Cigarillo Public Education Messaging for Black Young Adults

NCT ID: NCT06863168

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-17
• Study Completion Date: 2026-08-31

Brief Summary

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.

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.

Conditions

Cigarillo Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Cigarillo Health Harm and Nicotine Addiction Messaging

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Cigarillo Health Harm and Nicotine Addiction Messaging Contextualized to Outcome Expectancies

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Drexel University

Philadelphia, Pennsylvania, United States

Site Status: NOT_YET_RECRUITING

Drexel University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lilianna Phan, PhD, MPH, MS

Role: CONTACT

lp954@drexel.edu

267-359-6069

Facility Contacts

Lilianna Phan, PhD, MPH, MS

Role: primary

lp954@drexel.edu

267-359-6069

Role: primary

267-359-6069

Other Identifiers

R00CA272919

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2307010033

Identifier Type: -

Identifier Source: org_study_id