Vaper to Vaper: A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping
Phase: NA
Conditions: E-cigarette Use, Vaping
Sponsor: University of Massachusetts, Worcester

 
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Study Protocol (including Statistical Analysis Plan (SAP)) 
 
Official Title: Vaper to Vaper: A Multimodal Mobile Peer Driven Intervention to Support 
Adolescents in Quitting Vaping (V2V) 
 
NCT#: NCT05140915   
 
IRB Approval Date: March 3, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1. TITLE 
Vaper to Vaper (V2V): A Multimodal Mobile Peer Driven Intervention to Support Adolescents 
in Quitting Vaping 
 
2. EXTERNAL IRB REVIEW HISTORY* 
None. 
 
3. PRIOR APPROVALS: 
None. 
 
4. OBJECTIVES* 
In this study, we will develop Vaper-to-Vaper (V2V), a suite of mobile peer driven tools, including 
peer texting and coaching, based on lessons learned in our prior tobacco intervention work. These 
tools will engage and help adolescents use strategies to manage cravings and successfully quit e-
cigarettes. The specific aims of the V2V study are to: 
Aim 1: Adapt the existing peer-driven and gamification mobile tools to develop the V2V 
intervention.  
1A. Conduct a qualitative study to (1) explore issues unique to e-cigarette use (e.g., concerns, 
motivations, triggers, symptoms of nicotine dependence), and (2) understand perceived needs 
for cessation support (preferences for technology (e.g., texting, app-based) to inform adaptation 
of the toolset. 
1B. Work with these users to build the V2V innovations, including peer messaging for 
adolescents, peer-to-peer videos, and game narratives for gamification.  
1C. Refine the V2V mobile toolset with iterative usability testing (mini-pilot). 
 
There are no hypotheses for Aim 1. Aim 1 is just to adapt the existing peer-driven and gamification 
mobile tools to develop the V2V intervention. 
 
Aim 2: Evaluate the feasibility of the research protocols and the feasibility and acceptability 
of the V2V intervention (peer messaging, peer coaching, and gamification) compared to e-
cigarette cessation written materials (control) in a pilot feasibility study.  
2A. Assess the feasibility of the research protocols, including participant recruitment and 
retention.   
Hypothesis H1: We will be able to recruit 80 adolescents (20/school, 40 per study condition), 
and >85% will be retained in each study condition at 6-month follow-up.  
2B. Monitor V2V engagement (e.g., number of responses to texting quizzes, peer coaching 
interactions, peer videos viewed) and assess acceptability of and satisfaction with the program.  
2C. Assess preliminary effect size estimates of the V2V intervention on cotinine-validated 7-
day point prevalence abstinence, time to first quit attempt, and amount of use.   
Hypothesis H2: The intervention will be associated with greater cotinine-validated 7-day point 
prevalence vaping abstinence rates, lower time to first quit attempt, and less amount of e-
cigarette use compared to control at 6-month follow-up. 
 
5. BACKGROUND* 
Adolescent e-cigarette use has now exceeded combustible cigarette use, leading the FDA and the 
U.S. Surgeon General to call the increasing use of e-cigarettes among U.S. adolescents an 
epidemic.1-4 The 2018 National Youth Tobacco Survey found a 78% increase in e-cigarette use 
in just one year,5 with over 3.5 million youth currently using e-cigarettes. Alarmingly, 28% of 
high school e-cigarette users are vaping on 20 or more days in the past month.5 The high 
amounts of nicotine in e-cigarettes harm adolescent brain development, impacting learning, 

 
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memory, attention, mood, and impulse control.6  Further, adolescent e-cigarette users are at 
higher risk than non-users of transitioning to traditional cigarettes.1,2,6-10 Tobacco use continues 
to be the leading cause of preventable morbidity and mortality in the U.S., with nearly all 
tobacco use beginning during youth and young adulthood.11,12 Once transitioned, 80% of these 
adolescent smokers will continue to smoke into adulthood and, of those, one-half will die 13 
years earlier than nonsmoking peers.13,14  
 
Evidence-based and accessible e-cigarette cessation interventions are critically needed to help 
adolescent e-cigarette users quit.1,2,7 To our knowledge, there are currently no evidence-based 
interventions to assist adolescent e-cigarette users in quitting.1,2,7 E-cigarette users are a complex 
group, including all race and ethnic groups as well as youth of higher and lower socioeconomic 
status (SES).15 Although recent concerns regarding vaping and proposed regulatory changes 
(increasing purchasing age, banning flavors) may increase adolescent interest in quitting and 
demand for e-cigarette cessation interventions, the perception of lower risk of e-cigarettes may 
lead to a lower intention to quit,16,17 with the majority of youth e-cigarette users believing vaping 
only includes flavoring and not nicotine.18 Therefore, novel approaches specifically tailored to 
their unique needs that can be disseminated broadly are required to engage, educate, motivate, 
and support adolescent e-cigarette users to successfully quit.   
 
Although rates are higher among adolescents in higher SES groups, rates have increased among 
lower SES groups also.  For example, in a recent national online survey of youth aged 13 to 18 
between August and October 2017, weighted to be representative of the overall U.S. population, 
43% of adolescents who were from lower SES groups indicated that they were current e-cigarette 
users.19 Lower SES groups also have lower perceived health risks of e-cigarettes.20 If we do not 
appropriately address lower SES groups, we may end up in a similar situation to combustible 
cigarette use in which disparities have expanded considerably.20,21  To date, higher SES groups 
have benefited more from smoking cessation interventions and their rates are considerably low, 
whereas rates among lower SES groups are considerably higher.  Research addressing and 
boosting treatment potency among health disparities populations is also of considerable interest 
to NIDA as stated in the PAR (PAR-19-213).22 Consequently, we decided to target lower SES 
groups in our study to prevent these disparities in the future. 
 
The V2V multi-modal mobile peer driven intervention adapts our innovative, existing mobile 
technology into an e-cigarette cessation program for adolescents, creating a highly accessible, 
engaging and disseminatable treatment option. Delivery of treatment via multi-modal mobile 
technology may improve efficacy by providing adolescents coaching and support in considering 
quitting if they are not yet ready, and in quitting when ready, within their real-world contexts. 
The use of multi-modal mobile technology overcomes many of the challenges youth experience 
in accessing treatment for their nicotine dependence, potentially increasing reach and creating a 
highly accessible and disseminatable treatment option.  
  
6. INCLUSION AND EXCLUSION CRITERIA* 
 
Aim 1 Study Population (20 adolescent e-cigarette users (Peer Advisory Panel) and two key 
informants) 

 
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The study population will be derived from 20 adolescent e-cigarette users in one high school 
selected for its high rate of racial/ethnic minorities and low SES status. We will also recruit two 
key informants (school nurse and Vice Principal) from the same high school. 
 
Inclusion criteria for peer advisory panel: (1) enrolled in grade 9-12 at a local high school; (2) 
current e-cigarette user; (3) have a smartphone; and (4) English- or Spanish-speaking. Current e-
cigarette user is defined as a response greater than “0 days” to the question: “During the past 90 
days, on how many days did you use e-cigarettes?” This eligibility criterion is modeled on a 
question in the 2018 National Youth Tobacco Survey (NYTS), a survey of U.S. middle and high 
school students which used a 30-day timeframe. 
 
Exclusion criteria for peer advisory panel: (1) unable or unwilling to provide informed assent 
or consent (in the case of those aged 18 years or older). 
 
Inclusion criteria for two key informants: (1) employed as a school nurse or Vice Principal at 
the Aim 1 high school. 
 
Exclusion criteria for two key informants: (1) unable or unwilling to participate in the study. 
 
Aim 2 (80 adolescent e-cigarette users and up to 12 key informants) 
In Year 2 of the project, 80 adolescent e-cigarette users in 4-7 high schools selected for their high 
rates of racial/ethnic minorities and low SES status (20/school, 40/study condition) will be 
recruited and complete assessments at baseline and 6-month follow-up. 
 
Inclusion criteria for 80 adolescent e-cigarette users: (1) enrolled in grade 9-12 at a 
participating high school; (2) current e-cigarette user; (3) have a smartphone; and (4) English- or 
Spanish-speaking. Current e-cigarette use is defined as a response greater than “0 days” to the 
question: “During the past 90 days, on how many days did you use e-cigarettes?” This eligibility 
criterion is modeled on a question in the 2018 National Youth Tobacco Survey (NYTS), a survey 
of U.S. middle and high school students which used a 30-day timeframe. 
  
Exclusion criteria for 80 adolescent e-cigarette users: (1) unable or unwilling to provide 
informed assent or consent (in the case of those aged 18 years or older).  
 
Inclusion criteria for key informants: (1) employed as a school nurse, Vice Principal, or other 
academic administrator at a participating high school. 
 
Exclusion criteria for key informants: (1) unable or unwilling to participate in the study. 
 
Vulnerable Populations 
 
Pregnant Women 
Pregnant women may be included in this study as an incidental population. 
 
Adults Unable to Consent  
Adults unable to consent will not be included in the study population. 

 
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Prisoners 
Prisoners will not knowingly be included in the study population. 
 
Children 
We will be recruiting adolescents in grades 9 through 12, aged 13-19 years old. The rationale for 
targeting adolescents in this study is that the FDA and the US Surgeon General call the 
increasing use of e-cigarettes among U.S. adolescents an epidemic, with e-cigarette use 
exceeding combustible cigarette use. The high amounts of nicotine in e-cigarettes harm 
adolescent brain development, impacting learning, memory, and attention. Adolescent e-cigarette 
users also are at higher risk than non-users of transitioning to traditional cigarettes. We are 
therefore interested in applying lessons learned in developing interventions for adolescents and 
another challenging population, low motivated adult smokers. Study investigators have extensive 
experience with conducting research with adolescents and a reputation for designing culturally 
sensitive, patient-centered programs, and we are accountable to those standards. Please see 
Section #11, Procedures Involved, and Section #30, Consent Process, for more information. 
 
We will include English- and Spanish-speaking individuals in this study. Should the intervention 
be proven efficacious, we will apply for further funding and plan to include additional non-
English speaking populations in future studies. 
 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
N/A; this is not a multi-site study. 
 
8. STUDY-WIDE RECRUITMENT METHODS* 
N/A; this is not a multi-site study. 
 
9. STUDY TIMELINES* 
The overall project timeline is described in the table below (Table 1): 
 
Table 1. Project Timeline 
 
 
 
 
 
 
 
 
 
 
This study is planned to take place over the course of two years. Primary analysis is expected to 
be complete by the end of year two. 
 
Duration of an Individual Subject’s Participation 

 
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Aim 1 adolescent participants (peer advisory panel) are expected to actively participate in the 
study for no more than one month. The peer advisory panel members will be invited to 
participate in four activities: 1) Semi-structured interview and brief survey; 2) Text message 
writing activity; 3) Peer video activity; and 4) Meaningful stories writing session. The semi-
structured interview for adolescent participants is expected to last 30-60 minutes, and the survey 
is expected to last no more than 10 minutes. The text message writing activity is expected to last 
no more than one hour. The peer video activity is expected to take no longer than one hour. The 
meaningful stories writing activity is expected to last no more than one hour. In addition to the 
four activities, after the completion of the qualitative interviews and text message/story 
development, peer advisory panel members will be invited to participate in a mini-pilot to 
provide iterative feedback on text message frequency and content. The mini-pilot is expected to 
take no more than 2 weeks. We will also conduct a qualitative interview at the end of the mini-
pilot; this interview is expected to take no more than one hour. 
 
Each activity and the mini-pilot may occur independently from other activities; activities and the 
mini-pilot may be spread out over the course of one month. 
 
Aim 1 key informant participants are expected to actively participate in the study for no more 
than one hour.  
 
Aim 2 adolescent participants are expected to actively participate in the study for no more than 
six months. Once enrolled, adolescents will participate either the control or intervention for six 
months. We will also conduct brief (30-60 minute) qualitative interviews with all adolescents at 
their six-month follow-up appointment to deepen our understanding of their experience with the 
V2V program and obtain specific feedback on ways to improve the program for future 
refinements.  
 
Aim 2 key informant participants are expected to actively participate in the study for no more 
than one hour.  
 
All study activities will take place outside of academic instructional hours.  
 
10. STUDY ENDPOINTS* 
The primary outcome for Aim 2 is the  feasibility of the research protocols, including participant 
recruitment and retention. Secondary outcomes include: preliminary effect size estimates of the 
intervention on cotinine-validated 7-day point prevalence abstinence, time to first quit attempt, 
and amount of use; acceptability of and satisfaction with the intervention; system use and 
adoption of cessation supporting strategies; Social Cognitive Theory (SCT) constructs; and 
demographics and tobacco use. 
 
11. PROCEDURES INVOLVED* 
 
As with our prior studies, all study activities will occur outside of academic instructional time. 
This means no student will be removed from their academic classes in order to participate in the 
study. We will use non-academic times such as physical education, study halls, etc. Study 

 
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activities, with the exception of peer coaching and texting, will not take place in the evenings 
and/or on the weekends. 
 
Aim 1:  
Peer Advisory Panel Recruitment: Letters will be sent to all parents (or legal guardians) of 
grade 9-12 students in the participating high school informing them of the study and asking them 
to contact us or the school if they do not wish their child to. Along with the letter, we will also 
send a fact sheet describing the study to all parents (or legal guardians). In the event that two 
parents (or legal guardians) are involved and residing at separate addresses, we will send letters 
and fact sheets to each individual parent (or legal guardian) – a letter and fact sheet will go to 
each parent at each individual address. Parents (or legal guardians) will have two weeks from the 
date the letter is sent to them to contact the study team or school. Objection from one parent/legal 
guardian would be sufficient in order to opt the student out from study participation. The 
Research Coordinator will maintain a list of all parents (or legal guardians) who have contacted 
the study team or school to indicate that their child may not participate in the study. If parents (or 
legal guardians) do not contact the study team or school within the two-week timeframe, their 
child will be eligible to meet with the Research Coordinator to discuss the study. Parental letters 
and fact sheets will be sent to all parents (or legal guardians) in the top 4-5 languages spoken at 
each school, including in English and Spanish. We are including the top 4-5 languages so as not 
to exclude any adolescents from potentially participating in the study based solely on the fact 
that their parent or parents’ (or legal guardians’) primary language is a language other than 
English. We will send a written letter to parents (or legal guardians) to confirm that their opt-out 
decision has been received and recorded.   
 
For mailing information to parents/guardians, the study team will use the same mailing address 
that is used by the school to communicate other important school-related information. 
 
After two weeks, we will recruit adolescent participants with approaches successfully used in our 
prior school-based studies, excluding those whose parents (or legal guardians) have indicated 
that their child may not participate in the study. Recruitment packets containing an informational 
brochure, eligibility criteria, and adolescent assent/consent forms will be given to all students. 
Flyers and posters will be placed in the school nurse’s office and throughout the school. The 
study will be announced in health education classes and through school-wide and class 
announcements. Flyers, posters, and announcements will be submitted to the IRB for review and 
approval prior to use in the study. Recruitment materials will be available in English and 
Spanish. 
 
Recruitment of the two key informants (school nurse and Vice Principal) will take place in-
person at one local high School. 
 
Enrollment: Recruitment materials will include the Research Coordinator’s contact information. 
After flyers and posters are placed in the school nurse’s office and throughout the school, and 
after the study has been announced in health education classes and through school-wide class 
announcements, interested adolescents will contact the Research Coordinator to indicate that 
they are interested in participating the study. The Research Coordinator will then confirm that 
the adolescent’s parents (or legal guardians) have not indicated that their child may not 

 
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participate in the study and will schedule a meeting with the adolescent for the earliest possible 
date. Interested adolescents whose parents (or legal guardians) have not opted out, or who are 18 
or older, will meet with the Research Coordinator in the privacy of the high school nurse’s 
office. The adolescent will not meet with the school nurse. After a brief screening, assent, or 
informed consent if the student is 18 years of age or older, will be explained by the Research 
Coordinator such that students understand they have a right to refuse to participate, that their care 
in the school health clinic and their grades will not be affected by whether or not they decide to 
participate, and confidentiality will be emphasized. The two consent forms will be used with 
Aim 1 participants are 18 years of age or older. See also #30, Consent Process. The brief 
screening form will be submitted to the IRB for review and approval prior to use in the study.  
 
Study Activities:  
The 20 peer advisory panel members will be asked to participate in four activities, as detailed 
below. Peer advisory panel members will be given the option to participate in all activities, but 
may choose to participate in only one or some of the activities. In addition, all peer advisory 
members will be invited to join a mini-pilot. 
 
Activity 1: Semi-Structured Interviews with Adolescents: We will employ semi-structured 
individual interviews with the 20 members of the peer advisory panel. We will develop an 
interview guide, specific to adolescents. Interview topics for the adolescents will include i) 
understanding their e-cigarette use and triggers; ii) positive and negative aspects of use, symptoms 
of nicotine dependence; iii) prior quit attempts; iv) what would help them and their friends quit, v) 
technologies they use; vi) their thoughts regarding our initial concepts and feedback on our prior 
technologies; and vii) what would support them in using a mobile program. To gather input on the 
technology, following an open-ended discussion, we will provide the participants’ access to our 
prior tools. This is a recommended approach for gathering input for technology development, and 
will facilitate more focused input as the participants will have a better understanding of how users 
will interact with the technology. Further, during this process, we will also seek their input on 
intensity/frequency of peer messages, peer coaching, and the texting assessments.  
 
The semi-structured interview is expected to last no more than 60 minutes. We will provide a 
$20 gift card for the completion of this activity. The interview will be conducted in-person or via 
phone/Zoom, depending upon a student’s preference. 
 
To keep interview questions to a minimum and use the interview time efficiently, we have 
developed a brief survey for Aim 1 adolescent participants. Survey questions include demographic 
information and e-cigarette use questions. Study staff will ask Aim 1 adolescent participants at the 
time they schedule their interview to complete the survey one week prior to their scheduled 
interview. The survey will take place online via REDCap or will be completed in-person via a 
paper survey, which will then be entered into REDCap (see #13, Data Analysis and Management, 
for more information).  
 
Activity 2: Peer Messages (70-75 messages): We will develop a comprehensive set of peer 
messages using multiple strategies. First, members of the peer advisory panel will be asked 
questions about their e-cigarette vaping patterns, and history of quit attempts. They also will be 
asked to describe 3-5 factors/situations that have facilitated or challenged their vaping or their 
efforts to quit vaping, and strategies that have been helpful to overcome barriers. Next, for each 
scenario described, they will be asked to write messages to assist other adolescents who might face 
the same situation. Second, we will ask peers to write messages by responding to 4 scenarios. 
Scenarios will be matched to the peer writer’s gender, vaping status, and other variables of interest. 
Third, because we may want to ensure inclusion of certain key messages (for example, messages 

 
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encouraging use of peer coaches), we will use a co-writing strategy. Our team will write specific 
messages for these topics and ask the peers to rewrite it in their own words. Co-writing has been 
shown to improve tone and relatedness of the message.  
 
This activity is expected to last no more than one hour. We will provide a $20 gift card for the 
completion of this activity. 
 
Activity 3: Peer videos (8-10 videos): Based on the first qualitative interview and examination 
of the peer messages, we will identify key themes and develop a peer video interview guide. We 
will invite those students who provide assent/consent to participate in the Aim 1 study to be 
filmed during the peer video interview. We will explain that portions of these filmed interviews 
will be used in subsequent videos for Aim 2 of the study, and may possibly be used in future 
iterations of the V2V intervention. For only those Aim 1 participants willing and interested in 
being videotaped, we will request active parental consent as well as adolescent assent for 
adolescents under the age of 18 prior to videotaping the peer videos. In addition, we will require 
all adolescents under the age of 18 and their parent to sign a video release authorization form 
prior to filming the peer videos. The video release form will state that the adolescent agrees to be 
videotaped responding to peer video interview questions, and that they understand that selected 
portions of their video will be digitally archived in a secure online video-sharing platform 
(example: Vimeo) and shared with others. We will require written consent for Aim 1 adolescents 
who agree to film the peer videos and are 18 years of age or older. We will also require that 
adolescents 18 years of age or older sign the video release form (but will not require that their 
parents (or legal guardians)  also sign). Please see #30, Consent Process for a description of 
consent and assent procedures. 
 
Only those adolescents under the age of 18 who provide assent to be videotaped and have active 
parental consent to be videotaped and whose parent signs the video release authorization, or 
adolescents aged 18 or older who have provided written informed consent and who have signed 
the video release authorization, will be videotaped responding to the peer video interview 
questions for the videos. As we did for the messages, we will generate meta-data for each of these 
clips. These meta-data will allow us to tailor presentation of these clips to the participant’s status.  
 
This activity is expected to last no more than one hour. We will provide a $30 gift card for the 
completion of this activity. The peer video will be conducted in-person or via phone/Zoom, 
depending upon a student’s preference. 
 
Peer coaching: In adapting the peer coaching scripts for V2V, we will include how to deal with 
common issues likely to be raised by adolescent e-cigarette users based on our qualitative work 
in Aim 1 (e.g., improving motivation and maximizing the teen’s readiness to change, learning to 
anticipate situations likely to lead to vaping, developing the adolescent’s skills and strategies to 
manage vaping triggers and address nicotine addiction symptoms, and how to maintain 
abstinence). We will submit peer coaching texting scripts to the IRB for review and approval 
prior to use in the study. As we have done in the past, peer coaches will receive training in the 
peer coaching protocol and motivational interviewing strategies, and ongoing fidelity checks will 
be conducted, with feedback provided to ensure the content of their texts are consistent with 
protocol. This activity is expected to last no more than one hour. 
 
V2V will differ from the approach we have used in our adult asynchronous coaching study in 
five ways. First, we will use texting instead of email, as texting is widely used by adolescents. 

 
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Second, the coaches will be peer coaches, instead of TTS. Third, these coaches will test 
proactively connecting adolescents via texting to a peer coach who has successfully quit vaping 
with effort (a mastery model, as used in our prior work). Each participant will receive periodic 
texts from their coach inviting them to chat by text. Fourth, we will tailor the facilitation texts to 
the adolescent’s gender and vaping status to increase the relevance of these messages.  
 
Activity 4: Gamification (2 game narratives): We will use a similar procedure to the 
development of peer messages. We will ask the peer advisory panel about their top 1-2 preferred 
games and ask them to think about the narrative for these games. They will then be asked how they 
would develop this narrative if given the opportunity to develop the games. To use as prompts, our 
team will conduct a review of top games played by adolescents and collect the narrative used for 
these games. Through a group review, we will finalize these narratives for V2V.  
 
This activity is expected to last no more than one hour. We will provide a $20 gift card for the 
completion of this activity. 
 
Activity 5: Mini-Pilot: We will conduct 2-4 real world mini-pilot studies with a maximum of 16 
participants. We will aim to conduct the mini-pilots with members of our peer advisory panel, 
but we may also invite other students from the high school to join the mini pilots (please see the 
description of Aim 1 recruitment strategies listed at the beginning of this section; all flyers, 
posters, and announcements will include mention of the mini-pilot). We will ask adolescents to 
provide separate assent for mini-pilot activities. 
 
We will use the mini-pilots to test i) V2V’s technical functioning; and ii) our protocols (e.g., data 
collection, peer coaching, gamification, frequency of texting quizzes). The mini-pilots in our past 
trials have been helpful in highlighting areas for improvement.23 The mini-pilot will mimic our 
Aim 2 protocol; however, adolescents will have access to V2V for only a period of 2 weeks. At 
the end of two weeks, we will conduct a detailed qualitative interview with these users to 
identify potential facilitators and barriers to study participation. We will group review these 
barriers and facilitators to make needed protocol changes. The mini-pilot qualitative interview 
guide will be submitted to the IRB for review and approval prior to use in the study. 
 
The mini-pilot is expected to last no more than 2 weeks.  The qualitative interview at the end of 
the mini-pilot is expected to take no more than 60 minutes. We will provide a $30 gift card for 
the completion of the mini-pilot. 
  
Key Informant Recruitment and Enrollment:  
Recruitment of the two key informants (school nurse and Vice Principal) will take place in-
person at the high school. We are requesting a waiver of documentation of consent for the two 
key informants. We will provide the key informants with a fact sheet. 
 
Semi-Structured Interviews with Adult Key informants: We will employ semi-structured 
individual interviews with the school nurse and vice principal (2 key informants) from the high 
school. We will develop two complementary interview guides, one for adolescents and one for 
adult key informants. The interview guides will be submitted to the IRB for review and approval 
prior to use in the study. 
 
Interview topics for adult key informants will include i) understanding the use of e-cigarettes in 
their school; ii) what they think might help students stop e-cigarette use, what they have tried and 

 
Page 11 of 34 
how it worked/did not work; iii) their thoughts regarding our initial concepts; and iv) what they 
feel would help students use a mobile program.  Interviews will employ a semi-structured open-
ended approach, allowing for natural conversation with opportunities to explore unanticipated 
issues. Interviews will be recorded, transcribed, and coded. 
 
The semi-structured interview is expected to last no more than 60 minutes. We will provide a 
$100 gift card to the key informants for completion of this interview. 
 
Compensation: Gift cards totaling up to $120 ($20-$30 for each activity and the mini pilot) will 
be provided to adolescents for completion of Aim 1 activities. Gift cards of $100 will also be 
provided to the key informants (school nurse and Vice Principal) and to the school nurses 
assisting with study activities (e.g., serving as the on-site point person for study recruitment, 
referring students requesting additional information regarding the study to research staff). There 
are two nurses at the high school, and we will provide a $100 gift card per nurse. 
 
See also Section #30, Consent Process. 
 
Aim 2  
 
We will recruit from 4-7 local high schools (that were not involved in Aim 1), selected for their 
high rates of racial/ethnic minorities and low SES status. Prior to recruitment, the study team will 
obtain IRB approval for the specific schools. To reduce the chances of imbalance across 
conditions, the schools will be matched based on percentage low income, percentage African 
American, and number of students, and divided into two sets of two. Within each set of two, we 
will randomly assign one school to each of the study conditions.  
 
Adolescent Recruitment: Letters will be sent to all parents (or legal guardians) of grade 9-12 
students in participating schools informing them of the study and asking them to contact us or the 
school if they do not wish their child to participate. Along with the letter, we will also send a fact 
sheet describing the study to all parents (or legal guardians). In the event that two parents (or 
legal guardians) are involved and residing at separate addresses, we will send letters and fact 
sheets to each individual parent/legal guardian – a letter and fact sheet will go to each 
parent/legal guardian at each individual address. Parents (or legal guardians) will have two 
weeks from the date the letter is sent to them to contact the study team or school. Objection from 
one parent/legal guardian would be sufficient in order to opt the student out from study 
participation. The Research Coordinator will maintain a list of all parents (or legal guardians) 
who have contacted the study team or school to indicate that their child may not participate in the 
study. If parents (or legal guardians) do not contact the study team or school within the two-week 
timeframe, their child will be eligible to meet with the Research Coordinator to discuss the study. 
Parental letters and fact sheets will be sent to all parents (or legal guardians) in the top 4-5 
languages spoken at each school, including in English and Spanish. We are including the top 4-5 
languages so as not to exclude any adolescents from potentially participating in the study based 
solely on the fact that their parent or parents’ (or legal guardians’) primary language is a 
language other than English. We will send a written letter to parents (or legal guardians) to 
confirm that their opt-out decision has been received and recorded.  
 

 
Page 12 of 34 
For mailing information to parents/guardians, the study team will use the same mailing address 
that is used by the school to communicate other important school-related information. 
 
We will recruit participants with approaches successfully used in our prior school-based studies. 
Recruitment packets containing an informational brochure, eligibility criteria, and adolescent 
assent/consent forms will be sent to all students. Flyers and posters will be placed in the school 
nurse’s office and throughout the school. The study will be announced in health education 
classes and through school-wide class announcements. Recruitment materials will include the 
Research Coordinator’s contact information. After flyers and posters are placed in the school 
nurse’s office and throughout the school, and after the study has been announced in health 
education classes and through school-wide class announcements, interested adolescents will 
contact the Research Coordinator to indicate that they are interested in participating the study. 
The Research Coordinator will then confirm that the adolescent’s parents (or legal guardians) 
have not indicated that their child may not participate in the study and will schedule a meeting 
with the adolescent for the earliest possible date. Meetings with the Research Coordinator will 
take place in the privacy of the school nurse’s office. The adolescent will not meet with the 
school nurse.  Informed assent, or informed consent if the student is 18 years of age or older, will 
be explained such that students understand they have a right to refuse to participate, that their 
care in the school health clinic and their grades will not be affected by whether or not they decide 
to participate, and confidentiality will be emphasized. Eligible students will be enrolled and 
follow the protocol for their school condition. All students in each school will receive the same 
intervention. Flyers, posters, and announcements will be submitted to the IRB for review and 
approval prior to use in the study. All recruitment materials will be available in both English and 
Spanish.  
 
Enrollment: Interested adolescents whose parents (or legal guardians) have not opted out, or 
who are 18 or older, will meet with the Research Coordinator in the privacy of the high school 
nurse’s office. The adolescent will not meet with the school nurse. After a brief screening, 
assent, or informed consent if the student is 18 years of age or older, will be explained such that 
students understand they have a right to refuse to participate, that their care in the school health 
clinic and their grades will not be affected by whether or not they decide to participate, and 
confidentiality will be emphasized. See also #30, Consent Process. The screening form will be 
submitted to the IRB for review and approval prior to use in the study. 
 
Study Activities: 
 
Trial: The control group will be provided written e-cigarette cessation materials. To the 
intervention group, we will provide access to the V2V toolkit, including access to peer coaches 
and peer messaging, detail how the peer messages and videos were pre-developed and set 
expectations for the response time from their peer coaches.   
 
Baseline (study entry) and 6-month follow-up data will be collected from all enrolled Aim 2 
participants in the privacy of the school nurse’s office. Baseline and 6-month data collection 
forms will be submitted to the IRB for review and approval prior to use in the study; see Table 2 
for a description of data to be collected. We have also included measures in the baseline and 6-
month data collection forms to assess psychosocial factors (including the Perceived Stress Scale 

 
Page 13 of 34 
and Depressive Symptoms Scale). We will calculate and monitor the scores for these scales in 
real-time. If we find a score above the pre-established clinically significant cutoff for that scale, 
we will notify the school nurse as soon as possible (within two business days) via phone and 
encrypted email. The school nurse will then follow the school’s established policies for 
addressing depressed, anxious, or stressed students. Scoring for the Perceived Stress Scale is as 
follows: Individual scores on the 4-item PSS (PSS-4) can range from 0 to 16, with higher scores 
indicating higher perceived stress. Scores ranging from 0-5 would be considered low stress. 
Scores ranging from 6-11 would be considered moderate stress. Scores ranging from 12-16 
would be considered high perceived stress. For the purposes of this study, we will consider any 
score in the 12-16 range to be clinically significant. The scoring for the Depressive Scale is as 
follows: Survey respondents are provided with four response categories, including "Never”, 
“Rarely”, Sometimes", and "Often." These four responses are assigned scores of 1, 2, 3, and 4, 
respectively, and then summed to produce an overall depressive symptom score which ranges 
from 6 to 24 points. In addition, these scores are increased by 10 to produce a new range of 16 to 
34 points. The cutoff score of 29 or greater indicates notable depressive symptoms. For the 
purposes of this study, we will consider a score of 29 or greater to be clinically significant. 
 
After completion of the surveys, we will verbally encourage all participants to speak with their 
health care provider or call or text the 988 Suicide & Crisis Lifeline at 988 or chat 988lifeline.org 
if they or someone they know is experiencing suicidal thoughts or is in emotional distress. 
Participants will be informed that the 988 Lifeline has trained crisis workers who are available to 
talk 24 hours a day, 7 days a week, that their call is confidential, and that it goes to the nearest 
crisis center in the Lifeline national network. These centers provide mental health crisis 
counseling and mental health referrals. 
 
We will pre-test these assessments to ensure the time burden does not exceed 15-20 minutes. 
Data confidentiality will be emphasized on the surveys and verbally by the Research 
Coordinator, and by using a unique identification number. Our study also includes texting 
quizzes, to be sent out over the course of the 6-month trial. 

 
Page 14 of 34 
With participant permission, we will collect complete and accurate contact information from the 
student at baseline, including home address, phone, cell phone, email, and phone numbers of 
three contacts and best times and days to reach them to maximize retention. A contact sheet will 
be completed by the participant that will include the above information. Care will be taken to 
maintain the confidentiality of the student’s participation; therefore all students will be asked to 
provide us with the individuals or contact information where they feel comfortable being 
contacted by study staff or where they feel assured that the confidentiality of their participation 
will be maintained. The other contacts provided by the student will not be informed of the 
student’s vaping status. We have found in prior studies that cell phone numbers and e-mail 
addresses are particularly helpful in remaining in contact with this population.  Tracking 
procedures will be implemented for any student who does not attend a scheduled study visit or 
who is not accessible by telephone or e-mail at the contact location provided.  Attempts to locate 
students will be made mainly through the schools and by telephone calls to the contacts provided 
or directory assistance.   
 
Semi-Structured Interviews: In addition to the above assessments, we will conduct brief 
qualitative interviews with all intervention participants after they have completed six-month 
follow-up to deepen our understanding of their experience with the V2V program and obtain 
Table 2. Study Assessments, Measures and Data Collection Timing 
Variable and Measure 
Relevant 
Aim 
Baseline 
6-month 
follow-up 
Recruitment: # screened and eligible, # and reasons for refusal 
2A 
•   
Retention: # of dropouts, reasons for dropping out 
2A 
 •  
Engagement (V2V only): # of completed responses to texting quizzes, peer 
videos viewed, peer coaching interactions  
2B 
 * 
Acceptability and satisfaction: Client Satisfaction Questionnaire (CSQ-8) 
semi-structured interview 
2B 
 •  
Cotinine-validated 7-day point prevalence abstinence: saliva samples 
collected from all; analyzed for those reporting 7-day abstinence; cut-off 11.4 
ng/ml 
2C 
 •  
E-cigarette use frequency (past 7 and 30 day) and intensity             (# days 
and amount vaped in past 7 and 30 day) 
2C 
•  •  
THC/marijuana and other tobacco use frequency (past 7 and 30 day) and 
intensity (# days and amount vaped)  
 
•  •  
Social Cognitive Theory (SCT) constructs 
Self-efficacy, confidence to quit: Self-efficacy Questionnaire (SEQ-12)  
 
•  •  
Demographics and tobacco use  
Demographics: age, gender, socio-economic status, race/ethnicity, grade in 
school, academic performance  
 
•  •  
History of all tobacco use, past and recent quit attempts, cessation strategies 
used 
 
•  
 
Attitudes about e-cigarette and other tobacco use 
 
•  •  
Stage of change: Prochaska's Stages of Change 
 
•  •  
Severity of nicotine addiction: Hooked on Nicotine Checklist (HONC) 
(adapted for vaping) 
 
•  •  

 
Page 15 of 34 
specific feedback on ways to improve the program for future refinements. The interviews will 
examine a series of topics, including constructs from our hypothesized conceptual model, as well 
as participant perceptions of each of the V2V components, message content, and system 
usability. Across these topics, our goal will be to understand what participants most valued and 
to elicit recommendations for further intervention enhancement. Interviews will be semi-
structured, allowing for natural conversation with opportunities to explore unanticipated issues. 
We anticipate interviews to be no more than 60 minutes in duration. The interview guides will be 
submitted to the IRB for review and approval prior to use in the study. 
 
Compensation: Gift cards worth $25 will be provided to adolescents for completion of each 
assessment (baseline and 6-months; $50 total). 
 
Key Informant Recruitment and Enrollment:  
Recruitment of eight key informants (school nurse, Vice Principal, or other academic 
administrator) will take place in-person at the high school. We are requesting a waiver of 
document of consent for the key informants. We will provide key informants with a fact sheet. 
 
Semi-Structured Interviews with Adult Key informants: We will employ semi-structured 
individual interviews with the school nurse, vice principal, or other academic administrator 
(minimum of 2 key informants) from  each participating high school. We will develop two 
complementary interview guides, one for adolescents and one for adult key informants. The 
interview guides will be submitted to the IRB for review and approval prior to use in the study. 
The semi-structured interview is expected to last no more than 60 minutes.  
 
Compensation: Gift cards of $100 will also be provided to the key informants (school nurse, 
Vice Principal, or other academic administrator). 
 
See also #30, Consent Process and #9, Study Timelines. 
 
12. DATA AND SPECIMEN BANKING* 
N/A 
 
13. DATA ANALYSIS AND MANAGEMENT* 
 
Aim 1: 
Data collection: Data collected from participants during Aim 1 will be obtained through semi-
structured individual interviews, peer video interviews, a survey and writing/material development 
sessions. Data confidentiality will be emphasized during the informed assent/consent process with 
adolescents (see section #30 for more details). Any data captured via the writing sessions and 
surveys will be entered into the regulated environment through a secure Research Electronic Data 
Capture (REDCap) form. REDCap is a secure web application for building and managing online 
surveys and databases that was funded by the National Institutes of Health. REDCap data is also 
stored in a regulated and secure environment. With the exception of the peer videos, we will retain 
study records and documents for a period of 3 years after the completion of the study. As peer 
videos will become part of our V2V multi-modal intervention, we may use them in future iterations 
of the intervention. Thus, the peer videos will not be deleted at the conclusion of the study. We 
have noted in the active parental consent form, adolescent assent form, the consent form for 
adolescents 18 years or older, and the video release form that there is no limit on the length of time 
we will store the peer videos and that it is possible that we might use the peer videos in future 
iterations of the V2V Intervention.   

 
Page 16 of 34 
 
Data Analysis:  
Data gathered through qualitative interviews will be managed and coded using NVivo 10. An 
integrated approach to coding will be used, employing a coding start-list based on protocol 
questions (deductive coding) and open coding driven by emersion in the qualitative data (inductive 
coding).24 Duplicate coding will be conducted with at least 10% of the interview transcripts and 
coding comparisons will be run to ensure inter-rater reliability.25 Disputes in coding decisions will 
be discussed within the research group until resolved. We will continue to test and refine coding 
until we attain a Kappa >.80.  NVivo qualitative analysis software will be employed to generate 
coding reports that summarize participant responses, ideas, and reflections related to relevant 
research questions.26 Two members of the research team will complete the thematic analysis 
 
Aim 2: 
Data collection: Data collected from participants will be obtained through interviews, paper and 
pencil surveys, and collection of saliva samples for cotinine assessment by the Research 
Coordinator in-person at the school nurse office at baseline and 6-months post-study entry. The 
student survey and assessment tools for this study will be adapted from our prior adolescent 
smoking cessation trials and will be submitted to the IRB for review and approval prior to use in 
the study. Survey and assessment tools are described in Table 2 on page 10 of the ISP. Data 
confidentiality will be emphasized on the surveys and verbally by the Research Coordinator (see 
section #30), and by the use of a unique identification number. Data will be entered into the 
regulated environment through a secure Research Electronic Data Capture (REDCap) form. 
REDCap is a secure web application for building and managing online surveys and databases that 
was funded by the National Institutes of Health. REDCap data is also stored in a regulated 
environment. These files will be deleted after study completion. Portable devices used to collect 
data (audio and film recordings) will be UMMS-issued devices and files will not be encrypted 
during the recording, but the recordings will be transferred as soon as possible (i.e.: typically within 
the same day) to UMMS servers. Once the files are transferred, they will be deleted from the 
portable devices. 
 
We will conduct biochemical verification using a saliva NicAlert® test (Nymox Corporation), 
which is a semi-quantitative method that uses a dipstick to measure the level of cotinine in a sample 
of saliva. The test strip displays the result in seven zones with each zone representing a range of 
levels of cotinine/smoking (e.g.: zone 0 [0–10 ng/mL, a nonsmoker] to zone 6 [>1000 ng/mL, a 
heavy smoker]). The results are read as 0-6, and as recommended, any value ≥ 1 is considered as 
tobacco use. Research staff will enter these values into the database, using the participant ID as an 
identifier, and destroy the samples.  
 
Data Analysis: 
Aim 2A (Feasibility) Hypothesis H1: We will be able to recruit 80 adolescents (20/school, 40 per 
study condition), and >85% will be retained in each study condition at 6-month follow-up. We 
will estimate recruitment rates, overall and per condition.  Also, for each condition, we will model 
6-month retention, using generalized estimating equation (GEE) logistic regression to account for 
within-school clustering and dependence over time.  
 
Proposed Sample Size. As appropriate for a pilot study, we are estimating our power and sample 
size based on the feasibility hypothesis  (H1). Because pilot studies do not provide meaningful 
estimates of effect sizes due to the imprecision inherent in small samples,  we base our proposed 
sample size of 40 students per condition (20 per school) on obtaining precision in estimating 
condition-specific retention rates, providing important information for design and recruitment for 
the future R01 study.  Based on our prior study of adolescent smoking cessation, estimated intra-
school correlation=0.01, for a design effect due to within-school clustering of 1 + [0.01 × (20 – 1)] 
= 1.19, and an effective sample size per condition of 40/1.19 = 34.  Based on our prior studies in 

 
Page 17 of 34 
adolescents in school settings, we anticipate at least 85% retention.  Thus, a conservatively wide 
95% exact CI for per-condition retention rate is (68.9%, 95.0%).   
 
Aim 2B (Monitor V2V Engagement and Assess Program Satisfaction) As the trial progresses, 
we will monitor engagement overall and by participant subgroups (e.g. by gender, race, age) as a 
formative assessment. Then, as the trial ends, we will also use this information as a component of 
our summative evaluation. We anticipate that engagement will lead to positive changes in 
acceptability, and satisfaction, and cessation.  
 
Defining V2V Engagement level: Engagement measures include: Number of intervention 
assessments completed, peer videos viewed, and peer coaching interactions. To assess each of 
these, we will first categorize an adolescent’s engagement with each component.  For example, for 
intervention assessments, we will calculate percent of assessments completed (number of 
assessments divided by the total number of assessment opportunities). Second, we will then 
calculate the median percent complete across the sample and dichotomize into higher engaged 
(adolescent’s percent completed was at the median or higher) or lower engaged (under the median). 
We will use a similar procedure for the peer videos viewed.  Third, for peer coaching, we will use 
the count of the number of messages to the peer coach. We anticipate that this count could vary 
considerably, as some will have sent 0 messages and there is no absolute maximum number of 
messages sent.  We will base the higher versus lower engaged based on the distribution (median 
split or another reasonable quantile). We could then look at the distribution of engagement with 
each component, and predictors of engagement (by the adolescent’s characteristics).   
 
From these three measures, we will create an engagement summary score.  The range for the 
summary score would be from 0 to 3 (0 = lower engagement in all 3 measures, 3 = higher 
engagement in all 3). We will assess the association of this score with the acceptability and 
satisfactions score using linear mixed modeling. Acceptability and satisfaction scores will be 
calculated using the Client Satisfaction Questionnaire (CSQ-8). The overall score is calculated by 
summing the respondent's rating (item rating) score for each scale item. Scores therefore range 
from 8 to 32, with higher values indicating higher satisfaction. Similarly, we will look for 
association between  summary score and cessation.  We recognize that, for these analyses, power 
will be limited due to the sample, and further we do not have estimates upon which to base 
estimates for power calculations. These analyses are conducted to guide our future R01. 
 
Aim 2C (Cessation Outcomes) Hypothesis H2: The intervention will be associated with greater 
cotinine-validated 7-day point prevalence vaping abstinence rates, lower time to first quit attempt, 
and less amount of e-cigarette use compared to control at 6-month follow-up. We recognize that 
there is some controversy about estimating effect sizes from pilot studies. However, we are 
calculating effect sizes in our study to provide a range, recognizing that there might be 
uncertainties because of our small sample size. To estimate effect sizes for V2V intervention 
versus control, between-condition differences over time will be estimated for cotinine-validated 
7-day point prevalence abstinence using GEE logistic regression  with a random effect for school 
and fixed effects of condition, time point (baseline and 6 months), and their interaction.  Missing 
data is handled using inverse probability weighting. By taking the repeated measurements into 
consideration, the GEE model is able to increase the power to test the difference in the outcome.  
COX regression modeling will be used to examine the intervention effect on time to first quit 
attempt adjusting for other covariates. Amount of e-cigarette use will be calculated as a reduction 
from baseline. We will model this reduction using negative binomial regression modeling if the 
variance of the distribution of risk reduction is over dispersed.  
 
Other information important for the design of a future study includes standard deviations, as well 
as preliminary assessment of possible mediators such as engagement, behavioral capability, and 
self-efficacy. We will identify important mediators in exploratory analyses. Guided by the 
conceptual model based on SCT, we will assess effects of intervention on the mediator and the 

 
Page 18 of 34 
effects of the mediator on the outcome, controlling for other mediators in the model, and 
confounders of the mediator-outcome relationship, and then estimate the proportion of the 
intervention effect explained. Given the limited sample size, conclusions from the mediation 
analyses will be limited and treated with caution, but modeling will allow us to explore the 
constructs of SCT and potential predictors towards a larger RCT.  
 
Brief Interviews for Future Refinements: In addition to the above assessments, we will 
conduct brief qualitative interviews with all study participants after they have completed six-
month follow-up to deepen our understanding of their experience with the V2V program and 
obtain specific feedback on ways to improve the program for future refinements. We will use the 
same approach as Aim 1A to analyze these interviews. Data gathered through qualitative 
interviews will be managed and coded using NVivo10. An integrated approach to coding will be 
used, employing a coding start-list based on protocol questions (deductive coding) and open 
coding driven by emersion in the qualitative data (inductive coding). Duplicate coding will be 
conducted with at least 10% of the interview transcripts and coding comparisons will be run to 
ensure inter-rater reliability.  Disputes in coding decisions will be discussed within the research 
group until resolved. We will continue to test and refine coding until we attain a Kappa >.80.  
NVivo qualitative analysis software will be employed to generate coding reports that summarize 
participant responses, ideas, and reflections related to relevant research questions. Two members 
of the research team will complete the thematic analysis. 
 
Data Security (Aim 1 and Aim 2) 
All persons collecting or handling data will be trained in human subjects’ procedures, 
confidentiality, and privacy protection. All investigators and project staff are required to receive, 
and complete, Human Subjects and HIPAA training.  
 
All computerized data, excluding data stored in REDCap (Research Electronic Data Capture), 
will be kept on secured computers or network servers, behind University of Massachusetts 
firewalls. These data will be accessible only to research staff with approved access, using 
confidential usernames and passwords. Any paper data will be kept in locked cabinets or a 
locked file room accessible only by research staff. Data downloaded from REDCap will be 
stored and secured according to these methods. 
 
Participant confidentiality will be maintained through a number of strategies. Each participant 
will be assigned a unique study identification number. Subsequent protection of study data will 
be assured by the use of locked files and password-protected computer databases. A key to link 
each code with subjects’ names and identifiers will be kept will be kept separate from the 
research dataset in a locked filing cabinet in the study office and in a password-protected excel 
sheet, stored on secure University of Massachusetts computers. This linkage data is necessary to 
implement the intervention and conduct the study. The linkage data file will be destroyed at the 
earliest possible time, once data collection is complete and data accuracy are verified. 
 
Film recordings of peer video interviews will be recorded on portable devices, which will be 
stored in a secure location (locked drawer that only study staff can access). Portable devices will 
be UMMS-issued devices and files will not be encrypted during the recording, but the recordings 
will be transferred as soon as possible (i.e.: typically within the same day) to UMMS servers. 
Once the files are transferred, they will be deleted from the portable devices. We will obtain 

 
Page 19 of 34 
assent and active parental consent from adolescents under the age of 18, and written consent for 
adolescents 18 years of age or older (see also section #30). Peer videos will be made available to 
study participants via a secure website (example: Vimeo), and will be password protected. As 
these peer videos will become part of our V2V multi-modal intervention, we may use them in 
future iterations of the intervention. Thus, the peer videos will not be deleted at the conclusion of 
the study. We have noted in the active parental consent form, adolescent assent form, the consent 
form for adolescents 18 years or older, and the video release form that there is no limit on the 
length of time we will store the peer videos and that it is possible that we might use the peer 
videos in future iterations of the V2V Intervention.   
 
We will utilize professional transcription services for interview transcription. Recordings will be 
uploaded to https://www.sendthisfile.com, a HIPAA compliant website, to be transferred to a 
professional transcriptionist. Send This File uses SAS70 type II/SSAE16 compliant data centers 
to ensure that private data is protected; features of this service include 128-bit Transport Layer 
Security (TLS) encryption and password protection, among other security precautions. The 
transcriptionist uses a password to access uploaded materials to Send This File, works on a 
password-protected desktop computer, and once transcribed and the transcript is received by the 
client, the transcriptionist deletes the recording. Recordings will be transcribed verbatim without 
subject identifiers. Once transcripts have been reviewed for completeness and accuracy, 
recordings will be deleted from the secure network drive and devices, but will remain on the 
secure website mentioned above for the duration of the study. Transcriptions will be kept in 
locked file cabinets in locked offices, and on password-protected computers. 
 
All data will be used for research purposes only; published data will not contain any individual 
identifiers and will be reported in the aggregate.   
 
See also #14, Provisions to Monitor the Data to Ensure the Safety of Subjects, #26, 
Confidentiality and #27, Provisions to Protect the Privacy Interests of Subjects.   
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
The proposed study involves no more than minimal risk to participants. Please see Section #11, 
Study Activities, Trial for further information. 
 
All study data will be stored in a HIPAA compliant regulated environment and access will be 
only through a secure VPN network. All participant-related identifiers are encrypted in the 
database. The study’s biostatistician will organize data security and archiving. In no way will 
individual participant data be released to the public or cited in a publication. We have substantial 
experience with successfully implementing these methods. 
 
Participant confidentiality will be maintained through a number of strategies. As noted in Section 
#13, Data Analysis and Management, each participant will be assigned a unique study 
identification number. The only individual who will have access to these identifiers will be the 
Research Coordinator responsible for data collection. Other UMMS personnel will not be privy 
to identifying information about the individual participants. The survey data collected from 
participants will not be accessible to the school nurse or other school personnel, as all completed 
surveys will be placed in a sealed envelope by the participants and given to the Research 

 
Page 20 of 34 
Coordinator to be brought to UMMS for data entry. However, if we find a survey score above 
the pre-established clinically significant cutoff for the Perceived Stress of Depressive scales, the 
school nurse will be notified of this survey result as soon as possible (within two business days) 
via phone and encrypted email. Subsequent protection of study data will be assured by the use of 
locked files and password-protected computer data bases with access available only to the 
principal study personnel. Data collected via texting will be identified only by a study subject 
specific numerical code to ensure protection of confidentiality. Data will be automatically 
downloaded to our secure server and checked for errors and completeness. A key to link each 
code with subjects’ names and identifiers will be kept in a locked filing cabinet in the study 
office and in a password-protected excel sheet, stored secure University of Massachusetts 
computers. 
 
Data and Safety Monitory Board: This trial is not a Phase III study of a pharmaceutical 
treatment, but as it is a behavioral intervention, we will establish a Data and Safety Monitoring 
Board (DSMB). The DSMB will be charged with reviewing protocols and consent documents for 
this trial, monitoring safety issues throughout the study, monitoring the quality of the 
accumulating data, providing guidance on interim analyses, and providing guidance on stopping 
rules. They will also serve as a liaison among the study investigators, the University of 
Massachusetts Medical School’s Office of Human Research Protections (IRB), and the National 
Institute of Health (NIH). The DSMB will be comprised of persons with no direct involvement in 
the study or conflict of interest with the research team conducting the randomized trial. The 
DSMB will include individuals with expertise in: 1) Biostatistics; and 2) Pediatric Psychology. 
Once recruitment for the trial has begun, the DSMB will meet two times per year or more 
frequently as determined by the DSMB members. The DSMB and the PI will decide upon the 
format of the meetings. Additional telephone conferences will be held if doing so is 
recommended by the DSMB. We will develop the DSMB Charter within the first three months 
of the study and will provide the IRB with a copy of the DSMB Charter once the document is 
available. 
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 
We do not anticipate withdrawing any participants without their assent (for those under the age 
of 18), consent (for those 18 years of age or older), or without parental/guardian permission (for 
the videotaped interviews of minors). 
 
16. RISKS TO SUBJECTS* 
 
Potential Loss of Confidentiality 
There are potential risks associated with data collection and information management. These 
include inadvertent disclosure of research variables collected. Participants may also feel uneasy 
about participating in the interviews. Reasonable efforts will be made to inform the subject of 
these potential risks and to minimize the risks. 
 
Protection Against Risks 
Minimizing Risks: Reasonable efforts will be made to minimize risks and participant 
inconvenience. Risks will be minimized by: 1) adequate training of all staff; 2) ensuring 
participants are verbally informed of the details of the semi-structured interviews and other study 

 
Page 21 of 34 
activities as they are delivered, including informing the participant that they do not have to 
answer any interview questions that they are not comfortable answering, and that they can stop 
the interviews at any time; and 3) frequently encouraging participant questions throughout the 
semi-structured interviews and other study activities. 
 
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
One potential benefit of being in this study is preventing personal health risks that 
can be caused by vaping. Participants will also be helping to develop vaping interventions for 
teens that may help support adolescents to quit vaping.  However, there are no direct benefits to 
participants from study participation.  
 
18. VULNERABLE POPULATIONS* 
  
Adolescents  
This study includes adolescent e-cigarette users, ages 13-19. For these participants, we will send 
letters and fact sheets to all parents (or legal guardians) of grade 9-12 students in participating 
schools informing them of the study and asking them to contact us or the school if they do not 
wish their child to participate. Informed assent with adolescents under the age of 18, or informed 
consent with adolescents 18 years of age or older, will be explained such that students 
understand they have a right to refuse to participate, that their care in the school health clinic and 
their grades will not be affected by whether or not they decide to participate, and confidentiality 
will be emphasized. We will request special permission during the assent/consent process to film 
the peer videos with our Aim 1 participants. After student participant assent is obtained, we will 
request active parental consent for those under the age of 18 to film the peer videos before 
proceeding with enrollment.  
  
For adolescents under the age of 18, we will obtain the adolescent’s overt agreement to 
participate in our study by providing the adolescent with an assent form describing the study. We 
will go through the assent process and study expectations with the adolescent and ensure any 
questions the adolescent may have about the study or their participation are answered. We will 
not enroll a child if there is any sign of unwillingness.  
  
Pregnant Women 
Pregnant women may be included in the study as an incidental population. We confirm the 
following criteria for federally-funded research involving this population: 
1. No inducements, monetary or otherwise, will be offered to terminate a pregnancy. 
2. Individuals engaged in the research will have no part in any decisions as to the timing, 
method, or procedures used to terminate a pregnancy. 
3. Individuals engaged in the research will have no part in determining the viability of a 
neonate. 
 
Prisoners 
Prisoners will not be knowingly included in the study.  
 
19. MULTI-SITE RESEARCH* 

 
Page 22 of 34 
N/A; this is not a multi-site study. 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
N/A 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
We do not plan on sharing the research results, including individual results, with study 
participants. 
 
22. SETTING 
The setting for this study (all aims) is five to eight high schools throughout Massachusetts. 
Assent/consent procedures and baseline and six-month data collection will take place in the 
privacy of the school nurse’s office. All other study activities (semi-structured interviews, peer 
message development, peer videos, peer coaching trainings, and gamification development) will 
take place in the privacy of the school nurse’s office or virtually via a secure Zoom call. 
 
23. RESOURCES AVAILABLE 
All study personnel will read the study protocol, receive the appropriate supervision and possess 
the appropriate experience (both higher education and related work experience) needed to fulfill 
their roles and complete their responsibilities for this study. All investigators and project staff are 
required to receive and complete Human Subjects and HIPAA training. All research personnel 
will hold a current Human Subjects Training Certificates. All study staff have adequate time 
budgeted to fulfill their responsibilities in the study and will meet periodically to ensure that they 
are adequately informed about the protocol, the research procedures, and their duties and 
functions. As study personnel roles are filled, we will update the list of Active Study Staff in the 
eIRB system. The Principal Investigators will oversee all personnel and all research activities 
conducted within this study. 
 
The Multiple Principal Investigators (MPIs) will also have responsibility for the overall conduct 
of the project at the study site. They will have primary oversight of all study personnel. They will 
participate in the design and the execution of the respective study analyses and will be 
responsible for the reporting and dissemination of study results.  
 
The Biostatisticians will assist in the design and performance of analyses relevant to the project 
and will assist in the development of study deliverables. The biostatisticians will direct the 
creation of data collection systems in year 1, monitoring of data collected in years 1-2, and 
statistical analyses for evaluating processes and outcomes of the study in year 2. In addition, the 
biostatisticians will provide statistical support and data collection supervision throughout the 
course of the project, will be responsible for maintaining the study’s REDCap database, and will 
conduct data analysis for the study.  
 
The Qualitative Expert will be responsible for designing and analyzing the project’s qualitative 
interviews. 
 
The Programmer will perform a range of programming and data management activities essential 
to conduct of the project. S/he will assist in the development of study databases, data cleaning 

 
Page 23 of 34 
and validation activities, and the performance of analyses under the direction of the principal 
investigator.  
 
The Project Directors will assist the Principal Investigators in implementing all aspects of the 
project. Under the direction of the investigators, the project directors will be responsible for day-
to-day oversight of the project, including:  developing timelines, work allocation, workflow 
plans, monitoring project progress and task completion, monitoring spending and effort 
allocation, and managing correspondence and administrative tasks. They will monitor/manage 
ethics and regulatory approvals (IRB, HIPAA), attend and plan for all project-related meetings, 
oversee recruitment, retention, data collection, and the distribution of incentives to participant.  
The project directors will also assist in supervising the Research Coordinator and initial set-up of 
recruitment. They will be responsible for maintaining communications with all parties 
participating in the project.  
 
The Research Coordinator will be the primary study staff member responsible for participant 
recruitment, enrollment, and retention. This includes scheduling and conducting participant 
baseline interviews, entering collected data into the project’s database, administering six-month 
follow-up assessments, including cotinine validation, and preparing and assembling all materials 
for the study. 
 
The Peer Coaches will be students from local colleges who had smoked as adolescents and 
successfully quit with difficulty, providing a mastery model for smoking cessation. They will be 
trained in motivational interviewing and behavior change counseling, and will be required to 
demonstrate competency prior to delivering the intervention. The Peer Coaches will be 
responsible for sending periodic texts to Aim 2 intervention participants. 
 
24. LOCAL RECRUITMENT METHODS 
Aim 1: 
Letters will be sent to all parents (or legal guardians) of grade 9-12 students in participating 
schools informing them of the study and asking them to contact us or the school if they do not 
wish their child to participate. Along with the letter, we will also send a fact sheet describing the 
study to all parents (or legal guardians). In the event that two parents (or legal guardians) are 
involved and residing at separate addresses, we will send letters and fact sheets to each 
individual parent – a letter and fact sheet will go to each parent at each individual address. 
Parents (or legal guardians) will have two weeks from the date the letter is sent to them to 
contact the study team or school. Objection from one parent/legal guardian would be sufficient in 
order to opt the student out from study participation. The Research Coordinator will maintain a 
list of all parents (or legal guardians) who have contacted the study team or school to indicate 
that their child may not participate in the study. If parents (or legal guardians) do not contact the 
study team or school within the two-week timeframe, their child will be eligible to meet with the 
Research Coordinator to discuss the study. Parental letters and fact sheets will be sent to all 
parents (or legal guardians) in the top 4-5 languages spoken at each school, including in English 
and Spanish. We are including the top 4-5 languages so as not to exclude any adolescents from 
potentially participating in the study based solely on the fact that their parent or parents’ (or legal 
guardians’) primary language is a language other than English. We will send a written letter to 
parents (or legal guardians) to confirm that their opt-out decision has been received and 

 
Page 24 of 34 
recorded. 
 
For mailing information to parents/guardians, the study team will use the same mailing address 
that is used by the school to communicate other important school-related information. 
 
After two weeks, we will recruit participants with approaches successfully used in our prior 
school-based studies, excluding those whose parents (or legal guardians) indicated that their 
child may not participate in the study. Recruitment packets containing an informational brochure, 
eligibility criteria, and adolescent assent/consent form will be given to all students, using the 
procedure(s) selected by the school. Flyers and posters will be placed in the school nurse’s office 
and throughout the school. The study will be announced in health education classes and through 
school-wide and class announcements. Recruitment materials will be available in both English 
and Spanish. Recruitment materials will include the Research Coordinator’s contact information. 
After recruitment materials and announcements have been distributed throughout the school, 
interested adolescents will contact the Research Coordinator to indicate that they are interested in 
participating the study. The Research Coordinator will then confirm that the adolescent’s parents 
(or legal guardians) have not indicated that their child may not participate in the study and will 
schedule a meeting with the adolescent for the earliest possible date. Interested adolescents 
whose parents (or legal guardians) have not indicated that their child may not participate will 
meet with the Research Coordinator in the privacy of the school nurse’s office. Assent for those 
under the age of 18, or informed consent for those 18 years of age or older, will be explained 
such that students understand they have a right to refuse to participate, that their participation is 
voluntary, that their care in the school health clinic and their grades will not be affected by 
whether or not they decide to participate, and confidentiality will be emphasized. We will request 
special permission during the assent/consent process to film the peer videos with our Aim 1 
participants. After student participant assent/consent is obtained, we will request active parental 
consent to film the peer videos before proceeding with enrollment. In addition, only adolescents 
under the age of 18 who provide assent to be videotaped and have active parental consent to be 
videotaped and whose parent signs the video release authorization, or adolescents 18 years of age 
or older and who provide informed written consent and who sign the video release authorization, 
will be videotaped responding to interview questions for the videos. 
 
Recruitment of the two key informants (school nurse and Vice Principal) will take place in-
person at the high school.  
 
Aim 2: 
Letters will be sent to all parents (or legal guardians) of grade 9-12 students in participating 
schools informing them of the study and asking them to contact us or the school if they do not 
wish their child to participate, as we have successfully done previously. Should individual 
schools require active parental consent, we will work with them to implement these procedures. 
Along with the letter, we will also send a fact sheet describing the study to all parents (or legal 
guardians). In the event that two parents (or legal guardians) are involved and residing at 
separate addresses, we will send letters and fact sheets to each individual parent – a letter and 
fact sheet will go to each parent at each individual address. Parents (or legal guardians) will have 
two weeks from the date the letter is sent to them to contact the study team or school. Objection 
from one parent/legal guardian would be sufficient in order to opt the student out from study 

 
Page 25 of 34 
participation. The Research Coordinator will maintain a list of all parents (or legal guardians) 
who have contacted the study team or school to indicate that their child may not participate in the 
study. If parents (or legal guardians) do not contact the study team or school within the two-week 
timeframe, their child will be eligible to meet with the Research Coordinator to discuss the study. 
Parental letters and fact sheets will be sent to all parents (or legal guardians) in the top 4-5 
languages spoken at each school, including in English and Spanish. We are including the top 4-5 
languages so as not to exclude any adolescents from potentially participating in the study based 
solely on the fact that their parent or parents’ (or legal guardians’) primary language is a 
language other than English. We will send a written letter to parents (or legal guardians) to 
confirm that their opt-out decision has been received and recorded. 
 
For mailing information to parents/guardians, the study team will use the same mailing address 
that is used by the school to communicate other important school-related information. 
 
Recruitment packets containing an informational brochure, eligibility criteria, and adolescent 
assent/consent form will be sent to all students. Flyers and posters will be placed in the school 
nurse’s office and throughout the school. The study will be announced in health education 
classes and through school-wide and class announcements. Recruitment materials will be 
available in both English and Spanish. Recruitment materials will include the Research 
Coordinator’s contact information. After recruitment materials and announcements have been 
distributed throughout the school, interested adolescents will contact the Research Coordinator to 
indicate that they are interested in participating the study. The Research Coordinator will then 
confirm that the adolescent’s parents (or legal guardians) have not indicated that their child may 
not participate in the study and will schedule a meeting with the adolescent for the earliest 
possible date. Interested adolescents will meet with the Research Coordinator in the privacy of 
the school nurse’s office. Informed assent/consent will be explained such that students 
understand they have a right to refuse to participate, that their care in the school health clinic and 
their grades will not be affected by whether or not they decide to participate, and confidentiality 
will be emphasized. Eligible students will be enrolled and follow the protocol for their school 
condition. All students in each school will receive the same intervention.  
 
Recruitment of the two key informants (school nurses, Vice Principals, or other academic 
administrators) will take place in-person at the participating high schools.  
 
25. LOCAL NUMBER OF SUBJECTS 
The local number of subjects for this study is as follows: 
 
Aim 1: 20 adolescent e-cigarette users (peer advisory panel) and 2 key informants (school nurse 
and vice principal) from 1 high school. 
 
Aim 2: 80 adolescent e-cigarette users from four high schools selected for their high rates of 
racial/ethnic minorities and low SES status (20/school, 40/study condition) will be recruited and 
complete assessments at baseline and 6-month follow-up. With a conservative 85% retention 
rate, we will achieve a total of 68 e-cigarette users (17/school, 34/study condition) at 6-month 
follow-up. We will also recruit up to 12key informants (school nurses, vice principal, or other 
academic administrator) from participating high schools. 

 
Page 26 of 34 
 
Overall, we plan to recruit up to 110 individuals. 
 
26. CONFIDENTIALITY  
Participant confidentiality will be maintained through a number of strategies. All study 
information will be stored on the UMMS regulated environment. Each participant will be 
assigned a unique study identification number. Subsequent protection of study data will be 
assured by the use of locked files and password-protected computer databases. A key to link each 
code with subjects’ names and identifiers will be kept will be kept separate from the research 
dataset in a locked filing cabinet in the study office and in a password-protected excel sheet, 
stored on secure University of Massachusetts computers on the UMMS regulated environment. 
This linkage data is necessary to implement the intervention and conduct the study. The linkage 
data file will be destroyed at the earliest possible time, once data collection is complete and data 
accuracy are verified. 
 
Recordings of the semi-structured interviews will be transcribed by a professional transcriptionist 
and will have identifiers redacted during transcription. All recordings will be destroyed after study 
completion. Portable devices will be used for the recordings. Portable devices used to collect data 
(audio and film recordings) will be UMMS-issued devices and files will not be encrypted during 
the recording, but the recordings will be transferred as soon as possible (i.e.: typically within the 
same day) to UMMS servers. Once the files are transferred, they will be deleted from the portable 
devices. 
 
As adolescents are particularly engaged by videos, a novel approach we will explore in this study 
is use of peer videos as an additional tool to deliver peer messages regarding vaping and quitting.  
Peer videos will be made available to study participants via a secure website (example: Vimeo), 
and will be password protected. As described in Section # 11, Procedures Involved, peer videos 
will be filmed as part of the Aim 1  activities, and will be used in Aim 2 of the study, when we 
will explore use of peer videos to deliver our messaging intervention. Our considerations for 
using peer videos is as follows: video-based peer-to-peer communication is very popular among 
adolescents, and videos (e. g., YouTube) are among the most engaged content by adolescents on 
social media. Most adolescents (69%) watch online videos every day (increasing from 34% in 
2015), and prefer watching these videos on their phones rather than on their computers. Further, 
the presence of disparities does not mean that we don’t consider these technologies for 
disadvantaged groups, rather that we explore different options to identify the best fit for the 
targeted groups. Otherwise, we might further perpetuate health disparities. These videos will be  
designed to be short (< 2 minutes) and each video will focus on one specific point. We will 
develop them to use less bandwidth for smartphone consumption. Please note that adolescents 
can wait to watch these videos when they have access to wi-fi. Further, we are delivering these 
videos as part of a multi-modal intervention; thus, adolescents can still benefit from V2V even if 
they are unable to view the videos. Our goal with this R34 is to explore engagement, 
acceptability and satisfaction with these technologies. As noted, we will require that all 
adolescents appearing in these peer videos provide assent (or consent for those 18 years or older) 
and sign a video release form. We will also require active parental consent and parental signature 
on the video release form for those under the age of 18. As these peer videos will become part of 
our V2V multi-modal intervention, we may use them in future iterations of the intervention. 
Thus, the peer videos will not be deleted at the conclusion of the study. We have noted in the 
active parental consent form, adolescent assent form, the consent form for adolescents 18 years 

 
Page 27 of 34 
or older, and the video release form that there is no limit on the length of time we will store the 
peer videos and that it is possible that we might use the peer videos in future iterations of the 
V2V Intervention. 
 
Data collected from participants will be obtained through interviews, paper and pencil surveys, 
writing sessions, and collection of saliva samples for cotinine assessment by the Research 
Coordinator, in-person at the school nurse office at baseline and 6-months post-study entry. 
Data confidentiality will be emphasized on the surveys and verbally by the Research 
Coordinator, and by the use of a unique identification number. Data will be entered into the 
UMMS regulated environment through a secure Research Electronic Data Capture (REDCap) 
form. Data (excluding peer videos) will not be distributed. Peer videos will be distributed to 
study participants via a secure website (example: Vimeo), and will be password protected. With 
the exception of the peer videos, we will retain study records and documents for a period of 3 
years after the completion of the study. 
 
See also #13, Data Analysis and Management. 
 
Protection for Risks Associated with Potential Loss of Confidentiality 
The study team have systems, oversight, experienced personnel, and an organizational culture 
that supports the appropriate use, access and storage of confidential information.  All persons 
collecting or handling data will be trained in human subjects’ procedures, confidentiality and 
privacy protection.  All investigators and project staff are required to receive and complete 
Human Subjects and HIPAA training. All research personnel will hold a current Human Subjects 
Training Certificate. 
 
Because the study will be funded by the NIH, we will follow the guidelines in the NIH certificate 
of confidentiality. The certificate keeps us from sharing identifiable sensitive information 
collected for the research unless the participants allow us to do so. This is included in the assent 
and consent form that was included as part of this IRB application. We will only disclose 
information about the students if they plan to harm themselves or others, or if they have a 
clinically significant score on the psychosocial factors scales included in the baseline and follow 
up data collection forms. We will not be disclosing information about illicit drugs issues to law 
enforcement agencies, parents, the school, or others. 
 
If a parent (or legal guardian) calls the study team to request information that their child provides 
regarding their substance use, such information will not be disclosed to the parent/legal guardian 
per the NIH Certificate of Confidentiality.  
 
We will not inform parents (or legal guardians) about their adolescent’s vaping status unless the 
student chooses to participate in the peer videos. In that case, parental/legal guardian consent will 
indicate that the child is an e-cigarette user. The student will be informed that their parent (or 
legal guardian) will be notified of their vaping status in the consent form if they choose to 
participate in the peer videos. 
 
See also #13, Data Analysis and Management. 
 

 
Page 28 of 34 
Data Collected via REDCap 
Study data will be captured via REDCap. The REDCap Consortium is comprised of hundreds of 
active institutional partners from CTSA and other institutions, and it supports a secure web 
application (REDCap) designed exclusively to support data capture for research studies 
(http://www.project-redcap.org).  University of Massachusetts Medical School is a REDCap 
Consortium site.   
 
REDCap is used to build and manage online surveys and databases.  The front end of REDCap is 
written in PHP, which is widely used, robust, open source scripting language.  Web servers, 
database servers, and security of communication between servers occur locally at each 
Consortium site where data capture is stored.  Thus, all study data is stored and hosted at the 
local institution, and no project data is ever transmitted at any time by REDCap from that 
institution to another institution or organization. 
 
Some additional security features include: a) specification of “user access”: by account, by 
project, or by User Access group; b) system Log-in: assigned username and user-identified 
password required, automatic inactivity logout, password specificity requirements, passwords 
must be changed every 30 days, restrictions on use of previous password; c) system lock-out: 
following succession of unsuccessful login attempts, or if no login to the system within 30 days.  
 
Data Destruction 
We will retain study records and documents (excluding peer videos) for a period of 3 years after 
the completion of the study. Identifying information will be destroyed at the earliest possible 
time, once data collection is complete and data accuracy is verified. Informed consent will be 
kept for 6 years after completion of the study in conformance with UMass and federal policy. 
There is no limit on the length of time we will store the peer videos.  
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
All participants will be told that participation is voluntary, that they are free to not respond or to 
terminate involvement at any time, with no adverse consequences.  
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
None; there are no resources available. We do not anticipate any research-related injuries. We 
believe the research poses no more than minimal risk to subjects. 
 
29. ECONOMIC BURDEN TO SUBJECTS 
N/A. There are no anticipated costs to participate in the study.   
 
30. CONSENT PROCESS 
 
Aim 1: 
• V2V_Aim 1 Parental Letter_English: This letter will be sent to all parents (or legal 
guardians) of grade 9-12 students at a local high school. The parental letter will inform 
parents (or legal guardians) of the study and will ask them to contact us or the school if they 
do not wish for their child to participate. Parents (or legal guardians) will have two weeks 
from the date the letter is sent to them to contact the study team or school. The Research 

 
Page 29 of 34 
Coordinator will maintain a list of all parents (or legal guardians) who have contacted the 
study team or school to indicate that their child may not participate in the study. If parents (or 
legal guardians) do not contact the study team or school within the two-week timeframe, 
their child will be eligible to meet with the Research Coordinator to discuss the study. 
Parental letters will be sent to all parents (or legal guardians) in the top 4-5 languages spoken 
at each school, including in English and Spanish. We are including the top 4-5 languages so 
as not to exclude any adolescents from potentially participating in the study based solely on 
the fact that their parent or parents’ (or legal guardians’) primary language is a language 
other than English.  
• V2V_Aim 1 Parental Fact Sheet: This fact sheet will be sent to all parents (or legal 
guardians) of grade 9-12 students at a local high school. It will contain additional information 
about the study not included in the parental letters. The fact sheet will be sent in the top 4-5 
languages spoken at each school, including in English and Spanish. 
• V2V_Aim 1 Adolescent Assent Form: This assent form will be used with interested 
adolescents under the age of 18 whose parents (or legal guardians) have not contacted us or 
the school indicating that they do not wish their child to participate in Aim 1 activities, 
including a one-hour semi-structured interview, peer message development, peer videos, and 
gamification. We will request special permission during the assent process to film the peer 
videos with our Aim 1 participants. Assent will be obtained by the Research Coordinator in 
the privacy of the school nurse’s office. Assent will be explained such that students 
understand they have a right to refuse to participate, that their care in the school health clinic 
and their grades will not be affected by whether or not they decide to participate, and 
confidentiality will be emphasized. We will obtain the adolescent’s overt agreement to 
participate in our study by providing the adolescent with an assent form describing the study. 
We will go through the assent process and study expectations with the adolescent and ensure 
any questions the adolescent may have about the study or their participation are answered. 
We will not enroll a child if there is any sign of unwillingness.  
• V2V_Aim 1 Mini-Pilot Assent Form. This assent form will be used with adolescents under 
the age of 18 who are participating in the Aim 1 Mini-Pilot. Assent will be explained such 
that students understand they have a right to refuse to participate, that their care in the school 
health clinic and their  grades will not be affected by whether or not they decide to 
participate, and confidentiality will be emphasized. We will obtain the adolescent’s overt 
agreement to participate in the mini-pilot by providing the adolescent with this assent form. 
We will go through the assent process and mini-pilot expectations with the adolescent and 
ensure any questions the adolescent may have about the mini-pilot or their participation are 
answered. We will not enroll a child if there is any sign of unwillingness.   
• V2V Aim 1_Parental Consent Form: This consent form will be used with parents (or legal 
guardians)  of adolescents under the age of 18 who agree to film the peer videos. After 
student participant assent is obtained, we will request active parental consent to film the peer 
videos before proceeding with filming. 
• V2V_Aim 1 Students 18 or Older Consent Form_Mini-Pilot: This consent form will be 
used with adolescents aged 18 years or older who are participating in the Aim 1 Mini-Pilot. 
• V2V_Aim 1 Students 18 and Older Consent Form: This consent form will be used with 
Aim 1 participants who agree to participate in Aim 1 activities and are 18 years of age or 
older. We will also require that these participants sign the video release form, as described 
below. 

 
Page 30 of 34 
• V2V_Aim 1 Video Release Form: This form will be used for both adolescents and parents 
(or legal guardians) of adolescents who agree to film the peer videos. While this is not a 
consent document, we do feel it is important to note that both adolescents under the age of 18 
and their parents (or legal guardians) will be required to sign this form prior to proceeding 
with the filming of the peer videos. We will also require adolescents 18 or older to sign this 
form, but will not require parental signature for those 18 or older. This form emphasizes that 
the adolescent and their parent (in the case of those under the age of 18) agree to participate 
in the filming of the adolescent’s interview about e-cigarette use, and that they understand 
that selected portions of the adolescent’s video regarding e-cigarette use will be digitally 
archived in a secure online video-sharing platform (example: Vimeo) and shared with others 
participating in the V2V multi-modal intervention without disclosing the adolescent’s 
identity. 
• V2V_Aim 1 Key Informant Fact Sheet: As per prior IRB recommendation, this fact sheet 
will be provided to the Aim 1 Key Informants (school nurse and vice principal) in lieu of a 
written consent form. We are requesting a waiver of documentation of consent for key 
informants.  
 
Aim 2: 
• V2V_Aim 2_Parental Letter_English: This letter will be sent to all parents (or legal 
guardians) of grade 9-12 students in the participating schools informing them of the study 
and asking them to contact us or the school if they do not wish their child to participate. 
Parents (or legal guardians) will have two weeks from the date the letter is sent to them to 
contact the study team or school. The Research Coordinator will maintain a list of all parents 
(or legal guardians) who have contacted the study team or school to indicate that their child 
may not participate in the study. If parents (or legal guardians) do not contact the study team 
or school within the two-week timeframe, their child will be eligible to meet with the 
Research Coordinator to discuss the study. Parental letters and fact sheets will be sent to all 
parents (or legal guardians) in the top 4-5 languages spoken at each school, including in 
English and Spanish. We are including the top 4-5 languages so as not to exclude any 
adolescents from potentially participating in the study based solely on the fact that their 
parent or parents’ (or legal guardians’) primary language is a language other than English. 
We will send a written letter to parents (or legal guardians) to confirm that their opt-out 
decision has been received and recorded. 
• V2V Aim 2 Parental Fact Sheet: This fact sheet will be sent to all parents (or legal 
guardians) of grade 9-12 students at participating high schools. It will contain additional 
information about the study not included in the parental letters. The fact sheet will be sent in 
both English and Spanish. 
• V2V Aim 2 Adolescent Assent Form_Intervention and V2V_Aim 2 Adolescent Assent 
Form_Control: This assent form will be used with interested adolescents under the age of 
18 whose parents (or legal guardians) have not contacted us or their school indicating that 
they do not wish their child to participate in Aim 2 study activities. Assent will be obtained 
by the Research Coordinator in the privacy of the school nurse’s office. Assent will be 
explained such that students understand they have a right to refuse to participate, that their 
care in the school health clinic and their grades will not be affected by whether or not they 
decide to participate, and confidentiality will be emphasized. We will obtain the adolescent’s 
overt agreement to participate in our study by providing the adolescent with an assent form 

 
Page 31 of 34 
describing the study. We will go through the assent process and study expectations with the 
adolescent and ensure any questions the adolescent may have about the study or their 
participation are answered. We will not enroll a child if there is any sign of unwillingness. 
Eligible students will be enrolled and follow the protocol for their school condition. 
• V2V Aim 2_Students 18 and Older Consent Form_Control: This consent form will be 
used in place of informed assent with Aim 2 participants who are 18 years of age or older and 
will be participating in the control arm of the study. 
• V2V Aim 2_Students 18 and Older Consent Form_Intervention: This consent form will 
be used in place of informed assent with Aim 2 participants who are 18 years of age or older 
and who will be participating in the intervention arm of the study. 
•  V2V Aim 2 Key Informant Fact Sheet:  Per prior IRB guidance, this fact sheet will be 
provided to Aim 2 Key Informants (school nurses, vice principals, or other academic 
administrator) in lieu of a written consent from. We are requesting a waiver of 
documentation of consent for key informants.  
  
For the consent process for both aims, we will follow HRP-802 INVESTIGATOR GUIDANCE: 
Informed Consent.   
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
We are requesting a waiver of written documentation of consent permission for all participants in 
Aim 1 and Aim 2 of the study, excluding adolescents aged 18 years or older. We feel that the 
waiver of documentation of written consent is reasonable in this instance, as: 
1. The research presents no more than minimal risk to subjects because it consists of 
materials development, semi-structured interviews, and surveys. This is a low-risk study. 
The intervention is fundamentally educational.   
2. The research involves no procedures for which written consent is normally required 
outside of the research context. Recorded semi-structured interviews and surveys have 
appropriate confidentiality protections. 
3. The investigator will provide a written statement regarding the research that embodies the 
elements of consent. 
4. The investigator will provide participants with that written statement. 
 
We are also requesting a waiver of parental permission for all adolescent participants under the 
age of 18 who participate in Aim 1 and Aim 2 of the study, excluding those who chose to 
participate in the filmed interview activity. In accordance with § 46.117, we feel that the waiver 
of parental permission is reasonable in this instance, as: 
1. The research presents no more than minimal risk to subjects because it consists of 
materials development, semi-structured interviews, and surveys. This is a low-risk study. 
The intervention is fundamentally educational.   
2. The research could not practicably be carried out without a waiver of parental permission, 
as adolescent e-cigarette users may be reluctant to participate if their e-cigarette use 
status is revealed to their parents (or legal guardians). Most 9-12 graders do not tell their 
parents (or legal guardians) that they use e-cigarettes. We would not be able to recruit 
enough students who both meet our eligibility criteria and tell their parents (or legal 
guardians) that they use e-cigarettes.   
3. A waiver of parental permission will not adversely affect the rights and welfare of the 

 
Page 32 of 34 
subjects, as we will be obtaining adolescent assent for participation in the study and 
providing parents (or legal guardians) with an opportunity to let us know if they do not 
wish to have their child participate in the study. 
4. The research could not practicably be carried out without using identifiable private 
information because we need access to participant names and contact information in 
order to conduct study activities and follow-up. 
5. If clinically relevant information is discovered over the course of the research, we will 
contact the IRB before contacting study participants and/or their parents (or legal 
guardians). 
 
We will request parental written consent for all adolescents participating in the filming of peer 
videos in Aim 1 and for participants aged 18 years or older. Each signed consent form will be 
maintained for a minimum of six years after the completion of the research.  
 
We will follow HRP-803 INVESTIGATOR GUIDANCE: Documentation of Informed Consent 
for the written consent forms. 
 
32. DRUGS OR DEVICES 
N/A; this research does not involve testing drugs or device. 
 
REFERENCES 
1. Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic 
of youth e-cigarette use [press release]. September 2018 2018. 
2. Statement of Susanne E. Tanski On behalf of the American Academy of Pediatrics Before 
the Food and Drug Administration. Public Hearing on “Eliminating Youth Electronic 
Cigarette and Other Tobacco Product Use: The Role for Drug Therapies”. 2019; 
https://www.fda.gov/downloads/NewsEvents/MeetingsConferencesWorkshops/UCM631355.
pdf. 
3. Surgeon General’s Advisory on E-cigarette Use Among Youth: The E-cigarette Epidemic 
Among Youth.  https://e-cigarettes.surgeongeneral.gov/documents/surgeon-generals-
advisory-on-e-cigarette-use-among-youth-2018.pdf. Accessed June, 2019. 
4. Jenssen BP, Boykan R. Electronic Cigarettes and Youth in the United States: A Call to 
Action (at the Local, National and Global Levels). Children (Basel, Switzerland). 2019;6(2). 
5. Jenssen BP, Walley SC, Section On Tobacco C. Policy Statement: E-Cigarettes and Similar 
Devices (Organizational Principles to Guide and Define the Child Health Care System and/or 
Improve the Health of all Children). Pediatrics. 2019;143(2). 
6. Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug 
Therapies.  Statement of Susanne E. Tanski, MD, MPH, FAAP on behalf of the American 
Academy of Pediatrics. American Academy of Pediatrics,2019:5. 
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