Graphic Messages to Prevent E-Cigarette Use Among Black and Latino Adolescents

July 14, 2025 updated by: Francisco Cartujano, MD, University of Rochester

Graphic Messages to Prevent E-Cigarette Use Among Latino and African American Adolescents: A Randomized Controlled Trial

The aim of this study is to determine if graphic messages prevent future vaping use among African American and Latino adolescents. The images have been developed in a user-design model and include four main themes: health reward, financial reward, self-efficacy, and social norms. We will assess pre- and post-exposure reactions on likelihood of future vaping among African American and Latino adolescents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
362

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • self-identify as African American/Black and/or Hispanic/Latino
  • know how to read and speak English and/or Spanish
  • have never used e-cigarettes
  • have access to a device that will be able to connect to the online survey

Exclusion Criteria:

  • not identifying as African American/Black and/or Hispanic/Latino
  • using e-cigarettes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Financial reward graphic message
Behavioral: Financial reward graphic message
Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference. Image includes the following text: Vaping leads to nothing. Don't let your money vaporize away.
Experimental: Health reward graphic message
Behavioral: Health reward graphic message
Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference. Image includes the following text: Dying for a vape? It hurts more than you know.
Experimental: Self-efficacy graphic message
Behavioral: Self-efficacy graphic message
Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference. Image includes the following text: Vaping companies are targeting Black and Latino teens. Your life matters. Don't let them take it away.
Experimental: Social norms graphic message
Behavioral: Social norms graphic message
Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference. Image includes the following text: Just because vaping is common, doesn't mean it's cool. Stay woke. Don't smoke.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Percentage of Participants Susceptible to Future Vaping
Time Frame: baseline to post-intervention, approximately 1 day
Susceptibility to future vaping was assessed before and after exposure to the graphic messages. Informed by prior foundational research on youth electronic cigarette use, susceptibility was measured with three items assessing curiosity, intent, and social influence. Participants were asked, "Have you ever been curious about using e-cigarettes/vaping?", "Do you think that you will use e-cigarettes/vape in the next 12 months?", and "If one of your best friends were to offer you an e-cigarette/electronic vapor product, would you use it?" (1 = "Definitely not" to 4 = "Definitely yes"). Responses were dichotomized: participants were categorized as susceptible if they answered anything other than "Definitely not" to at least one item. The percentage of susceptible participants was calculated before and after exposure; change in percentage reflects the difference.
baseline to post-intervention, approximately 1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Satisfied or Very Satisfied With the Graphic Message
Time Frame: Day 1
Satisfaction with the assigned vaping prevention graphic message was assessed using the item: "How satisfied are you with the image?" Responses were recorded on a 5-point Likert scale from 1 = "Extremely unsatisfied" to 5 = "Extremely satisfied." Participants selecting 5 ("Extremely satisfied") were categorized as satisfied. The percentage of satisfied participants was calculated per group. Higher percentages indicate greater satisfaction with the message.
Day 1
Percent of Participants Who Would Recommend the Graphic Message to a Friend
Time Frame: Day 1
participants were asked, "Would you recommend this picture to a friend?" with response options of Yes or No. The percentage of participants who responded "Yes" was calculated per group. Higher percentages indicate greater endorsement of the message.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00006267
  • U54CA228110 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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