Community Pharmacists Vaccinating Against Cancer (CPVAC): A Pilot Randomized Controlled Trial Aimed at Increasing Human Papillomavirus Vaccine Completion Rates Among Racially/Ethnically Diverse Yout
Phase: NA
Conditions: Human Papillomavirus Vaccines
Sponsor: Arizona State University

 
 
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1 
Protocol Title 
  Community Pharmacists Vaccinating Against Cancer (CPVAC): A Pilot Randomized Controlled Trial Aimed at Increasing HPV Vaccine 
Completion Rates Among Racially/Ethnically Diverse Youth     
 
2 
Background and Objectives 
The majority of HPV-related cancers and genital warts can be prevented through the timely uptake and completion of the HPV vaccine 
series.23,25,26 Human papillomavirus (HPV) is the most common sexually transmitted infection, and persistent infection with oncogenic HPV strains 
cause cancer.27 The HPV strains most commonly associated with cancer are HPV 16 and 18. However, strains 31, 33, 35, 39, 45, 51, 52, 56, 58, 
and 59 are also carcinogenic.28 Commercially available 9-valent HPV vaccines offer the potential of immunity against seven oncogenic strains 
(Types 16, 18, 31, 33, 45, 52, 58) and the two low-risk strains (Types 6 and 11) that cause over 90% of genital warts.29 Vaccine completion is 
critical because it boosts the body’s ability to fight off the virus.3  
 
In 2016 only 37.5% of HPV vaccine age-eligible males and 49.5% of females completed the HPV vaccine series7 with racial/ethnic minorities 
exhibiting lower rates of completion.8 Specifically, Black and Latino children and young adults have a higher rate of initiation of the vaccine;9 
however, they have a significantly lower likelihood of completing the vaccine series.9 Further, Latino patients who prefer speaking Spanish as 
opposed to English have lower HPV vaccine completion rates.10 It is critical to enhance HPV vaccine series completion among racial/ethnic 
minority HPV vaccine age-eligible individuals to reduce cancer disparities. Barriers to complete the HPV vaccine have included the following: lack 
of time to receive the follow-up vaccines,11 transportation needed to return for follow-up clinical visits,11, additional office co-pays, 31 lack of 
awareness to receive additional HPV vaccine doses,32 and Lack of strong provider recommendation for vaccine initiation/completion34 particularly 
for male patients. 
 
Traditionally, primary care providers (PCPs) administer all HPV vaccine doses. After individuals receive the first HPV vaccine dose from their 
PCP, they must return to their primary care clinic for additional doses. This places a burden on patients and their caregivers to schedule and 
attend additional, non-routine clinical visits.11-13 However, PCPs are not the only providers who can administer the HPV vaccine. Pharmacists can 
administer additional vaccine doses.14,15 Receiving additional vaccine doses with pharmacists may prove to be a more convenient method of 
ensuring vaccine adherence due to pharmacies’ extended hours (compared to PCP clinics) and lack of required appointment.16-18 Many have 
built-in text-message reminder systems, which increase vaccine adherence19 by prompting patients to return to the pharmacy when medication 
(vaccine dose) has been filled. Although numerous studies describe the potential for pharmacists to aid in HPV vaccine series completion, few, if 
any, intervention research studies have actually tested this integrated model of care.20-24  
 
Therefore, we propose to pilot and test a theoretically-informed (Diffusion of Innovation) integrated intervention model that we call CPVAC 
(Community Pharmacists Vaccinating Against Cancer). CPVAC will be a randomized controlled pilot intervention. Caregivers of patients who 
complete the initial HPV vaccine will be asked to take part in the study. The PI will recruit a stratified sample of patients, oversampling for Latino 
(English and Spanish speakers) and African American patients. Patients will be randomized to intervention or control group (usual care). After 
enrolling in the study, primary care providers of patients in the Intervention Group will contact the patients’ community pharmacy (e.g. CVS, 
Walgreens, Fry’s) and prescribe the remaining HPV vaccine dose(s). The pharmacy will electronically update patients’ files and schedule the HPV 
vaccine “refill” (additional doses) at the appropriate dosing schedule. The pharmacy will contact patients or (for minors) patients’ caregivers when 
it is time to complete additional HPV vaccine dose(s). Control group participants will receive usual care, returning to their PCPs to complete the 
additional HPV vaccine series. 
 
3 
Data Use 
 
Data will be published in peer-reviewed journals and presented at academic conferences.  Results will be released to Adelante Healthcare Mesa, 
the site for this research study.  
4 
Inclusion and Exclusion Criteria 
 
Inclusion Criteria 
Exclusion Criteria 
Caregivers of a child between ages 9-18 who has either not received any HPV 
vaccine doses or has received only initial HPV dose  
Caregivers whose child has completed additional HPV vaccine doses 
Receives care at Adelante Healthcare Mesa 
 
Fluent in English and/or Spanish  
 
Willing to provide informed consent 
 
 
 
 
 

 
 
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5 
Number of Participants  
90 participants will be enrolled in the study; 45 in the control group / 45 in the intervention group 
 
6 
Recruitment Methods 
The study research assistants (RA) will work directly with the clinic during the study enrollment period to generate a list of all patients (and their 
caregivers) who may be eligible to participate in the study. Adelante office staff will search patients’ online medical files to determine which 
individuals are age-eligible for the vaccine who have either 1) not initiated the vaccine series and/or 2) have only completed one of the HPV 
vaccine doses. They will generate a list of eligible patients with caregiver contact information to the RA. 
 
The RA will use a vacant office space for all recruitment and enrollment activities. To initiate contact with potential participants, she will send a 
letter to caregivers of children eligible for HPV vaccine, inviting them to take part in a study about HPV vaccine intentions. The letter will contain 
study-specific phone number that will reach RA’s office directly. RA will screen caregivers for eligibility and notify clinic staff of all patients/ 
caregivers eligible for study. Caregivers will work with clinic staff to schedule an office visit. When the clinic staff schedules the patient’s visit, they 
will ask caregivers to stay an addition 15-20 minutes after their scheduled appointment to complete the study informed consent and baseline 
surveys.  
7 
Study Timelines 
We anticipate participants being a part of the study for up to 8 months. We expect that individuals will spend up to 2 hours (1 hour on 2 days) 
on completing study surveys, one on the first day of the study and another after six months.  They will also spend time taking their child to 
receive the additional HPV vaccine doses. 
8 
Procedures Involved 
The project utilizes a software (REDCap) which randomizes individuals into intervention and control groups, using permuted block randomization. 
As participants enroll in the study, they will be given a study identification number (e.g. 1,2,3). Both the intervention and control groups will 
complete baseline surveys. 
 
Control group participants will receive standard care and will be expected to return to Adelante Healthcare Mesa to receive the additional HPV 
vaccine booster doses.  Intervention group participants will be referred to receive the additional HPV vaccine doses at their community pharmacy. 
At post-intervention, intervention participants will be asked if their children completed the HPV vaccine series.   
 
Primary behavioral outcome: At the end of the 16-month intervention, PI will ask clinic staff to report HPV vaccination dose completion (for 
vaccine doses 1,2,3) for all study participants. 
 
Follow-up Survey Data Collection: RA will call all participants and administer follow-up survey to measure potential changes in DOI theoretical 
constructs (see baseline survey). 
 
Qualitative telephone in-depth interviews: To qualitatively explore intervention feasibility and acceptability, PI will conduct telephone interviews 
with patients, patients’ caregivers, clinic primary care providers, and clinic pharmacists. 
• In-depth interview with Caregivers and/or Young Adult Patients: PI will conduct telephone interviews with caregivers from the control group 
(standard care) and from the intervention group (pharmacist-administered HPV vaccination)  related to their experiences taking part in the 
study. 
• In-Depth interviews with Providers and Pharmacists: Researchers will conduct telephone interviews with all the clinic’s participating primary 
health care providers and office manager (n= 4) and local pharmacists who work at pharmacies where patients were referred to receive the 
HPV vaccine (n=4) to explore their acceptability and perceived feasibility of the intervention. They will be asked how the intervention 
impacted the quality of patient care, ways in which the intervention impacted patient flow within the clinic, how satisfied they were with the 
intervention, and perceived fit of the intervention within their workplace. 
 
Participant Incentives: Research participants will receive e-gift card incentives (of their choosing from Tango Card, Inc) for completing study 
surveys ($20 dollars per survey completed) and for participating in telephone interviews ($30). 
9 
Withdrawal of Participants 
There are no anticipated circumstances under which participants will be withdrawn from the research study without their consent. 
If participants choose to no longer take part in this study, they are asked to contact the PI (Alexis Koskan, 602-827-2792) to notify her that they 
will no longer be involved in the study.  The PI will remove and destroy all participant data from the study.  
 
 

 
 
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10 Risks to Participants 
There are no foreseeable risks to research participants.  Risks of the HPV vaccine (a non-virus vaccine –which utilizes a protein which looks 
similar to HPV) include a fever, pain at injection site, and a headache.  A much less common side effect of the vaccine is fainting within 15 
minutes of injection.  For this reason /risk, patients are told to remain at the clinic/pharmacy for an additional 15 minutes after they receive the 
vaccine to ensure that they are safe to leave.  
11 Potential Benefits to Participants 
HPV vaccine age-eligible children will complete the HPV vaccine series, thus preventing the risk of HPV-related cancers.  Also, intervention 
participants will learn more about the role of the community pharmacist in administering vaccines and vaccine booster doses.  This may help aid 
in the completion of vaccine series without having to schedule and revisit primary care providers’ offices. 
12 Setting 
This study will be conducted at Adelante Healthcare Mesa, a local federally qualified health center.  Intervention participants will be referred to 
receive additional HPV vaccine booster shots with their community pharmacists.  Pharmacists are currently licensed to administer the HPV 
vaccine. 
13 Multi-Site Research 
NA 
14 Resources Available 
This clinically based study will take place at Adelante Healthcare Mesa, a Federally Qualified Health Center (FQHC) which predominantly serves 
ethnic/racial minority, low-income populations.   
15 Prior Approvals 
We have received prior approval and secured an MOU with Adelante Healthcare Mesa to conduct this study.  
16 Data Management and Confidentiality 
 
Data Analysis: 
Aim 1 Data Analysis: Assessing Preliminary Efficacy.  
The specific aim of the proposed project is to investigate the effect of CPVAC on HPV vaccination completion rate compared with primary care 
provider (Aim 1). 
       Patient-related outcomes: Two proportion Z tests will be used to examine the proportion differences in HPV vaccination completion between 
CPVAC and primary care provider (PCP) groups. We will also compare which medical professionals completed the vaccine doses. We will create 
codes for various health care professionals (e.g. nurse, nurse practitioner, physician, pharmacist, etc.) to differentiate who administered the 
vaccine. The HPV completion status will be classified as dichotomous variable (0 = no; 1 = yes). Independent variables will be classified as either 
categorical or continuous scale: age, gender, race; location, HPV vaccine dose (1, 2, 3, etc); provider types (PCP vs pharmacist); facility 
type/place of service (health clinic vs. pharmacy).  Multiple logistic regression with stepwise selection procedures will be used to identify whether 
these independent variables are associated with HPV completion status.   
         Psychosocial Constructs Data Analysis: Baseline characteristics of the study participants will be summarized using descriptive statistics. 
Multiple logistic regression will be used to investigate whether psychosocial factors (e.g. intention, norms, efficacy) relate to HPV vaccine 
completion (yes/no). General linear models or Mann-Whitney U tests will be used to test mean or median differences for self-efficacy and 
response-efficacy to complete the vaccine series between CPVAC and PCP groups. 
Missing Data: We will conduct sensitivity analyses including imputation methods and completer-only analyses. All statistical procedures and 
analyses will be performed in SPSS software. 
 

 
 
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Aim 2 Data Analysis: Qualitatively exploring feasibility and acceptability of CPVAC 
PI will submit the interview audio-recordings to an ASU-approved transcription company. Using the interview guide to determine a priori themes, 
PI will create a coding book for the interview data. Reading through all interview transcripts, PI will add emerging themes to expand the coding 
guide. PI will train the RA in descriptive content analysis. They will review and code one transcript together, code an additional three transcripts 
separately, meet to discuss coding choices, and reach an agreement on data interpretations and analysis before they split the remaining interview 
transcripts for review. PI and RA will upload all transcripts and codes into ATLAS.ti software. PI will take the outcomes from the analyses from 
ATLAS.ti and begin to summarize findings for each in-depth interview question with the RA to ensure interpretation consensus and create a 
comprehensive summary of the findings related to intervention acceptability and feasibility. 
 
Data Storage: 
Patients’ information will be de-identified and given a unique Participant Study Number for data analysis by an Adelante Healthcare Mesa 
healthcare practitioner. All signed informed consent documents will remain with the PI. She will secure them in a locked drawer of a locked office. 
These forms will be kept up to two years and will be destroyed at the end of those two years.  
17 Safety Monitoring 
Koskan (PI) and the research assistants will meet on a monthly basis to evaluate the data collected for the study.  They will review completeness 
of patient surveys and informed consent and updates related to HPV vaccine series completion.     
18 Consent Process 
The clinic will notify the RAs when potential participants have scheduled office visits. After the office visit, a nurse or office staff member will walk 
the patient to the RA’s research office. The RA will briefly explain that this study is about HPV vaccine intentions and vaccine completion and 
invite caregivers to sign up for the study. If patients decide not to sign up that day, they will be given a study information sheet and a phone 
number to call should they decide to participate later. RA will also write down their contact information to follow up on study enrollment. For 
caregivers interested in signing up for the study, the RA will administer the informed consent and baseline surveys.  
 
The project biostatistician will have already generated a randomization table for the intervention and control groups, using permuted block 
randomization. As participants enroll in the study, they will be given a study identification number (e.g. 1,2,3). Based on their study number and 
the randomization table, they will be assigned to either intervention or control group. 
 
For the in-depth interviews with caregivers (at post-intervention), the RA will contact participants via phone.  The RA will administer informed 
consent via the phone and verbally consent participants prior to conducting the phone interviews.  
19 Investigational New Drug or Devices 
NA 
20 CITI 
Provide the date that the members of the research team have taken the CITI training for human participants.  This training must be taken 
within the last 4 years. Additional information can be found at: http://researchintegrity.asu.edu/training/humans 
CITI certification for Koskan and Lee can be found at ASU’s IRB. 
Dr. Karuppana completed CITI certification. Documentation is soon to come.