Start date
- 9 Dec 2024
- Primary completion date
- May 2027
- Lead sponsor
- University of Kentucky
- Diseases
- HIV
- NCT number
- NCT05576350
What you commit to
- Study type: Interventional
- Planned participants: 405
- From 9 Dec 2024 to the primary completion date, May 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- a score of 20 or greater on the Alcohol Use Disorders Identification Test
Other
- do not speak English
- are actively detoxifying from substances and need medical supervision
Who the study is looking for
- 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.)
Age in the registry: 18 years to 35 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.