Cigarillo Warnings Image Sorting Study

Study Overview
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Brief Summary
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The goal of this study is to examine the impact of repeated exposure to cigarillo warnings on cigarillo users' intentions and behaviors for cigarillo smoking. Eligible participants will be randomized to one of three experimental conditions that will vary based on cigarillo warning format. For 6 weeks, participants will participate in an image-sorting task where they will be asked to sort a set of  20 cigarillo packages into flavor categories determined a priori by the research team (e.g., Mint, Fruit, Dessert). An additional survey will be conducted 4 weeks later to determine any lasting effects of the warning intervention. Participants will then be notified of the purpose of the study and provided links to resources with information about the harms of cigarillo smoking and cessation. The study will be conducted in an online survey, working with Qualtrics research company, who will program the survey, recruit and screen participants, and administer the survey.

Official Title
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The Impact of Cigarillo Warnings on Purchasing and Smoking Behaviors Among Young Adult Cigarillo Users, Aim 2 Survey

Conditions
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Smoking, Cigar

Intervention / Treatment
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* Other: Package image sorting with pictorial warnings
* Other: Package image sorting with Surgeon General text-only warnings
* Other: Package image sorting with FDA text-only warnings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current cigarillo user-used cigarillos at least one time per week in the past month Recruited through Qualtrics Research Services Exclusion Criteria: Not recruited through Qualtrics Research Services Non-English speaking

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pictorial warnings<br>Participants randomized to this group will view pictorial cigarillo warnings. | Other: Package image sorting with pictorial warnings<br>* Weekly for six weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories [fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other]. Participants will sort 18 images of cigarillo packages from various brands with pictorial warnings on each pack.<br>|
| Active Comparator: FDA text-only warnings<br>Participants randomized to this group will view FDA text-only warnings. | Other: Package image sorting with FDA text-only warnings<br>* Weekly for six weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories [fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other]. Participants will sort 18 images of cigarillo packages from various brands with FDA text-only warnings on each pack.<br>|
| Active Comparator: Surgeon General text-only warnings<br>Participants randomized to this group will view Surgeon General text-only warnings. | Other: Package image sorting with Surgeon General text-only warnings<br>* Weekly for six weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories [fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other]. Participants will sort 18 images of cigarillo packages from various brands with Surgeon General text-only warnings on each pack.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intention to quit smoking cigarillos in the next 30 days at baseline | Assessed by the score for 4 survey items: how interested participants are in quitting cigarillo smoking in the next 30 days; how likely they are to quit smoking cigarillos in the next 30 days; how much they plan to quit smoking cigarillos in the next 30 days; and how successful they think they would be if they tried to quit smoking cigarillos in the next 30 days. Each survey item has a 5-pt response scale (1=Not at all to 5= Extremely).Three of the four items will be averaged. Higher scores are associated with a greater intention to quit. | Baseline | 
| Intention to quit smoking cigarillos in the next 30 days at weeks 2-6 | Assessed by the score for 4 survey items: how interested participants are in quitting cigarillo smoking in the next 30 days; how likely they are to quit smoking cigarillos in the next 30 days; how much they plan to quit smoking cigarillos in the next 30 days; and how successful they think they would be if they tried to quit smoking cigarillos in the next 30 days. Each survey item has a 5-pt response scale (1=Not at all to 5= Extremely).Three of the four items will be averaged. Higher scores are associated with a greater intention to quit. | Weeks 2-6 | 
| Intention to quit smoking cigarillos in the next 30 days at 10 weeks | Assessed by the score for 4 survey items: how interested participants are in quitting cigarillo smoking in the next 30 days; how likely they are to quit smoking cigarillos in the next 30 days; how much they plan to quit smoking cigarillos in the next 30 days; and how successful they think they would be if they tried to quit smoking cigarillos in the next 30 days. Each survey item has a 5-pt response scale (1=Not at all to 5= Extremely).Three of the four items will be averaged. Higher scores are associated with a greater intention to quit. | Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarillo smoking behavior in the past week | Assessed by 4 survey items with response options of yes/no: in the past week, have you: 1) butted out a cigarillo before you finished because you wanted to smoke less? 2) stopped yourself from smoking a cigarillo because you wanted to smoke less? 3) tried to quit cigarillos completely; 4) tried cutting back on your cigarillo smoking? | Baseline, Weeks 2-6, Week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Current cigarillo user, Cigar/cigarillo quit intentions, Pictorial warning format, Surgeon General text warning format, FDA text warning format