Optimizing Risk Messages for Waterpipe Tobacco Cessation in Young Adults
Phase: NA
Conditions: Hookah Smoking
Sponsor: Georgetown University

Official Title: Optimizing risk messages for waterpipe tobacco cessation in young adults 
 
NCT Number: NCT03595280 
 
Study Protocol 
 
Initial Approval: November 28, 2017 

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MedStar Health Research Institute-Georgetown University
Oncology Institutional Review Board
 
Date:
12/1/2017
To:
Darren Mays
From:
Cindi Charles 
 
Institutional Review Board
IRB #:
2017-1378
 
Title:
Optimizing Risk Messages for Promoting Waterpipe Tobacco Cessation in Young
Adults
Approval
Date:
11/28/2017
Expiration
Date:
11/27/2018
Action:
Initial Review - Expedited
Attachments
being
reviewed:
Document
Version
Mays Hookah R01 CRC Exemption.doc
0.01
ICF for Vanguard Pilot.doc
0.04
ResearchMatch Contact Message.docx
0.01
CDC - Fact Sheet - Hookahs - Smoking & Tobacco Use.pdf
0.01
Recruitment Flyer.pdf
0.01
Scientific Review Correspondence.pdf
0.01
References.docx
0.01
Sample Image Directory.docx
0.01
Follow-Up Surveys 10102017.doc
0.01
Mays CV.pdf
0.01
ICF for Randomized Trial.doc
0.04
Baseline Survey 10102017.doc
0.01
Facebook Ad.docx
0.01
Mays Hookah R01 CRC Exemption.doc
0.01
Craigslist Advertisemen Message.docx
0.01
Hookah Messaging Matrix
0.01
Vanguard Pilot Interview Outline.docx
0.01
Waterpipe R01 Final.docx
0.01

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Stamped
Documents:
 
Document
Version
ICF for Vanguard Pilot.doc.pdf
0.01
ICF for Randomized Trial.doc.pdf
0.01 
2017-1378_Recruitment Flyer.pdf_IRB Stamped.pdf
0.01
2017-1378_Craigslist Advertisement Message.docx_IRB Stamped.pdf 0.01
2017-1378_Facebook Ad.docx_IRB Stamped.pdf
0.01
2017-1378_ResearchMatch Contact Message.docx_IRB Stamped.pdf
0.01
The above-referenced study and supporting documents were approved through expedited
review by the IRB Chair or a designee on 11/28/2017. The IRB has determined that the
research involves no greater than minimal risk and falls under the following expedited review
category:
7. Research on:
 
(a) individual or group characteristics or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or
practices, and social behavior), OR
 
(b) research employing survey, interview, oral history, focus group, program evaluation,
human factors evaluation, or quality assurance methodologies.
This is to inform you that you may commence your project. Please note that this approval is
granted through 11/27/2018.
This study will automatically become inactive when its approval expires on 11/27/2018 unless
a continuing review submission is approved by the IRB before that date. The IRB requires
that you submit an application for continuing review at the end of each approval period
and/or at study completion. It is the PI’s responsibility to submit the application for
continuing review and the appropriate IRB forms with adequate time for review and
approval prior to the expiration date.
Any investigator whose project is externally funded must submit the applicable sponsor grant
or contract for review and approval by the appropriate sponsored research office of the
recipient institution (GU or MHRI). The project cannot proceed without the approval of the
sponsored research office.
The International Committee of Medical Journal Editors (ICMJE) has established a
requirement for registration of clinical trials in a public registry prior to enrollment as a
condition of consideration for publication. Georgetown University has established a central
registration process through the National Library of Medicine's Clinical Trials Protocol
Registration System (PRS) known as ClinicalTrials.gov. Please contact the GU PRS
administrator, Patricia Mazar, by e-mail at mazarp@georgetown.edu to set up a PRS user
account to register clinical trials. The e-mail should contain the principal investigator's full
name, department, phone number, and e-mail address.
 
Additional information may be found at http://ora.georgetown.edu, http://clinicaltrials.gov/,
and at http://www.icmje.org/clin_trialup.htm.
For all Department of Defense (DoD) sponsored research, please note that you must obtain
approval from the DoD human subjects committee as well as the local IRB before
commencing this project.
** If promotional advertisements will be used for patient recruitment, they must be
submitted for IRB review and approval prior to their use.
** Any incentives for participation in research are subject to IRB review and approval as well.
Please remember to:
1. Seek and obtain prior approval for any modifications to the approved protocol.

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2. Promptly report any unexpected or otherwise significant adverse effects encountered in
the course of this study to the IRB within seven (7) calendar days. This includes
information obtained from sources outside GU or MHRI that reveals previously unknown
risks from the procedures, drugs, or devices used in this study.
Warning: If the reader of this message is not the intended recipient you are hereby notified that any dissemination, distribution or copying of this
information is STRICTLY PROHIBITED.
Georgetown University IRB
 
Medical-Dental Building, SW104
 
3900 Reservoir Road NW
 
Washington, DC 20057
 
(202)687-1506 telephone
 
(202)687-4847 facsimile
 
2017-1378_ResearchMatch Contact Message.docx_IRB Stamped.pdf
 

1 
 
Official Title: Optimizing risk messages for waterpipe tobacco cessation in young adults 
 
NCT Number: NCT03595280 
 
Study Protocol 
 
Initial Approval: November 27, 2017

2 
 
1.0 Application Information  
 
1. Title: Optimizing Risk Messages for Promoting Waterpipe Tobacco Cessation in Young Adults 
2. PI: Darren Mays 
3. Co-Investigators: Isaac Lipkus, Kenneth Tercyak 
6. Study Coordinator(s):  
9. Additional study members:  
 
1.1 – Training Certification 
Upload all co-investigators’ training  
 
1.3 – Is the Study Human Subject Research:  
1. Is the activity a systematic investigation designed to develop or contribute to generalizable 
knowledge? In other words, do you intend to publish or otherwise share the results outside the 
institution? Yes 
2. Does the research involve obtaining information about living individuals? Yes 
3. Does the research involve intervention or interaction with the individuals? Yes 
4. Is this activity an individual use of Humanitarian Use Device (HUD)? No  
 
1.5 – Type of Review:  
1. Please select the review type you are seeking: Expedited 
 
1.6 – Expedited Review Category (Check all that apply) 
7. Research on: 
(a) Individual or group characteristics or behavior (including, but not limited to, research on perception, 
cognition, motivation, identity, language, communication, cultural beliefs or practices, and social 
behavior), OR 
(b) Research employing survey, interview, oral history, focus group, program evaluation, human factors 
evaluation, or quality assurance methodologies. 
 
1.12 Expedited Review Subcategory  
(b) Research employing survey, interview, oral history, focus group, program evaluation, human factors 
evaluation, or quality assurance methodologies. 
 
2.0 – Type of research: Oncology 
2.0.1 – Status of research: Other  
2.0.2 – Pediatric Oncology: No 
2.1 – GHUCCTS network: No 
2.4 – Initiating Site: 1. Lombardi   2. Site accrual: 210 
2.5 – MedStar Network Study: No 
2.7 – NCI IRB: No 
2.9 – Collaborating with another institution: Yes 
2.10 – Is the Georgetown University IRB the IRB of Record for the study? Yes 
 
3.0 – Funding:  
1. Is the project being sponsored or funded by the GHUCCTS? No  
2.  Does the project utilize GHUCCTS services or facilities? No  
3. Please select the source of funding for your project:   
Federal/NIH 
4.0 – Conflict of Interest: None 
 

3 
 
 
3.5 Funding – Federal NIH 
1. NIH Agency: National Cancer Institute (NCI) 
2. Grant awarded: Awarded (R01217861) 
3. Primary award institution: GU is the primary awardee institution 
 
5.0 – Regulatory Information:  
5.1 – Study Phase: N/A 
5.2 – Scientific Review: No  
5.4 – Drug/Device/Biologics: None (blank) 
6.0 – Biohazards: No 
6.4 – Radioisotopes: No 
6.8 – Fetal Tissue: No 
6.10 – Placebo: No 
6.12 – Collection of Bio Specimens: No 
 
7.0 – Categories of Scientific Review  
1. Scientific review category: NCI 
2. Scientific review subcategory:  
3. Program Type: CPC 
4. Trial Type: Correlative 
5. Cooperative group: none (blank) 
 
8.0 Required Summary (Please create a brief summary, in Layman's Terms (8th grade language) of 
200 words or less for this protocol, outlining the salient features that may be useful to the public 
and/or health care professionals). 
Waterpipe (i.e., hookah) tobacco is one of the most commonly used tobacco products among U.S. young 
adults [1, 2]. It exposes users to dozens of harmful toxicants, is linked to symptoms of addiction [3, 4], 
progression to use other tobacco (e.g., cigarette smoking) [5-7], and long-term waterpipe use is associated 
with negative health outcomes including lung disease and cancer [8-10]. Despite these data, there is 
accumulating evidence that the high prevalence of use among young adults is driven by commonly held 
perceptions that hookah tobacco is not harmful or addictive [11-17]. Public health messaging is urgently 
needed to correct these misperceptions and curb hookah tobacco use among young adults [18-20]. This 
study will develop and test an innovative approach for designing and delivering messages conveying the 
harms and addictiveness of hookah tobacco use, and incorporating visual imagery delivered via mobile 
phone MMS messages among young adults ages 18 to 30 years. The findings will inform future public 
health communication and behavioral intervention efforts implemented as part of a strategy to reduce the 
public health burden of tobacco use in the U.S. 
 
 
9.0 Protocol Description 
1 – Purpose of the Project 
The purpose of this study is to examine the effects of messages conveying the harms and addictiveness of 
hookah tobacco delivered via mobile multimedia service (MMS) messaging for promoting hookah 
tobacco cessation among young adults ages 18 to 30.  
 
 
2 – Study Design 
 
The purpose of this study is to test the effects of messages communicating the risks (i.e., health harms, 
addictiveness) of hookah tobacco delivered via mobile multimedia messaging for promoting hookah 

4 
 
tobacco cessation. Participants will be young adults ages 18 to 30 who are current hookah tobacco 
smokers. The study will also compare two messaging approaches, a standard untailored approach where 
all participants receive the same message content, and a tailored messaging approach where message 
content is personalized to baseline measures of hookah tobacco use behavior, beliefs, and perceptions and 
interactively to exchanges that occur via mobile messaging sent and received during the exposure period. 
The study will consist of two elements: 
 
Vanguard Pilot. The vanguard pilot will preliminarily test the message delivery protocol and procedures 
to ascertain participants’ detailed feedback for changes, improvements, and modifications on the 
messaging content and study protocols. Through this step we will incorporate feedback from the target 
population into the message delivery and study processes. This portion of the study will include up to 20 
total participants (10 from each study site). Eligibility criteria, recruitment, screening, and enrollment 
methods, and study procedures will be the same as the randomized trial described below. However, 
instead of implementing the full trial randomization procedures, all participants in the vanguard pilot will 
be assigned to receive the tailored mobile messages as described below. In addition to completing all 
other study procedures, participants in the pilot portion of the study will be asked to complete two 
additional interviews by telephone. Interviews will occur at approximately the mid-point (i.e., 3 weeks 
post baseline) and at the conclusion of the message exposure period (i.e., 6 weeks post baseline). 
Interviews will be semi-structured in nature and will include closed and open-ended questions to ascertain 
participants’ feedback on message content and delivery, and suggestions for changes and improvement. 
Interviews will be conducted by a trained study team member, and audio recorded to ensure participants’ 
responses are fully captured. Detailed notes will also be taken, recordings will be transcribed, and 
participants’ feedback will be aggregated and analyzed for commonly-occurring themes and 
recommendations in participants’ feedback to modify the message content and delivery prior to launching 
the randomized trial. Pilot participants’ data will be excluded from the trial outcomes analysis. 
 
Randomized Controlled Trial. Following the vanguard pilot, we will conduct a randomized controlled 
trial to compare the aggregate effects of mobile MMS messages conveying the harms and addictiveness 
of hookah tobacco use and examine differences between standard and individually tailored messaging 
approaches. Participants will be 420 young adult hookah tobacco users between the ages of 18-30 
recruited from two study sites, Georgetown Lombardi and Duke University. Approximately half of total 
participants will be recruited from each study site. (Duke University will seek IRB review and approval 
for the site specific study protocol at their institution’s IRB.) Our approach draws from studies previously 
conducted by the Georgetown investigators (protocols #2017-0987, 2014-1031). Participants will be 
recruited through flyers, advertisements, and online media detailed below. After confirming eligibility 
and obtaining consent, participants will complete a baseline assessment online. At the conclusion of the 
baseline assessment all participants will be provided a link to standard-of-care information about the risks 
of hookah tobacco use: the Centers for Disease Control and Prevention (CDC) “Fact Sheet – Hookahs 
Smoking and Tobacco Use.” We will objectively capture participants’ visits to this site by directly 
recording click-throughs to this link presented at the conclusion of the baseline assessment. Within 1 
week of completing the baseline assessment, participants will be randomized to 1 of 3 conditions: 1) a 
control condition receiving no additional message content; 2) an untailored MMS condition; and 3) a 
tailored MMS condition. The MMS exposure will occur for 6-weeks. Participants randomized to both 
MMS conditions will receive prompts delivered to their mobile phones by an interactive messaging 
system on two days each week assessing hookah tobacco perceptions and behavior. After responding, 
participants will immediately receive MMS messages on harms and addictiveness of hookah tobacco. For 
the tailored MMS condition, messages will be tailored to baseline measures of hookah beliefs and 
behavior, and dynamically during the intervention period to responses to the interactive text message 
exchanges. Those randomized to the control condition will not receive messages after the baseline 
assessment.  
 

5 
 
All participants will complete follow-up assessments online 6-weeks post baseline (Follow-Up 1), 3-
months later (Follow-Up 2), and 6-months later (Follow-Up 3). We carefully chose these time points 
based on our team’s preliminary work on hookah tobacco messaging [21], recommendations for follow-
up duration in tobacco intervention research [22, 23], and because this follow-up frequency and duration 
will capture short term message effects and changes in hookah tobacco use and mediating processes over 
time [5, 13, 21, 22, 24-27]. 
 
The specific aims are as follows:  
 
Aim 1: Examine the overall effects of theoretically informed messages conveying harms and 
addictiveness of hookah tobacco on waterpipe tobacco perceptions and behavior. 
 
H1: Mobile MMS messages will increase perceived risk and worry about harms and 
addictiveness of hookah tobacco and motivation to quit, reduce frequency of hookah use, and 
increase cessation relative to the control condition. 
 
Aim 2: Investigate the added effects of message content tailored to hookah tobacco perceptions and 
behavior. 
 
H2: Tailored mobile MMS messages will produce greater increases in perceived risk and worry 
about harms and addictiveness of hookah tobacco and motivation to quit, greater reductions in 
frequency of hookah use, and higher cessation rates relative to untailored MMS messages and the 
control condition. 
 
Aim 3: Investigate mediating mechanisms and moderators of message effects on motivation to quit and 
hookah use. 
 
H3a: MMS message effects will be mediated by greater perceived risk and worry about harms 
and addiction and greater receptivity and emotional responses to the messages. 
 
H3b: MMS message effects will be greater among monthly users versus more frequent users, less 
dependent users versus more dependent users, and exclusive hookah users versus those who also 
use other tobacco products. 
 
3 – Rationale and Justification  
The prevalence of regular and intermittent hookah tobacco use among U.S. young adults rivals that of 
cigarette smoking and surpasses non-combustible products such as electronic cigarettes [1, 2]. A typical 
hookah smoking session lasts approximately 1 hour and exposes users to harmful chemicals at much 
higher levels than cigarette smoking, including at least 8 classes of carcinogens linked to lung, bladder, 
larynx, oral cavity, and esophageal cancer [28-30]. Hookah tobacco use increases the risks of cancer, lung 
disease, and other health outcomes, and in-vitro studies confirm hookah smoke exposure precipitates 
carcinogenesis [9, 10]. Hookah use also puts young people at risk for long-term addiction: users report 
symptoms of dependence, failed quit attempts, and withdrawal [3, 10], they are more likely than nonusers 
to be cigarette smokers (i.e., dual users) [31], and dual use drastically undermines the likelihood of 
smoking cessation [32]. Young adulthood is an especially vulnerable period when addictions unfold and 
transitions to regular tobacco use occur [33], and there is evidence this occurs for hookah tobacco [5, 6, 
24]. Young adult hookah tobacco use is a critically important problem for tobacco control and cancer 
prevention [34]. 
 
Public health messaging is urgently needed to correct these misperceptions and curb hookah tobacco use 
among young adults [18-20]. Our preliminary studies support the potential impact of this approach, 

6 
 
showing that such messages can increase young adult hookah tobacco users’ perceived risk and worry 
about harms and addiction and motivate cessation [21, 35]. Beyond our research, there is a paucity of 
evidence on public health messaging for hookah tobacco use: studies have primarily examined clinical 
cessation interventions [36, 37] that have limited reach and impact among young adult hookah tobacco 
users because young adults’ uptake of such interventions is low [38, 39] and they do not perceive a need 
for such cessation supports [3, 11]. 
 
Research suggests that additional strategies are needed to optimize the impact of public health messages. 
There is strong evidence that message effects can be enhanced by incorporating visual imagery [40], and 
research demonstrates high potential reach and efficacy of mobile text messages and personally tailored 
mobile message content for promoting cigarette smoking cessation [41, 42]. However, these strategies 
have not been tested for messages targeting the unique perceptions and beliefs that set young adults’ 
hookah tobacco use apart from cigarette smoking [11, 12, 14, 16]. Evidence-based public health 
messaging is a recommended component of comprehensive tobacco control efforts [43]. For cigarette 
smoking, strategies such as mass media campaigns and targeted messaging interventions are effective for 
preventing smoking uptake and promoting cessation [40, 44, 45]. Young adults’ use of hookah tobacco is 
characterized by unique perceptions and beliefs about the harms and addictiveness of hookah [11, 12, 14, 
16], and messages aimed at these factors are needed to promote behavior change. Our research supports 
the hypothesis that messages conveying health harms and addictive potential of hookah use resonate with 
young adult hookah users and can motivate cessation [21, 35], but research examining innovative 
strategies to optimize message impact is sorely needed to curb this growing public health problem. Novel 
messaging strategies are needed to reach young people with information on harms and addictiveness of 
hookah tobacco. 
 
Our objective is to rigorously investigate the effects of messages conveying harms and addictiveness of 
hookah tobacco using text and visual imagery delivered via mobile phone multimedia messaging service 
(MMS) and to examine the added effects of personally tailored MMS message content. The approaches 
we will test have high potential for translation into population-based interventions, including FDA’s 
public education efforts (e.g., media campaigns, mobile communications) [46, 47], mobile tobacco 
cessation programs (e.g., NCI’s SmokeFreeTxt), and other interventions targeting young adults such as 
those on college campuses [48]. 
 
 
4 – Primary Objective 
To examine the effects of messages conveying harms and addictiveness of hookah tobacco on hookah 
tobacco perceptions and behavior. 
 
5 – Secondary Objective 
 
To investigate the added effects of message content tailored to hookah tobacco perceptions and behavior; 
and to examine mediators and moderators of message effects. 
 
6 – Inclusion Criteria 
Eligible participants will be: (1) young adults ages 18 to 30 years who are current hookah tobacco users, 
defined as using hookah tobacco at least once in the past month and now using hookah tobacco on at least 
a monthly basis; (2) have access to the Internet to complete study assessments; and (3) have a personal 
mobile phone capable of sending and receiving MMS messages. 
 
7 – Exclusion Criteria 
Study exclusion criteria include: (1) individuals who are younger than 18 or older than 30; (2) those who 
are not current hookah tobacco users; (3) participants unable to complete study procedures including 

7 
 
online assessments and receiving/sending text messages to their personal mobile phones; and (3) those 
unable to complete all procedures in English.  
 
8 – Treatment Plan 
 
8.1 Recruitment & Enrollment: Recruitment will occur at the Georgetown Lombardi and Duke 
University sites (Duke Site PI and Collaborator Dr. Isaac Lipkus). These geographic locations provide 
access to large, diverse young adult populations for recruitment. In the Washington, DC area, U.S. Census 
Data indicate young adults within the study age range comprise approximately 25% of the population. 
The population features high racial/ethnic diversity with more than 60% of residents identifying as non-
white racial minorities and 10% as Hispanic or Latino. In the Raleigh-Durham area, more than a quarter 
of the population is young adults, approximately 30% identify as non-white racial/ethnic minorities, and 
15% are Hispanic or Latino according to Census data. Several major colleges and universities also 
provide settings for targeted recruitment. 
 
We will use multiple recruitment media including flyering at local recruitment sites, local media ads, 
Internet ads (e.g., Craigslist, Facebook), and existing databases of potential research participants (e.g., 
ResearchMatch) to achieve accrual goals. We use these methods in ongoing protocols (Protocols 2014-
1031, 2013-0646) to effectively recruit young adults for behavioral cancer prevention and tobacco control 
research. Additionally, through Dr. Mays’ ongoing Georgetown University IRB approved protocols, we 
ask study participants for their permission to be re-contacted for future studies as part of the informed 
consent process. Each of these protocols focuses on tobacco use or other cancer-preventive behaviors 
among young adults within the study age range. We will review these study consent forms and tracking 
databases to identify participants who have provided their permission to be contacted for future studies 
and may be eligible to participate. We will contact them first by e-mail and then by telephone follow-up 
to assess their interest in participating. The protocol numbers from which potential participants will be 
contacted are: 2017-0987, 2012-1549, 2014-1031. 
 
Recruitment documents will describe study procedures and direct interested individuals to complete a 
brief survey online assessing their eligibility and ascertaining their contact information. The eligibility 
screener will be administered confidentially and securely online using Qualtrics. Qualtrics is a secure, 
encrypted online survey data collection platform for which the university has an institutional site license 
maintained by University Information Services. Interested individuals who have additional questions or 
want more information about the study can also call or email our study team. After answering any 
questions they may have about the study, they will be directed to the online eligibility screener or 
screened for eligibility by a trained study team member by telephone depending on their preferred 
screening method. Once eligibility is confirmed, individuals meeting eligibility criteria will be directed to 
an online study informed consent form. The online consent form will also be confidentially and securely 
administered via Qualtrics. Participants will also be sent a copy of the consent form via email for their 
individual records once it is completed. Those who wish not to provide informed consent online will be 
sent a study informed consent form to sign and return by postal mail. All study recruitment, enrollment, 
and tracking milestones will be recorded in a secure database administered through REDCap. Personnel at 
both sites will have database access to recruit, screen, and enroll participants into the study. Once 
participants are enrolled, staff at the Georgetown Lombardi site will implement remaining study 
procedures. Please see a draft of the recruitment materials and ad language as shown in Section 14. 
Attachments “Recruitment Flyer”,“Example Online Recruitment Advertisements”, and “Study Website.” 
 
8.1.2 Vanguard Pilot Procedures: The vanguard pilot will preliminarily test the message delivery 
protocol and procedures and ascertain participants’ detailed feedback for changes, improvements, and 
modifications on the messaging content and protocols. This portion of the study will include up to 20 total 
participants. They will be recruited using the methods detailed above, and asked to complete procedures 

8 
 
for the trial described below. However, instead of implementing the full trial randomization procedures all 
participants in the vanguard pilot will only be assigned to receive the tailored mobile messages as 
described below. In addition to completing all other study procedures, pilot participants will complete two 
additional interviews by telephone. Interviews will occur at approximately the mid-point (i.e., 3 weeks 
post-baseline) and at the conclusion of the message exposure period (i.e., 6 weeks post-baseline). 
Interviews will be semi-structured in nature and will include closed and open-ended questions to ascertain 
participants’ feedback on message content and delivery, and suggestions for changes and improvement. 
Interviews will be conducted by a fully trained study team member, and audio recorded to ensure 
participants’ responses are fully captured. Detailed notes will also be taken, recordings will be 
transcribed, and participants’ feedback will be aggregated and analyzed to modify the message content 
and delivery prior to launching the randomized trial. 
 
8.1.1 Randomize Trial Procedures:  
 
After confirming eligibility and obtaining consent, participants will complete a baseline assessment 
online. The baseline assessment will be administered using Qualtrics as with online assessments and 
consent described above. Participants will receive a unique survey link to complete the baseline 
assessment, sent to them from study staff via email. This link allows us to track completion of the 
baseline assessment for each participant, and is encrypted to ensure confidentiality and privacy. 
Participants’ completion of the survey will be monitored in Qualtrics and tracked in the study REDCap 
tracking database by study staff. The baseline survey will consist of validated items assessing participant 
characteristics (e.g., demographics), hookah tobacco smoking behavior, use of other tobacco products, 
and comprehensive assessment of hookah tobacco attitudes, beliefs, and perceptions of harms and 
addictiveness. Details of measures are described below, and an example of the survey is attached. 
 
After completing the study baseline assessment online, participants will be randomized in approximately 
equal numbers to the three study conditions: 1) a control condition receiving no message content; 2) an 
untailored MMS condition; and 3) a tailored MMS condition. Randomization will be implemented using 
an algorithm within the study REDCap database. Randomization and the 6-week message exposure 
period for the untailored and tailored MMS conditions will begin within one week of completing baseline. 
Our approach to text message prompt and MMS message delivery is informed by prior research and the 
unique contexts of young adults’ waterpipe tobacco use. At enrollment, we will assess participants’ sleep-
wake cycles and preferred times of day for message delivery. This will be included as data uploaded to 
schedule text message prompts and MMS message delivery. We use this strategy in our text messaging 
studies to maximize protocol adherence and retention [49-52]. 
Participants in both MMS conditions will interact with the messaging system by responding to up to two 
text message prompts delivered to their personal mobile phones on two days each week during the 6-week 
exposure period (i.e., responding to up to a total of four text message prompts per week). Prompts will be 
delivered on two days each week based on the timing of participants’ enrollment to target the timing and 
social contexts in which young adults use hookah tobacco [11]. The text message prompts will capture 
hookah tobacco use and cognitive and emotional aspects of perceived harm and addictiveness based on 
measures from our recent work [35, 53]. After responding to prompts, participants will immediately 
receive an untailored or tailored MMS message based on the conditions to which they are randomized. 
This dose of text message prompts and MMS messages is based on typical patterns of young adult 
waterpipe tobacco use (i.e., usually non-daily use) and recommendations for message dose in mobile 
behavior change programs to ensure sufficient exposure and avoid burnout over time [54-56]. Total MMS 
messages delivered to participants will vary depending on frequency of responses to the text message 
prompts, which will enable us to explore MMS message dose effects in analyses [55]. 

9 
 
MMS messages will be sent and received using the software platform Mobile Commons [57]. Mobile 
Commons has an extensive track record supporting NIH and privately funded research and provides the 
technology backbone for the NCI’s national SmokeFreeTxt program. Mobile Commons provides 
researchers with a user-friendly, secure platform to implement interactive mobile phone text and MMS 
messaging protocols. The platform features a content management system that allows for the creation of 
preprogrammed, automated schedules to send messages and collect responses without the need for 
technical programming. Messaging protocols are implemented as branching tree structures specifying the 
parameters for delivery of text message prompts, collection of participant responses, and triggers for 
message content delivered in return.  
 
8.1.2 Study Conditions:  
 
Untailored MMS Condition. Participants randomized to the untailored MMS condition will respond to 
two mobile phone text message prompts delivered on two days each week assessing hookah tobacco use 
and perceptions during the 6-weeks exposure period. After responding to the prompts, participants will 
immediately receive MMS messages with text and visual imagery communicating the risks of hookah 
tobacco use. MMS messages will be organized as a matrix by day and theme, and delivery scheduled such 
that prompts assessing hookah tobacco use and perceptions and messages conveying potential health 
harms, toxicant exposure, and addictiveness will be alternated with no two consecutive days repeating 
message themes and ensuring unique MMS content is delivered in each interaction. Message delivery will 
be based on data uploaded to the Mobile Commons system including preferred timing of delivery. Please 
see the attached message matrices for examples.  
 
Tailored MMS Condition. Baseline data from individuals randomized to the tailored MMS messaging 
condition will be uploaded to Mobile Commons to tailor MMS message content based on the following 
variables: 1) participants’ preferred name and message delivery timing; 2) hookah tobacco use frequency 
(monthly versus weekly/daily); 3) beliefs and perceptions about the harms and addictiveness of hookah 
tobacco use. As with the untailored MMS condition, participants will respond to two text message 
prompts delivered on two days each day each week assessing hookah tobacco use and perceptions. 
Tailored MMS messages will be organized as matrices [58] by day, theme, and tailoring variable and 
uploaded in Mobile Commons. The matrices dictate the logic of branching tree structures that will be 
programmed to personalize message content based on baseline variables and dynamically during the 
intervention based on participants’ reported hookah tobacco use, beliefs, and perceptions through the text 
messaging prompts. The system will capture participants’ responses to text message prompts and using a 
preprogrammed algorithm will calculate a tailored MMS response based on the tailoring matrices. As in 
the untailored MMS condition, prompts assessing participants’ hookah use and perceptions and MMS 
message themes will be scheduled such that no two consecutive days on which they are delivered will 
repeat message themes and unique MMS content will be delivered in each interaction. Our message 
tailoring approach is based on recommendations for the development of tailored interventions [58, 59] 
and prior studies [56, 60, 61]. The goal of the tailoring algorithm is to shift cognitive and emotional 
aspects of participants’ perceptions of the harms and addictiveness hookah tobacco in order to motivate 
and achieve cessation based on behavioral change theoretical frameworks [58]. Please see the attached 
message matrices for examples. 
 
Control Condition. For those randomized to the control condition, after completing the baseline 
assessment, participants in the control condition will complete study assessments only and will receive no 
further messages. 
 
8.1.3 Follow-Up Assessments: All participants will complete secure, confidential follow-up assessments 
online 6-weeks after baseline (Follow-Up 1), 3-months later (Follow-Up 2), and 6-months later (Follow-
Up 3).  Follow up assessments will be administered securely and confidentially online using Qualtrics in 

10 
 
the same manner as the baseline assessment described above. Participants will be emailed a personal 
survey link to complete follow-up assessments online. Measures administered will be similar to the 
baseline and designed to assess changes in hookah tobacco use behavior, beliefs, attitudes and 
perceptions. 
 
8.1.4. Measures 
The proposed measures for this study have all been validated and found to be reliable assessments across 
our studies and research by others. These measures follow recommendations for assessment of hookah 
tobacco use and related constructs. Baseline measures will assess demographics, motivation to quit 
hookah tobacco (9,10) and frequency of use in the past 30 days (9, 140) as the primary outcomes, as well 
as hypothesized mediators (9,10), moderators (9,10, 28,37), and potential covariates (4-6,21,28, 
80,87,143,144-149). Follow-ups at 6-weeks (Follow-Up 1), 3-months (Follow-Up 2), and 6-months 
(Follow-Up 3) will measure similar outcomes. For details of measures to be implemented at each of these 
time points please see the attachments in Section 12.9.  
 
8.1.5 Study Retention & Follow-Up Procedures: Assessment completion will be monitored in real time 
through Qualtrics and tracked in the study REDCap database by the Georgetown Lombardi study staff. 
The RA will conduct telephone/email follow-up with participants to ensure assessments are completed 
according to the protocol and to address any questions or challenges encountered. Participants will also be 
encouraged to contact research staff if they encounter any difficulties with study procedures. For the 
MMS conditions, message delivery and receipt will be recorded in real time in Mobile Commons and the 
RA will follow up by phone with participants as needed to provide technical support, resolve any 
problems, and bolster adherence. Participants will receive gift cards to acknowledge their time devoted to 
achieving study milestones: $20 for baseline, $25 for the 6-week and 3-month follow-up, and $30 for 
completing the 6-month follow-up. Vanguard pilot participants will receive an additional $10 gift card for 
each telephone interview completed. We have used these procedures in our research described above with 
good adherence to online and mobile messaging protocols and high prospective sample retention 
(Protocol 2014-1031).  
 
9 – Primary End Point 
Hookah tobacco use perceptions, beliefs, attitudes, and behavior. 
 
10 – Setting 
Study procedures will take place at the Georgetown Lombardi Comprehensive Cancer Center and Duke 
University.  
 
11. Multicenter 
Yes 
 
13. Local Accrual 
210 
 
14. Total Accrual  
420 
 
15. Duration of Accrual 
4 years 
 
16 – Duration of Study 
5 years 
 

11 
 
17 – Open Protocols 
No 
 
18- Sample Size 
Please provide a description of the statistical considerations (justifications for sample size or n, 
power or degree of change): 
Descriptive analyses will characterize study participants overall, by trial condition, and by study site, and 
will evaluate for assumptions of normality/equality of variance for continuous variables. Non-normal data 
will be transformed as needed. Bivariate analyses will examine if baseline covariates have non-trivial 
associations (p < 0.10) with six-month outcome measures; those associated with outcome measures will 
be included in analyses as covariates. For Aim 1, since the primary outcomes are continuously measured 
variables at the 6-month follow-up (Follow-up 3), we will utilize an Analysis of Covariance (ANCOVA) 
model. The ANCOVA model will include the baseline covariates significantly associated with the 
outcomes of interest in the bivariate analyses and the stratification variables used for randomization. In 
exploratory analyses we will repeat this type of analysis for the 6-week and 3-month time points and also 
perform a longitudinal data analysis using mixed effects models [62] to examine if the effect of study 
condition (control versus combined MMS conditions) varies by time (a study condition by time 
interaction), controlling for any covariates associated with the outcome of interest. The primary outcomes 
and analytic approach for Aim 2 are similar to Aim 1, however we will compare differences in the 6-
month outcomes across the control, untailored MMS, and tailored MMS conditions to evaluate the added 
effects of tailored messaging. 
For Aim 3, we will draw from traditional mediation frameworks for preliminary analyses [63] and 
applying more robust methods to formally test for mediation [64]. We will also conduct exploratory 
analyses of MMS message dose effects in the untailored and tailored MMS conditions. After examining 
the distribution of message exposures and responses, we will explore dose effects in two ways: 1) 
dichotomized on whether a participant received less than or equal to or greater than the median MMS 
dose; and 2) as a continuous variable based on a count of total MMS messages delivered. Based on prior 
research [55], we will use ANCOVA and logistic regression to explore the potential effects of message 
dose on the primary outcome measures at 6-months controlling for any baseline variables that are 
associated with the message dose and the primary outcome measures. 
We calculated statistical power to test our study hypotheses assuming a two tailed α = .05 and 80% 
sample retention at 6-months based on our ongoing and previous work. The power calculations were 
performed for 6-month outcome measures. For the continuous outcome variables, a baseline sample of 
400 participants for the randomized trial (approximately 130 per condition and excluding participants 
from the vanguard pilot) with 80% retention at 6-month follow-up will provide 80% power to detect 
effect sizes smaller than Cohen’s d = 0.37 in analyses comparing the combined MMS conditions to the 
control condition for Aim 1. For the binary hookah tobacco cessation outcome, this sample will provide 
80% power to detect differences in proportions such as 51% vs. 30% between any two conditions. For 
Aim 2, in analyses comparing continuously measured outcomes between any two conditions we will have 
80% power to detect effect sizes smaller than Cohen’s d = 0.43. For Aim 3, simulation studies provide 
estimated power to detect mediation effects using bias-corrected bootstrap analyses [65]. The sample will 
provide 80% power to detect medium indirect (i.e., coefficients in the range of 0.40) effects. Similarly, for 
analyses of the interaction between study condition and two-level moderators we will have 80% power to 
detect moderator effects smaller than Cohen’s f = 0.22. These effect sizes are comparable to those 
observed in our recent work after a single exposure to messages online [35, 53]. 
 
19 – Importance/Value 
Young adult hookah tobacco use is a critically important problem for tobacco control and cancer 
prevention [34]. Personally tailored message content can enhance the impact on cigarette smoking 

12 
 
cessation [41, 66], but this has not been tested for messages targeting hookah tobacco use. There is a 
critical need to adapt intervention strategies that have proven efficacy for cigarette smoking cessation to 
target factors known to influence young adults’ waterpipe use [67]. Our study will test an innovative 
strategy for personalizing hookah tobacco message content by engaging in a two-way, interactive 
exchange where participant-generated data dynamically shape message content to enhance their impact. 
 
9.2 – Risks  
This study does not involve drugs, devices, or medical procedures. The primary potential source of risks 
in this study is the risk of gathering behavioral information about tobacco use and viewing messages 
about the potential harms and addictiveness of tobacco use.  
 
9.3 – Data Safety and Monitoring 
The primary potential source of risks in this study is the social risk of gathering behavioral information 
about hookah tobacco use. This includes potential embarrassment and fear of disclosure of potentially 
sensitive information about waterpipe and other tobacco product use and confidentiality concerns. 
Additionally, the messages that we will test will include text and images that may be unsettling to certain 
participants. We have plans in place to protect participants with respect to both of these risks. 
Because the primary risks associated with this study are participant privacy and confidentiality, data 
security and privacy of records are of upmost importance. Participants’ privacy and confidentiality will be 
protected in several ways. We have several institutional and procedural safeguards in place to ensure that 
all study data are treated as secure and confidential. No data collected on assessments for this research 
will be directly linked to participant identifying information (e.g., names, birthdates).Any paper study 
records will be stored in a locked file cabinet within locked offices at Georgetown Lombardi and Duke 
University study sites in order to ensure records are kept secure. This includes study data collected at the 
participant recruitment and screening stages. Only the site PIs and authorized staff will have access to 
these hard copy records. 
Participant screening, enrollment, and study tracking will be securely maintained and entered in a 
dedicated study REDCap database. REDCap is a secure data management resource maintained by 
Georgetown University’s Information Services data center. The REDCap application and databases are 
secured on Georgetown University Information Service’s server with firewall, backup, and environmental 
and user-level controls. Study eligibility screeners, assessments, and online consents will be separately 
administered using Qualtrics. Qualtrics is a secure survey software platform, the license for which is 
maintained by Georgetown University’s Information Services. Assessment completion will be monitored 
in Qualtrics and separately recorded in the REDCap tracking database by study personnel as Qualtrics is 
monitored. All electronic study data files from REDCap and Qualtrics, and electronic recordings of 
telephone interviews, will be securely stored on a GUMC/LCCC network drive. This network space is 
encrypted and directories are password-protected at the individual user level to ensure electronic data files 
are treated as secure and confidential. Only the PI, co-investigators, and fully trained, authorized study 
personnel will be granted access to the data after appropriate permissions are established. These data 
security layers ensure electronic study tracking and assessment data are securely maintained with rigorous 
access restrictions. 
Mobile phone text message prompts and participants’ responses among those randomized to the 
untailored and tailored MMS conditions will be sent and received using Mobile Commons, a secure, 
encrypted online software system available through a subscription. The study will be administered 
through a research-dedicated Mobile Commons account and short code (a six digit phone number) that 
will be used to send and receive messages for the study. This service allows for advance programming of 
scheduled text message assessments using a script to automate delivery and personalized MMS message 

13 
 
tailoring as described in the research plan. To protect participant confidentiality, prompts will not gather 
participant identifying information directly. Mobile Commons specializes in providing researchers with 
an IRB and HIPAA compliant service for text message protocols. Details of Mobile Common’s 
information security protocols are available in a security document on the Mobile Commons website 
(https://uplandsoftware.com/mobilecommons/resources/white-paper/hipaa-text-messaging-whitepaper/). 
Participant responses are stored confidentially using a dedicated research identifier that our staff will 
assign. .Participant responses and tracking data such as the dates and times when messages were sent and 
responses were received will be recorded using their identifier into a secure study database. At the 
conclusion of the study, the database will be downloaded from Mobile Commons and stored on 
GUMC/LCCC’s secure data server and permanently removed from the Mobile Commons system. Similar 
backups will be periodically downloaded and stored on GUMC/LCCC servers throughout the study. 
Finally, participants will be viewing messages about hookah tobacco use, some of which will include text 
and visual images emphasizing the potential health harms and addictiveness of waterpipe tobacco and 
may be upsetting. Although we have not experienced such an adverse event in our research to date testing 
similar messages for behaviors such as cigarette smoking and the occurrence is unlikely, throughout the 
enrollment and informed consent process and over the course of the study participants will be encouraged 
to contact Georgetown Lombardi study staff or the study PI Dr. Mays if they have any questions or if the 
experience feelings of discomfort or distress as a result of participation. We will re-emphasize this again 
in instructions for all study assessments. In the event that a participant contacts the study staff or the PI 
and reports experiencing distress, they will be referred to the study co-investigator Dr. Tercyak for 
consultation and follow-up. Dr. Tercyak is a licensed clinical psychologist and will assess participants 
who may experience elevated stress and refer these participants for additional follow up as needed.  
 
2. Adverse event  
Dr. Mays is responsible for reporting unexpected problematic events involving any aspect of the study to 
the Georgetown IRB according to institutional guidelines. Safety monitoring will also be conducted by 
the PI on an ongoing basis. Unanticipated problems to be assessed include adverse events, deviations 
from the study design or protocol, problems with informed consent, and confidentiality violations. Dr. 
Mays will report unanticipated problems to the IRB within 7 business days of the occurrence. The 
Georgetown IRB will review such cases and determine what actions must be taken to address or resolve 
the situation. Participants will be encouraged to contact Dr. Mays at any time during the study. 
 
3 Risk/benefits  
The primary potential source of risk in this study is the social risk of gathering behavioral information 
about tobacco use behaviors and perceptions. These include potential embarrassment and fear of 
disclosure of information about tobacco use behavior, and discomfort due to viewing messages about the 
potential health risks of tobacco use. Participants will be apprised of these risks as part of the consent 
process. There are no direct benefits to young adults who choose to participate in this research. The 
knowledge gained may contribute to advances in tobacco control research, including how to optimally 
communicate the risks of hookah tobacco. 
 
4 DSMB – No 
 
5 Safety monitoring 
Safety monitoring will be performed by the Principal Investigator Dr. Mays and in consultation with 
study co-investigators as needed. Participants will receive full contact information to the study 
investigators and the IRB as part of the informed consent process to report any issues or adverse events 
that occur, and will be encouraged to do so in the informed consent process and instructions for online 
assessments. 
 

14 
 
For all components of this research, safety data will be gathered and reviewed by the PI Dr. Mays. Dr. 
Mays will be the primary person responsible for evaluating any unanticipated problems and determining 
whether they affect the risk/benefit ratio of the study and whether modifications to the protocol and 
consent processes are required. A monitoring report will be generated at the end of each year of the study 
period. Dr. Mays will be responsible for reporting any unexpected problematic events involving any 
aspect of the study to the local IRB per institutional guidelines. Unanticipated problems to be assessed 
include adverse events, deviations from the study design or protocol, problems with informed consent, 
and confidentiality violations. Dr. Mays will report unanticipated problems to the IRB within 7 business 
days of their occurrence, per institutional policy.  
 
6 Plans for interim analyses 
Monitoring study progress and safety of participants is ongoing throughout data collection as noted 
above. 
 
7 Plans for ensuring compliance  
Dr. Mays will be responsible for reporting unexpected adverse events involving any aspect of the study to 
the Georgetown IRB according to institutional guidelines. Dr. Mays will report unanticipated problems to 
the IRB within 7 business days of the occurrence. The Georgetown IRB will review such cases and 
determine what actions must be taken to address or resolve the situation. 
 
8 Plans for recruitment/follow up 
Our proactive recruitment procedures will ensure that study participants complete all procedures. See 
details in the treatment plan for details of the follow up and retention procedures.  
 
9 Risk categorization 
Minimal Risk 
 
9.5 – Information for Protocol Review [Unanticipated Problems and Procedures for Minimizing 
Risks] 
1. Individuals and/or entities to whom unanticipated problems will be reported: PI 
2. Individual/entity primarily responsible for reporting unanticipated problems: Darren Mays, 
Principal Investigator  
3. Safety Contact Information: Please indicate who will manage subjects and be responsible for 
assessing subjects’ response including potential unanticipated problems during their participation in the 
protocol 
Name: Darren Mays 
Role on Study: PI 
Can be contacted 24/7: Yes 
Contact Information: (202) 687-8937 
4. N/A 
 
5. Please describe what will happen to the data if subjects decide to withdraw/dropout before study 
completion. Please include examples of reasons that may prompt subject withdrawal/dropout:  
We anticipate subject attrition to be 10% or less based on previous studies. Reasons for which subjects 
may drop out over the course of the study might include loss of interest in participating or lack of time to 
complete the procedures. Subject data collected prior to withdrawal will be analyzed. 
 
6. Please describe partial withdrawal and its safety implications: Not applicable; withdrawal/partial 
withdrawal has no safety implications for participants. 
 

15 
 
7. Potential Benefits: While the direct benefits to participants are likely to be minimal, the findings of 
this study will be applied to inform future research and tobacco control efforts designed to reduce the 
population-level burden of tobacco-induced morbidity and mortality. 
 
8. Alternative to participating: The only alternative is not participating. 
 
11.0 Recruitment Techniques 
Other 
 
11.1 – Other 
We will use multiple recruitment outlets including flyers at local college campuses and online 
advertisements (e.g., student/community newspapers, websites, and internet classifieds such as Craigslist, 
Facebook) to achieve accrual goals, a cost-efficient strategy for young adult smoking studies [68]. We 
will also re-contact participants who have consented to previous research studies and granted their 
permission to be re-contacted as part of the consent process (2017-0987, 2012-1549, 2014-1031). Finally, 
we will recruit participants via ResearchMatch, a free national database supported by the GHUCCTS and 
maintained by NIH. 
 
11.5 Advertisements (Check all that apply) 
1. Physical placement (e.g. bulletin board, hallway, doorway, kiosk, etc.) 
2. Online advertisements 
 
11.6 – Selection of Subjects 
1. Please enter the age range of the subjects: Adults ages 18 to 30.  
2. Please select the gender of subjects (select all that apply): Male and Female 
3. Please describe your source of subjects:  
Recruited locally from study sites Washington, D.C. and Durham, NC.  
 
11.8 – Safeguards for vulnerable populations:  
Please describe the additional safeguards that will be put in place to protect this population from 
coercion or undue influence to participate: No vulnerable populations are included in this research. 
The consent form emphasizes the voluntary and confidential nature of the research, states the limits to 
confidentiality, and assures participants that they may withdraw from the study at any time without 
penalty. 
 
12.0 – Population Exclusions: 1. Open to men and women of all racial groups?: Yes, 2. Separate accrual 
targets?: No, 3. Subgroup analysis for difference in gender, race, and interaction: Yes;  
 
 
12.6 – Specify Population Exclusions: Pediatric populations excluded.  
12.8 - Please explain the rationale for excluding these populations: The study focuses on adults ages 18 to 
30, therefore pediatric populations are not eligible to participate.  
12.9 Type of Consent – Written Consent 
Online Consent: Vanguard Pilot 
Online Consent: Randomized Trial 
Draft Baseline Survey 
Draft 6-Week Survey 
Draft 3-Month Survey 
Draft 6-Month Survey 
Message Matrices 
 

16 
 
12.12 - Informed Consent Process 
1. Please describe the process that will be used to obtain consent for this study: 
This study will include young adults ages 18-30 years who are current waterpipe tobacco users and 
consent procedures will be implemented based on the age of participants who are recruited for 
participation. Therefore, adults ages 18 – 30 will provide their own electronic informed consent to 
participate in the study.  
 
Trained study staff will be responsible for monitoring eligibility screening and informed consent as 
described above. These steps will primarily occur online. Additionally, trained study staff may administer 
screening participants for eligibility and facilitate the informed consent process among eligible young 
adults who are interested in participating but respond to study recruitment advertisements via telephone or 
e-mail. To obtain informed consent, interested eligible participants will be directed to an electronic-
consent form. Electronic-Consent allows participants to complete informed consent at home using a 
computer based consent form rather than traditional paper documentation and returning signed consent 
forms by postal mail. Consent forms will be implemented in Qualtrics and participants can access consent 
forms via any internet enabled device (i.e., computer, mobile phone, or tablet). Those who wish not to 
provide informed consent online will be sent a study informed consent form to sign and return by postal 
mail. The consent will use institutional templates to include clear written instructions to participants to 
guide the consent process, and our research staff will also be available to follow-up by telephone and 
email to discuss the study and clarify any questions that potential participants may have. The consent 
forms are based on standard institutional templates and protocols from the Georgetown University IRB. 
The forms emphasize the voluntary and confidential nature of the research, state the limits to 
confidentiality, and assure participants that they may withdraw from the study at any time without 
penalty. Please see the informed consent document attached with this protocol. 
 
12.13 - Collection of Private Information On Individuals Other Than Study Subject 
1. Will this research involve collection of private information pertaining to individuals other than 
the study subject who is giving consent (i.e. third parties)? No 
 
12.18 - Subject Compensation 
1. Will subjects receive any compensation for participation either in cash or in kind? Yes 
 
12.19 Subject Compensation 
Participants will receive gift cards for achieving study milestones: $20 for baseline, $25 for 6-week 
follow-up (Follow-up 1), $25 for the 3-month follow-up (Follow-up 2), and $30 for the 6-month follow-
up (Follow-up 3). Participants in the vanguard pilot will receive an additional $10 gift card for each of the 
two telephone interviews completed (up to $20 in total). 
 
13.0 Privacy and Confidentiality of Study Records 
1. Describe methods for protecting the confidentiality of data provided by study participants. Please 
address the following in the description: What information about study participants is being 
collected, why it is necessary to the conduct of this study, what is the plan for protecting these data 
from improper use and disclosure, and when and how the plan will be initiated. 
 
Any paper records of eligibility screening and recruitment process will be stored inside of a locked office 
within a locked file cabinet at the study recruitment sites. All files for this study will be confidential, 
using a unique study identifier. This study identifier will not include any personally identifiable 
information. This study identifier will only be linked to personally identifiable information within 
REDCap that will be accessible only to the study Principal Investigator and authorized, trained study 
personnel. Access to data files will be limited to fully-trained members of the study team, all of whom 
have received human subjects and HIPAA certification. 

17 
 
 
The primary assessments completed for this study will be conducted online in Qualtrics. As with any 
study that relies on online communication, security of information that is provided via online study 
assessments is a concern. All online assessments will be confidential, using a unique individual link. 
Survey data will be downloaded by authorized personnel and stored in a password protected database 
behind Georgetown’s server. Electronic recordings from telephone interviews for the vanguard pilot will 
be stored in a similar, secured fashion. Access to these data will be strictly controlled by the PI and will 
only be accessible by study staff with permission and training to do so.  
Study data collected from text message prompts and responses will be collected using Mobile Commons, 
a secure, encrypted, HIPAA compliant tool available through a software subscription. Mobile Commons 
maintains a comprehensive set of information security policies, and has implemented procedures to 
ensure compliance with these policies. The Mobile Commons information security program includes 
measures to protect the confidentiality, integrity, and availability of sensitive client data, including 
Electronic Protected Health Information (EPHI). All sensitive data, including PHI and authentication 
credentials for system and application access, are transmitted via encrypted protocols (SSL or SSHv2) 
when traversing public or untrusted networks. Strong encryption is used for sensitive data stored on 
Mobile Commons systems. 
 
2. Will Protected Health Information be accessed or used in this study? Yes 
 
13.2 - Privacy and Confidentiality of Data Records - PHI Sources 
Please select the source(s) of protected health information: 
Interviews/questionnaires 
 
13.6 - Privacy and Confidentiality of Data Records - Recording of Health Information 
1. Please indicate how the research team will receive health information: Without any identifiers 
2. Please indicate how the research team will record health information: Without any identifiers 
 
13.10 - Privacy and Confidentiality of Data Records - Protection / HIPAA Waiver 
1. Retain this info: Data will be retained for a minimum of 3 years following the completion of the study, 
per institutional policy. 
2. Info Shared: This information will not be shared. 
 
3. Plan to protect privacy of participants:  
Paper study records will be stored in a locked file cabinet within a locked office at in the study 
recruitment sites in order to ensure records are kept secure. This includes study data collected at the 
participant recruitment and screening stages and any paper records associated with data collection or 
participant tracking. Only the PI and authorized staff will have access to these hard copy records. 
 
All online assessments administered will be confidential, completed using a personalized survey link 
provided by Qualtrics. No data collected on assessments will be directly linked to participant identifying 
information (e.g., names). Assessment completion will be recorded in the REDCap tracking database by 
study personnel as Qualtrics is monitored. Survey data will be downloaded by authorized personnel and 
stored in a password protected database behind Georgetown’s server. User-level restrictions will be in 
place to ensure only authorized, fully trained study staff have access to these data. 
 
Text message prompts and participants’ responses will be sent and received through Mobile Commons, a 
secure, encrypted online tool available through a software subscription. We will have a research-
dedicated account that will be used to administer messages for this study. Prompts will not gather 

18 
 
participant identifying information directly, but use only the unique study identifier to access. We will 
record participants’ responses and tracking data such as the dates and times when prompts were sent and 
responses were received directly into a study REDCap database. 
 
4. No HIPAA Form  
 
6. Confidentiality maintained for research data:  
A primary source of risk for this study is the risk for improper or unauthorized disclosure of personal 
information. We will carefully monitor and report any issues including unauthorized access to the data to 
the IRB according to our plan for monitoring study safety and reporting adverse protocol events detailed 
in this protocol. Additionally, information obtained during this study will be kept secure and access will 
be limited to trained study staff only. All study data will be stored securely on password-protected 
computers within locked offices at the LCCC. The study team has many safeguards in place to maintain 
confidentiality of study data gathered with the platforms utilized in this study, detailed below. 
All online study assessments will be administered using Qualtrics, which uses a SSL cryptographic 
protocol in order to ensure secure transmission of information provided through the surveys. Qualtrics is a 
survey software licensed to the University and managed by University Information Services. This data 
will be downloaded by authorized personnel and stored on highly secure servers maintained by 
Georgetown University Information Systems (UIS). These servers have firewall protection, backup, as 
well as environmental and user-level controls. Access to electronic study data files is restricted at the 
individual user NetID level. Data collected through Mobile Commons will similarly be collected through 
a secure encrypted network. Mobile Commons has a comprehensive information security program in 
place that addresses the requirements set forth by federal regulations such as Health Information 
Technology for Economic and Clinical Health (HITECH) and other regulations and best-practice security 
standards. Only the Principal Investigator and authorized staff with required human subject protections 
training will have access to this data. 
 
7. Please provide details on the measures taken to ensure the confidentiality of electronically transmitted 
data: 
All online assessments will be administered using a secure commercially available survey platform 
Qualtrics that utilizes a state-of-the-art encryption protocol in order to ensure secure transmission of 
information provided through the study assessments. This encryption protocol secures a connection 
between a client (i.e., study participant) and server (i.e., online survey tool) to ensure that data are 
transmitted securely that is commonly used by online banking websites and other sites that require secure 
transmission of client information. Participants will complete the online survey using a unique survey link 
and no personally identifying information will be collected directly via the survey. Data collected online 
will be downloaded by authorized personnel and stored in a password protected database behind 
Georgetown’s server. Furthermore, text message prompts and participants’ responses will be sent using 
Mobile Commons, which has implemented security controls and associated processes that are 
appropriately aligned with standard information security requirements. Prompts will not gather participant 
identifying information directly. Participants’ responses will be recorded directly in the Mobile Commons 
database along with the date/time prompts were sent and responses were received. All messages will be 
sent and received using Mobile Commons’ secure server with encryption and firewalls to maintain 
confidentiality of electronically transmitted data. 
 
8. No names 
 
9. No recordings made public 
 

19 
 
13.13 – Privacy and Confidentiality of Data Records:  
1. Electronic data storage: Secure network; Password access 
2. Hardcopy data storage: Locked suite, locked office 
3. Length info retained:  We intend to retain the information for a minimum of 3 years as is required by 
the institution and until all analyses are completed. 
4. Data destroyed: Electronic data will be securely destroyed, including any stored backups to network 
files. 
6. No one/not applicable 
7. Data sharing: The data will not be shared  
8. N/A 
14.0 – Attachments: 

20 
 
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