PROMOTE Pilot Study: Pharmacy Multimodal Communication Strategy to Promote HPV Vaccination
Phase: NA
Conditions: Human Papillomavirus Infection
Sponsor: Fred Hutchinson Cancer Center

 
 
Official Title: 
PROMOTE Pilot Study 
Pharmacy multimodal communication strategy to promote 
HPV vaccination 
NCT Number: 
NCT04660331 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
DEC 05 2022 
 
 

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PROMOTE Pilot Study 
Pharmacy multimodal communication strategy to promote HPV vaccination 
IRO REC'D 11/17/2022
FHCRC IRB Approval  
DEC 05 2022 
Document Released Date

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Table of Contents  
LIST OF ABBREVIATIONS AND ACRONYMS ........................................................................... 3 
1. SHORT TITLE ........................................................................................................................ 4 
2. INVESTIGATORS ................................................................................................................... 4 
PRINCIPAL  INVESTIGATOR ..................................................................................................... 4 
3. EXECUTIVE SUMMARY ........................................................................................................ 5 
4. BACKGROUND INFORMATION AND RATIONALE ............................................................... 6 
5. SPECIFIC AIMS ..................................................................................................................... 7 
6. STUDY DESIGN AND DATA MANAGEMENT......................................................................... 7 
7. DATA MANAGEMENT .......................................................................................................... 13 
9.  TRAINING PROCEDURES AND QUALITY ASSURANCE................................................... 17 
10. DATA AND SAFETY MONITORING PLAN.......................................................................... 17 
11. ETHICAL CONSIDERATIONS ............................................................................................ 18 
12. STUDY DISSEMINATION PLAN ........................................................................................ 19 
13. STUDY LIMITATIONS AND HOW TO MINIMIZE THEM ..................................................... 19 
14. STUDY TIMELINE .............................................................................................................. 20 
REFERENCES ......................................................................................................................... 20 
 
 

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List of Abbreviations and Acronyms 
 
FHCC 
Fred Hutchinson Cancer Center 
HICOR 
Hutchinson Institute for Cancer Outcomes Research 
HPV 
Human papillomavirus 
IOF 
Implementation Outcomes Framework 
IRB 
Institution Review Board 
TDF 
Theoretical Domains Framework 
 
 

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1. Short Title 
PROMOTE Pilot Study 
 
2. Investigators 
Principal  Investigator 
 
Parth Shah PharmD, PhD 
Assistant Professor, HICOR 
Fred Hutchinson Cancer Center 
1100 Fairview Ave N 
M3-B232 
Seattle, WA 98109 
pshah@fredhutch.org  
 
Co-Investigators 
 
Linda Ko, PhD 
Associate Professor, Public Health Sciences 
Fred Hutchinson Cancer Center 
1100 Fairview Ave N 
M3-B232 
Seattle, WA 98109 
 
 
Jennifer Bacci, PharmD, PhD 
Assistant Professor, Department of Pharmacy 
University of Washington School of Pharmacy 
H-361C Box 357630  
1959 NE Pacific St  
Seattle, WA 98195 
 
William Calo, PhD  
Assistant Professor, Department of Public Health Sciences 
Pennsylvania State University College of Medicine 
3400 Public Health Sciences  
Hershey, PA 17033 US 
 
Project coordinators  
 
Debbie Delaney 
Project Coordinator, HICOR 
Fred Hutchinson Cancer Center 
1100 Fairview Ave N 
M3-B232 
Seattle, WA 98109 
 
Morgan Glascock 
Project Coordinator, HICOR 
Fred Hutchinson Cancer Center 
1100 Fairview Ave N 
M3-B232 
Seattle, WA 98109 

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3. Executive Summary 
 
 
 
 
 
Background & 
Significance 
 
 
 
 
 
Objective: 
HPV vaccination of children ages 9-17 in Washington state is sub-
optimal, particularly among underserved populations.  Convenient 
and easy to access, pharmacies are promising vaccination settings 
that have potential to increase HPV vaccination rates. However, low 
parent awareness of services and poor engagement by pharmacy 
staff are significant barriers to wider implementation.  
 
This will be a mixed methods pilot intervention study exploring the 
use and development of a multimodal communication strategy to 
increase pharmacy‐located HPV vaccination for adolescents. The 
multimodal strategy includes adapting an existing electronic 
“forecasting” system to identify vaccine eligible children who are due 
for vaccination and communication training for pharmacy staff to 
effectively recommend HPV vaccination. The study will involve the 
enrollment of parents/guardians with children between the ages of 9-
17 and pharmacy staff at pharmacies in Western Washington state.  
 
 
Methods 
Aim 1: Conduct key informant interviews to inform/adapt an existing 
electronic forecasting system and behavioral counseling framework 
to match barriers and facilitators to HPV vaccination in pharmacies.  
 
Aim 2: Pilot and test the impact of an adapted multimodal 
communication strategy in pharmacies to support HPV vaccination.  
Population: 
Aim 1:  Key informant interviews will be conducted with up to 12 
parents/guardians of children aged 9-17 and up to 18 Bartell Drugs 
pharmacy staff members. 
 
Aim 2: Administer a pre/post implementation study questionnaire to 
all pharmacy staff in up to four independent pharmacies in Western 
Washington state and assess the adoption of the intervention based 
upon audits. 
 
Sites: 
Bartell Drugs and independent pharmacies in Western Washington 
state (independent pharmacies provided letters of support) located in 
the Cancer Consortium Catchment Area 
 
 
Study Duration: 
12 months   
 

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4. BACKGROUND INFORMATION AND RATIONALE  
 
Background 
Human papillomavirus (HPV) causes 34,800 new cancer cases in men and women each year in 
the US, over 90% of which could be prevented by HPV vaccine1. Despite national recommendations for HPV 
vaccination since 20062 the Centers for Disease Control and Prevention reports the percentage of US 
adolescents who are  with HPV vaccination in 2018 is only 51%, well below the Healthy People 2020 goal of 
80%3. Low vaccination rates are persistent in Washington State (including the Cancer Consortium’s Catchment 
Area), with significant geographic variation in up‐to‐date coverage (Figure 1). The President’s Cancer Panel4 
and the National Vaccine Advisory Committee5 have recommended expanding HPV vaccination to pharmacies 
to capitalize on the “medical neighborhood” to increase vaccine access and coverage. Pharmacies are 
promising HPV vaccination settings: 89% of US residents live within 5 miles of a pharmacy6; 50 states and US 
territories allow pharmacists to administer HPV vaccine7; and pharmacists have a long history as vaccine 
providers8, administering millions of doses of several types of vaccines every year9. Our previous national 
surveys showed parents are willing to have pharmacists administer HPV vaccine to their children10‐12 and 
primary care physicians are supportive of pharmacist-provided HPV vaccination13. Our analysis of 
demonstration projects in 5 states also showed that while pharmacy-located HPV vaccination was highly 
acceptable, there are significant barriers to wider implementation: low awareness for services among parents 
and poor engagement by pharmacy staff with adolescent vaccinations undermine HPV vaccine uptake in the 
pharmacy setting14. Our findings prompt the policy question: How can HPV vaccination be effectively 
implemented in pharmacies to help achieve the Healthy People 2020 goal? To date, no implementation 
research has methodically evaluated strategies that could support HPV vaccination in pharmacies. 
 
Rationale 
Our long‐term goal is to increase HPV vaccination rates by strengthening existing capacity in pharmacy‐
located vaccination. The objective of this CCSG catchment area pilot is to adapt and test a multimodal 
communication strategy that can mitigate barriers pharmacies face in communicating about HPV vaccination 
with parents and patients. The strategy will consist of two evidence‐based communication approaches: 1) 
Electronic forecasting to identify vaccine‐eligible children15; and 2) Pharmacy staff using the 5A’s (Ask, Advice, 
Assess, Assist, and Arrange) Behavioral Counseling Framework to recommend HPV and other vaccines. 
Electronic forecasting allows pharmacy staff to proactively check which of their patients are eligible for 
vaccines. A study lead by Dr. Bacci found that proactive prompting improved pharmacy staff engagement with 
vaccination services, resulting in a 15% increase in adult vaccinations at Bartell Drugs, a regional pharmacy 
chain in Western Washington.15 Although the forecasting system improved staff engagement, vaccination rates 
may have been further improved linking the electronic forecasting with communication training on how to 
effectively communicate about vaccines with patients. The 5A’s Framework is a behavioral counseling 
approach endorsed by the United States Preventive Services Task16 and has been effectively used in smoking 
cessation and physical activity interventions for two decades. The framework provides an easy rubric for 
clinicians to evaluate and engage patients’ readiness and intentions for behavior change. Training clinical staff 
to use the 5A’s has been successful for behaviorally intensive interventions, so it would be reasonable to 
believe that it could be used to motivate HPV vaccination. Dr. Shah recently lead a study, published in 
Pediatrics, that identified effective HPV vaccine message characteristics17 that could be applied to the 5A’s. 
The two communication approaches would work together by preempting pharmacy staff to proactively engage 
adolescents/their parents with vaccinations and teach pharmacy staff how to effectively communicate about 
HPV vaccination. However, these communication approaches have not been used in pharmacies to improve 
HPV vaccination. 
 
 
 

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5. SPECIFIC AIMS 
 
Aim 1: Adapt an existing electronic forecasting system and behavioral counseling framework to match 
barriers and facilitators to HPV vaccination in pharmacies. Guided by the Theoretical Domains Framework 
(TDF)20, we will conduct in‐depth interviews with pharmacy staff (n=18) and parents or guardians of children 
aged 9‐17 (n=12) to identify factors that impede or promote parent and patient engagement with pharmacy‐
located vaccination services.  
 
Aim 2: Test the impact of an adapted multimodal communication strategy in pharmacies to support 
HPV vaccination. We will deliver a communication strategy training to pharmacy staff at predetermined 
pharmacy sites within Western Washington. We will assess pharmacy staff’s experiences with the multimodal 
communication strategy and delivering HPV vaccination at baseline and post‐implementation, measuring 
outcomes selected from Proctor’s Implementation Outcomes Framework (IOF).21 We will also develop an 
environmental scan25 to characterize a pharmacy’s environment, vaccination workflow, and team dynamics. 
The findings will be used to adapt the pharmacy’s workflow to better use the currently available forecasting 
system and tailor a vaccine communication training for pharmacy staff based on the 5A’s. 
 
 
6. STUDY DESIGN AND DATA MANAGEMENT 
 
6.1 Study design 
This is a mixed methods pilot study aimed at improving the dissemination and implementation of adolescent 
vaccination services in community pharmacies, particularly HPV vaccination. These services are readily 
available in all pharmacies in Washington state, and, as such, this protocol is largely focused on quality 
improvement of vaccination services. 
 
Aim 1. This aim will use qualitative approaches to identify facilitators and barriers of behavioral determinants 
related to the adolescent vaccine communication and delivery in community pharmacies, with an emphasis on 
HPV vaccination. The activities of this aim will include 1) Conducting cognitive testing with a convenience 
sample of non-participants to get feedback on our interview questions to ensure that they are understandable 
as intended.  No personal information or data will be collected during this phase; 2) Conducting key informant 
interviews with Parents/Guardians and Pharmacy staff using semi-structured interview techniques and 
environmental scans. Interviews will be guided using the TDF. The TDF provides a sound theoretical 
foundation for our inquiry into barriers/facilitators of HPV vaccination in pharmacies, as it provides a 
comprehensive framework of behavioral determinants that impact how well individuals like a pharmacist can 
adopt and integrate an evidence-based practice like HPV vaccination. The TDF constructs we initially include 
in the guide will be informed by our previous research on HPV vaccination in pharmacies[26-28] and our other 
implementation research in pharmacies.[29, 30]  
 
Aim 1 outcomes. Qualitative information will be used to evaluate how well the proposed communication 
strategy matches barriers and facilitators to HPV vaccination in pharmacies for both parents/guardians and 
pharmacy staff. The activities of this aim will result in findings that will be used to adapt the existing forecasting 
system in pharmacies to identify vaccine-eligible children and develop a vaccine communication training for 
pharmacy staff. 
 
Aim 2. This aim will use quantitative approaches to evaluate the feasibility and impact of the communication 
strategies developed in Aim 1 on adolescent vaccination rates in pharmacies, emphasizing HPV vaccination. 
We will use a pre/posttest quasi-experimental design to evaluate the change in vaccination rates at selected 
pharmacy sites after implementation of the multimodal communication strategy, as well as changes in 
perceptions and behavioral predictors of pharmacy staff.  We will also develop an environmental scan[25] to 
characterize a pharmacy’s environment, vaccination workflow, and team dynamics. Conducting environmental 
scans of pharmacies will further contextualize barriers/facilitators to HPV vaccination.[31]  
 
 

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Aim 2 outcomes.  Quantitative information will be collected through the use of online surveys at baseline and 
follow-up. Surveys will assess the acceptability, appropriateness, and feasibility of the proposed 
communication strategy to support HPV vaccination and other adolescent vaccinations. Additionally, pharmacy 
audits will be conducted from the pharmacy electronic records to assess adoption of HPV vaccination, 
measured as the average HPV vaccination rate per pharmacist at each pharmacy. We will also assess the 
impact of the communication strategy on adoption of other adolescent vaccines (e.g., tetanus, diphtheria, 
acellular pertussis; meningoccocal conjugate; influenza). 
 
 
6.2 Study area description 
The catchment area includes independent pharmacies in Western Washington state. 
 
6.3 Study population 
This study will include: 
 
6.3.1 Inclusion and exclusion criteria 
 
Aim 1 
 
Aim 2 
Group 
Parents/Guardians 
Pharmacy staff 
 
Independent pharmacies in Western 
Washington state  
Number targeted 
Parents/Guardians:  
Up to 12 
 
Pharmacy staff: 
Up to 18  
(9 pharmacists, 9 pharmacy technicians) 
Up to 4 sites 
All pharmacy staff at participating sites (up 
to 25 staff members) 
 
Age restriction 
>18 years  
>18 years 
Inclusion 
Parent/Guardians - Individuals with 
children between the ages of 9-17 in 
their care who are English speakers, live 
in Washington state, and have access to 
a telephone or computer with internet 
access (up to 12 parents) 
 
Pharmacy staff - Employed at a Western 
Washington Bartell Drugs pharmacy 
sites and have access to a telephone or 
computer with internet access 
Pharmacy staff employed at up to four 
independent pharmacies in  Western 
Washington who speak English and have 
access to a computer with internet access 
 
 
Exclusion 
Pharmacy staff: Floaters/per diem. Those who object to having their interview audio 
recorded. 
Parents/Guardians: Those who object to having their interview audio recorded. 
 
 
6.3.2 Representation of women, children and minorities 
All parents/guardians, pharmacy technicians and pharmacists will be eligible to participate in this study 
regardless of sex/gender and race/ethnicity. Since the research will be conducted in community pharmacies in 
Washington state, majority (>60%) participants are expected to be White/Caucasian, which is typical of the 
population in Washington state. We expect roughly equal numbers of male and female participants across all 
populations. Pharmacy staff recruited into the study will likely be 60% female based on current demographics 
of this professional workforce in Washington state. 
 
6.3.3 Co-enrollment guidelines 
There are no restrictions on co-enrollment for aims 1 & 2.  
 
6.4 Sample size considerations and sampling strategy  
Aim 1: Purposive sampling will be used to identify potential parent/guardian study participants. Purposive 
sampling from participating pharmacies will be used to identify pharmacy staff. Since the research components 

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of this aim are entirely qualitative in nature, no power calculation is required. Based on previous research 
studies with parents/guardians and pharmacy staff, we believe that the proposed sample sizes for Aim 1 will 
allow us to capture a diverse range of viewpoints and to achieve thematic saturation, where no new information 
is gained by additional interviewing. Sample sizes were determined based on qualitative literature that indicate 
that thematic saturation can be achieved with as few as 12 participants. 
 
Aim 2: Purposive sampling of independent pharmacies in Western Washington state. As this is a pilot study 
aimed at understanding the feasibility, appropriateness, and potential impact of a multimodal communication 
strategy, a power calculation is not necessary for Aim 2. Additionally, this study is purposively designed to be 
of limited scope based on the Fred Hutch/UW Cancer Consortium expectations for CCSG pilot project. Our 
planned future study to conduct a large scale implementation trial will have resources available to hire a 
biostatistician who can support the study team in trial design and conducting power calculations/appropriate 
statistical analyses. 
 
Definition of cases and controls: Not applicable 
 
6.5 Recruitment, screening, consent and enrollment procedures 
 
6.5.1 Aim 1 
 
6.5.1.A Participant recruitment for cognitive testing the interview guides 
We will use convenience sampling to identify participants for cognitive testing the interview guides. The 
convenience sample will include family and friends who have children aged 9-17 and pharmacy staff known by 
the research team. These individuals will not be participating in research. They will be providing feedback on 
interview guides to improve interview questions and to ensure interview questions are understood as the 
research team intended. 
 
6.5.1.B Parents/Guardians with children ages 9-17 
Recruitment & screening: We will use both in-person and online recruitment. Parents will be approached during 
Health Fairs and community events by community health educators employed at the Fred Hutch Office of 
Community Outreach and Engagement. Approached participants will receive a flyer that provides an overview 
of the study, what their participation will entail for the key informant interview, and the incentive they will receive 
upon completion. Additionally, we will recruit parents online through social media platforms such as the Fred 
Hutch Facebook page and provide similar details about the study as with our in-person recruitment method. 
Interested parents will contact study staff by email or phone. The study staff will provide interested participants 
with additional study information and schedule them for a key informant interview that will be conducted either 
by phone or in-person (if permitted). If the participant is interested in participating, study staff will obtain contact 
information for participants to schedule key informant interview appointments. A waiver of documentation of 
written consent will be obtained prior to the beginning of the project for those who are not consented in person. 
 
Enrollment: Interested parent/guardian participants will complete a demographic survey (approximately 10 
minutes to complete) and participate in a key informant interview either in-person or over the phone.  
 
List of procedures for all parent/guardian participants – Online recruitment 
a. Participants interested in participating in key informant interviews will click on the Fred Hutch Facebook 
recruitment ad which will send them to a secure online form set up by Fred Hutch’s Communication and 
Marketing team. This form will provide information about the study and fields to enter their contact 
information if they wish to participate in key informant interviews. 
b. Study staff will contact participants by email or phone and provide additional information about the 
study and answer any questions.  
c. Study staff will schedule key informant interviews with interested participants and provide them with an 
option to conduct the interview in-person (subject to appropriate social distancing procedures) or by 
telephone. 

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d. During the interview time, study staff with go over the informed consent process with participants and 
obtain their verbal consent which will be documented by the study staff. 
e. During the interview time, study staff will conduct the 90-minute key informant interview and 
demographic survey. 
 
List of procedures for all parent/guardian participants – In-person recruitment (subject to appropriate 
social distancing procedures) 
a. We will work with the Fred Hutch Office of Community Outreach and Engagement (OCOE). OCOE 
community health educators will approach parents at health fairs and community events. They will 
provide information about the study through a recruitment flyer. This flyer with have instructions for how 
parents can contact study staff (e.g., study email and phone number) if they wish to participate in key 
informant interviews. 
b. Study staff will contact participants by email or phone and provide additional information about the 
study. 
c. Study staff will schedule key informant interviews with interested participants and provide them with an 
option to conduct the interview in-person (subject to appropriate social distancing procedures), by 
telephone, or by approved video conferencing platforms that are HIPAA compliant. 
d. During the interview time, study staff with go over the informed consent process with participants and 
obtain their verbal consent which will be documented by the study staff. 
e. During the interview time, study staff will conduct the 90-minute key informant interview and 
demographic survey. 
 
6.5.1.C Pharmacy Staff  
Recruitment & screening: Christina Ree, Director of Clinical Programs, will approach Bartell’s pharmacy staff to 
inquire about their interest in participating in the key informant interview portion of the study. Interested 
participants will reach out to study staff, who will further explain the study and obtain contact information for 
participants and schedule key informant interview appointments. A waiver of documentation of consent will be 
obtained prior to the beginning of the project; thus, written consent will not be provided. 
 
Enrollment: Interested pharmacy staff will participate in a key informant interview either in-person or over the 
phone and complete a demographic survey at the end of the interview. 
 
 
List of procedures for all pharmacy staff participants 
a. Study staff will provide a recruitment flyer for pharmacy staff to Christina Ree, Director of Clinical 
Programs, at Bartell Drugs. The recruitment flyer will contain pertinent study information and 
instructions for how pharmacy staff can contact study staff (e.g., study email and phone number) if they 
wish to participate in key informant interviews. 
b. Christina Ree will approach Bartell’s pharmacy staff (in-person, by telephone, or email) to inquire about 
their interest in participating in the key informant interviews and ask them to contact the study staff if 
interested. 
c. Study staff will contact participants by email or phone and provide additional information about the 
study. 
d. Study staff will schedule a 90- minute key informant interview with interested participants and provide 
them with an option to conduct the interview in-person (subject to appropriate social distancing 
procedures), by telephone, or by approved video conferencing platforms that are HIPAA compliant. 
e. During the interview time, study staff with go over the informed consent process with participants and 
obtain their verbal consent which will be documented by the study staff. 
f. 
During the interview time, study staff will conduct the 90- minute key informant interview and 
demographic survey. 
 
6.5.2 Aim 2 
6.5.2.A Participant recruitment for cognitive testing the survey questions 

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We will use convenience sampling to identify participants for cognitive testing the survey questions. The 
convenience sample will include family and friends who are pharmacy staff known by the research team. 
These individuals will not be participating in research. They will be providing feedback on survey questions to 
improve survey items and to ensure survey items are understood as the research team intended. 
 
6.5.2.B Pharmacy Staff 
Recruitment & screening: Mylinh Nguyen, Director of Practice Development for the Washington State 
Pharmacy Association (WSPA), will introduce study information to independent pharmacy owners in Western 
Washington state. Pharmacy owners who are interested in participating in the study must manage/operate an 
independently-owned community pharmacy. Pharmacy owners will contact the study team. Pharmacy owners 
will provide documented confirmation of their pharmacy site’s agreement of participation in the communication 
intervention. We will select 2 to 4 independently-owned community pharmacies with similar patient case load, 
demographic and community characteristics to control for internal threats to intervention validity and 
confounding. A waiver of written consent for the pharmacy sites will be obtained prior to the beginning of the 
project; thus, no written consent will be provided. 
Enrollment: Once pharmacies have been enrolled into the pilot, pharmacy staff will be asked to complete a pre-
implementation online survey (i.e., pretest; 10-15 minutes to complete) via a survey link to assess the 
acceptability, appropriateness, and feasibility of providing HPV vaccination to children aged 9-17 in their 
pharmacies. They will be asked to attend training on the new communication strategy and employ the new 
communication strategy for HPV vaccinations for up to 6 months.   
Once the pilot is complete, pharmacy staff will again be asked to complete a post-implementation survey (i.e., 
post test) in the same fashion as the pre-implementation survey. 
 
Description of communication strategy intervention: The communication intervention will be planned to be no 
more than 120 minutes (target time 90 minutes). The strategy will consist of two evidence-based 
communication approaches: 1) Electronic forecasting to identify vaccine-eligible children; and 2) Pharmacy 
staff using the 5A’s (Ask, Advice, Assess, Assist, and Arrange) Behavioral Counseling Framework to 
recommend HPV and other vaccines. Electronic forecasting allows pharmacy staff to proactively check which 
of their patients are eligible for vaccines. The 5A’s Framework is a behavioral counseling approach endorsed 
by the United States Preventive Services Task and provides an easy rubric for clinicians to evaluate and 
engage patients’ readiness and intentions for behavior change. The two communication approaches would 
work together by preempting pharmacy staff to proactively engage adolescents/their parents with vaccinations 
and teach pharmacy staff how to effectively communicate about HPV vaccination. This strategy capitalizes on 
existing vaccination systems in pharmacies and interpersonal communication training pharmacy staff will be 
familiar with using with patients. 
 

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The communication training will consist of 5 parts delivered during the session: 
1) An educational overview of adolescent vaccination, with an emphasis on HPV vaccination 
2) Overview of the communication strategy 
3) Process for integrating the communication strategy into clinical workflow at the pharmacy 
4) Training on communication strategy 
5) Pharmacy staff practice with the communication strategy 
 
List of procedures for pharmacy staff 
a. Mylinh Nguyen, Director of Practice Development for the Washington State Pharmacy Association ( 
WSPA) will invite independent Western Washington pharmacies to participate in the pilot study 
b. Pharmacy staff at enrolled sites will provide a waiver of written consent to the study team prior to the 
intervention. Waiver will be provided before completing the pre-implementation survey. 
c. Enrolled pharmacies will ask pharmacy staff to consent to the study and complete the pre-
implementation survey 
d. Pharmacy staff will complete the 2-part vaccine communication strategy training (2 sessions, 60 
minutes each) 
i. 
The first session will be online provided as pre-recorded continuing education provided through 
the Washington State Pharmacy Association (WSPA). This session will be used to teach the 
vaccine communication strategy. 
ii. 
4-6 weeks later, the second session will be live, in person or conducted online using Zoom, and 
will also count as CE administered through WSPA. This session will be used to answer any 
follow-up questions about the training, garner feedback on how the pharmacy staff has been 
using the vaccine communication strategy, and retrain on any components of the strategy. 
e. The enrolled pharmacies will partake in the communication intervention pilot for up to six months. 
f. 
After pilot completion, pharmacy staff will be asked to complete the post-implementation survey 

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List of procedures to conduct environmental scan of pharmacy (subject to appropriate social 
distancing procedures) 
a. Study staff will contact the owners of each pharmacy  to schedule a time to visit the pharmacies where 
pharmacy staff who participated in the Aim 2 intervention work. 
b. Under the supervision of the pharmacy managers (in compliance with pharmacy policies and 
procedures), study staff will be granted permission to enter the pharmacies and conduct the 
environmental scan. 
c. The study staff member will observe the pharmacy staff and make note of the environment (e.g., 
workflow set up, features of the pharmacy, medical services provided, etc.) and complete the 
environmental scan. The scan is designed to avoid disturbing or contacting pharmacy staff while they 
are working. No personal identification of staff members will be collected during this observation. Study 
team members completing the environmental scans will be compliant with local jurisdictions’ policies 
and procedures with wearing personal protective equipment (PPE) to reduce risk of coronavirus 
exposure as needed. 
 
 
6.6 Compensation for study participation 
Participant Incentives. Compensation of $50 (as a check, cash, or gift card) will be provided to 
parents/guardians and pharmacy staff for completing the Aim 1 key informant interviews. Compensation 
totaling $40, in the form of cash, will be provided to pharmacy staff for completing the Aim 2 pre- and post- 
intervention surveys.   
 
Pharmacy Incentives. Compensation of $1,000 (as a check) will be given to each participating pharmacy in 
the Aim 2 pilot intervention.  
 
6.7 End of study/final contact  
Aim 1: Parent/guardian and pharmacy staff participants will exit the study after completing their key informant 
interview.  
 
Aim 2: Pharmacies will exit the study once their pharmacy staff have completed the post-implementation 
survey (i.e., post test, 10-15 minutes to complete) . This post survey will be administered up to 5 months after 
the communication strategy intervention has been delivered to the pharmacy sites. The data management 
team from the participating Western Washington independent pharmacies will conduct an audit of the 
pharmacy sites’ vaccination data and send it to the study team for data analysis using a secure data transfer 
method approved by the independent pharmacy and Fred Hutch.  
 
 
6.8 Participant retention  
For Aim 1, participants who do not present for the key informant interview will be called using contact 
information obtained at enrollment. A participant will be considered lost to follow up (LTFU) after 5 attempts 
have been made to contact them on 5 separate occasions without successful rescheduling of an interview. Aim 
2’s retention is based upon pharmacy contractual agreement to participate in the pilot. Therefore, retention is 
not applicable. 
 
6.9 Participant withdrawal  
Participants may voluntarily withdraw from the study for any reason at any time. The PI and research team 
may also withdraw participants from the study in order to protect their safety. 
 
7. Data Management  
7.1 Key informant interview audio recordings and transcripts 

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An interview Excel tracking file with study ID numbers will be used and kept by the project coordinator in a 
password protected server at Fred Hutch and accessible only to the PI and authorized staff. Participants will be 
assigned a study ID number to track their interview audio data and transcript. 
 
Procedure for audio recordings and transcriptions 
a. One day before the interview, the interviewer will ensure that the recorder is fully operational and that 
the batteries are charged.  
b. Prior to the start of the interview, the interviewer will test the recorder to ensure that the audio is being 
well captured.  
c. At the end of the interview, the research staff will play the recording in a private office or room to ensure 
that the discussion was well captured. 
d. After ensuring the interview was well captured, the interviewer will download the recordings into a Fred 
Hutch study folder on a secured server.  
e. After the download is done and confirmed, the file in the audio recorder will be deleted. 
f. 
The interviewer will then hand over the audio recording device to Fred Hutch staff for safekeeping after 
all the interviews have been completed.  
g. Audio Files will be labeled:  
 
Parent interviews  
Parent_ParticipantNumber_Date 
Example: Parent_009_2020.05.07 
Pharmacy staff interviews 
Pharm_ ParticipantNumber_Date 
Example: Pharm_009_2020.05.07 
 
a) The audio files will then be uploaded to GMR Transcription to produce a verbatim transcription.  
b) Audio files and transcriptions will be stored on a password protected server at Fred Hutch that only 
study staff have access to.  
 
7.2 Demographic survey 
The demographic survey will be completed at the time of the key informant interview is conducted. Once the 
interview is completed, study staff will ask participants about the demographics (e.g., age, sex/gender, 
race/ethnicity, etc.) using the questionnaire developed for the survey. The answers will be recorded on a paper 
survey with the participants’ study ID as described in section 7. 1 above. Study staff will enter the data in an 
electronic database created in either REDCap or Qualtrics. This database will be stored securely on Fred 
Hutch servers in a password protected folder only accessible by authorized study staff. Paper copies of the 
demographic survey will be stored in a study folder in either the PI or study coordinator’s office at Fred Hutch in 
a locked file cabinet.  Demographic data will also be collected as part of the Aim 2 online surveys mentioned in 
7.4 below.  
 
7.3 Environmental scan 
The environmental scans will be completed by study staff during their observation of the pharmacy under the 
supervision of the pharmacy owner or their delegate. Study staff will complete the scan using paper copies. 
The data collected will be entered into an electronic database created in either REDCap or Qualtrics. This 
database will be stored securely on Fred Hutch servers in a password protected folder only accessible by 
authorized study staff. Paper copies of the demographic survey will be stored in a study folder in either the PI 
or study coordinator’s office at Fred Hutch in a locked file cabinet. 
 
7.4 Pre- and post-implementation survey. 
Surveys will be administered online through REDCap or Qualtrics. Participants will be assigned a unique ID to 
identify their pre- and post-implementation survey responses. These individuals will receive a survey link sent 
by the study team that will give them secure access to complete the online questionnaire. Survey data will be 
stored on a password protected server at Fred Hutch. Access to data identifying individual subjects will be 
restricted to investigators and staff directly involved in the study, all of whom have completed human subjects 
and standard data confidentiality training. 
 

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7.5 Vaccination audit data from the Independent Pharmacies. 
The study team will establish a data use agreement with the independently pharmacies for the secure transfer 
and management of patient vaccination data from pharmacy sites participating in the pilot intervention. The 
agreement will describe variables to be included, data format, and data management. Data shall consist of the 
following for each patient aged 9-17 receiving vaccinations at the pilot sites: Age, sex/gender, race/ethnicity (if 
captured), insurance status, vaccine type, pharmacy where the patient was immunized, pharmacist who 
immunized the patient (using a unique code assigned to each pharmacist). 
 
7.6 FHCC infrastructure that will secure data files.  
The database management is built with multiple layers of security and the center practices appropriate due 
diligence to ensure the data is maintained in an appropriate manner. The file and database servers at FHCC 
are housed in a dedicated computer machine room containing emergency backup power, a UPS, a back-up 
power generator, a non-liquid fire suppression system, and authorization-based limited access. In addition to 
personal workstations, administrative access to databases and corresponding data will be limited to Virtual 
Private Network (VPN) and/or Terminal Server access. Furthermore, all databases will reside behind a 
redundant firewall system and intrusion prevention system.  
 
A copy of the data will be stored in an Amazon Web Services (AWS) VPC. This account is covered by a 
Business Associates Agreement (BAA) signed by Fred Hutch and Amazon Web Services. The data will be 
transferred to this secure location via an IPsec VPN tunnel between the Fred Hutch Data Center and the AWS 
VPC. While stored in the VPC, all data will be encrypted at rest using custom encryption keys managed with 
AWS Key Management Service. All transport between authorized AWS services including AWS EC2 and AWS 
S3 will be over secure TLS connections. Any processing of the data will be performed using dedicated EC2 
instances to ensure compliance. All access to the AWS Environment is controlled via Security Groups and 
Network Access Control Lists and audited to ensure no unauthorized access occurs.  
 
The electronic data files for this study will be processed on this dedicated, layered-security system. Access to 
data identifying individual subjects will be restricted to investigators and staff directly involved in the study, all of 
whom have completed standard data confidentiality training. Data will be accessed by the study team 
exclusively using encrypted desktop computers.  Per institutional standards, all desktops connecting to Fred 
Hutch networks must be baselined by Center IT to ensure adequate encryption, password protections, and 
configuration for the network to recognize an approved device.  Unauthorized users do not have access to 
areas of the network which contain sensitive data, including PHI. All paper records and forms will be stored in 
locked drawers when not in use. Access to computer records will be strictly controlled and will require 
simultaneous knowledge of the database structure, database language, and multiple passwords. Since the 
system is behind a firewall and is accessible only to study staff, the risk of unlawful penetration is not a 
significant data safeguard concern. 
 
7.7 Policies and procedures regarding the physical possession and storage of data files.  
Access to data identifying individual subjects will be restricted to investigators and staff directly involved in the 
study, all of whom have completed standard data confidentiality training. All hard and soft copies of the data 
with identifiable information will be stored in locked drawers when not in use. Physical media that are received 
from the distributer or any physical copies of the data will be encrypted while at rest and will be held in a locked 
cabinet within the user’s office. All paper records and forms will be stored in locked drawers when not in use. 
Secure pulping will be used on any printed material containing individual identifiers 
 
In order to access data, all individuals on the study team must have completed FHCC’s Confidentiality Training 
for Investigators and Research Staff and will have to apply for access according to the Center’s Information 
Security Policy by submitting a CIT Data Services Data Request Form. The granting of access is contingent 
upon agreement to these security policies, which dictate responsible data usage and the loss of use privileges 
if violated. 
 
7.8 Data destruction 
 

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Study records will be destroyed 7 years after the study IRB file is closed per Fred Hutch data destruction 
guidelines. 
The Aim 2 limited data set from the independent pharmacies, showing vaccination rates, will be destroyed after 
the study manuscript is published.  
 
Data stored on:  
Will be destroyed by:  
Server or workstation hard disks, or  
Removable media (e.g. floppies, USB flash drives, 
portable hard disks) excluding optical discs  
Using a “wipe” utility which will overwrite the Data at 
least three (3) times using either random or single 
character data, or  
Degaussing sufficiently to ensure that the Data 
cannot be reconstructed, or  
Physically destroying the disk  
Paper documents with sensitive or Confidential 
Information.  
Recycling through a contracted firm provided the 
contract with the recycler assures that the 
confidentiality of Data will be protected.  
Paper documents containing Confidential Information 
requiring special handling (e.g. protected health 
information)  
On-site shredding, pulping, or incineration  
 
7.9 Endpoints and variables 
Aim 1: Qualitative information will be used to evaluate how well the proposed communication strategy matches 
barriers and facilitators to HPV vaccination in pharmacies for both parents/guardians and pharmacy staff. See 
interview question guides for the interview content.  
 
Aim 2:  Quantitative information will be collected to assess the acceptability, appropriateness, and feasibility of 
the proposed communication strategy to support HPV vaccination. See the Pre and Post Implementation 
Survey. Pharmacy audits will be conducted from the pharmacy electronic records to assess adoption of HPV 
vaccination, measured as the average HPV vaccination rate per pharmacist at each pharmacy. We will also 
assess the impact of the communication strategy on adoption of other adolescent vaccines (e.g., tetanus, 
diphtheria, acellular pertussis; meningoccocal conjugate; influenza). 
 
8. Data collection procedures & data management of study records 
 
8.1 Case Report Forms (CRFs):  
Enrollment & Demographic Survey Information 
Data collection instruments will be developed by the research team. Surveys and outcomes from in-depth 
interviews will be collected by study staff. Survey data will be collected electronically using REDCap. 
Compared to paper data collection, electronic data collection has the potential to be more secure, in that all 
data will be password protected from the moment of data collection. Data will be uploaded directly to the 
study's secure server from REDCap. The secure server that warehouses data will be password protected and 
accessible only to study personnel directly involved in data cleaning and analysis. We will plan to use wireless 
internet to send digital data. To protect the data, the website to which data will be uploaded will use existing 
well-known SSL/TLS (Secure Socket Layer/Transport Layer Security), as indicated by "HTTPS" in the URL. 
SSL/TLS is used by sites such as Google to protect data. All digital data will be sent and received using 
HTTPS. 
 
8.2 Record Storage: PI and study team will maintain, and store in a secure manner, complete, accurate, and 
current study records throughout the study.  The investigator will retain all study records for at least seven 
years after completion of the study.  Study records include administrative documentation and regulatory 
documentation as well as documentation related to each participant screened and enrolled in the study, 
including informed consent forms, contact information forms and case report forms from all visits during the 
study. 
 

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8.3 Data analysis  
 
For both Aim 1 & Aim 2:  
 
 
Aim 1: Using community‐based sampling in collaboration with the Fred Hutch Office of Community 
Engagement and Outreach, we will conduct audio‐recorded, semi‐structured interviews with parents of 
children aged 9‐17 (up to n=12) and Bartell Drugs pharmacy staff (up to n=18; 9 pharmacists, 9 pharmacy 
technicians) to evaluate how well our proposed communication strategy match barriers and facilitators to HPV 
vaccination in pharmacies. Interview guides will be informed by the TDF20, a widely used theoretical framework 
to understand behavioral determinants to successfully implement health promotion programs. Interviews will be 
about 90 minutes and qualitative data will be analyzed using framework‐guided rapid analyses described by 
Gale et al.22 The qualitative data will be used to adapt the pharmacy staff’s workflow to improve their use of the 
electronic forecasting system and develop a tailored vaccine communication training based on the 5A’s. 
Adaptations made to the communication strategy will be methodically documented using Stirman’s Taxonomy 
of Adaptation Characteristics23. 
 
Aim 2: We will evaluate the impact of the communication strategy using a pre/post implementation study 
design in independent pharmacies located in Western Washington state. This design is commonly used in 
exploratory/development studies. The communication strategy will be delivered at the pharmacy study sites by 
study staff members. We will use the IOF21 which identifies distinct implementation outcomes widely used to 
determine how successful implementation of an evidence‐based practice, like HPV vaccination, was in a 
specified setting, like pharmacies. We will use validated survey measures to assess pharmacy staff’s report of 
the acceptability, appropriateness, and feasibility of the communication strategy to support HPV vaccination.24 
We will also conduct audits of the pharmacy electronic records to assess adoption of HPV vaccination, 
measured as the average HPV vaccination rate per pharmacist at each pharmacy. We will also assess the 
impact of the communication strategy on adoption of other adolescent vaccines using pre-post data analysis 
methods like Wilcoxon signed-rank test or other nonparametric tests appropriate for small sample statistics. 
 
9.  Training procedures and quality assurance 
Study PI will supervise training of study staff and clinic/pharmacy staff in study procedures, including 
recruitment, enrollment, conduct of the interviews, and maintenance of confidentiality and privacy. Specific 
expertise in the conduct of qualitative research will be provided by our team’s qualitative expert, who has 
conducted qualitative research in numerous settings. All staff have been or will be trained in the responsible 
conduct of human subjects’ research (NIH or CITI courses). 
 
Clinical care:  No clinical care will be provided by study staff.  
 
Adherence to protocol:  For Aim 1, bi-weekly reporting of enrollment will enable us to monitor if the study is 
running according to approved protocols. Frequent reporting will also enable us to quickly respond to any 
problems that may arise during the study.  
 
For Aim 2, we will rely on periodic reporting from the independent pharmacies who will audit their pharmacy 
records and report their vaccination rates. Periodic reporting will occur at baseline (Month 0) and at least 1 
follow-up time point after implementation of the communication strategy (Month 2). 
 
10. Data and Safety Monitoring Plan 
All members of the research staff and the personnel employed by the community-based organization will be 
trained in responsible conduct of research, including enrollment of human subjects, by Dr. Shah and the 
research recruitment training offered by the Fred Hutchinson Cancer Center.   
To protect against the risk of loss of confidentiality, only Dr. Shah and the Project Coordinator will have access 
to identifiable information or the study database. The study database will be password-protected and housed 
on a secure server at the Fred Hutch. Immediately after the semi-structured in-depth interviews data will be 
collected, the Project Coordinator will transport the data to locked offices at the Fred Hutch. Survey data will be 

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collected via a secure online survey platform. Survey data will be kept in a secured cabinet under lock and key 
in the locked office at the Fred Hutch. For analysis, identifiable information will be removed from the datasets 
and participants will be assigned a unique study identifier. Audiotaped data from the semi-structured interviews 
will be transcribed and kept on a password-protected server. The participants will be encouraged to use a 
pseudonym during the semi-structured interviews, and the transcripts will identify each participant by their 
pseudonym. 
 
11. Ethical considerations 
 
11.1 Consent explanation 
The relevant consents include the following information: 
▪ 
Title 
▪ 
Researchers’ contact information 
▪ 
Introduction 
▪ 
Purpose of the study 
▪ 
Procedures 
▪ 
Risks, stress, or discomfort 
▪ 
Alternatives to taking part in this study 
▪ 
Benefits of being in the study 
▪ 
Funding 
▪ 
Confidentiality 
▪ 
Fred Hutchinson HSD contact information 
▪ 
Study participant statement 
▪ 
Study participant signature page  
 
11.2 Institutional Review Board  
The study will be reviewed by the Institutional Review Board (IRB) at Fred Hutchinson Cancer Center. The 
study will not recruit subjects prior to approval from the Fred Hutchinson Cancer Center IRB. 
 
11.3 Risks to subjects 
 
The primary risk of participation in the study is the loss of confidentiality. Although study staff will take all 
necessary precautions to protect confidential data, it is possible that participants’ involvement in the research 
could be discovered by a third party. Employment of pharmacy staff will not be affected if staff either wish or do 
not wish to participate in this study. 
 
In-Depth Interviews: Some questions may be sensitive or cause embarrassment to participants. Participants 
will be informed they can withdraw at any time and do not have to answer any questions if they do not want to.  
 
Surveys/Questionnaires: Questions may cause emotional stress or embarrassment. The surveys have been 
designed in such a way as to minimize questions implying blame or judgment. Participants will be informed and 
reminded periodically that they can refuse to answer any question or stop the survey at any time.  
 
 
Study staff will attend training sessions by the study investigators and receive ongoing supervision in areas 
related to ethical conduct, confidentiality protection, and other topics of human subject’s protection. We will 
ensure that study staff are trained to clearly explain the purpose of the study to obtain informed consent and 
inform respondents about their rights and benefits without coercion to participate. We will also ensure that our 
interviewers inform the potential respondents about the confidentiality measures put in place to protect their 
privacy.  

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11.4 Potential benefits of the proposed research to the subjects and others 
While there are no direct benefits to the participants for their involvement in this study; the information obtained 
from this study will be used to inform refinement and implementation of pharmacy-located HPV vaccination 
programs; such interventions are expected to increase coverage of HPV vaccination rates and benefit a child’s 
future adult health and survival. 
 
11.5 Alternatives to participation 
There are no noted alternatives to participating in this study.  
 
11.6 Study discontinuation 
This study may be discontinued at any time by the Protocol Chairs, regulatory authorities, or the relevant IRB.  
 
12. Study dissemination plan  
Use of Information and Publications 
The PI and research team intend to submit final findings to peer-reviewed journal manuscripts and present 
findings at local, national, and international conferences. 
 
13. Study Limitations and how to minimize them  
With this study being conducted only in Washington state, the results may not be generalizable to the rest of 
the country. Were the findings of this study to generate further interest in scaling up of pharmacy-located HPV 
education and vaccinations, further research would need to be done.  
 
 

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14. Study Timeline  
 
 
 
 
 
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