Clinical trial NCT06863168: Cigarillo Public Education Messaging for Black Young Adults
Official title: Effective Cigarillo Public Education Messaging for Black Young Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cigarillo Smoking
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-03-07
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention consists of cigarillo public education messages that will be delivered online for four days each week for four weeks. Messages will communicate the health harm and nicotine addiction risks of cigarillo smoking alone (i.e., long-term health risks, short-term health risks, social health risks, nicotine addiction); or, contextualized to outcome expectancies of cigarillo smoking sensory experience, anticipated pleasure, relaxation, and satisfaction from cigarillo smoking, social persona/admiration related to cigarillo smoking, and that smoking does not align with personal values and authenticity. These intervention messages will be compared to a control messaging arm. Messaging order of the 16 messages per study arm will be randomized.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Cigarillo harm perceptions
timeFrame: 1-month; 3-month
measure: Cigarillo outcome expectancies
timeFrame: 1-month; 3-month
measure: Cigarillo use intentions
timeFrame: 1-month; 3-month
Secondary outcomes:
measure: Cigarillo use behaviors
timeFrame: 1-month; 3-month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
References: