PREVENT: Practice-based Approaches to Promote HPV Vaccination in the Safety Net - BootCamp Translation
Phase: NA
Conditions: HPV Vaccination, Vaccine; Uptake, Vaccination; Series Completion
Sponsor: University of Utah

 
 
Official Title 
PREVENT: Practice-based Approaches to Promote HPV Vaccination 
in the Safety Net - BootCamp Translation   
Protocol ID 
HCI161649-1 
NCT Number 
NCT06290206 
Date of Document 
June 6, 2022 

 
 
SPECIFIC AIMS 
Human papillomavirus (HPV) infection causes of over 36,000 new cancer cases of cervical, ano-genital, and 
oropharyngeal cancers in the United States each year.1 While multi-valent vaccinations to prevent HPV 
infections have been available since 2006, uptake of the HPV vaccine is well below national Healthy 
People 2030 targets (80% of adolescents at ages 13-15 years up-to-date with HPV vaccination).2 Adolescent 
vaccination rates are especially low in rural areas (more than 11% lower than in urban areas).3 
Compared to urban residents, rural residents have a higher incidence of HPV-related cancers and face unique 
barriers to HPV vaccination, including limited access to providers, fewer vaccine reminders, longer travel time 
to clinics, and less favorable societal norms about HPV vaccination.4-8 Moreover, rural adolescents are less 
likely than their urban counterparts to receive a provider recommendation for the HPV vaccine.9 Rural 
healthcare teams are often limited by a lack of systematic methods to identify and track eligible patients and/or 
their parents for outreach.9, 10 While much is known about clinic-based approaches to improve HPV vaccination 
among urban residents, less is known about their effectiveness among rural residents, including rural Hispanic 
populations, the fastest growing sub-population in rural settings. Hispanic persons have a higher incidence of 
HPV-related cancers than non-Hispanic white persons.11 As a result, ensuring that Hispanics persons are up to 
date on HPV vaccination is a public health priority. The proposed study is designed to address these barriers 
by adapting and testing approaches to effectively communicate the importance of vaccination to improve HPV 
vaccination rates for rural populations, and the sub-populations within (e.g., Hispanic persons). 
The most promising approaches to increase HPV vaccine uptake include the use of patient reminder systems 
and strong provider recommendations (e.g., presumptive messages and bundling HPV vaccination with other 
recommended vaccines).12 While these communication strategies often occur during clinic visits, they have not 
been incorporated into low-cost reminders for rural patients, such as automated phone calls and text 
messages. Research is critically needed to leverage public health messages to promote broad-scale 
vaccination and lessen HPV vaccination disparities. Our study includes a randomized controlled trial of 
adapted HPV vaccination reminders to address the needs of diverse rural populations. We will create clinic 
systems to prompt vaccination for eligible children/adolescents and deliver messages to parents/caregivers, 
whose mode and content is specifically tailored for rural and rural Hispanic populations.  
Our study, Practice-based Approaches to Promote HPV Vaccination in the Safety Net (PREVENT), 
incorporates formative patient- and clinic-informed research to design and evaluate an automated data-driven 
reminder intervention using low-cost approaches (automated phone calls and text messages). We will compare 
usual care to Automated Patient Reminders (Auto), and to a higher-intensity intervention arm using 
automated messages plus linguistically and culturally tailored interventions to deliver live reminders, 
Automated Plus Live Patient Reminders (Auto-Plus). PREVENT’s design and evaluation will involve 
tailoring message mode and content for parents/caregivers of rural and ethnically diverse rural patients.  
Our Specific Aims are listed below: : 
Aim 1: Design format and content of an intervention to promote adolescent HPV vaccine coverage 
that will consider the unique information needs of diverse rural parents/caregivers. Bootcamp 
Translation methods will provide the framework to effectively target HPV vaccination messages for rural and 
rural Hispanic Mountain West parents/caregivers of HPV vaccine eligible children/adolescents.  
Aim 2: Test a set of automated reminders (defined during Aim 1) on timely receipt of next needed 
HPV vaccine dose and on series completion. Hypotheses: Auto and Auto-Plus interventions will be more 
effective than usual care and Auto-Plus will be more effective than Auto at increasing HPV vaccination. 
Aim 3: Assess implementation outcomes and identify multi-level barriers and facilitators to 
implementation and effectiveness. Implementation outcomes (e.g., acceptability, fidelity, adoption, 
acceptance, maintenance) are defined using Proctor and RE-AIM frameworks. 
This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV 
vaccination among diverse rural parents and caregivers of children ages 11-17 years in the Mountain West. 
Our strong multi-disciplinary research team demonstrates successful partnerships with primary care practices 
in rural populations. Once implemented into practice, our intervention could significantly reduce disparities in 
the burden of HPV-associated cancers among rural populations in the United States. 

 
 
RESEARCH STRATEGY 
 
A. SIGNIFICANCE 
A.1. Improving HPV vaccine uptake could prevent tens of thousands of cancer cases each year. HPV is 
a sexually transmitted infection that causes cervical, anal, penile, vaginal, vulvar, and oropharyngeal cancers, 
and genital warts. While HPV vaccination can prevent most HPV-related cancers, more than 21,000 women 
and 15,000 men are diagnosed with HPV-associated cancers each year in the United States (US).13 In 
addition, more than 200,000 women are diagnosed with HPV-related pre-cancer of the cervix, more than 
500,000 persons are diagnosed with genital warts, and thousands are diagnosed with recurrent respiratory 
papillomatosis (RRP).14 This is troubling given that HPV vaccination rates remain substantially lower than 
national Healthy People 2030 targets (80% of adolescents at ages 13-15 years up-to-date with HPV 
vaccination).15 Indeed, only about 55% of adolescents have met this target more than 14 years after the 
vaccine was recommended for girls and 9 years after the recommendation for boys.16 Improving uptake of the 
HPV vaccine is a public health imperative.  
A.2. Higher HPV vaccine uptake in rural communities could 
improve health outcomes for this unique population. US 
nonmetropolitan residents have higher cervical cancer incidence, 
late-stage diagnoses, and HPV-related cancer death rates than 
metropolitan residents.4 Data from the 2020 National Immunization 
Survey-Teen survey show startlingly low HPV vaccine initiation 
and series completion rates for adolescents in rural regions at up 
to 11.2 percentage points lower than for urban regions. In 2019, 
similar disparities are shown for HPV vaccination by rurality in the 
US (Figure 1).16 Using vaccine registry data, in Utah, teens living 
in rural areas were 1.8 times more likely than urban residents to 
have a missed opportunity for HPV vaccination. This occurs when 
another immunization is received without concomitant delivery of 
the HPV vaccine.17 In Montana, 54% of more than 71,000 
vaccination visits were missed opportunities. Furthermore, rural 
adolescents had more than a 1.1 adjusted relative risk for a 
missed opportunity for the HPV vaccine compared to urban 
residents.18 Developing and deploying effective strategies for 
improving rural HPV vaccine coverage is critical. 
Hispanics represent the fastest growing rural subgroup in the US.19 Nevertheless, data on HPV vaccination 
practices among rural Hispanics are scarce. National Immunization Survey-Teen (2018) data show that while 
Hispanics ages 13–17 years have higher overall HPV vaccination rates than non-Hispanic whites (76% vs. 
64%), the Hispanic urban-rural disparity is particularly stark: a 17–21 percentage-point difference 
exists in Hispanic urban-rural rates of HPV vaccine initiation (73% vs. 56%) and series completion (61% 
vs. 40%).20 In a survey carried out by Dr. Kepka in 2020-21 of young adults in the Western United States 
(N=2,937), rural Hispanic young adults ages 18-26 were less likely to have received any dose of the HPV 
vaccine compared to urban Hispanics (50.5% vs. 59.0%, respectively). Moreover, significantly fewer Hispanic 
rural young adults (55.0%) expressed vaccine confidence compared with their Hispanic urban counterparts 
(71.0%). Hispanics face a disproportionate burden of HPV-related cancers, including a 1.4-fold increased 
cervical cancer incidence and a 1.5-fold increased penile cancer incidence, compared to non-Hispanic 
whites.11 Furthermore, compared to urban Hispanics, rural Hispanics often have lower incomes, fewer 
resources, lower levels of education, and face additional challenges related to access to healthcare in rural 
settings.21-23 Thus, closing the disparity in HPV vaccination rates will require efforts to engage 
parents/caregivers (P/C) of rural adolescents, including rural Hispanic subpopulations.  
A.3. Rural barriers to HPV vaccination are multi-factorial. A robust body of literature explicates barriers to 
receiving preventive health services, including vaccination for HPV,5-8 underscoring distinct challenges faced 
by rural residents.24-26 At the patient level, individuals and P/C often lack awareness of the importance of 
vaccination, experience fear or fatalism, or are dissuaded by prevailing anti-vaccination norms.7, 12, 27-29 Rural 
residents may experience limited health care (H/C) access. For example, studies show that rural adolescents 

 
 
are less likely than urban counterparts to attend a well-child 
visit and to receive a provider recommendation for HPV 
vaccination.9, 30-33 In addition, providers and clinics are often 
limited by a lack of systematic methods for identifying 
patients eligible for vaccination; inadequate reimbursement 
and time for counseling about vaccination; and follow-up 
systems that do not track intervals for repeated doses.10 
Rural clinics also face shortages of medical providers, 
especially pediatricians, well-versed in delivering vaccines.8, 
34, 35 
Rural communities have been further challenged by the 
coronavirus disease pandemic (COVID-19) from early 
2020-present. Rural communities have lost more lives than 
urban communities from 2020-2021.36 Rural communities 
have also had higher rates of COVID-19 vaccine hesitancy 
compared to urban communities in the US.37, 38 In the 
Mountain West, our team found that rural young adults, 
compared to urban young adults, were less likely to say that would receive the COVID-19 vaccine and were 
more likely to state that they do not trust vaccines in general.39  
Specifically, COVID-19 has placed unprecedented strain on the entire US healthcare (HC) system.40 In the US, 
the vast majority of non-essential medical care (e.g., well-child visits) did not occur during the peak of the 
COVID-19 pandemic.41, 42 Early in the pandemic, up to 40% of appointments for children’s immunizations, and 
up to 80% of appointments for teen’s HPV vaccinations, have been missed.43 As well-child visits have been 
resuming, adolescents have been the least likely to catch-up on immunizations, compared to younger children 
and infants.44 Furthermore, publicly-insured adolescents have experienced significantly greater declines in 
immunizations since March 2020 than privately insured adolescents.45, 46 Although doses delivered during 
June-September 2020 increased, this increase was insufficient to achieve adequate catch-up coverage.47 HPV 
vaccination has declined as a major priority for healthcare teams during the complications of the pandemic.48 It 
is expected that it will take from 2-10 years to recover from the losses in adolescent and childhood 
immunizations related to disruptions in care from the COVID-19 pandemic.49 In a recent survey of rural 
healthcare team members in Utah, Dr. Kepka and her team found that throughout the pandemic, rural clinics 
faced many healthcare system levels challenges that took priority over getting adolescents back on track with 
adolescent immunizations.  
A.4. Now is the time to improve HPV vaccinations in rural settings to accomplish our Healthy People 
2030 goal of 80% of adolescents ages 13-15 years up to date on HPV vaccination. Assisting primary care 
providers with tailored and effective P/C reminder systems for child and adolescent (C/A) vaccinations may 
facilitate timely P/C access to primary care services following COVID-19 related interruptions in non-essential 
medical care services. Our study will specifically design and evaluate an intervention to address the needs of 
diverse rural populations whose members are predominantly Hispanic (primarily of Mexican origin) and non-
Hispanic white.  
A.5. Strategies are needed to reduce HPV vaccine hesitancy in rural communities. Our proposed 
intervention will reduce vaccine hesitancy. Vaccine hesitancy is influenced by aspects of P/C confidence, 
complacency, and perceived convenience (Figure 2). HPV vaccination confidence relates to a P/C’s trust in 
their HC team’s recommendation,50, 51 complacency reflects prioritization and perceived importance of 
vaccination,52-54 and convenience describes the ease of receiving the vaccine.55, 56 These factors are influenced 
by contextual components such as a global pandemic. For this project, the COVID-19 pandemic may raise 
awareness about the importance of vaccination, enhance P/Cs’ trust in provider recommendations,57, 58 and 
activate P/C to engage in preventive practices (e.g., vaccination for HPV). Other epidemics have been 
associated with improved vaccination rates and attitudes in some populations.59-61 However, the COVID-19 
pandemic may also increase P/C levels of vaccine hesitancy due to ongoing exposure to anti-vaccine 
sentiment in social, political, media-related, and institutional environments.62 
A.6. Multi-level interventions are needed to reduce HPV vaccination disparities. Solving complex public 
Figure 2. Vaccine Hesitancy Model 

 
 
health issues requires consideration of factors at multiple levels, including the individual (e.g., fear and 
fatalism), clinician (e.g., missed opportunities), clinic (e.g., limited operating hours), community, and society 
(e.g., low awareness and prioritization of vaccine). Current studies find that multi-level interventions are 
synergistic: interventions targeting P/C and HC teams achieve higher levels of HPV vaccine uptake than 
interventions targeting either group alone. 12,36,63 However, past studies lack adequate rigor because few multi-
level interventions assessing HPV vaccine receipt have been developed and tested, and even fewer have 
been tested in rural settings.37-39,63 Our study will develop and test effective multi-level intervention components 
for vulnerable populations. We will use intervention mapping (IM), developed by Bartholomew and others,64 to 
identify factors and to plan each step of the intervention with the Intermountain West (IMW) HPV Vaccination 
Coalition (Figure 3; Section C2; letters of support).65 The IM model has been implemented in multiple 
settings and uses six components for improved intervention outcomes: needs assessment, matrices, theory 
and practice, program, implementation, and evaluation.64 IM is increasingly used to systematically plan 
preventive care interventions and ensure incorporation of stakeholder input at each step.66-68 We will apply IM 
to develop and test HPV vaccination patient reminders for P/C.  
A.7. HPV reminder programs show promise, but face important barriers. Our team summarized the 
literature on HPV reminder programs with a subgroup of IMW HPV Vaccination Coalition members (IM Step 1: 
Figure 3).65 Technology-based approaches hold several advantages, including broad availability, low cost, and 
use of formats both minimally intrusive and highly flexible.12, 69 Generally, patient reminders and strong provider 
recommendations (e.g., presumptive, bundled messages) offer the most promising evidence.12 In an 
integrative review of the literature that included more than 50 studies, results found that improved HPV 
vaccination rates through text message reminder systems were found.70 Reminder and recall systems 
demonstrate an untapped positive HPV vaccine intervention strategy for rural US settings.71, 72 However, 
several important gaps remain, including limited knowledge about differential improvement in combining 
technology-based interventions with human-delivered components.73 Few previous studies have tested strong 
HC team recommendations with automated reminders.74 Our study will fill these gaps by developing messages 
crafted by rural parents/caregivers, delivering them through recommended modes, testing the addition of live 
interactive components, and reporting intervention reach and effectiveness.  
A.8. Summary and Impact. In 2020, only 
about 55% of US adolescents were up to 
date with HPV vaccination, a troubling fact 
given that timely vaccinations could 
prevent more than 90% of HPV-associated 
cancers and reduce cervical cancer 
incidence by up to 100%.16, 75, 76 Due to the 
COVID-19 pandemic, the 2021 HPV 
vaccination rates are expected to be lower 
than in 2020. Completion of HPV 
vaccination is exceedingly low in rural 
areas (49.2% nationally),16, 76 far below 
national averages and target rates. This 
study will target the groups least likely to 
undergo vaccination—those living in rural 
areas who have minimal education, low 
access to HC, lower incomes, and those of 
Hispanic ethnicity.76 Our participatory 
approach will provide valuable information on translating evidence-based interventions to optimize HPV 
vaccination coverage in diverse rural clinics. Once implemented into practice, our intervention could 
significantly reduce disparities in HPV-associated cancers and cancer burden.  
B. INNOVATION 
This project builds upon Drs. Kepka (PI) and Coronado’s (Co-I) history of successful collaborations with rural 
primary care clinics. The PREVENT Program will make unique scientific contributions in the following ways:  
• PREVENT is designed to address the needs of rural population subgroups. A well-recognized limitation 
Figure 3. Intervention Mapping 

 
 
of rural research is the lack of attention paid to population subgroups within rural communities. PREVENT 
will be the first to tailor its approaches to address the needs of the fastest growing rural population subgroup, 
Hispanic persons. This subgroup experiences a pronounced urban-rural disparity in HPV vaccination rates. 
PREVENT will accelerate the adoption of proven approaches in health systems with diverse rural clinics. 
• PREVENT will be tailored for language and culture, will be both practice and patient-centered. Most 
previous studies have applied a one-size-fits-all approach to promoting HPV vaccination. While such 
approaches are important, they often cannot answer clinic administrators’ critical questions, such as “will this 
intervention work in my setting?” or “can I pare down this intervention and expect the same result?” Our 
interventions will leverage existing resources (including electronic health records [EHR], state-level registries, 
and clinic/community services) and innovatively tailor the intervention for cultural factors and language. 
• PREVENT is designed for sustainability. PREVENT will first adapt and test an intervention to promote 
HPV vaccine initiation and timely series completion in rural clinics. This approach allows for tailoring based 
on the best available evidence and local system preferences. It also aims to achieve long-term sustainability.  
• PREVENT will apply proven approaches to engage parents/caregivers and other stakeholders in all 
stages of the research process. Building on our established partnership with a multi-state HPV Vaccination 
Coalition, our approach will involve P/C and HC teams and will consider state-of-the-art communication 
approaches—e.g. strong, presumptive recommendations bundled with other vaccine recommendations and 
reminders sent through preferred modes—while prioritizing the needs and preferences of end users.  
• PREVENT will incorporate innovate modalitities for parent/caregiver engagement in Bootcamp 
Translation follow-up activities and will also include live interactive and tailored HPV vaccination 
reminders.  We will adapt text and phone-delivered messages using Bootcamp Translation (BCT), then 
iteratively refine them by gathering real time feedback on them from Hispanic and non-Hispanic white rural 
parents/caregivers. Furthermore, our Auto-Plus intervention includes an interactive web-based coaching tool 
that prompts patient navigators during live phone calls with P/C on how to best respond to varying types and 
levels of P/C vaccine hesitancy.  
C. APPROACH 
C.1. Project Overview: This two-stage study was 
designed in collaboration with Sea Mar Community 
Health Centers, an active member of Dr. Kepka’s IMW 
HPV Vaccination Coalition.65 The proposed project 
optimally aligns with the expertise of the study team 
and leverages our clinic partner’s commitment to 
improving HPV vaccination and reducing disparities in 
HPV-related cancer incidence and mortality. Our study 
will test automated and live reminders for HPV 
vaccination (Figure 4). In Phase I (Years 1-2), we will 
refine intervention components and messages to 
increase HPV vaccination among rural C/A. We will 
use a validated patient-engaged approach for 
P/Cs, BCT, with separate sessions conducted in 
English and Spanish. In Phase II, we will conduct a 
P/C randomized controlled trial (RCT) that tests 
automated strategies (e.g., automated phone calls, 
text messages) and combined automated and interactive live strategies to prompt P/Cs of vaccine-eligible C/A 
to complete the next dose of the HPV vaccine (i.e. first, second, or third dose depending on age of C/A). The 
individual-RCT will include P/Cs of 1038 vaccine-eligible patients at 4 rural clinics in Washington (Rural-Urban 
Continuum Codes of 3-9). This trial could significantly reduce HPV-associated cancer disparities and can be 
sustained long-term.  
C.2. Research Team and Preliminary Data: Our multidisciplinary team includes investigators with a record of 
developing and testing multiple cancer prevention interventions; analysts with years of experience designing 
registries and reminder and recall systems; implementation scientists; and qualitative researchers. Dr. Kepka 
will lead this project in partnership with Dr. Coronado and Dr. Ricardo Jimenez, Medical Director at Sea Mar, 

 
 
who has 28 years of experience at Sea Mar and collaborated on 3 previous quality improvement projects with 
Dr. Coronado. Dr. Noel Brewer (consultant) and Dr. Heather Brandt (consultant) will provide research expertise 
in HPV provider communication and dissemination and implementation science. Dr. Chelsey Schlechter (Co-I) 
is also an expert in dissemination and implementation science.  Biostatistician Dr. Ben Haaland has more than 
a decade of experience designing, analyzing, and reporting on RCTs, and Drs. Erin Rothwell and Warner 
contribute expertise in qualitative methodologies. Dr. Turok, a primary care physician, has been one of Dr. 
Kepka’s mentors and collaborators since she was a KL2 scholar (2013-15). Lastly, Dr. Echo Warner is an  
expert on text message-delivered research methodologies. Dr. Kepka has successfully collaborated with Dr. 
Brewer in the past77 and has worked with Drs. Haaland, Rothwell, Brandt, Schlechter and Warner on many  
funded studies.65, 78-83 
Dr. Kepka is a health services researcher who leads a 
successful, independent program in HPV-related 
cancers, vaccination, and cancer screening among 
vulnerable populations. A national leader in HPV 
vaccination research, she has more than 15 years of 
experience collaborating with at-risk communities 
through community-based partnerships. At the 
Huntsman Cancer Institute, Dr. Kepka formed and 
directs the multi-state IMW HPV Vaccination Coalition 
(Section C3).65 In partnership with the Coalition, Dr. 
Kepka conducted 14 focus groups involving HC team 
members and providers (HCP), community 
stakeholders, and P/Cs of children ages 11–17 years in 
rural Utah, Colorado, Nevada, Montana, and Arizona (N=140 participants; 3P30 CA042014-2958). Focus 
groups assessed system-level barriers and needed adaptations for implementing evidence-based HPV 
vaccination strategies in rural primary care clinics (Table 1).84 The findings underscore P/Cs’ uncertainty about 
which vaccines to get and providers’ and stakeholders’ desire for systems to remind P/Cs to obtain the 
vaccine. Dr. Kepka hosts monthly video-call meetings with partners (Letters of support).65, 82   
Dr. Coronado, an 
epidemiologist, is 
bilingual in English 
and Spanish and a 
national leader in 
practice-based 
cancer prevention 
research in safety 
net clinics. Dr. 
Coronado and her 
team have 
established formal 
collaborations 
(through research subcontracts and impact fees) with over 18 community organizations; she has led or co-led 
more than 15 NIH-funded grants using community-engagement to improve health and HC in rural and Hispanic 
populations. Drs. Coronado and Kepka first collaborated on a pilot study to improve HPV vaccine awareness 
and knowledge among Hispanic P/C of age-eligible adolescents in rural Washington. Radionovela to Improve 
HPV Vaccination (PI: Coronado) developed and tested a community-informed HPV vaccination intervention 
that included a pamphlet and Spanish-language radionovela.85, 86 At the Center for Health Research, Dr. 
Coronado has led several practice-based cancer prevention initiatives. One initiative, focused on colorectal 
cancer (CRC) screening, STOP CRC, demonstrated the feasibility of testing reminders at Sea Mar 
(UH3CA188640; MPIs: Coronado, Green). As part of STOP CRC, Coronado’s team designed a series of real-
time EHR reports that relied on a library of user-expandable metrics to gather data from several sources.87 An 
embedded Sea Mar sub-study tested various FIT reminders, including text messages, automated and live 
phone calls, letters and patient portal messages. Findings showed an overall FIT completion rate of 33%, with 
the highest completion observed the combination of automated plus live phone calls for Hispanic individuals 
Table 1. Multi-level Barriers to HPV Vaccination in Rural 
Settings Identified in Rural Mountain West Focus Groups 
Parent/caregiver challenges (n = 34) 
N (%) 
Uncertainty about which vaccines to get 
12 (35.6) 
Cost of vaccine 
7 (21.1) 
Time to clinic 
5 (15.2) 
Cost of clinic visit 
5 (15.2) 
Scheduling clinic appointment 
4 (12.1) 
Distance to clinic 
1 (3.03) 
Provider/stakeholder challenges (n = 99) 
N (%) 
No system to remind parents for 2nd dose 
21 (21.2) 
No records of previous vaccines for patient 
13 (13.1) 
No system to remind providers to talk with 
Parents/Caregivers 
12 (12.1) 
No standing orders for the HPV vaccine  
8 (8.1) 
Table 2. Selected Sea Mar Community Health Center Clinics* 
Sea Mar 
Clinic 
Location 
N 
patients 
(2019) 
% 
Rural 
%  
His- 
panic  
N 
patients 
ages  
11-17 
years 
Among Patients 
Ages 11-12 Yrs.* 
Among Patients  
Ages 13-17 Yrs.* 
% HPV 
vac. 
Initiat. 
% HPV 
vac. 
complet. 
% HPV 
vaccine 
initiat. 
% HPV 
vaccine 
complet. 
Ocean 
Shores 
2971 
40.1 
5.6 
158 
36.7 
2.6 
45.5 
25.6 
Aberdeen 
3941 
40.1 
14.9 
241 
45.4 
8.5 
62.1 
44.8 
Elma 
982 
40.1 
21.8 
73 
53.3 
16.3 
74.7 
67.7 
Yelm 
4088 
29.0 
13.0 
566 
48.3 
18.2 
58.5 
44.3 
*Estimated 5% decline in HPV vaccination rates shown due to COVID-19 pandemic challenges 

 
 
(49%).88 The Center for Hispanic Health Promotion: Reducing Cancer Disparities (U54CA153502; 
Research Director: Coronado) engaged in a partnership with a rural health center to test a culturally-tailored 
cervical cancer screening curriculum developed using IM.89-91 SMARTER CRC (UG3CA244298) focuses on 
improving CRC screening, follow-up, and referral to care in rural populations. The program has recruited 3 
Medicaid Plans and 30 clinics, further demonstrating our success in partnering with rural clinics. 
Preliminary Data Collected During the COVID-19 Pandemic. Since January 2021, we have interviewed 
22 rural and rural Hispanic P/Cs in the Mountain West. These P/Cs have explicitly stated that they need 
targeted HPV vaccine intervention messages that answer specific concerns and counter misinformation. The 
rural and rural Hispanic P/Cs prefer text, emails, and phone calls to address vaccine hesitancy domains 
(Figure 2). In our recent survey of young adults ages 18-26 (n=2937), receiving information and reminders 
about the HPV vaccine from a HC professional was associated with receipt of the HPV vaccine for rural (76% v 
24%, P<.0001) and Hispanic participants (73% v 28%, p<.01). Dr. Kepka and her team successfully pilot-
tested a targeted HPV vaccination automated messaging campaign in rural Colorado that improved the 
intention of rural parents and caregivers to receive the HPV vaccine and complete the multi-dose series.82 
C.3. Research Design 
C.3.a. Study Setting: Community participation is crucial to the success of studies and programs targeting 
underserved populations.92-95 PREVENT will be carried out in a 3-way partnership between Huntsman Cancer 
Institute, Kaiser Permanente Center for Health Research, and Sea Mar Community Health Centers. Through 
Sea Mar and the IMW HPV Vaccination Coalition’s large network, the proposed trial can improve HPV 
vaccination rates, accelerate dissemination of findings, and lessen HPV-related cancer mortality.96 
Huntsman Cancer Institute (HCI): Headquartered in Salt Lake City, HCI is the only National Cancer Institute-
designated comprehensive cancer center in the Mountain West. The Institute sponsors the IMW HPV 
Vaccination Coalition, formed by Dr. Kepka in 2014.65 The Coalition brings together immunization program 
representatives, P/C, HCP, and community members who share the common goal of improving HPV 
vaccination rates. Initially formed with 100 members in Utah, Idaho, and Nevada, the Coalition now includes 
more than 400 members in 12 Mountain West states, including Washington and Oregon. Through cross-sector 
collaborations among diverse stakeholder communities, the Coalition is building a coordinated plan to 
implement innovative and evidence-based strategies to address regional barriers to HPV vaccination.65  
Kaiser Permanente Center for Health Research (CHR): A member of the Health Care Systems Research 
Network and Cancer Research Network, CHR has a long track record of successful practice-based research, 
including a history of productive collaboration with Sea Mar. Dr. Coronado began a partnership with Sea Mar in 
2004, launching a pilot study to improve rates of CRC screening, using mailed FIT outreach.97 Since that time, 
Dr. Coronado and Sea Mar have worked on 3 NIH-funded projects with sharing data across organizations.  
Sea Mar Community Health Centers: Sea Mar is a federally qualified health center (FQHC) that operates 35 
primary care clinics (4 rural clinics will participate in this trial; Table 2), serving more than 300,000 unique 
patients in Western Washington, of whom 70% have household incomes at or below the federal poverty level 
and about 40% are Hispanic persons.98, 99 Sea Mar is well equipped to serve as a partner in PREVENT (IM 
Steps 1 & 2: Needs Assessment & Matrices). Dr. Jimenez has engaged in efforts over the past 3 years to 
create systems to track and improve HPV vaccination rates. Community health and outreach staff in all Sea 
Mar clinics are fluent in Spanish and English. Sea Mar has strong technological resources to carry out this 
project, including the Epic EHR, with nearly complete data capture for vaccinations and demographic 
characteristics. Sea Mar maintains an ongoing contract with ClientTell (Valdosta, GA), who provides state-of-
the-art automated telephone reminders for patients with upcoming appointments and delivered automated 
phone calls and text messages for the STOP CRC project (Section C.2.). The system, fully integrated in the 
EHR, notifies the user as to whether a phone message or text was received. Sea Mar also uses a patient 
portal that allows patients and P/C to view their health summaries and test results, request medical 
appointments, see vaccinations that are due, and communicate electronically and securely with their HCP. 
HPV vaccine events are recorded as laboratory procedures. Vaccines completed outside of Sea Mar are 
obtained from the Washington State Immunization Information System (WA-IIS), through a bi-directional health 
information exchange. HPV vaccines for uninsured or Medicaid-eligible individuals <18 years old are covered 
through the Centers for Disease Control and Prevention’s (CDC) Vaccines for Children Program.100 Insurance 
covers all other vaccines. In addition to the four Sea Mar clinics that will participate in this trial, we can offer 

 
 
participation to an additional 30 
Sea Mar clinics as alternate 
performance sites, and other 
rural clinics affiliated with the 
IMW HPV Vaccination Coalition 
are also available as 
performance sites (Letters of 
Support).65, 84 
C.3.b. Conceptual model (IM 
Step 3): We will use several 
frameworks and validated 
processes to guide PREVENT 
activities (Figure 5). IM outlines 
steps for organizing our efforts to 
adapt and implement research-
tested interventions in new 
settings (Figure 3). Our 
participatory research methods 
engage multiple partners as 
equitable collaborators in the 
research process.101, 102 We will 
use BCT to engage parents/caregivers in translating health information into concepts, messages, and 
materials that are understandable, meaningful, and engaging to the target population,103, 104 and to develop 
new messages that leverage national attention on vaccinations and public health prevention initiatives, as a 
result of the pandemic.103, 105 Dr. Coronado, trained as BCT facilitator, will use the method to culturally and 
linguistically adapt material and define intervention components. Applying the Proctor Implementation 
Framework, including RE-AIM Framework domains,106-111 we will gather quantitative data to assess the Reach 
and Effectiveness of the reminder intervention and gather qualitative data from P/C, HCP, and community 
organizations to identify clinic-level enhancements and assess barriers/facilitators to PREVENT’s broad 
Adoption, Implementation, and Maintenance.112  
 
We will use BCT to develop locally relevant intervention materials (e.g., reminder phone scripts for automated 
calls, text messages, and patient portal messages for P/C). Targeted promotional materials for HPV 
vaccination are available in Spanish and could be translated into other languages, as needed.99  Newly 
designed messages and materials will seek to counter anti-vaccination sentiment by leveraging cancer 
prevention, vaccine effectiveness, and vaccine safety messages. BCT methods will provide the framework to 
tailor HPV vaccination messages for rural and Hispanic IMW P/C. (IM Step 4). 
C.4.a. Bootcamp Translation: BCT, a method for engaging diverse stakeholders in a consensus-building 
process,103, 104 has been used by our team to actively develop and adapt study interventions.105, 113 It uses an 
iterative, flexible schedule of face-to-face meetings combined with short, focused teleconferences in a process 
that addresses 2 questions: “What do we need to say in our message to the community (newly HPV vaccine-
eligible adolescents and adolescents who have not completed the HPV vaccination series)?” and “How do we 
deliver that message to our community?” BCT emphasizes no wrong answers and no hierarchy of expertise. 
The process requires 15-20 hours of participant time over 3-6 months.  
We will recruit P/C (i.e., participants) for BCT sessions by working with Sea Mar’s project manager to generate 
a list of potential P/C of patients across the 4 clinics. Eligible participants: a] are P/C of C/As ages 11-17 (age 
eligible for HPV vaccination); b] P/C with active clinic patients (i.e., have been seen in the clinic in the last 12 
months); and c] P/C who speak either English or Spanish. About 1038 patients in the 4 rural Sea Mar partner 
clinics (Table 2) meet these criteria. We will select participants to achieve a mix of HPV vaccination behaviors 
(from never vaccinated to up-to-date), sex of parent, sex of child, age, and language. We will send letters to 
prospective participants on clinic letterhead (in English and Spanish). Within 2 weeks, we will make follow-up 
C.4. Specific Aim 1: Design format and content of an intervention to promote adolescent HPV vaccine 
coverage that will consider unique information needs of diverse rural parents/caregivers. 
EHR tools to identify 

 
 
calls to discuss BCT and conduct a brief intake survey. We will recruit 6 participants from each clinic (24 total): 
12 whose preferred language is English and 12 whose preferred language is Spanish. Two Sea Mar providers 
(Dr. Gibbs and Ms. Torres) and 2 members of the Coalition (Dr. Shannon and Ms. Jaquette) will participate.  
Dr. Coronado will lead the project team in applying Bootcamp Translation. We will conduct 2 parallel 
sessions, one in English and one in Spanish, with approximately 14 participants per session (12 
patients, 2 Sea Mar staff). The in-person or live Zoom presentation will consist of an expert presentation by 
Drs. Kepka and Coronado (for the Spanish-language presentation) with input from Drs. Brewer and Brandt. 
They will share research on the safety and effectiveness of the HPV vaccine and social norms about 
vaccination. They will educate participants about the six different types of cancers that are prevented by the 
HPV vaccine among women and men in the United States. Drs. Kepka and Coronado will also present up-to-
date evidence on effective messaging by clinicians (e.g., using presumptive statements, bundling HPV vaccine 
recommendations with recommendations for other vaccines)114-117 as well as novel formats for educational 
messages (e.g., digital videos, narratives).51, 118  
Participants will be assigned to a Spanish-language or English-language text message group, as appropriate, 
to provide iterative feedback to the research team on HPV vaccination messages over a 3-month period. Our 
clinical partners in rural communities emphasized the high prevalence of mobile phone use among the 
parents/caregivers in their communities for seeking and sharing health information, and nationally 95% of 
adults ages 18-49 have a smartphone, including the majority of Hispanics (85%) and rural residents (80%).119 
Further, obtaining feedback from P/C about the suitability of HPV vaccine messages through text messaging 
will facilitate more specific and tailored feedback from participants, increased accessibility for individuals who 
may have limited access to meet in-person,120 and provides an opportunity where individuals may feel more 
comfortable sharing their opinions and perceptions than they would during a face-to-face or synchronous 
online experience. Text messages will emphasize individual involvement and personal meaning to 
enhance retention and promote engagement. Text messages between study staff and BCT participants will 
occur through the text messaging Twillio, which we have previously used to pilot HPV vaccine reminders. Text 
messages will be designed to elicit feedback on the HPV vaccination messages (which are suitable for girls vs. 
boys, English vs. Spanish speaking parents/caregivers) that are developed during the Bootcamp sessions, on 
reminder scripts (i.e., automated call scripts, text messages, patient portal messages), and on key intervention 
components (e.g., reminder type, number, sequence). The text messages will occur two times per week. This 
process can be automated using the text-messaging tool Twillio. Each text will ask participants to provide their 
feedback via text response. Messages will be pilot tested.121 
Because the BCT process is interactive and iterative, recording and transcribing sessions is often impractical. 
Instead, field notes will be taken by our team in English and/or Spanish during each session and shared during 
weekly meetings of the project team. Reminder materials tailored through BCT and proposed protocols for the 
intervention will be reviewed by members of the IMW HPV Vaccination Coalition and tested during study Aim 
2. Following BCT, we will finalize our trial protocol, including procedures for the Auto and the Auto-Plus arms of 
the intervention, and will finalize methods for data coordination, management, and ongoing monitoring. 
Because our goal is to craft materials and messages that are motivating for English- and Spanish-speakers, 
we do not anticipate directly translating materials from English to Spanish. Instead, we rely on BCT and native 
speakers to craft messages from the ground up; this approach was successful in prior research.113 We aim for 
a broad scale-up, all English and Spanish materials will be reviewed by the Sea Mar marketing and 
communications office for appropriateness and equivalency.122  C.4.b. Update Data Sources and Codes: In 
preparation for the RCT, we will define automated codes to manage interventions so that P/Cs of vaccine 
eligible C/As, who receive initial HPV vaccination, are prompted to receive follow-up vaccine on time. Dr. 
Coronado, a community clinic EHR data expert, will lead this work.  
Inclusion and Exclusion Criteria and Data Sources: Working with clinic staff, our research team will use patient-
level inclusion and exclusion criteria based on current HPV vaccine guidelines to determine P/C participant 
eligibility. These criteria will consider previous HPV vaccination history, clinic visits (as a proxy for patient 
enrollment), clinical conditions that influence CDC HPV vaccine recommendations (e.g., pregnancy), age (11-
17), and other factors.123 For this study, language will also be a criterion, as we plan to conduct the intervention 
in English and Spanish. We anticipate that EHR systems at our 4 clinics will likely provide complete information 
on vaccination status for HPV and other vaccines (e.g., Tdap, meningococcal). The Washington State 
Department of Health maintains accurate, up-to-date information on vaccination status in the WA-IIS, and 

 
 
patient-level immunization data are already routinely provided to Sea Mar through a health information 
exchange.124  As part of Aim 1, we will perform sensitivity analysis, cross tabulation, and targeted chart audits 
(of up to 100 charts from each clinic) to assess the agreement between HPV vaccine events found in the EHR 
and in the state-level vaccine registries, recognizing that previous studies have reported agreement ranging 
from 96% to 99%.125 Epic offers existing tools for documenting external procedures and discrete code-based 
fields for categorizing laboratory events and needed follow-up. We will provide support and training to enter 
these data within our clinics’ EHR, to assure complete data when possible.  
 
We hypothesize that Auto and Auto-Plus interventions will be more effective than usual care, and Auto-Plus 
will be more effective than Auto at increasing receipt of the next needed HPV vaccine dose and on series 
completion. We will implement and evaluate the intervention in 4 clinics using an individual-RCT design (IM 
Steps 5 and 6). Our quantitative evaluation will assess intervention effectiveness and reach. We will gather 
P/C-, patient- and HCP-level data to identify possible program enhancements, as well as barriers and 
facilitators to adoption, implementation, and maintenance.  
C.5.a. Convene Teams and Train Staff: Each participating clinic will convene an implementation team 
comprised of a clinic champion, clinic coordinator, and relevant laboratory and administrative personnel whom 
we will select for their ability to facilitate the intervention within the clinic settings. Once the team is formed, 
members of the PREVENT research team and clinic staff will train the participating clinics in delivering the 
intervention. Staff training will take place during a half-day session (with additional phone support) and will 
address procedures for identifying P/C of eligible patients and tracking automated outreach (e.g., automated 
phone calls, text messages). Clinics will receive training specific to the Auto-Plus components, such as the live 
phone call and patient navigation protocols using as computer assisted interactive system.  
C.5.b. Intervention Process: Focused on HPV vaccine initiation. Through BCT, we will select a set of HPV 
vaccine initiation reminders to encourage uptake among age- and vaccine-eligible adolescents. Reminders 
could include letters (with strong provider recommendations, and bundled recommendations), text messages 
with links to digital stories, patient and/or P/C narratives, letters, automated phone calls, or email messages. 
Because we hope to implement this trial as part of standard care, our study will apply to obtain a waiver of 
informed consent, which was successful in STOP CRC because intervention components are similar to 
primary health care settings’ standards of care and imply minimal risk (See Section C.2). Sea Mar analysts will 
create a real-time list of patients due for an initial HPV vaccine dose, and the clinic outreach coordinator will 
review the list and remove any patients missing telephone number or address (if a mailed intervention is 
selected). P/C of remaining children and adolescent patients (i.e., participants) will be individually randomized 
to either Auto or Auto-Plus intervention or UC, in a 1:1:1 ratio. The PREVENT study will only target one 
child/adolescent per parent/caregiver (siblings will be excluded from intervention assessments). In Sea Mar 
clinics, 87% of phone numbers of patients eligible for CRC screening (aged 50-75) could receive text 
messages; we expect a higher percentage for the younger cohort in this trial.88 Participant lists will be sent to 
Sea Mar’s communications vendor (ClienTell) for delivery of automated HPV vaccine initiation prompts; the UC 
group will not receive tailored reminders but will only receive opportunistic vaccine reminders that are delivered 
during clinic visits or MyChart EHR-based patient portal reminders. As in STOP CRC, real-time participant lists 
will be refreshed to discontinue reminders for P/C of patients who have received a given vaccine dose. 
Consistent with the desire of clinic staff to integrate this project into their standard workflows, we will use 
automated codes to manage interventions so that eligible patients get initial HPV vaccines on time and P/C are 
prompted to repeat vaccination, as recommended. Our EHR tools rely on Reporting Workbench, a population 
management tool in Epic which will be customized to include tools needed for tracking completion of HPV 
vaccination at the 4 intervention clinics.126 The registry will list patients’ HPV vaccination history as well as key 
demographic variables for the intervention (e.g., name, address, preferred language). We will select a cohort of 
approximately 1,038 P/C of patients from the 4 clinics, randomized to intervention arms (UC, Auto, and Auto-
Plus) stratified by clinic, sex, and language preference (English, Spanish, other) to ensure a nearly balanced 
distribution of clinic, sex, and language preference among study arms. The registry will generate 2 real-time 
reports: 1] HPV vaccination outcomes (i.e., date of vaccination events, and whether the event represents 
series initiation, second dose, and/or series completion); and 2] PREVENT intervention activities (i.e., date of  
C.5. Aim 2: Test a set of automated reminders (defined during Aim 1) on timely receipt of next needed 
HPV vaccine dose and on series completion. 

 
 
mailing, date of automated phone 
calls, text messages, patient portal 
messages). We will use reports to  
monitor and maintain quality 
assurance during intervention 
implementation, and Reporting 
Workbench to automate patient-
specific mass mailings for P/C, and 
HPV vaccine orders. 
Automated Intervention (Auto): Auto 
intervention participants will be 
eligible for outreach delivered using 
automated phone calls, text or email 
messages with the mode, frequency, 
timing of reminders, and message 
content refined using BCT. 
Automated outreach may also 
include innovative communication 
strategies, such as text-linked 
videos, P/C, or patient narratives 
(based on BCT). Auto outreach to 
P/C will invite P/Cs to attend free 
HPV vaccination visits and will 
emphasize family-friendly hours.  
Automated Intervention Plus (Auto-
Plus): Auto-Plus intervention 
participants will be eligible for 
automated reminders, plus 
additional P/C prompts for patients 
who do not undergo vaccination 
within 3 weeks. These prompts may 
be delivered via live phone call 
outreach or patient navigation. 
Working with clinic leadership and using the findings BCT, activities will be selected from a list of possible 
options from the National HPV Vaccination Roundtable (previously chaired by Dr. Brewer), and our ranking of 
the effectiveness of language- and culturally-tailored intervention materials. Recommended interventions:  
• Live phone call outreach: Live phone call outreach allows outreach staff to answer P/C questions, ease 
vaccination resistance, and facilitate appointment scheduling in real-time. Sea Mar outreach staff are 
already trained in motivational interviewing, and we prompt them in HPV-specific communication 
techniques (i.e., presumptive language, bundled recommendations, as appropriate).  
• Interactive web-based coaching tool: Live calls will be facilitated by an interactive web-based coaching tool 
that prompts patient navigators during live phone calls with P/C on how to best respond to varying types 
and levels of P/C vaccine hesitancy. This tool will be developed by Drs. Kepka and Coronado in 
partnership with HCI’s bioinformatics core. P/C identified vaccine hesitancy barriers may fall within the 
broad domains related to vaccine confidence, vaccine complacency, and vaccine convenience (Figure 2). 
• Patient navigators: trained staff who promote healthful behaviors by addressing barriers to care. Navigators 
can respond to the cultural needs of their patients—such as values of personalismo or respeto.127, 128  
C.5.c. Intervention Process: Focused on HPV vaccine series completion. The BCT process will define the 
format (mode and frequency) and content of messages to promote vaccine series completion. The clinic-level 
analysts will generate real-time lists of patients who have initiated the HPV vaccine and are due for a follow-up 
dose, stratified by age group (11–14 vs. 15–17). The list will include adolescents age 11–14 years who have 
completed an initial dose of the HPV vaccine and are due for a second dose (within 6-12 months) and those 
aged 15–17 who are due for a second or third dose. While Auto and Auto-Plus interventions for series 
Table 3: Schedules of Measures (part.=participants; T=time, Y=year; M=month)  
Variable 
Data source 
How 
measured 
Proctor/ RE-
AIM domain 
T  
Aim 1: Bootcamp Translation (BCT) 
Rural parent-/ caregiver- & 
provider-driven adaptations/ 
program acceptance 
Parents / 
providers 
Notes from BCT 
sessions 
Adaptations, 
Acceptance 
Y
1 
Aim 2: PREVENT Randomized Controlled Trial (RCT) 
Reach of RCT – primary 
outcome (next needed HPV 
vaccine dose) 
EHR; vendor 
logs 
N part. receive 
program/ N 
anticipated, 
reasons  
Reach 
6
m 
Reach of RCT – secondary 
outcome (completion of 
HPV vaccine series) 
EHR; vendor 
logs 
N part. receive 
program/ N 
anticipated, 
reasons  
Reach 
6
m 
Effectiveness of RCT – 
primary outcome 
EHR 
N C/A complete 
next HPV 
vaccine dose/ N 
anticipated 
Effectiveness 
6
m 
Effectiveness of RCT – 
secondary outcome 
EHR 
N C/A complete 
all doses of HPV 
vaccine2/ N 
anticipated 
Effectiveness 
13
m 
Aim 3: Tertiary and Qualitative Outcomes 
Moderators (e.g., sex of 
parent, sex of child, age, 
ethnicity, etc.) 
EHR data 
Effectiveness of 
intervention by 
presence of 
moderator 
Equity 
6
m 
Parent/caregiver reactions 
Interviews 
Coded 
transcripts 
Acceptance 
Y
3 
Provider/staff reactions 
Interviews 
Coded 
transcripts 
Acceptance, 
Adoption, 
Implementati
on, 
Maintenance 
Y
3 
Parent/caregiver/child 
EHR/Admini
strative data 
Delivery/receipt 
of interventions 
as intended 
Fidelity 
Y
3 
Clinic-, community-level 
barriers / facilitators to 
implementation/ sustainability 
Interviews 
Coded 
transcripts 
Adaptations, 
Acceptance, 
Maintenance 
Y
3 

 
 
completion may use some of the same components as vaccine initiation (automated calls, live calls, text 
messages, emails, and mailings), some notable differences will likely exist. HPV vaccine initiation may bundle 
recommendations for HPV and for other needed vaccines (e.g., “[Patient name] is due for the following 
vaccines: HPV; meningococcal; Tetanus, Diphtheria, Pertussis”), whereas series completion will not need 
bundled messages. Series completion reminders will include scheduling and appointment reminders.69  
C.5.d. Evaluation: Based on our previous research and conversation with clinic staff, we have designed 
Phase I to include multiple components. Using the Proctor Implementation and RE-AIM frameworks, we will 
track intervention reach and effectiveness. We will conduct one-on-one interviews with participants and debrief 
interviews with HCP to illuminate persistent barriers to HPV vaccination uptake and factors important to 
program acceptability, maintenance, and sustainability. Table 3 summarizes these measures. 
Program Effectiveness: We will assess intervention effectiveness for each of the three study arms, calculated 
as the proportion of eligible children/adolescents who received any HPV vaccine within 6 months and 13 
months (series completion by one year) of randomization. We will assess the proportion of C/A who initiated 
HPV vaccination, those who received the next needed dose and the percent who completed the series. 
Study Design:  We propose a 3-arm RCT to compare rates of completing the next step in the HPV vaccination 
series at 6 months and completing the HPV vaccination series at 13 months between Auto, Auto-Plus, and UC 
arms. P/C of C/A who have not completed the HPV vaccination series will be randomized 1:1:1 to study arms, 
with separate randomizations within each clinic (Ocean Shores, Aberdeen, Elma, or Yelm) and patient-level 
HPV vaccination initiation status (series initiated or not initiated). Participants will be assessed for eligibility 
and, if eligible, enrolled within the 4 clinics at their first visit time during the 12-month study period, with a total 
participant time on study of 13 months, for a total of 25 months of enrollment, execution, and follow-up. 
Statistical Approaches: The primary comparisons are between the rates of completing the next step in the HPV 
vaccination series at 6 months in the Auto, Auto-Plus, and UC arms (Primary Outcome), and between the rates 
of completing the HPV vaccination series at 13 months (Secondary Outcome). Completing the next step in the 
vaccine series and completing the vaccine series outcomes will be compared via logistic generalized 
estimating equations (GEE) models,129, 130 with bias-reduced robust sandwich variance estimators131 clustered 
by clinic. These logistic GEEs will be adjusted for P/C and patient features that may influence HPV vaccination 
series next step and completion, including age, sex, race/ethnicity, rurality, and HPV vaccination initiation 
status at study enrollment. Models comparing the Auto, Auto-Plus, and UC groups, will also include study arm. 
Comparisons between the study arms of the next-step and series-completion endpoints will be performed 
separately. For each endpoint, pairwise differences between arms will be assessed with a Bonferroni 
correction to achieve type I error control at 0.05, with p<0.017=0.05/3 needed for statistical significance. Pre-
defined subgroup analyses will be performed by P/C and/or patient sex, age group, race/ethnicity, rurality, and 
HPV vaccination initiation status at study enrollment, and each of these characteristics will be assessed for 
effect moderation. Since next step completion and series completion will be captured via the EHR and the 
state-wide vaccine registry, we anticipate little missing data for these outcomes. Statistical Analysis and Power: 
Based on the Table 2, there are 1038 patients in the appropriate age range, of whom <50% will have 
completed the HPV vaccination series, for at least 519 patients within the eligible age range who have not yet 
completed the HPV vaccination series, with at least 173 in each study arm. 173 participants per study arm will 
ensure >80% power for detecting rate differences for both the next step endpoint and series completion 
endpoint exceeding 0.17, under the Bonferroni statistical significance benchmark of p<0.017. If the completion 
endpoint rate is 50% in the Auto-Plus arm and is 33% in the UC arm (rate difference 0.17), then the proposed 
study will have 80% power for detecting a difference by arm. Moderators: We will assess differences across 
study arms in our secondary outcome: missed opportunities, defined as patients who receive other 
recommended vaccinations, but not HPV. We will also explore possible moderators of effectiveness: age (11–
14, 15–17), ethnicity (Hispanic vs. non-Hispanic white), sex (male vs. female vs. other), language (Spanish vs. 
English), poverty status (<100% Federal Poverty Level vs ≥100% Federal Poverty Level), and insurance status 
(commercial vs. Medicaid vs. other). Thus, we will consider sex a biological variable, an important distinction 
because of differing rates of HPV vaccination and barriers faced by adolescent males and females.132-135 By 
assessing differences in effectiveness across the life course of ages 11–14 and 15–17, we will understand 
differences in groups for whom 2 doses and 3 doses of the vaccine is recommended. Each potential moderator 
will be tested separately by considering its main effect and interaction with study arm in the logistic mixed 
effects models (Aim 2). Evidence of differential intervention effectiveness will be supported by an overall test of 

 
 
the potential moderator by study arm interaction effects.  
 
We will accomplish this aim using mixed methods assessment (IM Steps 5 and 6) and assessing 
implementation outcomes from administrative and EHR data. With guidance from Dr. Brewer (consultant), we 
will conduct qualitative assessment that will consist of P/C interviews conducted 6 months following 
randomization in Phase II of the PREVENT study as well as HCP interviews conducted in Year 4. The 
assessments will gather P/C and HC team member reactions to the intervention and recommended areas for 
improvement, including provider- and clinic-level practices that could enhance the program and organizational-
level factors that influence adoption, implementation, and maintenance over time.  C.6.a. Parent/Caregiver 
Interviews: During the intervention-testing stage, we will conduct one-on-one interviews to elucidate factors 
related to non-adherence to HPV vaccination recommendations (e.g., awareness, anti-vaccination norms) 
among English- or Spanish-speaking P/C who received HPV reminders. One-on-one interviews can help 
identify salient constructs related to health behavior and are recommended for sensitive topic areas.136 About 
40 P/C who received reminders during the previous 6 months will participate in the interviews. An interview 
guide will be developed based on study team expertise, BCT experiences, process notes taken during 
meetings, a literature review, and factors hypothesized to influence implementation and effectiveness 
outcomes derived from the Proctor and RE-AIM frameworks. We expect that 40 interviews will suffice to obtain 
both the breadth and depth of information and data saturation.137-139 Interviews will be held either by phone or 
in person at the clinic and will last about an hour. Participants will be offered a stipend ($25) as a token of 
appreciation. Eligible participants, identified using clinic records, will be mailed an introductory letter (including 
a phone number for the project office), then called by phone. Interviews will be digitally recorded using 
password-protected devices, professionally transcribed, and imported into ATLAS.ti for data management and 
analysis. Bilingual study team members (Dr. Coronado and Ms. Rivelli) and a qualitative methodologist (Dr. 
Rothwell) will content analyze the interviews.139-141 A subset of transcripts will be reviewed to develop a 
codebook, applying codes to passages of transcript text, then iteratively reviewing code reports to identify 
common themes. Team members will meet regularly to discuss differences in coding and themes until 
consensus is reached; inter-rater reliability will be established by between-coder agreement in coded text. 
High-level summaries of acceptability/maintenance will occur. C.6.b. Provider/Staff Interviews: Staff 
interviews will address clinical practices, plans for adaptations and stakeholder attributes that influence 
implementation and long-term maintenance, using questions informed by Proctor and RE-AIM, and based on 
instruments developed by Weiner et al., Brownson et al. and others.142-145 We will ask about the HPV 
Vaccination Roundtable’s evidence-based HPV vaccination recommended practices (i.e., standing orders, 
EHR provider prompts, family-friendly office hours, immunization champion(s), strong recommendation, 
provider feedback, vaccination recommendation at every visit, and team huddles).146 Debrief interviews with 
HCP will be conducted by phone and audio-recorded, and will last about 45 minutes. Recorded interviews will 
be transcribed, and analyzed according to the process described above for P/C interviews, involving design 
and application of a codebook, iterative review of reports against actual transcripts, and development of 
summarized themes (acceptance, adoption, maintenance, and future recommendations). C.6.c. Intervention 
Fidelity: Administrative and EHR data will be used to obtain the extent to which interventions were delivered 
and received as intended. Metrics include intervention fidelity (e.g., proportion of C/A that received/interacted 
with outreach staff and patient navigators, received/interacted with interventions).   
C.7. Potential Challenges and Alternative Solutions: By design, we are conducting this research in 4 
clinics, so will likely encounter barriers inherent to research in real-world delivery systems, such as changes in 
operating conditions or practice guidelines. The registry tools we will develop will be flexible to such changes. 
Our selection of P/C of eligible patients relies partially on data from other vaccination sites; nevertheless, we 
will cross-reference our EHR list with immunization registry data, minimizing the possibility of outreaching to 
P/C of patients who are not due. Clinic drop-out and slower-than-anticipated participant recruitment can 
hamper study progress; nevertheless, we can recruit from among the other 30+ clinics that Sea Mar operates, 
and Coalition partner clinics (Letters of Support). To prevent contamination, only one child per household will 
be targeted with the P/C intervention components.  
C.8. Conclusion: Timely HPV vaccinations could prevent more than 90% of HPV-associated cancers.75, 76 
This study will target the groups least likely to undergo vaccination, US rural and rural Hispanic communities.76  
C.6. Specific Aim 3: Assess implementation outcomes and identify multi-level barriers and facilitators 
to implementation.  

 
 
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