Nicotine and Tobacco Message Framing Among LGBT Young Adults

Study Overview
=================
Brief Summary
-----------------
This trial refines and evaluates how cultural targeting influences the effectiveness of anti-tobacco messages among lesbian, gay, bisexual, and transgender (LGBT) young adults at risk for the use of more than one tobacco product (polytobacco use). Polytobacco use is associated with nicotine dependence and tobacco use into adulthood, and is disproportionately high among LGBT young adults. This trial seeks to determine how cultural targeting can be applied to communicate polytobacco use risk to at-risk LGBT young adults.

Detailed Description
-----------------
The goal of this study is to identify if culturally targeted (CT) or non-targeted (NT) anti-polytobacco messages are most effective for engaging LGBT consumers. Using the most effective NT messages from Aim 1, investigators will create a set of CT messages. Message framing will remain consistent between CT and NT messages; however, CT messages will include language and graphics representing LGBT values formative research and the existing peer-reviewed literature. Participants will be randomized to view CT or NT messages in a virtual lab where investigators will assess eye-tracking, self-reported perceived effectiveness, risk perceptions, and behavioral intentions. Participants will also complete a 1-week follow-up. The study aims to determine the effects of cultural targeting on attention to anti-polytobacco messages and perceived effectiveness among LGBT young adults susceptible to polytobacco use.

Official Title
-----------------
The Effect of Nicotine and Tobacco Message Framing on Use Among Diverse Groups of Young Adults

Conditions
-----------------
Tobacco-Related Carcinoma

Intervention / Treatment
-----------------
* Behavioral: Health communications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Speaks English fluently Self-identifies as lesbian, gay, bisexual, transgender, queer, or another non- heterosexual orientation or non-binary gender identity Ever used e-cigarettes AND combustible cigarettes Currently uses e-cigarettes, combustible cigarettes, or both e-cigarettes and combustible cigarettes Resides in the United States Access to a laptop or desktop computer with a camera for virtual eye-tracking Exclusion Criteria: Glaucoma Cataracts

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally targeted messages<br>Participants will view 8 nicotine and tobacco health messages with LGBT culturally targeted messages and imagery | Behavioral: Health communications<br>* Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use.<br>|
| Other: Non-targeted messages<br>Participants will view 8 nicotine and tobacco health messages with universal messages and imagery | Behavioral: Health communications<br>* Participants will view eight culturally targeted or non-targeted health communications about the health risks of nicotine and tobacco use.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual attention - dwell time | Visual attention measured by dwell time (milliseconds) on areas of interest (text, graphic) measured via eye-tracking | During intervention | 
| Visual attention - time to first fixation | Time (milliseconds) to first fixation on areas of interest (text, graphic) measured via eye-tracking | During intervention | 
| Perceived message effectiveness - message perceptions | 6-items on a 5-point scale where 1 = Not at all and 5 = Very much. Please rate each statement from 1 (not at all) to 5 (very much). These message are worth remembering. These messages grabbed my attention. These messages are powerful. These messages are convincing. These messages are meaningful. These messages are informative. | Immediately post-exposure to intervention | 
| Perceived message effectiveness - effects perceptions | 6-items. 5-point scale where 1 = Strongly disagree to 5 = Strongly agree These messages discourage me from smoking cigarettes. These messages make me concerned about the negative effects of smoking cigarettes These messages make smoking cigarettes seem unpleasant to me. These messages discourage me from vaping nicotine. These messages make me concerned about the negative effects of vaping nicotine. These messages make vaping nicotine seem unpleasant to me. | Immediately post-exposure to intervention | 
| Change in harm perceptions | 3-items; 4-point scale 1=No harm to 4 = A lot of harm How harmful are nicotine vapes to your health? Compared to combustible cigarettes, how harmful are nicotine vapes to your health? How harmful are combustible cigarettes to your health? | Change from Baseline in harm perceptions immediately post-exposure to intervention | 
| Change in harm perceptions | 3-items; 4-point scale 1=No harm to 4 = A lot of harm How harmful are nicotine vapes to your health? Compared to combustible cigarettes, how harmful are nicotine vapes to your health? How harmful are combustible cigarettes to your health? | Change from Baseline in harm perceptions at 1-week follow-up after intervention exposure | 
| Change in behavioral intentions | 8 items total. 4-point scale 1 = Definitely not to 4 = Definitely will. How likely is it that in the next 3 months, you will refrain from vaping nicotine.... completely and permanently? when you get lonely? when you are with your friends who use them? when someone hands you a vape? How likely is it that in the next 3 months, you will refrain from smoking cigarettes... completely and permanently? when you get lonely? when you are with your friends who use them? when someone hands you a vape? | Change from Baseline in behavioral intentions immediately post-exposure to intervention | 
| Change in behavioral intentions | Do you plan to quit smoking cigarettes in the next 30 days (Yes/No) Do you plan to quit vaping in the next 30 days (Yes/No) | Change from Baseline in behavioral intentions at 1-week follow-up after intervention exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactance | 3-items; 5-point Likert scale where 1 = Strongly disagree and 5 = Strongly agree These messages are trying to manipulate me. These messages annoy me. The health effects of these messages are overblown. | Immediately post-exposure to intervention | 
| Ad relevance | 5 items; 7-point Likert scale where 1 = Strongly Disagree and 7 = Strongly agree These ads were created just for me. These ads were created for people like me. These ads were relevant to me. These ads were of value to me. These ads were important to me. | Immediately post-exposure to intervention | 
| Liking | Single item; 5-point Likert scale where 1 = Strongly disagree and 5 = Strongly agree I like these messages. | Immediately post-exposure to intervention | 
| Attitudes | Two items; 7-point Likert scale where 1 = These message made me feel much worse and 7 = These message made me feel much better. Did these messages change how you feel about smoking combustible cigarettes? Did these messages change how you feel about vaping nicotine? | Immediately post-exposure to intervention | 
| Response efficacy | 6-items; 5 point Likert scale where 1 = Strongly disagree and 5 = Strongly agree These messages will motivate CIGARETTE SMOKERS to switch to vaping. These messages will motivate people to quit ALL smoking and vaping. These messages will motivate NON-USERS to start vaping. These messages will motivate NON-USERS to start smoking cigarettes. These messages will motivate CIGARETTE SMOKERS to quit. These messages will motivate VAPERS to quit. | Immediately post-exposure to intervention | 
| Qualitative recall of health messages | Participants will be asked the following question: The images that you viewed included health messages. What do you remember about the health messages? | 1-week follow-up after intervention exposure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
health communication, LGBT