Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine Series
Phase: NA
Conditions: Human Papilloma Virus
Sponsor: University of Colorado, Denver

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Intervention to Educate and Improve Underserved 
Populations’ Uptake and Completion of the HPV 
Vaccine Series. 
 
Protocol Number:  
 
 
19-2236 
 
Principal Investigator:  
 Evelinn Borrayo, PhD 
Mail Stop F434 
13001 E. 17th Place, Room N6203C 
Aurora, CO 80045 
 
 
Funded by:  
National Cancer Institute  
University of Colorado Cancer Center  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol # 19-2236 
 
PI: Evelinn Borrayo 
 
Version Date 9/06/2024 
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PROTOCOL AMENDMENT HISTORY 
Version 
Date 
Description of Change 
Brief Rationale  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol # 19-2236 
 
PI: Evelinn Borrayo 
 
Version Date 9/06/2024 
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TABLE OF CONTENTS 
STATEMENT OF COMPLIANCE ............................................................................................................................. 5 
LIST OF ABBREVIATIONS ....................................................................................................................................... 7 
PARTICIPATING SITES ............................................................................................................................................ 8 
1 
PROTOCOL SUMMARY ............................................................................................................................... 8 
1.1 
SYnopsis .............................................................................................................................................. 8 
1.3  
STUDY schema ................................................................................................................................ 10 
2. INTRODUCTION .................................................................................................................................................. 10 
2.1 
STUDY RATIONALE ........................................................................................................................ 10 
2.2 
BACKGROUND ................................................................................................................................. 10 
2.3 
rISK/BENEFIT ASSESSMENT ....................................................................................................... 11 
2.3.1 
Known Potential Risks ...................................................................................... 11 
2.3.2 
Known Potential Benefits .................................................................................. 11 
2.3.3 
assessment of potential risks and benefits .................................................... 11 
3 
OBJECTIVES AND ENDPOINTS .............................................................................................................. 12 
4 
STUDY DESIGN ........................................................................................................................................... 12 
4.1 
OVERALL Design ............................................................................................................................ 12 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN ....................................................................... 12 
4.3 
end of study definition ................................................................................................................... 13 
5 
STUDY POPULATION ................................................................................................................................ 13 
5.1 
Inclusion Criteria ............................................................................................................................. 13 
5.2 
Exclusion Criteria ............................................................................................................................ 14 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION ........................................................... 14 
6 
STUDY INTERVENTION ............................................................................................................................ 14 
6.1 
Study INTERVENTION(S) ADMINISTRATION ........................................................................... 14 
6.1.1 
STUDY INTERVENTION DESCRIPTION ........................................................... 14 
6.2 
study intervention compliance .................................................................................................... 15 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL .................................................................................................................... 15 
7.1 
discontinuation of study intervention (Study stopping rules) ............................................. 15 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM STUDY ..................................... 15 
7.3 
lost to follow-up ............................................................................................................................... 16 
8 
STUDY PROCEDURES .............................................................................................................................. 16 
8.1 
Study procedures/evaluations ..................................................................................................... 16 
8.2 
Study schedule ................................................................................................................................ 17 
8.2.2 
Enrollment/Baseline .......................................................................................... 17 
8.2.3 
INtervention visits .............................................................................................. 17 
8.2.4 
Follow-up visIts .................................................................................................. 17 
8.2.5 
Early Termination Visit ...................................................................................... 17 
8.2.6 
Schedule of Events Table ................................................................................. 18 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ........................................................ 18 
8.3.1 
Definition of Adverse Events (AE).................................................................... 18 
8.3.2 
Definition of Serious Adverse Events (SAE) ................................................... 18 
8.3.3 
CLASSIFICATION OF AN ADVERSE EVENT ................................................... 18 
8.3.3.1 
severity of event ................................................................................................. 18 

Protocol # 19-2236 
 
PI: Evelinn Borrayo 
 
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8.3.3.2 
Relationship to Study INTERVENTION ............................................................ 18 
NA8.3.3.3 
Expectedness ..................................................................................................... 18 
8.3.4  
time period and frequency for event assessment and follow-up ................. 18 
8.3.6  
 serious adverse event reporting ..................................................................... 18 
8.4  
UNANTICIPATED PROBLEMS ...................................................................................................... 18 
8.4.1 
Definition of Unanticipated Problems (UAP) ................................................... 18 
8.4.2 
REPORTING of Unanticipated Problems ......................................................... 19 
9 
statistical considerations ............................................................................................................................. 19 
9.2  
sample size determination ............................................................................................................ 19 
9.3  
population for analyses ................................................................................................................. 19 
9.4  
STATISTICAL ANALYSES ............................................................................................................. 19 
9.4.1 
 General Approach ............................................................................................. 19 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 20 
10.1  
regulatory, ethical, and study oversight considerations ...................................................... 20 
10.1.1 
 informed consent process ............................................................................... 20 
10.1.1.1 
 Consent/assent and Other Informational Documents Provided to 
Participants 
20 
10.1.1.2 
 Consent Procedures and Documentation ...................................................... 20 
10.1.3  
confidentiality and privacy ................................................................................ 21 
10.1.4 
 future Use of Stored Specimens or Data ........................................................ 21 
10.1.5 
 safety oversight................................................................................................. 21 
10.1.6 
 clinical monitoring ............................................................................................ 22 
10.1.7 
 quality assurance and quality control ............................................................ 22 
10.1.8 
 data handling and record keeping .................................................................. 23 
10.1.8.1 
 data collection and management responsibilities......................................... 23 
10.1.8.2 
 study records retention .................................................................................... 23 
10.1.9 
protocol deviations ............................................................................................ 23 
10.1.11 
publication and data sharing policy................................................................. 24 
10.1.12 
 conflict of interest policy ................................................................................. 24 
11 
 references ..................................................................................................................................................... 24 
 
 

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STATEMENT OF COMPLIANCE 
 
This is an investigator-initiated study.  The principal investigator (PI), Evelinn Borrayo, PhD, is 
conducting the study and acting as the sponsor.  As the sponsor-investigator, both the legal/ethical 
obligations of a PI and those of a sponsor will be followed. 
 
The trial will be carried out in accordance with Good Clinical Practice (GCP) as required by 
applicable United States (US) laws and applications, including but not limited to United States 
(US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46). 
 
 
The PI will assure that no changes to the protocol will take place without documented approval 
from the Institutional Review Board (IRB). All personnel involved in the conduct of this study 
have completed Human Subjects Protection Training.  
 
I agree to ensure that all staff members involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.  
 
 
 
Sponsor-Principal Investigator:    
Evelinn Borrayo, PhD 
 
 
 
  
 
 
 
 
 
 
                        Print/Type Name  
 
 
Signature:  
 
 
 
 
 
 
 
 
 
 
Date:    
 
  
 
 
Site Principal Investigator:   
Mona Krull, MD  
 
 
 
  
 
Print/Type Name  
 
 
Signature:    _________________________________ 
 
 
 Date:   
 
 
 
 
 

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Protocol #:   19-2236 
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PI:   Evelinn Borrayo, PhD 
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LIST OF ABBREVIATIONS 
 
CHE 
COMMUNITY HEALTH EDUCATOR 
PN 
PATIENT NAVIGATOR 
DENVER HEALTH & HOSPITAL AUTHORITY 
DHHA 
 
 
HPV 
HUMAN PAPILLOMA VIRUS  
UNIVERSITY OF COLORADO CANCER 
CENTER 
UCCC 
ENTERTAINMENT EDUCATION 
E-E 
ELECTRONIC MEDICAL RECORD  
EMR 
PERTECTED HEALTH INFORMATION  
PHI 
 
 

PI:   Evelinn Borrayo, PhD 
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PARTICIPATING SITES 
Denver Health and Hospital Authority (DHHA) 
University of Colorado Cancer Center (UCCC) 
 
1 
PROTOCOL SUMMARY  
1.1 
SYNOPSIS  
Protocol Title: 
Intervention to Educate and Improve Underserved Populations’ 
Participation in Clinical Trials and the Uptake and Completion of 
the HPV Vaccine Series 
 
Objectives: 
 
• Primary Objective: 
 
1) Educate parents (and young adults) via CHEs about the HPV 
vaccine, in order improve knowledge and intentions to 
increase uptake of the vaccine for individuals aged 9-26. 
2)  We will collect socio-demographic data to explore its 
association with knowledge, intentions, & vaccine uptake. 
 
• Secondary Objectives:  
 
1) Increase completion of the HPV vaccine via PN to promote 
uptake of one, two, or three vaccine doses among adolescents 
and young adults (9-26 years old). 
 
2) Assess intervention delivery and patient-, clinic-, and system-
level impact of the PN intervention to increase vaccine 
completion among adolescents and young adults. 
 
 
Endpoint: 
• Primary Endpoint: 
 
1) Knowledge and intentions to initiate or complete the HPV 
vaccine series among project participants.  
 
2) Association of sociodemographic variables (e.g., age, gender, 
ethnicity, health insurance, income, zip code) to knowledge, 
intentions, and uptake of the HPV vaccine among participants 
 
• Secondary Endpoints: 
 

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1)  Uptake of one, two, or three HPV vaccine doses among 
adolescents (9 to 17 years of age)  
2) Uptake of one, two, or three HPV vaccine doses among young 
adults (18-26 years of age). 
 
• Tertiary/ exploratory: 
 
1) To assess PN impact we will record the number of 
participants to whom the PN scheduled to, a) receive a 
recommended 1st dose, 2nd dose, or 3rd dose of the HPV 
vaccine; b) connect to care services such as health insurance, 
discount or no-cost HPV vaccine programs, and c) facilitate 
other services such as language translation, appointment 
scheduling assistance, transportation services, and childcare. 
 
2) To assess patient-level impact, we will track for each 
participant their (a) baseline HPV vaccine doses, and (b) the 
number of those they obtained in total, and quarterly (c) the 
number of patients who received a 1st dose, 2nd dose, or 3rd 
dose of the HPV vaccine.  
 
3) To assess clinic-level impact, we will obtain clinic 
vaccination reports  track the number of patients at each 
clinic who received: (a) 1st dose, 2nd dose, or 3rd dose of the 
HPV vaccine at baseline; and record quarterly: (b) 1st dose, 
2nd dose, or 3rd dose of the vaccine broken by age for 
adolescents (9 to 17 years old) and young adults (18-26 years 
old).  
Population: 
• Sample size 
 
o Maximum number of participants that can be enrolled is 
1000 
o Minimum number of participants to be enrolled 400 
(number of participants needed for analyses) 
 
Phase: 
N/A 
Participating Sites: 
Denver Health and Hospital Authority 
 
Description of Study 
Intervention: 
Education and Patient Navigation 
Study Duration: 
36 months  

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Participant 
Duration:  
Duration will vary for each participant and will be determined by 
vaccination status. Participants will be contacted to complete a post-
education at baseline using the NCI survey. We will only administer 
the survey pages 1-3. 
 
1.3  
STUDY SCHEMA  
 
 
 
 
 
 
 
 
 
 
 
 
 
2. INTRODUCTION                        
2.1 
STUDY RATIONALE  
The Cancer Prevention and Control Program within UCCC works to develop, evaluate, and 
disseminate evidence-based interventions for primary, secondary, and tertiary prevention, and to 
improve health services delivery for patients. Efforts to meet the Cancer Center’s priorities 
include promoting awareness to increase vaccinations against HPV as part of its goal to eliminate 
HPV-related cancers in Colorado; giving priority to underserved Hispanic, residents in outlying 
rural areas, and residents living in areas of high poverty. This proposal leverages several ongoing 
community outreach efforts to improve HPV vaccine uptake, by educating and navigating 
patients where HPV vaccine rates are low and where HPV-related cancers are most prevalent. 
 
2.2 
BACKGROUND  
Dr. Borrayo leads a supplemental award to the University of Colorado Cancer Center (UCCC; 
3P30CA046934-31S4) by the National Cancer Institute (NCI) to enhance its community 
outreach and engagement to underserved populations (i.e., ethnic minority, low-income, 
uninsured, or underinsured) disproportionately affected by cancer incidence, mortality, and 
morbidity. More specifically, this project seeks to implement interventions to improve these 
Figure 1. Delivery Schema for Subjects Recruited to Participate in the CHE and PN Intervention 
 
 
Patients receive primary care including vaccinations per their providers recommendation 
 
 
 
 
 
 
 
Patients  
 
Participants  
 
Participants  
 
Study 
Begins 
 
eligible for 
 
eligible for   
 
eligible for   
 
 
HPV vaccine 
 
HPV vaccine 
 
HPV vaccine 
 
 Timeline: 
 
1st, 2nd, or 3rd 
dose  
 
 2nd or 3rd 
dose 
 
3rd dose 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruit 
Education 
Navigation 
Follow-up 
Navigation 
Follow-up 
Navigation 
 
Consent 
CHE delivers 
HPV vaccine 
PN schedules 
HPV vaccine 
Patients who 
have not 
PN schedules 
HPV vaccine 
Patients who 
have not 
PN schedules 
HPV vaccine 
 
 
education w 
doses needed 
& addresses 
completed the 
HPV vaccine 
doses needed 
& addresses 
completed the 
HPV vaccine 
dose needed 
& addresses 
 
 
to parents & 
young adults 
structural 
barriers 
series 
structural 
barriers 
series 
structural 
barriers 
 
Baseline 
Surveys 
 
 
3-Months 
Outcomes 
 
 
6-Months 
Outcomes 
 
Note: CHE=Community Health Educator; PN=Patient Navigator; HPV=Human Papillomavirus; Participants will receive 
only the intervention strategies they need at strategic points. Timeline of the intervention delivery not drawn to scale. 
 

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populations’ knowledge, uptake, and completion of the human papilloma virus (HPV) vaccine to 
prevent HPV-related cancers. We will partner with Denver Health and Hospital Authority 
(DHHA) which serves communities with populations where HPV-related cancers’ incidence, 
mortality, and burden are high. Denver Health mostly serves medically underserved patients with 
a significant percentage of patients covered by Medicaid (62%) and of patients without health 
insurance (14%). The Denver County population served by Denver Health is at high risk for 
cancer-related health inequities. The age-adjusted annual incidence of cervical cancer (cases per 
100,000), using 2010-2014 county data, 35 is higher for Denver County (6.6) than for the state of 
Colorado (5.9).  Cervical cancer and oropharyngeal cancers are the most common HPV-related 
cancers in women and men respectively, impacting more than 29,000 individuals in the US each 
year8. One model predicts that HPV infection can be eliminated with global 80% vaccination 
coverage, but even with more modest rates of vaccine uptake there can still be significant 
reductions in HPV-related malignancies. Statewide in Colorado in 2016 only 48% of adolescents 
had completed the HPV series13Our intervention will focus on providing education delivered by 
Community Health Educators (CHEs) and on referring participants to Patient Navigators (PNs) 
who will facilitate their access to the HPV vaccine. 
2.3 
RISK/BENEFIT ASSESSMENT  
2.3.1 KNOWN POTENTIAL RISKS  
Loss of confidentiality for patients in the educational intervention delivered by the CHE. 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
Improve knowledge about importance of HPV vaccine among parents of adolescents and young 
adults eligible for the vaccine and uptake of the vaccine among the interventions’ participants. 
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
This a minimal risk study that does not place participants in any increased risk of harm. 
Thus, the benefits to be gained in knowledge far out way the risks. 
 
The risks to participants are reasonable in relation to the anticipated benefits to participants and/or 
society, and in relation to the importance of the knowledge that may reasonably be expected to 
result, thereby falling in favor of performing the study: 
• To Participant: Improved knowledge an intention to initiate or complete the 
HPV vaccine series. 
• To Society: Increased uptake of the HPV vaccine, could lead to decreased 
rates of HPV related malignancies in a population that is disproportionally 
affected by HPV related malignancies.  
• Justify the importance of the knowledge gained: We will gain understanding 
on how to implement a combination of a CHE and PN intervention to increase 
knowledge, intentions, and uptake of the HPV vaccine to prevent HPV-related 
malignancies in areas of most need. Additionally, we will evaluate the 
influence NCI designed educational presentations and materials on increasing 

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knowledge and intentions about HPV and the HPV vaccine series. Exploring 
these interventions will shed knowledge on practices to use when addressing 
some of HPV-related cancers among underserved populations. 
 
3 
OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
Parents & young adults’ knowledge & 
intentions to obtain the HPV vaccine 
Behavioral factors precede 
uptake of preventive vaccines 
 
Sociodemographic data (e.g., age, gender, 
ethnicity, insurance, income, zip code) 
Variables known as associated 
with vaccine uptake 
Secondary 
 
 
 
Uptake of one, two, or three HPV vaccine 
doses among adolescents (9 to 17 years 
old) and young adults (18-26 years old). 
Number of vaccine doses are 
used to assess full protection 
(3 doses) or partial (<3 doses) 
Tertiary/Exploratory Intervention’s delivery and patient-level 
& system-level impact. 
Interventions that can be 
delivered to impact patients & 
clinics are easier to implement  
4 
STUDY DESIGN  
4.1 
OVERALL DESIGN 
We will use a one-group post-test design to assess the effects of the intervention on the primary 
outcomes. The educational intervention will be delivered to 400 participants by a trained CHE 
who will deliver the educational materials to eligible DHHA patients. The CHE will administer 
the post-education survey at baseline to participants. Additionally, we will use a one-group post-
test design to assess the impact of the intervention on the secondary outcomes. At the patient-
level, we will track participants that receive (a) 1st dose, 2nd dose, or 3rd dose of the HPV 
vaccine; and the number of referrals to care by recording the number of patients received (b) 
referrals to health insurance, discount, or no-cost HPV vaccine programs; or (c) to other services 
to facilitate HPV vaccine dose completion. To assess clinic-level impact, we will track each 
clinic’s HPV vaccine rates for adolescents (9-17 years old) and young adults (18-26) and 
compare rates from before we start the intervention and then quarterly there after we have 
introduced the intervention to each respective Denver Health clinic. 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
This is a pragmatic study that seeks to evaluate in real-world practice the use of a CHE and PN 
intervention to improve the uptake of evidenced-based HPV vaccinations. Thus, it uses a post-
design to evaluate participants’ changes in knowledge and intentions to vaccinate by comparing 

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outcomes at baseline to outcomes after exposure to the CHE educational intervention. Similarly, 
it uses a post-test design to evaluate the uptake of the HPV vaccine after participating in the PN 
intervention. In real-world practice it is important to measure an intervention’s impact not only at 
the patient-level but also at the clinic- and system-level. Consequently, we will measure post-
intervention the rates of the HPV vaccine1st dose, 2nd dose, and/or 3rd dose uptake for each clinic 
and for the DHHA systems by comparing its rates to state level HPV vaccine rates.  
 
4.3 
END OF STUDY DEFINITION 
This study will end when the minimum number of participants (400 participants) for analyses is 
recruited. The protocol will be closed once data analysis and publications have been completed. 
 
5 
STUDY POPULATION  
5.1 
INCLUSION CRITERIA 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
 
Denver Health Patients: 
1. Be a Denver Health patient* 18-26 years old, who has not started or completed the HPV 
vaccine series (Vaccine completion for this age group is 3 doses).  
2. Be a parent of a Denver Health adolescent patient* aged 9-17 years old (), who has not 
started or completed the HPV vaccine series. (Vaccine completion is 2 doses for 9-14-
year-old, and 3 doses for 14-17-year-old)   
3. English and/or Spanish Speaking 
4. Stated willingness to comply with all study procedures and be available for the duration 
of the study. 
 
* Denver Health patients will be identified from one of the following clinics: Denver 
Health Clinics Eastside Adult Clinic, Eastside Women’s Care Clinic, Westside Adult 
Clinic, Westside Women’s Care Clinic, Pavilion C: Women’s Care Clinic, La Casa-
Quigg Newton Family Health Center, Lowry Family Health Center, Montbello Family 
Health Center, Westwood Family Health Center, Parkhill Family Health Center, Webb 
Center For Primary Care, Pena Southwest Clinic 
 
 

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5.2 
EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
1. Individuals who do not meet eligibility criteria, including individuals who do not speak 
English or Spanish [at the discretion of the CHE or PN upon recruitment] 
2. Decisionally-challenged adults with cognitive or personality impairment or due to 
intoxication (alcohol or drugs) that might interfere with their ability to consent or 
participate in the study [at the discretion of the CHE or PN upon recruitment] 
3. Individuals from vulnerable populations (e.g., inmates, homeless, pregnant women, and 
those with auditory impairment [at the discretion of the CHE or PN upon recruitment] 
4. Individuals under the age of 18 years. 
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
HPV Educational Intervention:  To recruit participants we will distribute flyers regarding our 
educational events about HPV and the HPV partnering with each outpatient clinics at 
DHHA.Additionally, The PN and CHE will be fully onboarded at DHHA to access patient 
records, including upcoming clinic visits to identify potential participants who are eligible for the 
HPV vaccine. Thus, the PN will be able to call participants that meet the eligibility criteria and 
will recruit them to participate in the study. All participants will be identified through their own 
patient record. Young adults (18–26-year-old) will be contacted directly and invited to 
participate in the study. For individuals under the age of 18 (9–17-year-old), we will use the 
patient’s record to obtain parent contact information and invite the parent to participate in the 
study. Parents might indicate having additional children that are older than 18 years of age when 
completing surveys. For those parent participants we will capture vaccinations status on all their 
children aged 9-26, even if those children are not DH patients. However, the survey will not 
collect any PHI on children from parent participants, only vaccinations status. To assess uptake 
of the HPV vaccine from children participants and young adult participants, we will use their DH 
medical record number to determine vaccination status after the educational and patient 
navigation intervention has been delivered.  Additionally, for parent and adult participants, who 
volunteer to participate, we will collect name, phone number, mailing address, and email address 
for follow up at 3- and 6-months intervals if they report not having been vaccinated themselves 
or their eligible aged children (9-17) at baseline and/or at the 3-month follow up interval.  
 In order encourage participants to answer our surveys, we will incentivize them by 
compensating them with a $25 gift for filling the post-education survey at baseline. 
6 
STUDY INTERVENTION  
6.1 
STUDY INTERVENTION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION DESCRIPTION 

PI:   Evelinn Borrayo, PhD 
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The educational intervention to be delivered by the CHE consists of “toolkit education materials” 
developed by the National Cancer Institute (NCI) and a small media intervention (i.e., video) that 
our research team has developed. The NCI-produced toolkit education materials consist of Power 
Point presentations, flyers, and posters that contain information about HPV, HPV-related 
cancers, and the importance of the HPV vaccine series for adolescents (9-17 years old) and 
young adults (18–26-year-old) who are eligible for the vaccine.  
 
 
6.2 
STUDY INTERVENTION COMPLIANCE 
Study participants who volunteer to participate in this study will be asked to comply with the 
following interventions strategies: 
 
1. Watch or participate in approximately a 45-minute educational session conducted by the 
CHE.  
2. Receive a referral to the PN if they and/or their children are eligible for the HPV vaccine 
but have not completed all the recommended HPV vaccine series doses. 
3. Receive navigation for the number of HPV vaccine series doses needed until completion. 
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 
DISCONTINUATION OF STUDY INTERVENTION (STUDY STOPPING RULES) 
The Sponsor-Investigator has the right to terminate this study at any time. Reasons for terminating 
the study may include, but are not limited to, the following: 
o The incidence or severity of adverse events in this or other studies indicates a potential 
health hazard to patients. 
o Patient enrollment is unsatisfactory. 
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request. 
In addition, the investigator has the right to withdraw a patient from the study at any time. Reasons 
for withdrawal from the study may include, but are not limited to, the following: 
o Patient withdrawal of consent at any time 
o Any medical condition that the Sponsor-Investigator determines may jeopardize the 
patient’s safety if he or she continues in the study. 
o Sponsor-Investigator determines it is in the best interest of the patient 
o Patient non-compliance 
 

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Every effort should be made to obtain information on patients who withdraw from the study. The 
primary reason for withdrawal from the study should be documented on the appropriate eCRF.  
 
7.3 
LOST TO FOLLOW-UP   
The evaluation of the educational intervention occurs at baseline during the post education 
survey. Our sample size of 200 will achieve 80% power the moment the 200th participant 
completes the post survey at baseline. Thus, lost to follow-up is not a concern in our study. 
Follow-up is only to capture vaccination status, as well as to facilitate patient navigation if it 
applies. Furthermore, follow-up will only occur for some participants. Only those that indicate at 
baseline not being vaccinated themselves or indicate being parents of children that have not been 
vaccinated will be contacted at 3 months post baseline. Similarly, only those that indicate not 
being vaccinated themselves or indicate having children not being vaccinated at 3 months post 
baseline will be contacted at 6 months post baseline. For those that are contacted at 3 months and 
6 months, we will make a maximum of 6 contacts (e.g., phone calls, texts, or letters) to each 
consented participant. After 6 unsuccessful contact attempts, we will consider participant as “lost 
to follow up” and no longer make attempts to contact them. 
 
8 
STUDY PROCEDURES 
8.1 
STUDY PROCEDURES/EVALUATIONS 
The CHE’s will deliver evidence-based educational material (i.e., toolkits) via one-on-one 
sessions to a total sample of 400 participants.  Participants will be given the option to have the 
education presented over the phone or via zoom. The CHE will use educational materials on 
HPV, HPV-related cancers, and the HPV vaccine and to motivate participants to initiate and 
complete the HPV vaccine. The CHE will administer post education surveys to participants. 
Educational material will be presented separately in English or in Spanish. Participants will be 
invited to participate in their preferred language. Name, telephone number, address will also be 
collected in order to administer the follow-up calls. Participants will be given a $25.00 gift card 
for completing the post education survey. 
Those that choose to participate in the evaluation process of the education materials will 
complete the informed consent process and complete the immediate post education survey. 
Those that indicate not being vaccinated on the immediate post education survey will be 
contacted to participate in the 3-month follow up survey. If participants missed a scheduled 
vaccine dose or indicate they have not been vaccinated at 3 months, they will be contacted again 
at 6 months for follow up.   
 Additionally, the PN will refer those that are interested in receiving the HPV vaccine to the PN. 
During the delivery of the PN intervention, the PN will track participants that a) receive a 1st 
dose, 2nd dose, or 3rd dose of the HPV vaccine; and connections to care by recording the 
number of services provided including (b)  patients connected to health insurance, discount or 
no-cost HPV vaccine programs; or (c) other services to facilitate HPV vaccine dose completion 
(e.g., language translation, appointment scheduling assistance, transportation services, childcare). 

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We will track HPV vaccine doses at the patient-level and rates at DHHA clinics to the access the 
system-level impact of the interventions on increases overall HPV vaccination rates for 
adolescents (9-1\7 years old) and young adults (18-26) in the respective DHHA clinics. Our goal 
is to conduct the educational sessions and the post education survey in person. However, current 
circumstances as a result of the COVID-19 outbreak require we execute our educational sessions 
remotely. We will send educational material to be watched via REDCap links or present the 
materials over Zoom or over the phone. Secured REDCap links will be used to obtain the post 
education survey. We will also use REDCap to obtain any PHI needed to for follow up. 
Post education surveys will be physically mailed, without any PHI, to the NCI after we have 
uploaded and stored the surveys in REDCap.  
8.2 
STUDY SCHEDULE 
8.2.2 ENROLLMENT/BASELINE 
 
Enrollment will occur at the educational sessions s to be hosted by CHE’s to eligible DHHA 
patients. 
 
8.2.3 INTERVENTION VISITS  
 
Participants who indicate that either their adolescent children or they have not completed the 
HPV vaccine series at baseline, they will be refer to the PN intervention to schedule the needed 
HPV vaccine dose. Participants whose children or them missed the HPV vaccine dose 
appointment will receive a recall text or phone call to reschedule another vaccine appointment. 
 
8.2.4 FOLLOW-UP VISITS 
 
If participants indicate that their children or they have not completed the HPV vaccine series at 
3-months and 6-months, they will be schedule for the HPV vaccine dose needed, and if they 
missed receiving it, they will be followed through a recall text or call to reschedule to receive the 
missed dose. 
 
8.2.5 EARLY TERMINATION VISIT 
 
If participants who receive the CHE education intervention indicate that their children or they 
have completed all the HPV vaccine doses recommended for them, they be terminated from 
receiving the PN intervention. Participants who are referred to the PN intervention to receive a 
needed HPV vaccine dose, will be terminated for further PN intervention if they complete the 
HPV vaccine series at the 3-month or 6-month follow-up period.  
 

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8.2.6 SCHEDULE OF EVENTS TABLE 
.  
 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS  
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
 
NA 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
NA 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
 
8.3.3.1 
SEVERITY OF EVENT  
 
NA 
8.3.3.2 
RELATIONSHIP TO STUDY INTERVENTION 
 
NA8.3.3.3 
EXPECTEDNESS  
 
NA 
8.3.4  TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP  
 
NA 
8.3.6   
SERIOUS ADVERSE EVENT REPORTING  
 
NA 
8.4  
UNANTICIPATED PROBLEMS  
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UAP) 
 
HPV Educational Intervention 
and Data Collection 
Baseline/ 
Intervention 
 
 
Recall upon 
missed dose 
Quarterly 
Informed Consent  
X 
 
 
 
 
 
 
 
 
 
 
Post-education (baseline survey) 
X 
 
 
 
 
 
 
 
 
 
 
Gift card compensation  
X 
 
 
 
 
PN vaccine referral/navigation  
X 
 
 
X 
 
PN vaccine follow-up/navigation  
 
 
 
X 
X 
Clinic Assessment of HPV 
vaccination rates EMR system 
 
 
 
 
X 

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NA 
8.4.2 REPORTING OF UNANTICIPATED PROBLEMS  
 
NA 
 
9 
STATISTICAL CONSIDERATIONS   
9.2  
SAMPLE SIZE DETERMINATION 
 
A sample size of 200 participants achieves 80.0% power to reject the null hypothesis of zero 
effect size (i.e., improvement in, HPV and HPV vaccine knowledge, and HPV vaccine 
intentions’ scores) when the Cohen’s effect size is 0.20 (small effect size)34 and the significance 
level is 0.050 using a two-sided one sample paired t-test.  
9.3  
POPULATION FOR ANALYSES 
 
 
The population for analyses will constitute all patients at DHHA  who are parents of adolescents 
aged 9 to 17 years old who are eligible for the HPV vaccine series, as well as young adults ages 
18 to 26 years old who are also eligible for the HPV vaccine series.  
 
9.4  
STATISTICAL ANALYSES 
9.4.1  
GENERAL APPROACH  
 
The effects of the education intervention on the primary outcomes measured by the continuous 
scales regarding, HPV and HPV vaccine knowledge, and HPV vaccine intentions, will be 
assessed using two-sided one-sample paired t-test for the null hypothesis that the paired 
difference is 0 against the alternative hypothesis that the paired difference is not 0. Appropriate 
transformation and/or the non-parametric Wilcoxon test will be performed if the data suggests 
severe non-normality. The significant level is 0.05. 
 
Exploratory analysis of the characteristics that influence participants’ adherence (0=non-
adherent; 1=adherent) to the recommended HPV vaccine dosage will be conducted use logistic 
regression analysis. Our analyses will adjust for co-variates that likely influence the primary 
outcomes and exploratory outcomes, which include prior HPV vaccine dosage. We will also 
adjust for other potential co-variates if our descriptive analysis suggests this may be needed. 
Summary descriptive statistics will be calculated and presented for all primary, exploratory 
outcomes for all participants, and for subgroups defined by participants predisposing (e.g., 
gender, age), enabling (e.g., insurance, barriers), and need (e.g., cancer risks) characteristics. The 
demographic characteristics of the participants will be presented with descriptive statistics also. 
The means, medians and the 95% confidence intervals will be calculated for continuous 
variables; the frequencies, estimated rates, and the exact 95% confidence intervals will be 
calculated for the binary and categorical variables. 
 

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10 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
10.1  REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 
INFORMED CONSENT PROCESS 
 
10.1.1.1  
CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS 
PROVIDED TO PARTICIPANTS 
  
Consent form describing in detail the study procedures, and risks are provided to the participant.  
Completion of the informed consent process is required prior to starting intervention/ 
administering study product.  
 
10.1.1.2  
CONSENT PROCEDURES AND DOCUMENTATION 
 
Informed consent process will be initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Extensive discussion of risks 
and possible benefits of participation will be provided to the participants and their families.  
 
 
Consent forms will be IRB-approved, and the participant will be asked to read and review the 
document. The consent process will occur over the phone. All participants will receive a verbal 
explanation in terms suited to their comprehension of the purposes, procedures, and potential risks 
of the study and of their rights as research participants. Consent will be reviewed prior to 
participants receiving in any of the educational materials and before completing the surveys. The 
consent form will be read, and clarification will be confirmed, and questions will be addressed as 
needed. Participants will have time to review the consent prior to deciding if they would like to 
participate and will verbally acknowledge understanding and willingness to participate in the study 
prior to any procedure being done specifically for the study. We are unable to hold in person 
meetings due to COVID-19 restrictions. At this point in time those restrictions will remain 
indefinitely. Hosting virtual education sessions requires a high level of computer and technological 
literacy that has become a barrier to enrollment. Similarity, asking patients to complete a consent 
form that requires a digital e-signature and join a zoom call is too cumbersome and creates a barrier 
to enrollment. Thus, we will use a postcard consent that will be sent via text or email or will 
otherwise be made available to the subject in advance of the informed consent discussion. The 
participants may withdraw consent at any time throughout the course of the trial. The rights and 
welfare of the participants will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
 

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The study allows the inclusion of non-English speaking and non-reading participants. Witnesses 
to these consent processes will be individuals not associated with the trial and will not have a 
conflict of interest. 
 
10.1.3  
CONFIDENTIALITY AND PRIVACY 
Participant confidentiality is strictly held in trust by the participating investigators, their staff, 
and the sponsor-investigator(s) and their agents. This confidentiality is extended to cover the 
clinical information relating to participants. Therefore, the study protocol, documentation, data, 
and all other information generated will be held in strict confidence. No information concerning 
the study, or the data will be released to any unauthorized third party without prior written 
approval of the sponsor. 
 
The study monitor, other authorized representatives of the sponsor-investigator, or 
representatives of the IRB may inspect all documents and records required to be maintained by 
the investigator, including but not limited to, medical records (office, clinic, or hospital) for the 
participants in this study. The clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for 
internal use during the study. At the end of the study, all records will continue to be kept in a 
secure location for as long a period as dictated by local IRB and Institutional regulations. 
 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored at the University of Colorado Cancer Center. This 
will not include the participant’s contact or identifying information. Rather, individual 
participants and their research data will be identified by a unique study identification number. 
The study data entry and study management systems used by clinical sites and by the University 
of Colorado Cancer Center, research staff will be secured, and password protected. At the end of 
the study, all study databases will be de-identified and archived at the University of Colorado 
Cancer Center.  
 
10.1.4 
FUTURE USE OF STORED SPECIMENS OR DATA 
 
 
• Intended Use: Data collected under this protocol will only be used to complete the scope 
of this project.  
• Storage: Data will be stored using codes assigned by the investigators. Data will be kept 
in password-protected computers. Only investigators will have access to the samples and 
data. 
• Tracking: Data will be tracked using REDCap.  
• Disposition at completion of the study: No samples will be collected in this study.  
 
 
10.1.5 
SAFETY OVERSIGHT  
 

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The principal investigator will be responsible for the conduct of this study, overseeing participant 
safety, executing the data and safety monitoring (DSM) plan, and complying with all reporting 
requirements to local and federal authorities. This oversight will be accomplished through 
additional oversight from the Data and Safety Monitoring Committee (DSMC) at the University 
of Colorado Cancer Center (CU Cancer Center).  The DSMC is responsible for ensuring data 
quality and study participant safety for all trials at the CU Cancer Center. A summary of the 
DSMC’s relevant activities is as follows: 
• Conduct of internal audits 
• May submit recommendations for corrective actions to the CU Cancer Center’s 
Executive Committee 
Study audits conducted by the DSMC will consist of a review of the regulatory documents, 
consent forms, and source data verification.  Documentation of the audit conducted by the 
DSMC will then need to be submitted to the IRB of record at the time of the IRB’s continuing 
review of this trial (if applicable). 
 
 
10.1.6 
CLINICAL MONITORING 
 
 
Risks to patients include the potential loss of confidentiality if identifiable study data are 
inappropriately disclosed. However, several steps will be taken to prevent this: Patients will be 
given a coded identifier for research purposes which will be stored with identifier data separate 
from research data. We will use best practices for IT based security such as utilizing OIT supported 
hardware and software, the use of VPNs to access research data, the use of REDCap whenever 
possible, the use of secure data transfer protocols, and access and change logging which will be 
reviewed monthly for any aberrant activity. We have experience in implementing such enterprise 
security processes for similar uses; however, we anticipate we will work closely with OIT to ensure 
that the design and implementation of these systems mitigate the risk of loss of confidentiality. 
 
 
10.1.7 
QUALITY ASSURANCE AND QUALITY CONTROL  
 
 
Quality Control (QC) procedures will be implemented beginning with the data entry system and 
data QC checks that will be run on the database will be generated. Any missing data or data 
anomalies will be communicated to the site(s) for clarification/ resolution. 
 
Following written SOPs, the study monitor will verify that the clinical trial is conducted, and data 
are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the 
applicable regulatory requirements. 
 

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The investigational site will provide direct access to all trial-related sites, source data/ documents, 
and reports for the purpose of monitoring and auditing by the DSMC audit team, and inspection 
by local and regulatory authorities. 
 
10.1.8 
DATA HANDLING AND RECORD KEEPING  
 
10.1.8.1  
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the 
site PI. The PI is responsible for ensuring the accuracy, completeness, legibility, and timeliness of 
the data reported.  
 
All source documents should be completed in a neat, legible manner to ensure accurate 
interpretation of data. When making changes or corrections, cross out the original entry with a 
single line, and initial and date the change. DO NOT ERASE, OVERWRITE, OR USE 
CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
 
Copies of the electronic CRF (eCRF) will be provided for use as source documents and maintained 
for recording data for each participant enrolled in the study. Data reported in the eCRF derived 
from source documents should be consistent with the source documents or the discrepancies should 
be explained and captured in a progress note and maintained in the participant’s official electronic 
study record. 
Data will be entered into REDCap. The data system includes password protection and internal 
quality checks, such as automatic range checks, to identify data that appear inconsistent, 
incomplete, or inaccurate. Clinical data will be entered directly from the source documents. 
 
10.1.8.2  
STUDY RECORDS RETENTION 
 
There is no plan to destroy study data.  
10.1.9 PROTOCOL DEVIATIONS 
 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or SOP 
requirements. The noncompliance may be either on the part of the participant, the investigator, or 
the study site staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly. These practices are consistent with ICH E6, sections: 
• 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3. 
• 5.1 Quality Assurance and Quality Control, section 5.1.1. 
• 5.20 Noncompliance, sections 5.20.1 and 5.20.2. 
It is the responsibility of the study team to use continuous vigilance to identify and report 
deviations. All deviations must be addressed in study source documents, reported to COMIRB. 
Protocol deviations must be sent to the local IRB per institutional guidelines. The site PI/ study 
staff is responsible for knowing and adhering to their IRB requirements. Further details about the 
handling of protocol deviations will be included in the -SOP and/or study procedures manual.  
  

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10.1.11 PUBLICATION AND DATA SHARING POLICY 
This study will ensure that the public has access to the published results of this research.  
 
10.1.12  
CONFLICT OF INTEREST POLICY 
 
Independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed.by the 
University of Colorado Denver’s (UCD) Office of Regulatory Compliance Conflict of Interest and 
Commitment Management (COIC) program. Persons with a perceived conflict of interest will have 
such conflicts managed in a way that is appropriate to their participation in the trial. Conflict of 
Interest management plans are project-specific and are reviewed at least annually. UCD has 
integrated the institutional conflict of interest management program with its existing program. 
 
11 
 
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