Risk BehaviorTRAC-ERNCT05576350
TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk
A study testing Smartphone Based Alcohol Monitoring (SAM), Tracking and Reducing Alcohol Consumption (TRAC) and TRAC-ER in people with Risk Behavior and Alcohol Use Disorder, run by University of Kentucky at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Behavior, Alcohol Use Disorder, HIV Infections
- What is being tested?
- Smartphone Based Alcohol Monitoring (SAM), Tracking and Reducing Alcohol Consumption (TRAC) and TRAC-ER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Dec 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Carolyn K Lauckner, PhD, 859-562-3335, carolyn.lauckner@uky.edu
Carolyn Lauckner, Ph.D.
- Recruiting
Yale University
New Haven, Connecticut, 06520
Trace Kershaw, PhD, 203-785-3441, trace.kershaw@yale.edu
Trace Kershaw, Ph.D.
About this study
Official title: Evaluation of a Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Risky Alcohol Use Among Individuals Vulnerable to HIV/AIDS
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.
Read the 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.
- Conditions
- Risk Behavior, Alcohol Use Disorder, HIV Infections
- Being tested
- Smartphone Based Alcohol Monitoring (SAM), Tracking and Reducing Alcohol Consumption (TRAC), TRAC-ER
- Keywords
- motivational interviewing, behavior, ecological momentary intervention, EMI, TRAC, mobile, GPS
- Medical subject headings
- Risk-Taking, Alcoholism, HIV Infections, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone Based Alcohol Monitoring (SAM)Behavioural
Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys.
Tracking and Reducing Alcohol Consumption (TRAC)Behavioural
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 alcohol consumption, which will be discussed during intervention sessions.
TRAC-ERBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SAM-Only Comparison Group | Experimental | Participants in this group will engage only in smartphone-based alcohol monitoring. Receives: Behavioral: Smartphone Based Alcohol Monitoring (SAM) |
| TRAC plus SAM | Experimental | Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention and smartphone-based alcohol monitoring. Receives: Behavioral: Smartphone Based Alcohol Monitoring (SAM); Behavioral: Tracking and Reducing Alcohol Consumption (TRAC) |
| TRAC-ER plus SAM | Experimental | 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. Receives: Behavioral: Smartphone Based Alcohol Monitoring (SAM); Behavioral: Tracking and Reducing Alcohol Consumption (TRAC); Behavioral: TRAC-ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of drinking days
Number of days in which alcohol was consumed based on breathalyzer readings greater than 0.00
Measured: Measured daily for 30 day periods during months 1, 2, 3, 6, and 9
Secondary outcomes (2)
Number of binge drinking episodes
Number of binge drinking episodes (occasions when participants had 5+ drinks based on self-reported number of drinks)
Measured: Measured daily for 30 day periods during months 1, 2, 3, 6, and 9
Number of drinks/drinking day
3 items: alcohol consumed (yes or no), number of drinks, and time spent drinking
Measured: Measured daily for 30 day periods during months 1, 2, 3, 6, and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start9 Dec 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Risk BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Yale University
- Responsible party
- Principal investigator, Carolyn Lauckner, University of Kentucky
- Investigators
- Carolyn Lauckner, PhD, Principal investigator, University of KentuckyTrace Kershaw, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576350
- Sponsor's protocol ID
- 79109
- Other IDs
- 1R01AA030487-01
- Acronym
- TRAC-ER
- Status last verified
- Mar 2025
- First submitted
- 29 Sep 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lauckner C, Takenaka BP, Sesenu F, Brown JS, Kirklewski SJ, Nicholson E, Haney K, Adatorwovor R, Boyd DT, Fallin-Bennett K, Restar AJ, Kershaw T. Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Hazardous Alcohol Use Among Sexual Minority Cisgender Men and Transgender Individuals: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 5;13:e55166. doi: 10.2196/55166.
PubMed 38578673
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Risky Alcohol Use Among Individuals Vulnerable to HIV/AIDS
- ClinicalTrials.gov ID
- NCT05576350
- Acronym / sponsor ID
- TRAC-ER / 79109
- Conditions
- Risk Behavior, Alcohol Use Disorder, HIV Infections
- Keywords
- motivational interviewing, behavior, ecological momentary intervention, EMI, TRAC, mobile, GPS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Yale University
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAM-Only Comparison Group | Experimental | Behavioral: Smartphone Based Alcohol Monitoring (SAM)Participants in this group will engage only in smartphone-based alcohol monitoring. |
| TRAC plus SAM | Experimental | Behavioral: Smartphone Based Alcohol Monitoring (SAM), Behavioral: Tracking and Reducing Alcohol Consumption (TRAC)Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention and smartphone-based alcohol monitoring. |
| TRAC-ER plus SAM | Experimental | Behavioral: Smartphone Based Alcohol Monitoring (SAM), Behavioral: Tracking and Reducing Alcohol Consumption (TRAC), Behavioral: TRAC-ERParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone Based Alcohol Monitoring (SAM)Smartphone-based alcohol monitoring (SAM) using mobile breathalyzers and surveys. | Behavioural | SAM-Only Comparison Group, TRAC plus SAM, TRAC-ER plus SAM |
| 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 alcohol consumption, which will be discussed during intervention sessions. | Behavioural | TRAC plus SAM, TRAC-ER plus SAM |
| TRAC-EREcological 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. | Behavioural | TRAC-ER plus SAM |
Primary outcome
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
2 secondary outcomes
Number of binge drinking episodes
Time frame: Measured daily for 30 day periods during months 1, 2, 3, 6, and 9
Number of drinks/drinking day
Time frame: Measured daily for 30 day periods during months 1, 2, 3, 6, and 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 38578673Lauckner C, Takenaka BP, Sesenu F, Brown JS, Kirklewski SJ, Nicholson E, Haney K, Adatorwovor R, Boyd DT, Fallin-Bennett K, Restar AJ, Kershaw T. Combined Motivational Interviewing and Ecological Momentary Intervention to Reduce Hazardous Alcohol Use Among Sexual Minority Cisgender Men and Transgender Individuals: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 5;13:e55166. doi: 10.2196/55166.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carolyn Lauckner, PhD principal investigator
University of Kentucky
Trace Kershaw, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Based Alcohol Monitoring (SAM), Tracking and Reducing Alcohol Consumption (TRAC) and TRAC-ER in people with Risk Behavior and Alcohol Use Disorder, run by University of Kentucky at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Lauckner, PhD (859-562-3335, carolyn.lauckner@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of drinking days (time frame: Measured daily for 30 day periods during months 1, 2, 3, 6, and 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05576350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.