The Effect of Nicotine and Tobacco Message Framing on Use Among Diverse Groups of Young Adults
Phase: NA
Conditions: Tobacco-Related Carcinoma
Sponsor: Ohio State University Comprehensive Cancer Center

THE OHIO STATE UNIVERSITY 
 
 
 
 
 
  CSRC PROTOCOL OSU_20427 
INITIAL APPROVAL: 03/05/2021 
 
 
 
 
 
  IRB PROTOCOL #: 2021C0020 
LAST UPDATED PROTOCOL (Aim 1): 07/22/2022  
 
 
  NCT05393869 
 
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Evaluating Anti-Tobacco Message Effectiveness Among Lesbian, Gay, Bisexual, 
and Transgender Young Adults 
 
Name and Department/Positions of PIs:  
1. Joanne G. Patterson, Assistant Professor, Division of Health Behavior and Health Promotion, The Ohio 
State University, College of Public Health 
Co-investigators:  
1. Amy K. Ferketich, Professor, Division of Epidemiology, College of Public Health, The Ohio State 
University; Member, Cancer Control Program, The James - The Ohio State University Comprehensive 
Cancer Center; Member, Center for Tobacco Research 
2. Elizabeth Klein, Interim Division Chair and an Associate Professor in the Division of Health Behavior 
and Promotion, College of Public Health, The Ohio State University; Member, Cancer Control Program, 
The James - The Ohio State University Comprehensive Cancer Center; Member, Center for Tobacco 
Research 
3. Theodore L. Wagener, Director, Center for Tobacco Research, Co-Leader, Cancer Control Program, 
The James - The Ohio State University Comprehensive Cancer Center, Associate Professor, Division 
of Medical Oncology, Wexner Medical Center 
4. Darren Mays, Associate Professor Associate Professor, Department of Internal Medicine, College of 
Medicine, The Ohio State University; Member, Center for Tobacco Research 
5. Michael Pennell, Associate Professor, Division of Biostatistics, College of Public Health, The Ohio State 
University; Member, Cancer Control Program, The James - The Ohio State University Comprehensive 
Cancer Center 
6. Paul Nini, Professor, Department of Design, College of Arts and Sciences, The Ohio State University 
7. Michael Slater, Director and Social and Behavioral Sciences Distinguished Professor, School of 
Communication, College of Arts and Sciences, The Ohio State University; Member, Cancer Control 
Program, The James - The Ohio State University Comprehensive Cancer Center 
 

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  CSRC PROTOCOL OSU_20427 
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Table of Contents 
I. OBJECTIVES ................................................................................................................................................. 2 
II. BACKGROUND and RATIONALE ................................................................................................................. 3 
III. PROCEDURES ............................................................................................................................................ 6 
A. K99/R00 Aim 1 Research Design Overview ............................................................................................... 6 
B. AIM 1 Phase 1 study .................................................................................................................................. 6 
B.1 Sample ..................................................................................................................................................... 7 
B.2. Measurement / Instrumentation .............................................................................................................. 9 
IV. DETAILED STUDY PROCEDURES ........................................................................................................... 10 
A. Aim 1, Phase 1: Study 1- FOCUS GROUP Procedures ........................................................................... 10 
B. Aim 1, Phase 1: Study 2—ONLINE RATING SURVEY Procedures ......................................................... 11 
C. Aim 1, Phase 1: Study 3:-IN-DEPTH INTERVIEW Procedures ................................................................ 12 
D. Aim 1, Phase 2: ONLINE FACTORIAL EXPERIMENT Procedures ......................................................... 13 
V. RISKS, BENEFITS, SAFETY PLANS .......................................................................................................... 14 
A. Risks associated with the study ............................................................................................................... 14 
B. Benefits associated with the study ........................................................................................................... 14 
VI. DATA ANALYSIS ....................................................................................................................................... 15 
A. Aim 1, Phase 1: Study 1—FOCUS GROUPS Data Analysis .................................................................... 15 
B. Aim 1, Phase 1: Study 2-ONLINE RATING SURVEY Data Analysis ........................................................ 15 
C. Aim 1, Phase 1: Study 3—IN-DEPTH INTERVIEWS: .............................................................................. 16 
D. Aim 1, Phase 2: ONLINE FACTORIAL EXPERIMENT Data Analysis ...................................................... 16 
VII. DATA SAFETY and MONITORING PLAN ................................................................................................. 16 
VIII. REFERENCES ......................................................................................................................................... 18 
 
I. OBJECTIVES 
Summary. Through the proposed K99/R00 studies, Dr. Joanne Patterson will receive direct training in 
communications and tobacco regulatory science, and application of this knowledge to mentored research to 
develop and gain skills necessary to develop anti-tobacco messages that effectively communicate the risks of 
polytobacco use to lesbian, gay, bisexual, and transgender polytobacco users. Using a conceptual model 
based on the Extended Parallel Process Model (EPPM)1-3 and message impact framework4 we will develop 
and refine anti-tobacco messages targeting young adult polytobacco users; specifically, lesbian, gay, bisexual, 
and transgender young adults—a polytobacco use disparities population (Aim 1, Phases 1 and 2). 

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Brief Background. Between 21-40% of lesbian, gay, bisexual, and transgender (LGBT) young adults 
(YA)5-8 (vs 12-21% of non-LGBT YA9,10) report polytobacco use, defined as using more than one 
tobacco product including electronic nicotine delivery systems (ENDS). This difference is alarming as 
polytobacco use is associated with nicotine dependence11 and continued tobacco use12-16 into adulthood, which 
may widen existing tobacco disparities.17 Markedly low tobacco risk perceptions8,18-24 among LGBT YA may 
reinforce polytobacco use.25 National anti-tobacco communications are a successful strategy for increasing 
public knowledge about tobacco health risks and decreasing tobacco use;26-29 however, they may not engage 
YA LGBT polytobacco users for two reasons: First, existing YA anti-tobacco communications are not 
framed to specifically address polytobacco use risks. Second, LGBT populations report low 
engagement with non-targeted anti-tobacco communications.30,31 The proposed study will use 
experimental methods to address these concerns. This proposal directly supports the FDA’s mandate to 
educate the public about the risks of tobacco32 by addressing the FDA research priority of 
Communications: The study goal is to determine effective communication of polytobacco use risk to 
at-risk LGBT YA. We propose to:  
Aim 1. Identify absolute and relative risk anti-tobacco messages that effectively communicate polytobacco risks 
to LGBT young adults (K99). Hypothesis: Messages emphasizing relative (vs absolute) risk of polytobacco use 
will most effectively increase tobacco risk perceptions. Hypothesis: AR and RR messages emphasizing quit 
efficacy will increase intentions to quit all tobacco while AR and RR messages emphasizing switch efficacy will 
increase intentions to switch to exclusive ENDS use. 
 
Aim 2. Determine the effects of cultural targeting on LGBT young adult polytobacco users’ attention to anti-
tobacco messages and perceived effectiveness (K99). Hypothesis: Exposure to culturally targeted messages 
will result in greater engagement with and perceived effectiveness of anti-polytobacco messages among LGBT 
YA.  
 
Aim 3. (a) Assess the feasibility of delivering MMS anti-tobacco messages developed in the K99 to LGBT 
young adults via texting; and (b) Estimate effect sizes of exposure to anti-tobacco messages on risk 
perceptions and tobacco use over time (R00). Hypothesis: LGBT young adult polytobacco users exposed to 
any anti-tobacco messages (vs not exposed) will report greater risk perceptions and reduced tobacco use. 
 
A team of exceptional NIH-funded researchers will provide mentorship for the proposed K99/R00 mentored 
research: Amy Ferketich, a tobacco prevention and control expert, with experience leading health 
communications studies to inform tobacco regulatory policy will provide primary mentorship with collaborative 
support from a team of co-mentors. This team is comprised of Elizabeth Klein and Darren Mays who are 
experts in leveraging psychophysiological measurement for health communications studies; and Theodore 
Wagener, Director of the Center for Tobacco Research and expert in lab-based tobacco studies. A Mentoring 
Advisory Committee will provide further mentoring support and include Michael Pennell, biostatistician and 
expert in the statistical analysis of psychophysiological data and experimental studies, Michael Slater, health 
communications expert, and Paul Nini, an expert in applied visual communications design.  
II. BACKGROUND and RATIONALE 
This K99/R00 proposal addresses the FDA research priority area of Communications. The rationale for 
the scientific aims is the following. While tobacco regulation has contributed to steady declines in combustible 
tobacco use, there has been a marked increase in the use of novel tobacco products, including electronic 
nicotine delivery systems (ENDS).6,33 Polytobacco use, defined as using more than one tobacco product 

THE OHIO STATE UNIVERSITY 
 
 
 
 
 
  CSRC PROTOCOL OSU_20427 
INITIAL APPROVAL: 03/05/2021 
 
 
 
 
 
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including ENDS, is increasing34 and is high in LGBT populations.5,21,35-37 Between 22-40% of LGBT young 
adults (YA)5-7 (vs 12-21% of non-LGBT YA9,10) report past 30-day polytobacco use. This is concerning as many 
polytobacco users progress to exclusively using combustible tobacco.38,39 Both LGBT people8 and polytobacco 
users8,18-24 are also less likely to perceive tobacco as harmful, which may reinforce tobacco use.25 The Food 
and Drug Administration (FDA) Center for Tobacco Products (CTP) is mandated to educate the public about 
the risks of tobacco products.26-29,32 Yet, no evidence describes how to effectively frame anti-tobacco 
messages to communicate risks to LGBT YA. Anti-tobacco campaigns may use cultural targeting40 to increase 
engagement, but this strategy demonstrates mixed effectiveness for health communications.41-45 If culturally-
targeted anti-tobacco messages are not more engaging than non-targeted messages, then general anti-
tobacco campaigns may reach LGBT YA. We propose to develop and test anti-tobacco messages for an at-
risk group, LGBT YA, with the goal of increasing risk perceptions and reducing tobacco use over time. 
While anti-tobacco communications effectively reduce cigarette smoking46,47 by preventing initiation48-
51 and progression,50,52 no campaigns have specifically addressed polytobacco use. Existing campaigns 
(e.g., The Real Cost, This Free Life) focused on communicating absolute risks (AR) of specific tobacco 
products (e.g., “cigarette smoking leads to lung cancer”) with the goal of preventing uptake in non-users or 
experimental users. YA polytobacco users have established tobacco patterns, so anti-tobacco campaign goals 
must also aim to: (1) prevent uptake of additional products, and (2) promote total tobacco cessation, or (3) 
harm reduction53 by switching to lower risk products, like ENDS.54,55 The FDA’s regulatory plan places tobacco 
products on a risk continuum,56 yet little evidence describes the effect of relative risk (RR) communications 
(e.g., “cigarettes contain 9 times more cancer-causing chemicals than ENDS) on risk perceptions and tobacco 
use.57-59 Among smokers, RR communications increase intentions to quit smoking58 and switch to ENDS.57,58 
RR messages may also influence quitting and switching behaviors in polytobacco users.  
Targeting is a broadly supported communications strategy40 to increase engagement with anti-tobacco 
communications. LGBT adults engage less with anti-tobacco campaigns than heterosexuals;30,31 however, 
they report high exposure,30,60,61 engagement,30,62 and receptivity60,63 to LGBT-targeted tobacco industry 
marketing.60,63,64 Tobacco marketing messages emphasize LGBT community values of choice and pride.65 
These values have been leveraged in health campaigns targeting LGBT people,66,67 including This Free Life, 
the FDA’s first anti-tobacco campaign for LGBT YA who occasionally smoke.68 The campaign’s culturally 
targeted smoking prevention messages reached perceived effectiveness ratings similar to prior youth49,69 and 
adult70 anti-tobacco campaigns. Yet, no studies have tested if LGBT culturally targeted (vs non-targeted) 
messages are more engaging or effective for reducing polytobacco use.71 Targeted anti-tobacco campaigns 
are costly.72,73 To manage costs74 anti-tobacco communications must effectively engage audiences. If cultural 
targeting does not increase engagement and effectiveness of anti-tobacco messages, then the FDA 
may be able to reach at-risk LGBT people via campaigns targeting YA more generally.  

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A conceptual model based on the Extended Parallel Process Model (EPPM)1-3 and message impact 
framework4 will guide the proposed research (Figure 2). Together they posit that, upon exposure to anti-
tobacco messages, a person proceeds through three steps: attention, reaction, and formation of attitudes and 
intentions. These steps determine whether a person engages in the behavior promoted in the message.75 The 
EPPM includes four key variables: perceived susceptibility, perceived severity, response efficacy and self-
efficacy.25,76 The model predicts that messages which cause a high perceived threat and high efficacy will 
result in action (quitting, switching). The effectiveness of high threat58,77,78 messages for behavior change 
is well established; however, less is known about how to effectively frame efficacy messages. Prior 
anti-tobacco campaigns have omitted efficacy statements entirely1 or encouraged tobacco 
avoidance/cessation.28,79 Yet for polytobacco users, both cessation and harm reduction efficacy 
messages may be needed. Recent studies have applied combination efficacy messages that emphasize total 
tobacco cessation, while stating that if smokers are not ready to quit, switching to exclusive ENDS use can 
reduce health risks.58,80 However, combined quit/switch messages may be confusing for users.81 We will 
investigate optimal framing of threat/efficacy messages to communicate absolute and relative risk of 
polytobacco use.  
Bio-behavioral methods may be used to objectively quantify attention to culturally targeted anti-
tobacco messages. Studies using self-report after anti-tobacco message exposure have revealed important 
information about behavioral intentions to use tobacco27,82-84; however, self-report outcomes are subject to 
social desirability bias85 and can be enhanced by bio-behavioral methods.86-88 More specifically, 
psychophysiological measures can clarify which messages capture polytobacco users’ attention (eye-tracking) 
and evoke emotional responses (skin conductance).89 These processes are prerequisite steps that inform risk 
perceptions, behavioral intentions and, ultimately, behaviors.89 Bio-behavioral methods are used in studies of 
tobacco advertising90-92 and warnings,87,93,94 and will be used here to objectively study attention to anti-tobacco 
messages. 
Anti-tobacco messages delivered via texting may effectively increase tobacco risk perceptions and 
reduce tobacco use. Texting-based communications have demonstrated effectiveness for increasing 
cessation in YA smokers95-97 and preliminary efficacy97 for changing risk perceptions and behaviors in YA 
waterpipe users. It is possible that anti-tobacco mobile multimedia messages (i.e., text plus graphic; MMS) 
may be similarly applied to communicate polytobacco use risks and reduce polytobacco use in LGBT YA. Over 
96% of YA own a mobile device with MMS,98 and 75% use it to seek health information.99 By delivering anti-
tobacco messages via texting we can target content95 to LGBT YA and, using MMS, mimic real-life exposure to 
anti-tobacco communications that LGBT YA may encounter while seeking health information using their 
device. 

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  CSRC PROTOCOL OSU_20427 
INITIAL APPROVAL: 03/05/2021 
 
 
 
 
 
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The proposed research will have an impact on the growing field of tobacco regulatory science. This 
study will provide results that can directly inform future FDA anti-tobacco public education efforts. At the 
completion of the study, we will have conducted an evaluation of the effectiveness of absolute and relative risk 
anti-tobacco ENDS messages that includes both formative and summative evaluation.100  
III. PROCEDURES 
A. K99/R00 Aim 1 Research Design Overview  
Using qualitative and experimental designs, the proposed K99/R00 research is scientifically rigorous in its 
application of formative and summative evaluation.100 Aims are synergistic and focused on developing and 
evaluating effective anti-tobacco messages for LGBT YA. Aim 1 is formative evaluation and focuses on optimal 
message framing for AR and RR anti-tobacco messages. Aim 1 outcomes are presented in Table 1. 
 
Table 1. Overview of primary and secondary outcome measures for K99/R00 studies, by specific aim 
Aim 
Phase 
Domain 
Outcome Measure 
1 
1 + 2 
Cognitive 
General70,101 and health-specific102 perceived effectiveness 
1 
2 
Cognitive 
EPPM constructs: self-efficacy to quit tobacco,103 response efficacy,103 and reactance104 
1 
2 
Cognitive 
Risk perceptions: Significance, severity, and seriousness of health threats from tobacco use,105 
absolute/relative risks of polytobacco use (vs exclusive ENDS use) 
1 
1+ 2 
Behavioral 
Behavioral intentions to use tobacco; intentions quit all tobacco, intentions to switch to exclusive ENDS 
use58 
1 
1 
Qualitative 
Acceptability and perceived effectiveness, recommendations for further refining  
 
B. AIM 1 Phase 1 study procedures  
(K99 Grant Year 1) In Aim 1 we will develop anti-tobacco messages and assess effectiveness.  
 
In Aim 1 Phase 1, we will use multi-methods to gain feedback on textual anti-tobacco messages and gain 
insights about visual elements (images, fonts, colors) that are appealing to young adult polytobacco users. 
Phase 1 studies will include the following:  
 
• 
Aim 1, Phase 1: Study 1 – FOCUS GROUPS will explore terminology and message themes 
used in absolute and relative risk anti-tobacco messages and quit/switch efficacy statements  
 
• 
Aim 1, Phase 1: Study 2 – ONLINE RATING SURVEY will quantitatively assess how young 
adults rate absolute and relative polytobacco risk messages and quit/switch efficacy statements 
for perceived effectiveness and reactance 
 
• 
Aim 1, Phase 1: Study 3 – IN-DEPTH INTERVIEWS will explore qualitatively how young adults 
perceive 8 absolute risk and 8 relative risk anti-tobacco messages. 
Aim 1, Phase 1: Study 1 – FOCUS GROUPS: Focus group participants will be asked to share their opinions 
on possible textual anti-tobacco messages (Table 2). Anti-tobacco risk statements will pe presented in two 
sets; communicating either absolute (e.g., “tobacco smoke contains 69 cancer-causing chemicals, including 
arsenic and formaldehyde”) or relative risk (e.g., “combustible tobacco products contain 9 times more cancer-
causing chemicals than ENDS). Messages will address FDA-regulatory topics106; for example: addiction, toxic 

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  CSRC PROTOCOL OSU_20427 
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exposure, and health effects (see supplemental documents for sample risk statements). We will then 
present examples of efficacy statements including quit only (e.g., “Quit all tobacco products to reduce health 
risks.”), switch only (e.g., “Switch to using e-cigarettes to reduce health risks.”), or quit plus switch messages 
(e.g., “Quit all tobacco products to reduce your risk of cancer. If you’re not ready to quit, switch to e-cigarettes 
only.”). Focus group feedback will be used to further develop text for anti-tobacco messages that will be further 
tested in Aim 1, Phase 2. (see supplemental documents A for sample efficacy statements). Focus group 
participants will also be asked to provide feedback on the acceptability, appeal, and comprehension of specific 
terms (e.g., “traditional cigarettes” vs. “combustible cigarettes”, “e-cigarettes” vs. “nicotine vapes” vs “vapes”). 
 
To assess graphics that are appealing to using adult 
polytobacco users, we will present examples of existing  
anti-tobacco messages from FDA and Truth anti-tobacco 
campaigns (see samples in supplemental documents). 
We will ask focus group participants to identify the graphic 
components that are more and less appealing from 
existing anti-tobacco ads. We will use focus group 
feedback to add visual elements to the textual anti-
tobacco messages that will be further tested in Aim 1, 
Phase 2. Graphics will mirror visual styles of existing 
campaigns107 using bold colors and images of YA108 to 
represent topics conveyed in text. Messages and images 
will be refined based on focus group feedback. 
 
Aim 1, Phase 1: Study 2 –ONLINE RATING SURVEY: In Phase 1, Study 2 we will conduct an online survey 
to quantitatively examine young adults’ perceptions of 8 absolute risk and 8 relative risk anti-tobacco 
messages and quit/switch efficacy statements. To reduce participant burden, each participant will view a 
random sample of messages as follows: n = 5 absolute and relative risk anti-tobacco messages (of N = 24), 
and n = 3 (of N = 12) efficacy messages. They will be asked to rate absolute and relative risk antitobacco 
messages and quit/switch efficacy statements for perceived message effectiveness, likeability, and reactance. 
 
Aim 1, Phase 1: Study 3 –IN-DEPTH INTERVIEWS: Interviewees will be asked to share their reactions to the 
24 textual anti-tobacco messages tested in Study 2. Specifically, interviewees will be asked to rate their top 5  
(of N =12) absolute risk and top 5 (of N =12) relative risk antitobacco messages. We will then qualitatively 
explore their rationale for their top 5 selected messages. 
 
Aim 1, Phase 2: ONLINE FACTORIAL EXPERIMENT: Using a 2x3 factorial experiment (Table 2), plus control 
group design we will test the influence of AR and RR message framing on perceived effectiveness, tobacco 
risk perceptions, and behavioral intentions in young adult ever polytobacco users. Participants will be 
randomized to one of 8 conditions, including 6 experimental sets of AR and RR anti-tobacco messages(Table 
3) and a control set of AR or RR regulatory control messages. We will present 8 messages within each 
experimental and control set. An expert panel of scientists, selected and invited by the mentoring team, will 
review all messages, which we will further refine based on expert feedback prior to testing in Aim 1, Phase 2.  
B.1 Sample 
Participants for Aim 1, Phase 1 studies will be young adults (age 18-35 years) who live in the United States. 
and are susceptible to multiple nicotine and tobacco product use (i.e., have used combustible tobacco or e-
cigarettes at least once).  

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In the Aim 1 Phase 1 focus groups and interviews, participants expressed concern that relative risk messages 
comparing combustible cigarette and ENDS use could increase young adult non-users' curiosity and intentions 
to use ENDS. The goal of anti-tobacco messages being tested in this study is to increase harm perceptions 
and decrease use intentions among susceptible nicotine and tobacco users, However, we also do not want to 
negatively impact nonusers. After conferring with the mentoring committee and scientific experts, in Phase 2, 
we will address this concern by empirically testing whether responses to absolute and relative risk messages 
vary by nicotine and tobacco user type. As such, our sample will include young adults (age 18-35 years) who 
live in the United States. Per the Aim 1, Phase 1 studies, half of our sample will include young adults who are 
susceptible to multiple nicotine and tobacco product use (i.e., have used combustible tobacco or e-cigarettes at 
least once) and approximately half of the sample will comprise U.S. young adult nonusers. 
For Aim 1, Phase 1, Study 1--FOCUS GROUPS: The maximum overall sample size will be N = 58. However, 
our analytic sample size will start with 3 focus groups of size 6-8 individuals (N = 18-24 total participants). This 
sample size is standard in “usability research,” where existing messages are tested to uncover issues of 
effectiveness, and newly designed prototypes are tested to improve any communication issues. If we do not 
reach thematic saturation, we will conduct additional focus groups until thematic saturation is achieved, up to a 
total analytic sample size of N = 48 participants. We have inflated the overall sample size to 29 participants for 
each round of focus groups (N = 58) to allow for 20% dropout.   
Recruitment will occur online via social media, on OSU’s campus, and in the Columbus community. On 
campus, we will reach out to student groups and we will place flyers in residence halls and other buildings. We 
have used these methods in the past with success. We will also work with the Office of Minority Health at 
Columbus Public Health to reach a racially, ethnically, and economically diverse group of young men and 
women. Co-investigator Ferketich has partnered with this office in the past and they have helped successfully 
recruit young people through their community connections. We will also partner with The Equitas Health 
Institute to reach LGBT young adults. Both the PI (Patterson) and Co-I (Ferketich) have relationships with The 
Equitas Health Institute through the College of Public Health. Focus groups will be balanced by gender and 
sexual orientation. 
 
Aim 1, Phase 1: Study 2 –ONLINE RATING SURVEY: The overall sample size will be N = 550. Participants 
will be recruited via Prolific (https://www.prolific.co/), a platform for online subject recruitment for research, 
which is supported by Isis Innovation of the University of Oxford. In recent years, Prolific has been extensively 
used in social science research and by the PI in prior studies. Prolific enables researchers to recruit 
participants to perform tasks such as filling out surveys, opinion polls, cognitive psychological studies, and 
many others. Researchers advertise their studies on Prolific, and participants choose only those studies that 
interest them. Participants are paid for completing the studies. In the PI’s prior research using Prolific to recruit 
young adults into survey studies, approximately 3% of survey participants had inconsistencies between the 
prescreening questions asked by Prolific (e.g., age range) and demographic questions reported as part of the 
survey (e.g., numerical age). Data for these participants was not included in analyses, as we could not confirm 
that they met study eligibility criteria. As our analytic sample size is N = 500 participants; we have inflated our 
overall sample size is inflated by 10% to account for estimated inconsistencies between prescreening and 
survey responses.  
We will monitor enrollment with the goal of recruiting a balance of young adult participants by age (younger: 
age 18-25, older: age 26-35), gender, and sexual orientation. From current population-based estimates, we 
expect that study participants will be 57% non-Hispanic white, 19% non-Hispanic black, 15% Hispanic, and 6% 
Asian, and the remaining representing other race groups.  

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Aim 1, Phase 1: Study 3 – IN-DEPTH INTERVIEWS. For interviews, the maximum overall sample size will be 
N = 20. However, our initial analytic sample size will be N = 8 participants. If we do not reach thematic 
saturation, we will conduct additional interviews until thematic saturation is achieved, up to a total analytic 
sample size of N = 16 participants. We have inflated the overall sample size to 20 participants to allow for 20% 
dropout.   
 
Recruitment will occur online via social media, via email listservs, on OSU’s campus, and in the Columbus 
community. We will invite prior focus group participants to participate in in-depth interviews. On campus, we 
will reach out to student groups and we will place flyers in residence halls and other buildings. We have used 
these methods in the past with success. We will also partner with The Equitas Health Institute to reach LGBT 
young adults. Both the PI (Patterson) and Co-I (Ferketich) have relationships with The Equitas Health Institute 
through the College of Public Health. We will aim to balance interviews by gender and sexual orientation. 
 
For the Aim 1, Phase 2—ONLINE FACTORIAL EXPERIMENT: The overall sample size will be N = .2940. 
Participants will be recruited via Prolific (https://www.prolific.co/), a platform for online subject recruitment for 
research, which is supported by Isis Innovation of the University of Oxford. In recent years, Prolific has been 
extensively used in social science research and by the PI in prior studies. Prolific enables researchers to 
recruit participants to perform tasks such as filling out surveys, opinion polls, cognitive psychological studies, 
and many others. Researchers advertise their studies on Prolific, and participants choose only those studies 
that interest them. Participants are paid for completing the studies. In the PI’s prior research using Prolific to 
recruit young adults into survey studies, approximately 3% of survey participants had inconsistencies between 
the prescreening questions asked by Prolific (e.g., age range) and demographic questions reported as part of 
the survey (e.g., numerical age). Data for these participants was not included in analyses, as we could not 
confirm that they met study eligibility criteria. In our phase 1 study, <1% of the sample reported inconsistencies 
between prescreening and survey responses. As our analytic sample size is N =  2800 participants (n = 400 
participants per experimental or control group); we have inflated our overall sample size is inflated by 5% to 
account for estimated inconsistencies between prescreening and survey responses.  
We will monitor enrollment with the goal of recruiting a balance of young adult participants by age (younger: 
age 18-25, older: age 26-35), gender, and sexual orientation. From current population-based estimates, we 
expect that study participants will be 57% non-Hispanic white, 19% non-Hispanic black, 15% Hispanic, and 6% 
Asian, and the remaining representing other race groups.  
 
B.2. Measurement / Instrumentation 
For Aim 1, Phase 1: Study 1--FOCUS GROUPS: A focus group guide will be developed and will be used to 
facilitate the research for preliminary work. Participants will be asked about their opinions on a series of 
absolute and relative risk polytobacco use statements, efficacy statements, and visual elements of anti-tobacco 
communication campaigns. Participants will also be asked their thoughts on the types of images to pair with 
anti-tobacco risk statements. 
For Aim 1, Phase 1: Study 2—ONLINE RATING SURVEY: Primary outcome measures are presented in Table 
1. Baseline questionnaires will assess EC and combustible tobacco use,109 pro- and anti-tobacco advertising 
exposure,110 receptivity,111 social media use and risk perceptions105 and behavioral intentions.58 Post-viewing 
their randomly assigned messages participants will be asked to rate each message for perceived message 
effectiveness,70,101  likeability,112 and reactance.104 Finally, sociodemographic questions also include age, 
race/ethnicity, education level, location (state, zip code, rurality), sexual orientation113 and gender identity.114  

THE OHIO STATE UNIVERSITY 
 
 
 
 
 
  CSRC PROTOCOL OSU_20427 
INITIAL APPROVAL: 03/05/2021 
 
 
 
 
 
  IRB PROTOCOL #: 2021C0020 
LAST UPDATED PROTOCOL (Aim 1): 07/22/2022  
 
 
  NCT05393869 
 
Page 10 of 24 
 
For Aim 1, Phase 1: Study 3—IN-DEPTH INTERVIEWS: An interview guide will be developed and will be used 
to facilitate the research. Specifically, interviewees will be asked to rate their top 5 (of N =12) absolute risk and 
top 5 (of N =12) relative risk antitobacco messages. We will then qualitatively explore their rationale for their 
top 5 selected messages. We will also ask participants to share their opinions on the types of images to pair 
with anti-tobacco risk statements. 
 
For Aim 1, Phase 2-ONLINE FACTORIAL EXPERIMENT: Primary outcome measures are presented in Table 
1. These measures were largely selected from the Tobacco Regulatory Research PhenX Toolkit.115,116 
Baseline questionnaires will assess ENDS and combustible tobacco use,109 pro- and anti-tobacco advertising 
exposure,110 receptivity,111 social media use, risk perceptions,105 self- and response efficacy,103 and behavioral 
intentions.58 Post-viewing their assigned message condition, all participants will be asked about their 
responses to the posts including perceived acceptability, attitude toward, and effectiveness of the messages. 
All baseline measures (excluding social media use and prior anti-tobacco message exposure) will be asked 
post-viewing all messages. Finally, sociodemographic questions also include age, race/ethnicity, education 
level, location (state, county, rurality), sexual orientation113 and gender identity.114  
 
The purpose of the R00 Phase is to identify which anti-polytobacco messages most strongly influence LGBT 
YA’s attention, tobacco risk perceptions, and behavioral intentions (Aim 2) and evaluate the impact of exposure 
to anti-polytobacco communications delivered by mobile multimedia messaging (MMS) on tobacco use over 
time in YA polytobacco users of diverse sexual orientations and gender identities (Aim 3) 
 
IV. DETAILED STUDY PROCEDURES 
A. Aim 1, Phase 1: Study 1- FOCUS GROUP Procedures 
Prescreening and consent. Participants will be recruited from OSU student organizations, flyers on campus, 
Reddit, other social media, or through word of mouth from participants who completed the study. The 
recruitment materials will include a study phone number and an OSU email address that will be set up for the 
study. Individuals who are interested in the study will be asked to call or email the study email address. An 
IRB-approved research team member will call the individual and go through the screener that explains the 
study and determines eligibility.  
 
Eligible participants will complete a verbal informed consent. The research team member will read the informed 
consent script and verbally explain the online questionnaire and focus group process. The research team 
member will indicate that participation in the questionnaire and focus group is voluntary. The eligible participant 
will be given an opportunity to ask questions and have all questions answered to their satisfaction. Once the 
eligible participant understands the consent form and process, then and only then will the eligible participant be 
asked to give verbal consent. Eligible participants that do not consent will be released at this time.  Consenting 
participants will be emailed the informed consent script for their records. A PDF copy of the informed consent 
script will also be made available for download as part of the online questionnaire. 
 
The research team member will ask eligible and consented participants for an email address for online 
questionnaire distribution and to send information for the future focus group. After the call has concluded, the 
research team member will email participants a link to a short questionnaire distributed via Qualtrics with 
questions about tobacco use, intentions to quit smoking, and demographic characteristics.  
 

THE OHIO STATE UNIVERSITY 
 
 
 
 
 
  CSRC PROTOCOL OSU_20427 
INITIAL APPROVAL: 03/05/2021 
 
 
 
 
 
  IRB PROTOCOL #: 2021C0020 
LAST UPDATED PROTOCOL (Aim 1): 07/22/2022  
 
 
  NCT05393869 
 
Page 11 of 24 
 
Focus group procedures. On the day of focus group, OSU IRB approved study personnel will provide an 
opportunity for verbal reconsent immediately preceding the focus group. Prior to audio-recording, the IRB-
approved research team member will re-affirm participant consent. The research team member will indicate 
that participation in the focus group is voluntary and that participants may withdraw participation at any time. 
Eligible participants who do not reaffirm consent to focus group participation will be released at this time. 
 
Focus groups will take place online via CarmenZoom in a secure, private space. A growing body of evidence 
describes the use of web-based videoconferencing platforms—also known as Voice over Internet Protocol 
(VoIP)-mediated technologies (e.g., CarmenZoom, Skype, FaceTime)—for collecting data in qualitative 
studies.117-121 Zoom, in particular, has been cited by qualitative interview participants as straightforward, easy 
to use, and preferred for its “robust but simple privacy and security options” (e.g., secure webinar options and 
local device- or server-based recording).117 Online focus group are also a feasible option for conducting 
qualitative human subjects research during the COVID-19 pandemic where meeting in groups may not be 
preferred in order to protect participants’ health and wellbeing.  
 
All focus groups will be audio-recorded and transcribed for subsequent analysis. Focus group length is 
anticipated to be about 90 minutes. Audio-recorded data will capture participants’ verbal ratings and reactions 
to polytobacco use risk statements (absolute and relative risk), quit efficacy statements, and visual elements of 
existing national anti-tobacco campaigns. Specifically, participants will be asked to rate and then describe their 
reactions to anti-tobacco messages, including whether they believe the message effectively communicates 
tobacco risk (absolute or relative) and whether the message would be effective at preventing polytobacco use 
among young adults. Then, they will be asked to provide their opinion about how to visually represent that 
idea. They will also be asked about their reactions to self-efficacy statements promoting quitting and, if 
participants are not ready to quit, switching to lower harm products. Finally, participants will be asked to share 
their reactions to visual elements (images, fonts, colors) used in existing FDA and Truth© anti-tobacco 
campaigns. Participants will receive $30 via Amazon gift card distributed via email in appreciation of their time.  
 
Aim 1, Phase 1: Study 1-FOCUS GROUP data will be used to further develop/refine text and graphics for anti-
tobacco messages that will be further tested in Aim 1, Phase 2. 
 
B. Aim 1, Phase 1: Study 2—ONLINE RATING SURVEY Procedures 
Prescreening and consent. Participants will be recruited via Prolific, an online platform open to participants 
who are compensated for completing surveys and online behavioral experiments. Prolific is an efficient online 
recruitment platform, ideal for pilot studies, as it can deliver a high number of participants, per day, at low cost 
(recommended, minimum $0.175 per minute of survey participation time). Data quality provided by Prolific 
samples is high and comparable to that from traditional college student samples.122  Prolific offers access to 
over 38,000 United States nationals. Prolific samples are young; approximately 1/3 of the Prolific population 
reports ages < 35 years old, which makes Prolific an ideal pool for recruiting young adult survey participants. 
Prolific is also a viable method for recruiting hard-to-reach populations for survey research, including LGBT 
populations.123  
Prescreening will be conducted via Prolific. Prolific is able to segment our population of interest for age (18-35 
years) and currently residing the United States. It can also help us track gender and sexual orientation in order 
to balance recruitment. We are able to add in a custom pre-screening question to assess for prior history of 
ever nicotine or tobacco use (i.e., use of combustible tobacco or e-cigarette products at least once).  
Participants who meet eligibility criteria will be directed to an online survey administered via Qualtrics. Consent 
will be completed online prior to the Qualtrics survey.  

THE OHIO STATE UNIVERSITY 
 
 
 
 
 
  CSRC PROTOCOL OSU_20427 
INITIAL APPROVAL: 03/05/2021 
 
 
 
 
 
  IRB PROTOCOL #: 2021C0020 
LAST UPDATED PROTOCOL (Aim 1): 07/22/2022  
 
 
  NCT05393869 
 
Page 12 of 24 
 
Qualtrics survey procedures. Following online consent, participants will be directed to complete a survey that 
includes questions assessing tobacco use, including exposure to tobacco related advertising, coupons, and 
discounts; harms perceptions and tobacco-related behavioral intentions (i.e., quit, switch). It is estimated that  
the survey will take 20 minutes to complete. 
 
Participants will answer baseline survey questions before viewing a random sample of 5 messages (of N = 24); 
they will rate each message for perceived effectiveness70,101,102, likeability,112 and reactance.104 After viewing all 
messages, participants will complete a post-survey and receive $0.175/minute (estimated $3.50) via Prolific for 
participating.  
 
As per Prolific procedures, participants are paid via Prolific only when submitted work is approved by the study 
team. Participants are redirected back to Prolific at the end of the Qualtrics survey via a Completion URL, which 
proves that they have completed the study. This code is given to the participants who submit a complete and 
valid response to the survey. The study team compares the Qualtrics surveys to the participants redirected back 
to Prolific via the URL. If a survey participant is not matched to a redirect URL, a participant is not paid.  
 
To contextualize data quality, we will include an instructional manipulation check124 at the end of the survey. 
A participant’s answer to this question will not affect payment for survey participation; rather, it will be used 
during data analysis to identify potential problematic survey responses for in-depth data checks. Participants 
will be asked the following:  
 
Research suggests that, when making decisions and answering questions, people prefer not to pay 
attention and minimize their efforts. Some studies show that over 50% of people do not carefully read 
questions. You will be compensated for survey participation regardless of your answer to this 
question. If you are reading this question and have read all the other questions, please select the box 
marked ‘other” and type ‘yes” in the box below. Thank you for participating in our survey! 
 
o Yes 
o No 
o Other:___________ 
 
C. Aim 1, Phase 1: Study 3:-IN-DEPTH INTERVIEW Procedures 
Prescreening and consent. Participants will be recruited from OSU student organizations, flyers on campus, 
Reddit, other social media, email listservs, or through word of mouth from participants who completed the 
Phase 1 Focus group or interview study. The recruitment materials will include a study phone number and an 
OSU email address that will be set up for the study. Individuals who are interested in the study will be asked to 
call or email the study email address. An IRB-approved research team member will call the individual and go 
through the screener that explains the study and determines eligibility.  
 
Eligible participants will complete a verbal informed consent. The research team member will read the informed 
consent script and verbally explain the online questionnaire and interview process. The research team member 
will indicate that participation in the questionnaire and interview is voluntary. The eligible participant will be 
given an opportunity to ask questions and have all questions answered to their satisfaction. Once the eligible 
participant understands the consent form and process, then and only then will the eligible participant be asked 
to give verbal consent. Eligible participants that do not consent will be released at this time.  Consenting 
participants will be emailed the informed consent script for their records. A PDF copy of the informed consent 
script will also be made available for download as part of the online questionnaire. 
 

THE OHIO STATE UNIVERSITY 
 
 
 
 
 
  CSRC PROTOCOL OSU_20427 
INITIAL APPROVAL: 03/05/2021 
 
 
 
 
 
  IRB PROTOCOL #: 2021C0020 
LAST UPDATED PROTOCOL (Aim 1): 07/22/2022  
 
 
  NCT05393869 
 
Page 13 of 24 
 
The research team member will ask eligible and consented participants for an email address for online 
questionnaire distribution and to send information for the interview. After the call has concluded, the research 
team member will email participants a link to a short questionnaire distributed via Qualtrics with questions 
about tobacco use, intentions to quit smoking, and demographic characteristics.  
 
Interview procedures. On the day of interview, OSU IRB approved study personnel will provide an opportunity 
for verbal reconsent immediately preceding the interview. Prior to audio-recording, the IRB-approved research 
team member will re-affirm participant consent. The research team member will indicate that participation in 
the interview is voluntary and that participants may withdraw participation at any time. Eligible participants who 
do not reaffirm consent to interview participation will be released at this time. 
 
Interviews will take place online via CarmenZoom in a secure, private space. A growing body of evidence 
describes the use of web-based videoconferencing platforms—also known as Voice over Internet Protocol 
(VoIP)-mediated technologies (e.g., CarmenZoom, Skype, FaceTime)—for collecting data in qualitative 
studies.117-121 Zoom, in particular, has been cited by qualitative interview participants as straightforward, easy 
to use, and preferred for its “robust but simple privacy and security options” (e.g., secure webinar options and 
local device- or server-based recording).117 Online interviews are also a feasible option for conducting qualitative 
human subjects research during the COVID-19 pandemic where meeting in-person may not be preferred in order 
to protect participants’ health and wellbeing. 
 
All interviews will be audio-recorded and transcribed for subsequent analysis. Interview length is anticipated to 
be about 60 minutes. Audio-recorded data will capture participants’ verbal ratings and reactions to antitobacco 
risk statements (absolute and relative risk), quit efficacy statements, and visual elements of existing national 
anti-tobacco campaigns. Specifically, participants will be asked to rate their top 5 of both absolute and relative 
risk anti-tobacco messages, including whether they believe the message effectively communicates tobacco 
risk (absolute or relative) and whether the message would be effective at preventing polytobacco use among 
young adults. Then, they will be asked to provide their opinion about how to visually represent that idea. They 
will also be asked about their reactions to self-efficacy statements promoting quitting and, if participants are not 
ready to quit, switching to lower harm products. Participants will receive $30 via Amazon gift card distributed 
via email in appreciation of their time.  
 
D. Aim 1, Phase 2: ONLINE FACTORIAL EXPERIMENT Procedures 
Prescreening and consent. Participants will be recruited via Prolific, an online platform open to participants 
who are compensated for completing surveys and online behavioral experiments. Prolific is an efficient online 
recruitment platform, ideal for pilot studies, as it can deliver a high number of participants, per day, at low cost 
(recommended, minimum $0.175 per minute of survey participation time). Data quality provided by Prolific 
samples is high and comparable to that from traditional college student samples 122.  Prolific offers access to 
over 38,000 United States nationals. Prolific samples are young; approximately 1/3 of the Prolific population 
reports ages < 35 years old, which makes Prolific an ideal pool for recruiting young adult survey participants. 
Prolific is also a viable method for recruiting hard-to-reach populations for survey research, including LGBT 
populations 123.  
Prescreening will be conducted via Prolific. Prolific is able to segment our population of interest for age (18-35 
years) and currently residing the United States. It can also help us track gender and sexual orientation in order 
to balance recruitment. We are able to add in a custom pre-screening question to assess for prior history of 
ever nicotine and tobacco use.  
Participants who meet eligibility criteria will be directed to an online survey administered via Qualtrics. Consent 
will be completed online prior to the Qualtrics survey.  

THE OHIO STATE UNIVERSITY 
 
 
 
 
 
  CSRC PROTOCOL OSU_20427 
INITIAL APPROVAL: 03/05/2021 
 
 
 
 
 
  IRB PROTOCOL #: 2021C0020 
LAST UPDATED PROTOCOL (Aim 1): 07/22/2022  
 
 
  NCT05393869 
 
Page 14 of 24 
 
Qualtrics survey procedures. Following online consent, participants will be directed to complete a survey that 
includes questions assessing tobacco use, including exposure to tobacco related advertising, coupons, and 
discounts; harms perceptions and tobacco-related behavioral intentions (i.e., quit, switch); and online/social 
media use questions.  
 
Participants will answer baseline survey questions before random assignment to 1 of 6 experimental conditions 
in the 2 (Threat: Absolute/Relative Risk) X 3 (Efficacy: Quit, Switch, Quit plus Switch) design. Participants will 
view 8 randomly-ordered, anti-tobacco messages within their assigned condition; they will rate each message 
for perceived effectiveness70,101,102 and reactance.104 After viewing all messages, participants will complete a 
post-survey and receive $0.225/minute (estimated $4.50) via Prolific for participating. 
  
As per Prolific procedures, participants are paid via Prolific only when submitted work is approved by the study 
team. Participants are redirected back to Prolific at the end of the Qualtrics survey via a Completion URL, which 
proves that they have completed the study. This code is given to the participants who submit a complete and 
valid response to the survey. The study team compares the Qualtrics surveys to the participants redirected back 
to Prolific via the URL. If a survey participant is not matched to a redirect URL, a participant is not paid.  
 
To contextualize data quality, we will include an instructional manipulation check124 at the end of the survey. 
A participant’s answer to this question will not affect payment for survey participation; rather, it will be used 
during data analysis to identify potential problematic survey responses for in-depth data checks. Participants 
will be asked the following:  
 
Research suggests that, when making decisions and answering questions, people prefer not to pay 
attention and minimize their efforts. Some studies show that over 50% of people do not carefully read 
questions. You will be compensated for survey participation regardless of your answer to this 
question. If you are reading this question and have read all the other questions, please select the box 
marked ‘other” and type ‘yes” in the box below. Thank you for participating in our survey! 
 
o Yes 
o No 
o Other:___________ 
V. RISKS, BENEFITS, SAFETY PLANS 
A. Risks associated with the study 
Potential risks are minimal for the focus group and survey studies. Some of the questions may upset individuals; 
however, we have used these questions and procedures in many previous studies without upsetting 
participants. A potential risk is loss of confidentiality In our screener, we collect participant contact information. 
We have rigid procedures in place to protect against loss of confidentiality. Participant identifiers will be kept in 
password-protected files, stored on secure OSU servers. 
 
B. Benefits associated with the study 
There are no direct benefits to be gained by participants. However, the anticipated societal benefit resulting 
from this study is considerable, given the increasing prevalence of polytobacco use, including ENDS. 
Societal benefits include increased public health resulting from this study providing evidence that directly 
informs and strengthens FDAs tobacco public education efforts. Few studies have been conducted on 
effectively communicating tobacco risk to polytobacco users and at the same time, there is mounting 
evidence that LGBT young adult polytobacco users, a vulnerable population from a tobacco control 
perspective, are largely misinformed of the risks of combustible tobacco and ENDS use.  

THE OHIO STATE UNIVERSITY 
 
 
 
 
 
  CSRC PROTOCOL OSU_20427 
INITIAL APPROVAL: 03/05/2021 
 
 
 
 
 
  IRB PROTOCOL #: 2021C0020 
LAST UPDATED PROTOCOL (Aim 1): 07/22/2022  
 
 
  NCT05393869 
 
Page 15 of 24 
 
VI. DATA ANALYSIS 
A. Aim 1, Phase 1: Study 1—FOCUS GROUPS Data Analysis  
For focus groups, the goal is to refine messages and determine which images should be matched to the AR 
and RR anti-tobacco messages. These images will then move on to Aim 1 Phase 2 of this study. We will 
qualitatively summarize the feedback in response to each focus group question.  
 
Sample size justification: For Aim 1 Phase 1: Study 1—FOCUS GROUPS: A planned analytic sample 
size of N = 24 participants is standard for usability research, where the aim is to test existing messages 
to improve any communication issues. If we do not reach thematic saturation during the first round of 
focus group, we will enroll up to an additional 24 participants (for a maximum analytic of N = 48).The 
sample size was inflated to 29 participants for each round of focus groups to allow for 20% dropout; 
resulting in a maximum overall sample size of N = 58 focus group participants. 
 
B. Aim 1, Phase 1: Study 2-ONLINE RATING SURVEY Data Analysis 
For online rating survey data, we will describe mean and median values of participants’ ratings of perceived 
message effectiveness, likeability, and reactance.  
In exploratory analyses, we will l assess whether there are systematic differences in participants’ ratings by 
message type (AR vs RR), gender, LGBT status (vs non-LGBT), race/ethnicity, age (e.g., 18-24 vs 25-35) and 
tobacco user type (e.g., current, former, never polytobacco user). We will test mean differences between 
groups using t-tests or ANOVA. If there are violations of assumptions (e.g., normality) we will test median 
differences between groups using Wilcoxon rank-sum test (two groups) or Kruskal Wallis test (more than 2 
groups).  
We will also run exploratory regression models to evaluate the effect of risk message type (e.g., absolute risk 
vs. relative risk) and efficacy message type (e.g., quit; switch; combination) on messages on perceived 
message effectiveness, likeability, and reactance; controlling for pro- and anti-tobacco marketing exposure, 
baseline risk and efficacy perceptions and behavioral intentions. For models testing the effect of efficacy 
messages, we will conduct overall F-tests to determine if there is an effect of efficacy message type in each 
model. If so, pairwise t-tests will be conducted, and Holm’s procedure will be used to control Type I error rate.  
 
Sample Size Justification: For Aim 1, Phase 1, Study 2--ONLINE RATING SURVEY: An analytic 
sample size of 200 participants per group will allow us to detect differences between two groups in 
terms of perceived message effectiveness. Assuming a pooled standard deviation of 1.0 units, the 
study would require a minimum sample size of n = 199 for each group to achieve power of 80% and 
two-sided significance level of p = .05 for detecting a 0.25 unit difference in perceived message 
effectiveness scores, which has been reported previously in the literature.58 Under these same 
parameters, we will be able to detect a 0.25 unit difference in PME scores with 75% probability 
assuming a significance level of p = 0.1. As multi-group comparisons are exploratory, we believe this a 
prior sample size calculation is appropriate. As our desired analytic sample size is N = 500 participants 
(n = 250 participants per experimental group; AR vs RR messages); we have inflated our overall 
sample size is inflated by 10% to account for estimated inconsistencies between prescreening and 
survey responses, resulting in an overall sample size of N = 550. 

THE OHIO STATE UNIVERSITY 
 
 
 
 
 
  CSRC PROTOCOL OSU_20427 
INITIAL APPROVAL: 03/05/2021 
 
 
 
 
 
  IRB PROTOCOL #: 2021C0020 
LAST UPDATED PROTOCOL (Aim 1): 07/22/2022  
 
 
  NCT05393869 
 
Page 16 of 24 
 
 
C. Aim 1, Phase 1: Study 3—IN-DEPTH INTERVIEWS:  
For in-depth interviews the goal will be to refine messages and determine which images should be matched to 
the AR and RR anti-tobacco messages. These images will then move on to Aim 1 Phase 2 of this study. We 
will qualitatively summarize the feedback in response to each focus group question using rigorous and 
accelerated data reduction (RADaR) analytic methods.125 Used in applied research, RADaR organizes 
transcribed textual data from qualitative interviews into data tables; which are then organized and iteratively 
reduced, coded, and analyzed using team-based coding.  
 
Sample size justification: For Aim 1, Phase 1: Study 3—IN-DEPTH INTERVIEWS our planned analytic 
sample size of N = 8 is designed to maximize the information power of qualitative research in which an 
initial sample of 6- 8 participants for is recommended for qualitative interviews. The aim of these 
interviews is to test existing messages to improve any communication issues. If we do not reach 
thematic saturation, we will enroll additional participants up to a maximum of N = 16. We have inflated 
the overall sample size to 20 participants to allow for ~20% dropout.   
 
D. Aim 1, Phase 2: ONLINE FACTORIAL EXPERIMENT Data Analysis 
We will fit linear regression models to evaluate the effect of condition on perceived effectiveness, risk 
perceptions, and behavioral intentions. Covariates will include exposure to pro- and anti-tobacco marketing, 
and baseline risk perception and behavioral intention items (per respective models). Baseline and post-viewing 
scores may be transformed if violations of assumptions are detected. We will conduct overall F-tests to 
determine if there is an effect of condition in each model. If so, pairwise t-tests will be conducted, and Holm’s 
procedure will be used to control Type I error rate. Exploratory analyses will be conducted to determine if there 
is an interactive effect between Condition x Topic. Responses will be examined by gender and sexual 
orientation to determine if there are systematic differences. 
Sample Size Justification: For the Aim 1, Phase 2: ONLINE FACTORIAL EXPERIMENT an analytic 
sample size of 400 participants per group will allow us to detect the best message in terms of risk 
perception score with 75% probability assuming the mean score in the best group is at least 0.1 
standard deviations better than the mean score in the second best group.126 As effect sizes of 2 or 
greater are reported in the literature for this outcome, we do not consider smaller differences to be of 
interest. As our analytic sample size is N = 2800 participants (n = 400 participants per experimental or 
control group); we have inflated our overall sample size is inflated by 5% to account for estimated 
inconsistencies between prescreening and survey responses, resulting in an overall sample size of N = 
2940. 
VII. DATA SAFETY and MONITORING PLAN 
The Ohio State University Comprehensive Cancer Center Data Safety Monitoring Committee (DSMC) will be 
the DSMC of record and, thus, will be responsible for reviewing the study. The PI will submit a summary report 
of the study’s progress, including all subsite activities and data status to the DSMC on an annual basis. All 
adverse events related to the study will be recorded by the investigators. The study investigators will evaluate 
adverse events and study data during their weekly meetings and make a determination of whether any adverse 
events affect the risk/benefit ratio of the study and whether modifications to the protocol (e.g., Potential risks) 
or consent procedures are required.  

THE OHIO STATE UNIVERSITY 
 
 
 
 
 
  CSRC PROTOCOL OSU_20427 
INITIAL APPROVAL: 03/05/2021 
 
 
 
 
 
  IRB PROTOCOL #: 2021C0020 
LAST UPDATED PROTOCOL (Aim 1): 07/22/2022  
 
 
  NCT05393869 
 
Page 17 of 24 
 
 
Serious unanticipated events are not anticipated. In the unlikely case that such serious adverse events occur, 
they will be reviewed by the OSUCCC – James Data and Safety Monitoring Committee (DSMC). All reportable 
serious adverse events will be reported within 48 hours to the OSU IRB and any appropriate funding and 
regulatory agencies. The investigators will specify whether the serious unanticipated adverse event is related 
to the study. Adverse events will be reported to the NCI when frequency and magnitude clearly exceed 
expectations.  
 
The OSU IRB provides annual review of all open protocols and hence this is one level of monitoring that will 
occur. In this annual report, the investigator is required to report the number of subjects enrolled and treated, 
any adverse events that have occurred, and a summary of the findings from either the study or the literature 
that would affect the safety of the participants or the ethics of the trial. The PI will provide a summary of the 
Data Safety and Monitoring Plan annually as part of the progress report to the National Cancer Institute (NCI). 
 
All data and safety monitoring will adhere to the policies and procedures of the OSU Comprehensive Cancer 
Center’s Data and Safety Monitoring Plan which has been approved by NCI. 
 
 
 

THE OHIO STATE UNIVERSITY 
 
 
 
 
 
  CSRC PROTOCOL OSU_20427 
INITIAL APPROVAL: 03/05/2021 
 
 
 
 
 
  IRB PROTOCOL #: 2021C0020 
LAST UPDATED PROTOCOL (Aim 1): 07/22/2022  
 
 
  NCT05393869 
 
Page 18 of 24 
 
VIII. REFERENCES 
1. 
LaVoie NR, Quick BL. What is the truth? an application of the Extended parallel process Model to 
televised truth® ads. Health communication. 2013;28(1):53-62. 
2. 
Chung H, Ahn E, Kang S. Processing anti-smoking ads among college students: The role of emotional 
response and level of smoking. Journal of Promotion Management. 2016;22(3):370-385. 
3. 
Leshner G, Bolls P, Wise K. Motivated processing of fear appeal and disgust images in televised anti-
tobacco ads. Journal of Media Psychology. 2011. 
4. 
Noar SM, Francis DB, Bridges C, Sontag JM, Brewer NT, Ribisl KM. Effects of strengthening cigarette 
pack warnings on attention and message processing: A systematic review. Journalism & Mass 
Communication Quarterly. 2017;94(2):416-442. 
5. 
Ridner SL, Ma JZ, Walker KL, et al. Cigarette smoking, ENDS use and dual use among a national 
sample of lesbians, gays and bisexuals. 2019. 
6. 
Delahanty J, Ganz O, Hoffman L, Guillory J, Crankshaw E, Farrelly M. Tobacco use among lesbian, 
gay, bisexual and transgender young adults varies by sexual and gender identity. Drug and alcohol 
dependence. 2019. 
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Fallin-Bennett A, Lisha NE, Ling PM. Other tobacco product use among sexual minority young adult bar 
patrons. American journal of preventive medicine. 2017;53(3):327-334. 
8. 
Nayak P, Salazar LF, Kota KK, Pechacek TF. Prevalence of use and perceptions of risk of novel and 
other alternative tobacco products among sexual minority adults: results from an online national survey, 
2014–2015. Preventive medicine. 2017;104:71-78. 
9. 
Osibogun O, Taleb ZB, Bahelah R, Salloum RG, Maziak W. Correlates of poly-tobacco use among 
youth and young adults: Findings from the Population Assessment of Tobacco and Health study, 2013–
2014. Drug and alcohol dependence. 2018;187:160-164. 
10. 
Stanton CA, Bansal-Travers M, Johnson AL, et al. Longitudinal e-cigarette and cigarette use among US 
youth in the PATH Study (2013–2015). JNCI: Journal of the National Cancer Institute. 2019. 
11. 
Strong DR, Pearson J, Ehlke S, et al. Indicators of dependence for different types of tobacco product 
users: Descriptive findings from Wave 1 (2013–2014) of the Population Assessment of Tobacco and 
Health (PATH) study. Drug and alcohol dependence. 2017;178:257-266. 
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Dutra LM, Glantz SA, Lisha NE, Song AV. Beyond experimentation: Five trajectories of cigarette 
smoking in a longitudinal sample of youth. PLoS One. 2017;12(2). 
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Klein EG, Bernat DH, Lenk KM, Forster JL. Nondaily smoking patterns in young adulthood. Addictive 
behaviors. 2013;38(7):2267-2272. 
14. 
Saddleson M, Kozlowski L, Giovino G, Homish G, Mahoney M, Goniewicz M. Assessing 30-day 
quantity-frequency of US adolescent cigarette smoking as a predictor of adult smoking 14 years later. 
Drug and alcohol dependence. 2016;162:92-98. 
15. 
Taylor KA, Sharma E, Edwards KC, et al. Longitudinal pathways of exclusive and polytobacco cigarette 
use among youth, young adults and adults in the USA: findings from the PATH Study Waves 1–3 
(2013–2016). Tobacco Control. 2020;29(Suppl 3):s139-s146. 
16. 
Edwards KC, Sharma E, Halenar MJ, et al. Longitudinal pathways of exclusive and polytobacco cigar 
use among youth, young adults and adults in the USA: findings from the PATH Study Waves 1–3 
(2013–2016). Tobacco Control. 2020;29(Suppl 3):s163-s169. 
17. 
Institute of Medicine Committee on Lesbian G, Bisexual, and Transgender Health Issues and Research 
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