Graphic Messages to Prevent E-Cigarette Use Among Latino and African American Adolescents: A Randomized Controlled Trial
Phase: NA
Conditions: Vaping
Sponsor: University of Rochester

Date: 6/18/2021 
Graphic Messages to Prevent E-Cigarette Use Among Latino and 
African American Adolescents: A Randomized Controlled Trial  
 
Study Protocol and Statistical Analysis 
 
NCT04899999  
 
Date: 6/18/2021 
 

 
 
 
 
 
Graphic Messages to Prevent E-Cigarette Use Among Latino and African American 
Adolescents: A Randomized Controlled Trial  
 
Principal Investigator: Francisco Cartujano, MD 
 
 
1. PURPOSE OF STUDY 
 
The aim of this randomized controlled trial is to examine the effectiveness of newly 
developed, theoretical-based graphic messages at preventing future vaping use among African 
American and Latino adolescents. The images have been iteratively tested in a user-design model 
and incorporates four main theoretical constructs: health reward, financial reward, self-efficacy, 
and social norms. We will assess pre- and post-exposure reactions on likelihood of future vaping 
among African American and Latino adolescents (n=360). 
 
2. BACKGROUND AND RATIONALE 
 
Although conventional cigarette smoking has markedly declined over the past several 
decades among adolescents (ages 12 to 17), there has been substantial increases in the use of 
emerging tobacco products among these populations in recent years (Wang et al., 2018). From a 
product initially marketed as a smoking cessation aid, e-cigarette use, or vaping, rose 900% 
between 2011 and 2015 among adolescents (from 3% to 27%) and is now two to three times 
more common among adolescents than among adults (Wang et al., 2018). Vaping products have 
completely transformed the landscape of nicotine use in youth, combining advanced technology, 
attractive design, and flavors (now available via online sources), fueled by aggressive marketing 
and social media promotion (Huang et al., 2019; Kim et al., 2020).  
While e-cigarettes may support smoking cessation (Hartmann-Boyce et al., 2016; Kalkhoran 
& Glantz, 2016; Malas et al., 2016), there is robust evidence that exposure to nicotine during 
adolescence and young adulthood is not only associated with increased rates of use of other 
substances (Kandel & Kandel, 2014), but also that such use has long-term effects on the 
developing brain (Yuan, 2015). Chemical and heavy metal exposure from e-cigarettes, added 
flavorings, and risk of acute injuries and toxicity are a public health concern (Rubinstein et al., 
2018). Vaping has been connected to 2,807 lung injury cases and 68 deaths in the US (as of 
November 2019) (Centers for Disease Control, 2020) and should be considered an increasing 
public health concern.  
 
There is an urgent need to prevent vaping among adolescents. Adolescence is a period 
characterized by tobacco-use initiation, experimentation, and progression to long-term addicted 
behaviors (Sussman & Arnett, 2014; Thompson et al., 2018). Moreover, adolescence offers a 
critical window for prevention and cessation interventions to produce long-term reductions in 
tobacco-related morbidity and mortality (Jha et al., 2013; Pirie et al., 2013). In a cross-sectional 
survey looking at the current vaping prevalence in a diverse sample of 7th, 9th, and 11th grade 

 
students in a Title I school district in New Jersey (n=963; 66% Latinos, 37% White, and 36% 
African Americans) found a prevalence of 19% (compared to 6% for cigarettes) and 55% of 
students were susceptible to future vaping (no differences by race and ethnicity) (Tercyak et al., 
2021). Despite the adverse health effects, high prevalence, and high susceptibility of future 
vaping among AYAs, there is a lack of effective messages and communication channels to 
prevent initiation. Overcoming the burden of vaping among AYAs demands affordable, 
accessible, and effective preventive solutions.  
 
To date, we know little about whether messages can prevent vaping among AYAs and, 
if so, what messages and delivery formats may be most effective. One study found that 
chemical and anti-industry warning messages on television advertisements reduce intention to 
purchase e-cigarettes (Sanders-Jackson et al., 2015). Another study found that addiction 
warnings increase perceived harms and addictiveness of e-cigarettes and decrease thoughts about 
vaping, but only when these warnings were text-based – not on print advertisements (Mays et al., 
2016). One limitation of both studies is the lack of representation of Latino and African 
American AYAs. This leaves a substantial gap in communication research for vaping prevention 
among racial and ethnic minority groups. As the adolescent vaping epidemic continues to grow, 
there is an urgent need to develop, test, and implement messages and communication channels 
for vaping prevention.  
 
3. ADMINISTRATIVE ORGANIZATION  
 
The University of Rochester Medical Center (URMC) is recognized nationally and 
internationally for its excellence. The URMC schools and researches support and work with lines 
of research on contemporary parameters that acknowledge the need for a translational approach, 
traversing different realities. The existing structure, both human and material resources, was 
prepared to collaborate with making results available to the community quickly and effectively. 
The work developed and the structure existent for research attracts about 3,000 students, 
professionals, and researchers interested in joining leading-edge scientific studies and health 
activities, related to common or rare diseases. At the same time, patients feel confident in seeking 
the necessary assistance in their services to preserve and improve their health.  
 
Scientists research different topics and areas to improve care and make new treatments 
available to patients faster. "Investigating Cancer and Improving Care," "Discovering New 
Pathways to the Molecular Basis of Human Diseases," "Combating Infections and Vaccines 
Research," "Leading the way to find new treatments for brain diseases," "Keeping the body 
moving," and "Making children healthier and happier" are examples of URMC investment. To 
carry out all this work, the University of Rochester School of Medicine and Dentistry has received, 
in the last five years, financial resources that amount to more than the US $ 1.18 billion. The 
investment in biomedical research, financing federal entities, places the URMC in a prominent 
position (26th) among the various medical centers in the USA. The use of advanced and 
comprehensive methodologies resulted in the Clinical and Translational Sciences Award from the 
National Institutes of Health. The effort generates the receipt of funds continuously totaling US$ 
86 million, in addition to a US$ 19 million grant for integrating the coordination of the top 50 
academic medical centers in the country that are part of the Clinical and Translational Science 
Awards Program.  

 
 
Several departments and centers work individually and jointly to achieve high-quality results. 
Among the Departments, the Public Health Sciences (PHS) works to improve health and health 
care among diverse populations through research, learning, and community partnerships. The 
research fields explored have several objects, ranging from childhood to older ages, considering 
food, environment, and everything that involves human health and can impact the individual and 
the population in general. For this, there are six important programs (Epidemiology and Health 
Services Research; Master’s program in Public Health, Epidemiology; Clinical Investigations; and 
Health Services Research). PHS research is diverse, including research in behavioral interventions 
(e.g., smoking research program), environmental health (e.g., etiology of environmentally induced 
illnesses), maternal child health (e.g., racial/ethnic disparities in pregnancy outcomes), global 
health (e.g., improving linkage to and retention in HIV continuum of care in China), nutrition (e.g., 
infant feeding), and health policy and outcomes (nursing home policies that impact the quality of 
care for the elderly). Population’s priorities and concerns, including the needs of minority and 
underserved communities, define PHS research. 
 
Finally, an important highlight should be given to the Comprehensive Area-Wide Smoking 
Cessation Program Available through the Center for Community Health & Prevention. UR 
Medicine provide free smoking cessation counseling sessions for UR Medicine patients. The 
University of Rochester's experience in this field and the existing structure can be added to other 
outreach and research activities for the prevention of all smoking-related illnesses. 
 
4. STUDY DESIGN 
 
This study is a randomized controlled trial (RCT) with a heterogenous sample of 360 African 
American and Latino adolescents (ages 12-17) who do not vape; equal representation of Latinos 
and African Americans (180 African American adolescents and 180 Latino adolescents). After 
completing a preliminary baseline survey, participants will be randomized in equal numbers and 
representation to receive one of four (4) theoretical-based graphic messages: 1) Financial 
Reward, 2) Health Reward, 3) Self-efficacy, and 4) Social Norms. These graphic messages were 
developed in a previous research phase (STUDY00005312) using participatory research 
methods. See Appendix for the messages. We will assess pre- and post-exposure measures on the 
susceptibility of future vaping-use among African American and Latino adolescents.  
 
5. INCLUSION AND EXCLUSION CRITERIA  
 
Eligible individuals will 1) self-identify as African American/Black and/or Hispanic/Latino, 
2) know how to read and speak English and/or Spanish, 3) be at least 12, but no greater than 17 
years old, 4) have never used e-cigarettes, and 5) have access to a device that will be able to 
connect to the online survey (e.g., desktop, laptop, tablet, and/or smartphone). Exclusion criteria 
include: 1) not identifying as African American/Black and/or Hispanic/Latino, and 2) using e-
cigarettes. Eligibility assessment will be conducted by study staff in the participant’s language of 
preference, either English or Spanish.  
 
6. RECRUITMENT METHODS  
 

 
For this study, we will partner with schools (e.g., Hackensack High School) and community-
based organizations (e.g., Ibero American Action League) to identify and refer potential 
adolescents. We plan to advertise this study via printed and electronic materials (e.g., study 
flyers). Parents/caregivers interested will be referred to research staff to obtain parent permission 
and child assent. Our research team consists of a culturally diverse group of Latinos and African 
Americans, which will help build rapport with the participants and their parents/caregivers. 
 
7. CONSENT PROCESS  
 
We will not obtain written informed consent for participating in this study. Instead, we will 
provide informational sheets to both the parents/guardians and the adolescents. In accordance 
with Police 701 of Informed Consent, this study requests a waiver of documentation because the 
research involves no more than minimal risk and involves procedures for which written consent 
is normally required outside the research context. This study represents no greater than minimal 
risk because it is a study of a non-sensitive nature. We will obtain parents’/guardians’ permission 
over the phone. Then, we will obtain adolescents’ assent via REDCap by clicking “Yes, I assent 
to participate in the study” after reading the informational sheet. The informational letter will 
also contain language describing the study, the risk and benefits, and team contact information in 
case they have questions. Adolescents will also have the opportunity to discuss the study and ask 
questions by contacting the research staff. Participants will be informed that their participation is 
completely confidential and voluntary, and that participation may end at any time during the 
assessment. If an individual chooses to stop participation or withdraw from the study, the de-
identified data collected will be kept by the study team. 
 
8. STUDY PROCEDURES  
 
Once parents’/guardians’ permission and adolescent’s assent has been obtained, participants 
(n=360) will complete an individual baseline assessment on sociodemographic characteristics 
and susceptibility to future vaping. The survey will be hosted in REDCap, a secure, web-based 
system that has user-level access control. Each participant will receive a unique username and 
password to access the survey. At the end of the baseline assessment, participants will be 
randomized in equal number and representation to receive one of four (4) graphic messages: 1) 
health reward, 2) financial reward, 3) self-efficacy, and 4) social norms. The appropriate graphic 
message, available in English and Spanish, will be displayed in REDCap. Participants will be 
instructed to view the graphic messages carefully on their devices (e.g., desktop, laptop, tablet, 
and/or smartphone) and for as long as they wish. We will assess immediate post-exposure 
measures on susceptibility to future vaping (primary outcome). Study measures on susceptibility 
to future vaping are comprised of valid items derived from out and others’ research. We will 
assess three items: (1) Are you curious about using e-cigarettes (vaping)?; (2) Do you think that 
you will use e-cigarettes (vaping) in the next 12 months?; and (3) If one of your best friends were 
to offer you an e-cigarette, would you use it? Responses include 1= definitely not, 2= probably 
not, 3= probably yes, 4= definitely yes. Participants will receive $25 gift card for their time at the 
end of the assessment.  
 
9. RISK TO SUBJECTS  

 
The risk for this study is minimal. Loss of privacy of personal information is a small risk. 
Only Dr. Cartujano (Principal Investigator) and research team will have access to study data. 
Adequacy of Protection against Risks. Issues covered in the information sheet will include a 
description of study procedures, the time involved, the right to withdraw at any time without 
penalty, procedures used to protect participant anonymity, use of data, and potential benefits and 
risks of participating in the study.  
 
10. POTENTIAL BENEFITS TO SUBJECTS  
 
Participation in this study may prevent subjects from vaping. Moreover, this study will 
examine the effectiveness of newly designed, theoretical-based graphic messages at preventing 
future vaping use among African American and Latino adolescents. 
 
11.  COSTS FOR PARTICIPATION  
 
Participation in this study is at no financial cost to the participants.  
 
12. PAYMENT FOR PARTICIPATION  
 
 
Subjects will be compensated for their participation in the study by receiving a $25 gift card. 
In order to maintain anonymity of subject participants, those who complete the survey will be 
redirected to a code to claim an Amazon® gift card. 
 
13. SUBJECT WITHDRAWALS  
 
Subjects will be informed that they may withdraw from the study at any time without prejudice 
and compilation of that person’s data will cease as of the date of his/her written request for 
withdrawal. It is possible that individuals might not want to participate and/or may withdraw from 
the study, and that is their right. If a subject withdraws before completing the three phases, data 
collected until the point of withdrawal remains part of the study database and may not be removed. 
Other subjects will replace subjects withdrawn from the study. We do not anticipate any 
circumstances in which subjects will be withdrawn from the research without their consent.  
 
14. PRIVACY AND CONFIDENTIALITY OF SUBJECTS AND RESEARCH DATA 
 
The PI and research staff have completed all required training through the Collaborative 
Institutional Training Initiative (CITI), including the Human Subjects Protection and Good 
Clinical Practice Training. Subjects will be limited to interactions with the research staff only for 
this study. Collected data and all analysis of the data will adhere to HIPAA and institutional patient 
confidentiality requirements. More specifically, a coding system will be used for which a unique 
identifier will be assigned to each participant. Each subject whose data is collected will be assigned 
a unique study number. All electronic data will be managed using REDCap, a secure, web-based 
system that has user-level access control. Data will be stored for six years after completion of the 
study, per RSRB policy. This data will only be accessible to the PI and research staff. 
francisco_cartujano@urmc.rochester.edu UR data security requirements will be followed 
(http://www.rochester.edu/it/policy/index.html). 

 
  
15. DATA AND SAFETY MONITORING PLAN  
 
 
Some identifiers will be collected such as name and electronic mail. All the identifiable 
data will be coded, removing the identifiers and assigning a unique study ID/code to protect the 
identity of the subject. Any sensitive data will not be collected. 
 
Data Management and Transfer 
 
Dr. Francisco Cartujano will access the data to conduct analyses. Data will be summarized 
and tables to be presented to Co-Investigators. Dr. Cartujano will be responsible for maintaining 
the security of the data. 
 
All data will be stored on a URMC password protected computer only accessible by the 
investigator team. URMC password protected computers are only accessible by the P.I. and/or 
research staff.  Electronic data will be managed using REDCap, a secure, web-based system that 
has user-level access control. Analytical datasets will be stored on secure servers that also limit 
access to the investigator team. All identifiers (names and contact information including emails) 
will be kept separately and will not include in any reports or potential publications. Data collected 
will be maintained securely with limited access. Records will be retained in accordance with 
regulatory, organizational and sponsor requirements, but no less than six (6) years following the 
completion of the research.  Disposal of records will be done in such a manner that no identifying 
information can be linked to research data. 
 
17. DATA ANALYSIS PLAN 
 
We first will perform descriptive statistics to evaluate randomization success, 
nonresponses, and missing data. Mean and median will be presented for continuous variables, and 
frequencies will be presented for categorical variables. The outcome measures will be defined as 
(1) a binary variable of susceptibility to future vaping (0= definitely not, 1= probably not, probably 
yes, definitely yes) to ease interpretation of results, and (2) the overall susceptibility score 
aggregating three items. Bivariate analyses will be performed, followed by multivariable modeling 
to compare different message groups. Logistic regression model and the analysis of covariance 
(ANCOVA), respectively, will be performed to control for potential confunding, and inflated type 
I error rate will be adjusted in multiple testing. We will also assess differences within messages by 
theoretical construct (reward, self-efficacy, and social norms). Power Analysis. The goal of this 
pilot analysis is to provide preliminary data for future studies, including the possible effect size. 
Using the ANCOVA analysis for the power calculation, we expect the effect size to be 1.05 
(standardized mean difference in the aggregated score) between message groups. 
 
18. FUTURE RESEARCH PLANS 
 
We will report the results of this research in one or more publications in academic 
journal(s) to advance knowledge pertaining to effective communication with Latino and African 
American adolescents regarding vaping prevention. Additionally, we will disseminate our 
findings at national and international conferences. We have identified a request for applications 

 
to pursue support for this line of research through the trans-NIH Tobacco Regulatory Science 
Program (RFA-OD-19-019). An FDA and NIH defined priority research area is to understand 
how to effectively communicate to the public and vulnerable populations regarding nicotine and 
the health effects of tobacco products. 
 
19. REFERENCES  
 
• Centers for Disease Control. (2020). Outbreak of lung injury associated with the use of e-
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• Hartmann-Boyce, J., McRobbie, H., Bullen, C., Begh, R., Stead, L. F., & Hajek, P. 
(2016). Electronic cigarettes for smoking cessation. The Cochrane Database of 
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• Huang, J., Duan, Z., Kwok, J., Binns, S., Vera, L. E., Kim, Y., Szczypka, G., & Emery, 
S. L. (2019). Vaping versus JUULing: how the extraordinary growth and marketing of 
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McAfee, T., & Peto, R. (2013). 21st-century hazards of smoking and benefits of cessation 
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• Kalkhoran, S., & Glantz, S. A. (2016). E-cigarettes and smoking cessation in real-world 
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• Tercyak, K. P., Phan, L., Gallegos-Carrillo, K., Mays, D., Audrain-McGovern, J., 
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20. APPENDIX 
Financial reward 
 
 
 

 
 
 
Health reward 
 
 
 
 

 
 
 
Social norms 
 
 

 
 
Self-efficacy