Social Determinants of HPV Vaccine Completion Among Adolescents
Conditions: Human Papilloma Virus
Sponsor: Duke University

Document Cover Page 
  
Official Title of the Study: 
Social Determinants of HPV Vaccine Completion Among Adolescents   
  
NCT Number: NCT03709602 
  
Date of Document: September 25, 2018 
 
 
 

STUDY PROTOCOL 
  
PRIMARY STUDY OBJECTIVES 
Aim 1: Determine the effects of social determinants of health for adolescent HPV vaccine 
completion (age, sex, race/ethnicity, insurance type, area deprivation index for residence, and 
distance to clinic) within a 14-month period using EHR data from retrospective chart reviews. 
SECONDARY STUDY OBJECTIVES 
Aim 2: Explore barriers and facilitators to vaccine completion by describing parent and 
adolescent experiences with the HPV vaccine, including individual, relationship, and community 
level determinants influencing vaccine completion, and integrating interview data with social 
determinants explored in Aim 1. 
PURPOSE OF THE STUDY AND HYPOTHESES TO BE TESTED 
The purpose of this study is to identify individual-, relationship-, and community-level 
determinants of HPV vaccine completion among adolescents ages 11 to 14 who received one 
dose of the vaccine, and barriers and facilitators to completion as described by parents and 
adolescents. The following hypothesis will be tested for Aim 1: 
H1: Younger adolescents, boys, racial/ethnic minorities, adolescents without health insurance 
and those living in areas with high deprivation and far distances from the clinic will be less likely 
to complete the HPV vaccine series. 
BACKGROUND & SIGNIFICANCE 
The human papillomavirus (HPV) is the most prevalent sexually transmitted infection in the U.S. 
and causes nearly 90% of cervical and anal cancers and 70% of vaginal, vulvar, penile and oral 
cancers (Centers for Disease Control and Prevention (CDC), 2016; Gillison, Chaturvedi, & 
Lowy, 2008; Reiter et al., 2013). The HPV vaccine, Gardasil 9, is recommended for 
administration to adolescents before engaging in sexual activity to prevent exposure against 
nine commonly transmitted strands. Despite the efficacy of the vaccine in preventing HPV and 
associated cancers, HPV vaccine rates remain low, with initiation rates (i.e. receive 1 dose) at 
65% among adolescent girls and 56% among adolescent boys. Completion rates (i.e. receive 2 
or 3 doses depending on certain age groups) are significantly lower at 49.5% and 37.5% among 
adolescent girls and boys respectively (CDC, 2017; Walker et al., 2016). 
Recently, the Advisory Committee on Immunization Practices (ACIP) lowered the number of 
required doses for adolescents (ages 11 to 14 years) to 2 doses based on evidence 
demonstrating sustained immunogenicity after the second dose (Meites, Kempe, & Markowitz, 
2016). However, since these changes occurred in late 2016 (Walker et al., 2016), current 
completion rates do not reflect vaccine completion solely for this age group (Meites et al., 2016). 
Further, the vaccine remains on a 6 to 12-month administration schedule, requiring adolescents 
to return to clinics to receive subsequent doses (Meites et al., 2016). Given the gap between 
vaccine initiation and completion rates it is believed that disparities in HPV vaccination might be 
exacerbated due to social determinants. To date, most of the literature on HPV vaccination in 
adolescence has largely focused on individual-level determinants influencing parents to refuse 
vaccination and initiate the vaccine series, including parents’ beliefs, attitudes, awareness (Tsui 

et al., 2013; Askelson et al., 2010; Hertweck et al., 2013) and knowledge about the HPV vaccine 
(Dempsey et al., 2012; Thomas et al., 2012; Reiter, Katz, & Paskett, 2013), insurance coverage 
(Tsui et al., 2013; Ylitalo, Lee, & Mehta, 2013; Reiter et al., 2009), and family socioeconomic 
status (Polonijo et al., 2016; Gerend, Zapata, & Reyes, 2013; Perkins et al., 2013). Contrary to 
research on social factors influencing health (World Health Organization (WHO), 2018; Marmot, 
2017; Braveman & Gottlieb, 2014), adolescents with public health insurance, who were Black or 
Hispanic descent, and lived in low-income communities are more likely to receive the first dose 
of the HPV vaccine series. While these findings hold promise for addressing disparities related 
to vaccine initiation, they may not reflect potential determinants influencing vaccine completion. 
For example, although Black and Hispanic adolescents are just as likely to initiate the vaccine at 
the same rate as non-Hispanic White adolescents, they are less likely to complete the vaccine 
series (Reiter et al., 2013; Ylitalo et al., 2013; Spleen et al., 2012; Bartlett & Peterson, 2011). 
Thus, further exploration is warranted to identify which social determinants influence vaccine 
completion. 
DESIGN AND PROCEDURES 
Design: This study will use a parallel mixed method design that combines retrospective chart 
reviews and individual qualitative interviews to examine the effects of social determinants of 
health (SDH) for HPV vaccine completion among adolescents and explore parents and 
adolescents’ experience with the HPV vaccine including perceived barriers and facilitators to 
completing vaccine series. Chart reviews will be used to identify individual and community-level 
characteristics of adolescents (age 11 to 14 years) and determine vaccine completion by 
whether the second recommended dose was received within a 14-month period. A descriptive 
qualitative design will be used for Aim 2 to describe barriers and facilitators to vaccine 
completion among parents and adolescents who did or did not complete the vaccine series. 
Procedures: Aim 1. A request for waiver of informed consent will be submitted to the IRB to 
access previously collected data on adolescents’ charts retrospectively. The PI will collaborate 
with a research data manager to abstract eligible electronic health records through the Maestro 
Care database. Data pulled from the Maestro Care database will be imported and stored in a 
secure folder in PACE, a highly protected network space where users can analyze and work 
with identifiable protected health information. Data on adolescents’ HPV vaccine completion will 
be recorded on data collection forms using the number of vaccine doses received, the date in 
which the vaccine doses were administered, and clinic location in which the vaccine doses were 
received. The North Carolina Immunization Registry (NCIR) will be used to verify HPV vaccine 
completion in the event that the adolescent receives any of the vaccine doses outside of the 
Duke University Health System (DUHS) network. The NCIR is a secure, web-based database 
where healthcare providers report immunizations administered to patients within North Carolina. 
I have gained view-only access to the NCIR through the selected pediatric clinic and will only 
use the database to record the number of HPV vaccine doses, the dates in which the doses 
were administered, and clinic location in which the doses were received for eligible adolescent 
charts for Aim 1. A cohort of adolescents will be created by examining charts of all adolescents 
ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017. 
This cohort will be followed from January 2018 to February 2019 to assess vaccine completion 
within a 14-month period documented in the adolescents’ electronic medical chart. Data from 
chart reviews will be partially de-identified; zip codes, addresses from participants and the 
person listed as the emergency contact, and the dates of HPV vaccine administration will be the 
only identifiable data recorded from the chart reviews. Zip codes will be recorded to determine 

the area deprivation index of the adolescent’s place of residence. Addresses will be recorded to 
calculate the number of miles for the distance from clinic variable. Lastly, the date of HPV 
vaccine administration will be used to determine the number of months between receipt of the 
first and second dose within a 14-month period. However, once area deprivation index values 
have been determined, the distance from clinic miles calculated using geographic information 
systems (GIS) software, and the date of vaccine administration have been converted to months 
(e.g. 1st dose = 1 month; 2nd dose = 8 months from first dose) participants’ zip codes, 
addresses, and date of vaccine administration will be deleted from the dataset. Each eligible 
adolescents’ chart will be provided with a subject ID number. To minimize the risk of loss of 
confidentiality, all data will be stored and secured in the PACE network. Additional data (i.e. 
analyses results) will be stored in an electronic, password-protected share drive at Duke 
University School of Nursing and will be backed up daily. Only the study team will have access 
to both the share drive and PACE network. 
Procedures: Aim 2. Purposive sampling will be used to recruit key informants from the Duke 
Primary Care Pediatrics at Roxboro Road to complete individual interviews on barriers and 
facilitators to HPV vaccine completion. A request for waiver of informed consent will be 
submitted to the IRB to use adolescents’ charts and the NCIR database to prescreen for 
potential eligible subjects and gather contact information through chart reviews prior to obtaining 
consent from parents and assent from adolescents. The NCIR will be used for screening 
purposes to determine vaccine completion by identifying whether adolescents received any 
HPV vaccine doses at other clinics outside of the DUHS network, or if the adolescent is a new 
patient to the clinic and does not have their immunization records established with their chart. 
Names, date of birth, and/or EHR chart numbers of eligible participants will be used to search 
for adolescents in the database; however, will not be recorded. Key informants will include male 
or female adolescents who completed the vaccine series or began the series but did not finish it, 
as well as their parents (n=32). To ensure informational representation, 16 parents and 
adolescents who completed the vaccine series (Completers) and 16 parents and adolescents 
who did not complete the vaccine series (Non-completers) within 14 months will be recruited. 
Both English and Spanish-speaking participants will be recruited. For Spanish-speaking 
participants, an approved Duke University Health System, Spanish interpreter provided by the 
selected pediatric clinic will be used to assist with translating the study eligibility criteria, 
information about the study, and contact information from the participants. Face to face, semi-
structured, individual interviews will occur at one-time point in a private location at the 
preference of participants (i.e. reserved room at Duke University campus or local library, home, 
etc.) and will be conducted in either English or Spanish. For Spanish-speaking participants, a 
bilingual data collector will be assigned for the interview. The bilingual data collector is a native 
Spanish speaker and proficient in the Spanish language. All interviews will last approximately 45 
minutes to 60 minutes and will be recorded using a recorder device to be transcribed verbatim. 
Interview data will be transcribed verbatim from an electronic recording device by a hired, 
bilingual transcriptionist through a Duke University School of Nursing (DUSON) approved 
vendor. I will double-check the accuracy of the transcribed text. Audio recordings will be 
uploaded in a secure folder on an electronic share drive at DUSON which only key study 
personnel will have access to. These files will be sent to the transcriptionist using Duke Box, a 
secure method of sharing data that is approved by the Duke IRB. During transcription, 
participants’ names and other identifiable information (i.e. provider’s name, clinic name/location, 
etc.) will be removed from the text. Audio recordings will be destroyed after qualitative data 
analysis has been completed.  Field notes will capture parents’ and adolescents’ emotions and 

behaviors as responses are provided during the interviews. De-identified demographic data 
(e.g., age, race/ethnicity, and sex) collected after interviews will be recorded on paper surveys 
then entered into a password-encrypted Excel spreadsheet for descriptive statistics. Informed 
consents, child assents, transcribed text, field notes, and demographic surveys will be stored in 
a locked file cabinet until the study is completed. All participants will be provided with 
pseudonyms to protect their identity. 
Translation Plan: The informed consents, child assents, brief demographic survey, recruitment 
materials (e.g. mail or emails from the healthcare provider, study brochure) and interview guides 
will be provided to participants in both English and Spanish, at the preference of the participant. 
The PI and I will translate all documents previously mentioned above and conduct English to 
Spanish translations or Spanish to English back-translations of the documents. After translation, 
both the PI and a bilingual PhD student will compare the original English version and the back-
translated version to denote discrepancies and make revisions as necessary. The PI is of 
Cuban-American descent and is proficient in Spanish and conducted most of her research with 
primarily Spanish speaking participants. She has been translating documents for research 
purposes since 2001. The bilingual PhD student has achieved a level of proficiency in Spanish 
as indicated by advanced Spanish education (e.g., obtaining a minor or major in Spanish in 
college) and has experience conducting research with Spanish-speaking participants and 
assisting with back translation. 
MEASURES 
Data collected will include (1) adolescent and parent demographic characteristics, (2) vaccine 
completion, and (3) parent and adolescent individual interviews. 
Demographic Characteristics (Aim 1). The adolescent’s age, sex, race/ethnicity, insurance 
type, area deprivation index for residence, and distance from clinic will be obtained from EHR 
data and recorded on data collection forms. Adolescent’s insurance type will be determined by 
the parent’s insurance provider listed in the chart. Area deprivation index for residence, 
determined by the parent household where the adolescent lives, will be measured using zip 
codes and linked by subject ID number with the area deprivation index public database to 
determine the index value for their place of residence. This index value is assigned to 
neighborhoods using 9-digit zip codes and identifies the percentage of the population that 
experiences socioeconomic deprivation within a neighborhood in a given geographic area 
based on the following variables: Education, median family income, employment, income 
disparity, housing units, federal poverty level, single-parent households, and household 
characteristics. Higher index values indicate higher levels of deprivation among a geographic 
area which has been associated with poorer health outcomes (University of Wisconsin Health 
Innovation Program, 2017). Distance from clinic will be calculated using the adolescent’s 
address listed as the primary residence in their chart and measured as the number of miles from 
their place of residence to the pediatric clinic. The number of miles will be calculated using 
geographic information systems (GIS) software. All data will be used to describe the relationship 
between social determinants and vaccine completion. Parent or legal guardian characteristics 
including their age, sex, race/ethnicity, and relationship to the adolescent will also be collected 
to further describe the sample. 
Vaccine Completion (Aim 1). Data on the number of HPV vaccine doses that the adolescent 
received within a 14-month period will be obtained from EHR data. In addition, the date of 

vaccine administration and clinic location in which the vaccine doses were received will also be 
collected. The NCIR database will be used to determine vaccine doses received from clinics 
outside of the DUHS network for each subject. In the event that any of the HPV vaccine doses 
were received outside of the DUHS network, the clinic location in which the dose was received 
will be recorded. Vaccine completion will be operationalized as the receipt of 2 doses, as 
defined in the new vaccine administration guidelines for adolescents ages 11 to 14 years 
(Meites et al., 2016). Data on time to second dose and whether each dose was received during 
a well- or illness-visit will also be collected. 
Interviews (Aim 2). Semi-structured, individual interviews will be conducted with parents and 
adolescents from the selected pediatric clinic. Parents and adolescents will participate in 
separate, concurrent interviews to maintain confidentiality and capture specific individual 
experiences with the HPV vaccine and barriers and facilitators to vaccination completion. 
Interviews will be conducted at one-time point with two members of the research team and last 
approximately 45 to 60 minutes. An interview guide for parents and adolescents will be used 
during interviews. Following interviews, demographic information will be collected from parents 
and adolescents to obtain descriptive data from participants. 
SELECTION OF SUBJECTS 
Subjects will be identified in person at the Primary Care Pediatrics at Roxboro Road. I have 
gained permission from the selected clinic to conduct chart reviews and use the NCIR database 
to prescreen for eligible participants prior to their scheduled clinic visit. Eligibility will include: 
Adolescents ages 11 to 14 years who have received 1 dose of the HPV vaccine series between 
January 2017 and December 2017; parents as defined as the adolescent’s biological mother or 
father, step-parents, or legal guardian; and, parents or legal guardians who self-identified as the 
primary caregiver of the adolescent child and most likely to make medical decisions for the 
adolescent. Only one parent or legal guardian and one adolescent per household will be 
included in the individual interviews. Exclusion criteria includes: Parents and adolescents with 
cognitive impairment, adolescents emancipated from their parents or legal guardian, and 
pregnant adolescent girls will be excluded from this study. Pregnant girls will be excluded from 
the study because the vaccine is not recommended for use in this population (CDC, 2016). 
Further, adolescents who did not receive any doses of the series are excluded since the focus 
of this study is to understanding barriers and facilitators to HPV vaccine completion. 
SUBJECT RECRUITMENT AND COMPENSATION 
Recruitment will occur in-person at Duke University Primary Care Pediatrics at Roxboro Road, 
by phone, email or mail. Sixteen adolescents and 16 parents will be recruited from the clinic 
(n=32 participants). This clinic was carefully chosen for their diverse patient population of 
adolescents (26.4% White, 40.9% Black, 20.5% Hispanic, 2.8% Asian, and 16.7% Other). I will 
track race/ethnicity and gender of potential subjects to ensure participant selection is 
representative across all demographic groups. A request for waiver of informed consent will be 
submitted to the IRB to access previously collected data on adolescents’ charts and the NCIR 
database retrospectively for Aim 1. For Aim 2, a request for waiver of informed consent will be 
submitted to the IRB to use adolescents’ charts and the NCIR database to identify potential 
eligible subjects through chart reviews and to make initial contact with eligible subjects for study 
participation by the healthcare provider prior to obtaining consent from parents and assent from 
adolescents. I have gained permission to conduct chart reviews and access to use the NCIR 

database to prescreen for eligible participants prior to their scheduled clinic visit. Prior to the 
start of the clinic day, I will provide a list of eligible participants to each healthcare provider. 
Clinic healthcare providers have agreed (letters of support) to provide a brief introduction of the 
study during clinic visits, by phone, email, and through letters sent via mail. Initial contact with 
eligible parents and adolescents will occur after the study has been introduced and participants 
have expressed their interest in the study to the healthcare provider. A brochure will be given to 
healthcare providers and eligible participants to provide them with additional information about 
the study. 
In-person recruitment. After the study has been introduced by the healthcare provider, 
participants will be approached for recruitment in the patient’s room and taken to a private area 
in the clinic to further discuss information about the study including the purpose and aims, 
describe participant expectations in the study, address any questions or concerns, gather their 
contact information, and schedule a date, time, and location to conduct the interviews at the 
participant’s discretion and preference. The brochure and a copy of the informed consent and 
child assent will be provided during initial contact with participants to take home and allow them 
time to decide their participation in the study.  
Telephone recruitment. I will identify eligible participants at prescreen through chart reviews 
and provide a list of patients to the clinic healthcare provider. At this point, the clinic healthcare 
provider will call the participant to briefly introduce the study using a telephone script. Eligible 
participant’s phone numbers will be obtained from the EHR. If the participant expresses interest 
in the study, I will then further screen for eligibility, provide more information about the study—
including participant expectations, address any questions or concerns, gather their contact 
information, and schedule a date, time, and location to conduct the interviews at the 
participant’s discretion and preference. Contact information of the PI or study coordinator will 
also be provided to participants. A copy of the informed consent, child assent and study 
brochure will be provided to participants during their scheduled interviews. 
Mail recruitment. As described above, I will identify eligible participants at prescreen through 
chart reviews and provide a list of patients to the clinic healthcare provider to verify that the 
provider has previously seen the selected patient. A letter will be sent to all eligible participants 
on behalf of the healthcare provider using the listed address within the EHR. The letter will 
contain a brief introduction of the study from the healthcare provider, the eligibility criteria, 
participant expectations in the study, and contact information of the PI or study coordinator (e.g. 
phone number and email address) to follow-up with study participation. The study brochure will 
also be enclosed with the letter to provide the participant with further information about the 
study. Per DUHS IRB policy, a two-week period from the date of the postmarked mail will be 
allotted to allow participants time to contact me for study participation. After the two-week period 
and there is no response from the eligible participant, I will contact them with study participation. 
Once contact has been made with participants, I will further screen for eligibility, address their 
questions and concerns, and schedule a date to conduct the interview at the participant’s 
preference.  
Email recruitment. After eligible participants are identified at prescreen through chart reviews, I 
will provide the list of patients to the clinic healthcare provider. An email script will be provided to 
healthcare providers to send out to all eligible participants. The script will include a brief 
introduction of the study, the eligibility criteria, participant expectations in the study, and contact 
information of the PI or study coordinator for participants to follow-up with study participation. 

Eligible participant’s emails will be obtained from the EHR and provided to the healthcare 
provider. As previously mentioned, after initial contact with the eligible participant has been 
made, I will further screen for eligibility, address their questions and concerns, and schedule an 
interview date and time at the participant’s preference. A copy of the informed consent, child 
assent and study brochure will be provided to participants during their scheduled interviews. 
For all recruitment methods, informed consent from parents and assent from adolescents will be 
obtained at the beginning of the scheduled interviews. To compensate parents and adolescents’ 
time to participate in interviews, $45 in cash will be provided ($30 for parents; $15 for 
adolescents). 
RISK/BENEFIT ASSESSMENT 
This study poses minimal risk to participants. Nevertheless, there may be a small risk related to 
a breach of confidentiality and psychological distress related to topics discussed during the 
interviews. Further, children will be recruited in this study requiring special precautions to 
minimize potential additional risks for vulnerable populations. There will be no direct benefit to 
the adolescents and parents participating in this study. However, findings from this study may 
inform programs and interventions to reduce multi-level determinants influencing HPV vaccine 
completion among adolescents. 
Risks: To mitigate the potential risk for psychological distress related to discussion about 
cancer, sexual health, and the HPV vaccine, participants will be provided their rights to refuse 
answering questions during interviews that make them feel uncomfortable and withdraw from 
the study at any time as specified in the informed consent and child assent. Further, interviews 
will be scheduled at times convenient with participants’ schedule (as specified by parents and 
adolescents) and at a private location of their preference (i.e. reserved room at Duke University 
campus or local library, home, etc.) to promote schedule flexibility and to make participants feel 
at ease during interviews. To minimize risks to children, assent will be obtained from each child 
which will describe their rights to participate in the study and refuse to answer questions that 
make them feel uncomfortable. The child’s confidentiality will also be maintained through 
separate individual interviews away from their parents. The interviewer will promote open and 
honest communication with each participant to create a trusting environment. To protect 
confidentiality and prevent against a potential breach, each subjects’ charts will be provided a 
participant ID number. Names and date of birth will not be recorded on data collection forms or 
used in qualitative interviews. All electronic data will be stored in a password protected share 
drive in which only study personnel will have access to. All hard copy forms (i.e. informed 
consent, child assent, and demographic surveys) will be stored in a locked file cabinet at 
DUSON. For aim 1, EHR data containing protected health information (i.e. addresses, zip 
codes, and date of vaccine administration) will be imported and stored in a secure folder in 
PACE and later removed from the dataset once area deprivation values and the number of 
miles from participants’ place of residence to the selected pediatric clinic have been determined, 
and the date of vaccine administration has been converted to months. For aim 2, protected 
health information obtained for recruitment (e.g. names, addresses, phone numbers, and email 
addresses) will be recorded on a password-protected Excel document that will be stored in a 
secure folder within the study’s shared drive and destroyed at the completion of data analysis. 
All collected information will be stored in a database on a standalone database server hosted by 
Duke Health Technology Services (DHTS). The database server resides behind the DHTS 
internal firewall and access to the server is controlled via firewall rules. All collected data is 

backed up daily, both on the local server and by the DHTS enterprise backup system. The 
PACE network and secure folder on the shared drive for this study will be housed within this 
server. Only members of the study team will have access to this folder and PACE network. 
Benefits: This study presents a minimal risk to participants. While there are no anticipated 
benefits to participants from being in this study, the benefits to society by helping to reduce 
barriers to HPV vaccine completion among adolescents outweigh the risks to individuals.  
COSTS TO THE SUBJECT 
There are no direct costs to the participants of the study. 
DATA ANALYSIS & STATISTICAL PLAN 
Aim 1: Descriptive statistics will be used to detail the characteristics and key measures for the 
eligible adolescents and their parents. Logistic regression will be used to determine the role that 
social determinants play in predicting HPV vaccine completion within 14 months. Individual-level 
determinants will be adolescent's age, sex, race/ethnicity, and insurance type; community-level 
determinants will be area deprivation index for residence and distance from clinic. Power 
calculations indicated a required sample size of 600 charts for adolescents who received the 
first dose of the HPV vaccine to achieve 80% power when conducting the primary analysis 
using multivariable logistic regression and supplemental regression analysis using Cox 
proportional regression models. This sample size estimate was based on the following 
assumptions: (a) up to 10 predictor terms in the final model; (b) medium effects, indicated by 
adjusted odds or hazards ratios; (c) two-tailed tests with significance set at 0.05 per test; and (d) 
an overall missing rate of less than 5% for terms in the model after imputation when needed. 
However, all charts that meet the eligibility criteria will be analyzed and it is estimated that the 
sample size will exceed the required sample size of 600 charts. 
Aim 2: Directed qualitative content analysis will be conducted to examine parents and 
adolescents’ experience with the HPV vaccine and barriers and facilitators to completing the 
vaccine series across level of determinant (e.g. individual, relationship, and community). For 
data integration, quantitative and qualitative data will be analyzed separately initially. Then, 
results from each separate analysis will be presented in data displays with an integrative 
summary for each level of determinant to assess patterns between quantitative and qualitative 
data and provide further description of the role that social determinants play on HPV vaccine 
completion. 
DATA AND SAFETY MONITORING 
A Data and Safety Monitoring Boards (DSMBs) is not required for this study since this study 
does not involve a clinical trial or intervention (NOT-OD-00-038.html). Nevertheless, a plan has 
been developed to protect quality of data. This study will abide by the Quality Assurance 
policies of the Center for Nursing Research at DUSON. The QA’s services are to verify 
compliance; ensure all study personnel are properly trained to perform assigned duties and 
maintain regulatory requirements; monitor study procedures; and minimize the risk for protocol 
deviations that can affect data collection and maintenance of participants’ confidentiality. I will 
verify compliance to the study protocol regularly (i.e. screening, consenting, and data 
management) to ensure I am complying to all the regulations and standards for the responsible 
conduct of research. 

PRIVACY, DATA STORAGE AND CONFIDENTIALITY 
All collected information will be stored in a database on a standalone database server hosted by 
Duke Health Technology Services (DHTS). The database server resides behind the DHTS 
internal firewall and access to the server is controlled via firewall rules. All collected data is 
backed up daily, both on the local server and by the DHTS enterprise backup system. The 
PACE network and secure folder on the shared drive for this study will be housed within this 
server. Only the PI and faculty advisor will have access to this folder and PACE network.