Cigarillo Public Education Messaging for Black Young Adults

June 27, 2025 updated by: Drexel University

Effective Cigarillo Public Education Messaging for Black Young Adults

This is a 3-arm randomized controlled trial to examine the effects of cigarillo public education messages among Black young adults who are at-risk for established cigarillo smoking. The primary outcomes are cigarillo harm perceptions, outcome expectancies, and use intentions at 3-month follow-up. Exploratory outcomes are use behaviors (cigarillo smoking initiation and use behaviors) measured at 3-month follow-up. These outcomes will also be measured at 1-month follow-up time point.

Study Overview

Status

Status

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

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.

Detailed Description

This is a 3-arm randomized controlled trial to examine the effects of cigarillo public education messages among Black young adults who are at-risk for established cigarillo smoking. The primary outcomes are cigarillo harm perceptions, outcome expectancies, and use intentions at 3-month follow-up. Exploratory outcomes are use behaviors (cigarillo smoking initiation and use behaviors) measured at 3-month follow-up. These outcomes will also be measured at 1-month follow-up time point. Participants will be recruited online through research panel services. Eligible participants will be those who: 1) are of non-Hispanic Black or African American ethnicity and race, respectively; 2) are between 18 to 30 years of age; 3) have never used cigarillos fairly regularly but are deemed susceptible to cigarillo smoking or currently smokes cigarillos some days but not every day; and 4) have no history of fairly regular use of any other tobacco products (i.e., little cigars, large cigars, cigarettes, hookah tobacco, electronic vaping products, smokeless tobacco, and heated tobacco products). Potential participants will be provided with a brief description of the study and a link to the eligibility screener. Those who are eligible will proceed to the online consent form. Eligible and consenting participants will complete an online assessment of demographic characteristics, tobacco use intentions and behaviors, attitudes, and perceptions (e.g., harm perceptions, outcome expectancies), alcohol use, cannabis use, and life experiences. After completing the baseline assessment, participants will be randomly assigned in approximately equal numbers into one of three study arms: 1) cigarillo harm messaging alone; 2) cigarillo harm messaging contextualized to outcome expectancies; and 3) control messaging arm. Each arm includes 16 messages. Harm messaging includes messages about the risks of cigarillo smoking including long-term health risks, short-term health risks, social health risks, and nicotine addiction. Harm messaging contextualized with outcome expectancies includes messages about the health harm and nicotine addiction risks of cigarillos contextualized to cigarillo smoking sensory experiences, anticipated pleasure, relaxation, and satisfaction from cigarillo smoking, social persona/admiration related to cigarillo smoking, and that cigarillo smoking does not align with personal values and authenticity. Control messaging includes messages about food safety. Participants will be emailed and asked to view four study arm messages (i.e., one message per theme) on four days each week for four weeks. On the 4th day of each week, participants will also complete measures of message responses for the four messages viewed that day. Following the intervention period, message recall, tobacco use intentions and behaviors, attitudes, perceptions (e.g., harm perceptions, outcome expectancies), alcohol use, and cannabis use will be assessed at 1-month and 3-month follow-up.

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 (Estimated)

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.
360

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Lilianna Phan, PhD, MPH, MS
  • Phone Number: 267-359-6069
  • Email: lp954@drexel.edu

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Drexel University
        • Contact:
          • Phone Number: 267-359-6069
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Drexel University
        • Contact:
          • Lilianna Phan, PhD, MPH, MS
          • Phone Number: 267-359-6069
          • Email: lp954@drexel.edu
        • Principal Investigator:
          • Lilianna Phan, PhD, MPH, MS

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be between 18 to 30 years of age;
  • Self-identify as non-Hispanic Black or African American ethnicity and race, respectively;
  • Must be able to communicate, read, and write in the English language;
  • Have never used cigarillos fairly regularly based on a valid measure but are deemed susceptible to cigarillo smoking based on a valid 4-item susceptibility measure; OR currently smokes cigarillos some days but not every day (i.e., experimentation)
  • And must have no history of fairly regular use of any other tobacco products (i.e., little cigars, large cigars, cigarettes, hookah tobacco, electronic vaping products, smokeless tobacco, and heated tobacco products)

Exclusion Criteria:

  • Persons who are younger than 18 years of age or older than 30 years of age.
  • Persons who do not self-identify as a non-Hispanic Black/African American person.
  • Persons who are not deemed susceptible based on a valid susceptibility measure (i.e., not susceptible to cigarillo smoking)
  • Persons who have fairly regular use of any tobacco product (i.e., persons with a former or current established pattern of any tobacco use including cigarillos, little cigars, large cigars, cigarettes, hookah tobacco, electronic vaping products, smokeless tobacco, and heated tobacco products)
  • Persons who are unable to read, write, and communicate in English language. The informed consent and other materials, including surveys, are only available in the English language for this study. Additionally, trained staff members that will communicate and interact with participants for this study can only speak in English.

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.
No Intervention: Non-Tobacco Messages
Participants in the control arm will receive messages about food safety. Four of the 16 total messages will be emailed with a survey link on four days each week for four weeks.
Experimental: Cigarillo Harm Messaging
Participants in the harm messaging arm will receive messages about the 1) long-term health risks, 2) short-term health risks, 3) social health risks, and 4) nicotine addiction of cigarillo smoking. Four of the 16 total messages will be emailed with a survey link on four days each week for four weeks. Each week's 4 messages will be randomized and include one message from the four harm themes.
Behavioral: Cigarillo Health Harm and Nicotine Addiction Messaging
Participants in the harm messaging arm will receive messages about the 1) long-term health risks, 2) short-term health risks, 3) social health risks, and 4) nicotine addiction of cigarillo smoking.
Experimental: Cigarillo Harm Messages Contextualized to Outcome Expectancies
Participants in the harm messaging contextualized to outcome expectancies arm will receive messages about the health harm and nicotine addiction risks of cigarillo smoking contextualized to one of the following themes: 1) smoking sensory experience, 2) anticipated pleasure, relaxation, and satisfaction from smoking, 3) social persona/admiration related to smoking, and 4) that smoking does not align with personal values and authenticity. Four of the 16 total messages will be emailed with a survey link on four days each week for four weeks. Each week's 4 messages will be randomized and include one message from the four harm themes.
Behavioral: Cigarillo Health Harm and Nicotine Addiction Messaging Contextualized to Outcome Expectancies
Participants in the harm messaging contextualized to outcome expectancies arm will receive messages about the health harm and nicotine addiction risks of cigarillo smoking (i.e., 1) long-term health risks, 2) short-term health risks, 3) social health risks, and 4) nicotine addiction of cigarillo smoking) contextualized to one of the following themes: 1) smoking sensory experience, 2) anticipated pleasure, relaxation, and satisfaction from smoking, 3) social persona/admiration related to smoking, and 4) that smoking does not align with personal values and authenticity.

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
Cigarillo harm perceptions
Time Frame: 1-month; 3-month
Cigarillo absolute harm perceptions will be measured using three self-report items. One item assesses perceptions of how harmful cigarillo smoking is (1=not at all harmful to 5=extremely harmful). Another item assesses perceptions of likelihood of addiction (1=not likely to 5=very likely). A multi-item measure will measure the level of agreement (1=strongly disagree to 5=strongly agree) that cigarillo smoking would cause various health harms and nicotine addiction risks.
1-month; 3-month
Cigarillo outcome expectancies
Time Frame: 1-month; 3-month
Cigarillo outcome expectancies will be measured via level of agreement (1=strongly disagree to 5=strongly agree) with various statements of potential anticipated outcomes from cigarillo smoking.
1-month; 3-month
Cigarillo use intentions
Time Frame: 1-month; 3-month
Cigarillo use intentions will be measured using self-report items related to cigarillo smoking susceptibility (i.e., Do you think that you will use a cigarillo soon?; Do you think that you will use a cigarillo in the next year?; Do you think that in the future you might experiment with cigarillos?; If one of your best friends were to offer you a cigarillo, would you smoke it?) with response options including "definitely yes"; "probably yes"; "probably not"; and "definitely not". Combination of responses other than "definitely not" to all four items will be considered susceptible to cigarillo smoking. Cigarillo use intentions will also be assessed by one's willingness to smoke cigarillos in various situations with responses ranging from unwilling=0% to extremely willing=100%.
1-month; 3-month

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
Cigarillo use behaviors
Time Frame: 1-month; 3-month
Cigarillo use behaviors will be measured by assessing cigarillo smoking initiation (Have you smoked a cigarillo, even one or two puffs?) and use behaviors (e.g., fairly regular use, current use some days or everyday, the last time a cigarillo was smoked, and the number of cigarillos smoked in the past 30 days) from the baseline time-point.
1-month; 3-month

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.
Drexel University

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.
April 17, 2025

Primary Completion (Estimated)

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.
November 30, 2025

Study Completion (Estimated)

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.
August 31, 2026

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).
March 3, 2025

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.
March 3, 2025

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.
March 7, 2025

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.
July 2, 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.
June 27, 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.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 2307010033
  • R00CA272919 (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

product manufactured in and exported from the U.S.

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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