Community Pharmacists Vaccinate Against Cancer (CPVAC)

Community Pharmacists Vaccinating Against Cancer (CPVAC): A Pilot Randomized Controlled Trial Aimed at Increasing Human Papillomavirus Vaccine Completion Rates Among Racially/Ethnically Diverse Yout

Latino and African American populations have a higher rate of human papillomavirus (HPV) vaccine initiation; however, they have a significantly less likelihood of completing the vaccine series. Pharmacists are licensed to vaccinate against the HPV virus. However, they are less likely to administer the vaccine. Although past research has recommended incorporating pharmacists to increase adolescent vaccination, no intervention studies, to our knowledge, have tested a healthcare delivery model that incorporates pharmacists to complete the HPV vaccine series. The aims of this pilot randomized controlled trial are to 1) determine the preliminary efficacy of an intervention to increase HPV vaccine series completion with the community pharmacist vs. with the primary care provider among racially/ethnically diverse participants, and 2) assess perceived intervention feasibility and acceptability of the intervention among intervention participants and primary care clinic staff.

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus Vaccines
• Intervention / Treatment: Behavioral: Community Pharmacists Vaccinating Against Cancer

Detailed Description

Human papillomavirus (HPV) is the most common sexually transmitted infection, and persistent infection with oncogenic HPV strains causes cancer. Commercially available 9-valent HPV vaccines offer the potential of immunity against seven oncogenic strains and the two low-risk strains that cause over 90% of genital warts. The majority of HPV-related cancers and genital warts can be prevented through the timely uptake and completion of the HPV vaccine series. However, in 2016 only 37.5% of boys and 49.5% of girls completed the HPV vaccine series, and racial/ethnic minority youth populations are least likely to complete the vaccine series. More specifically, Latino and African American populations have a higher rate of initiation of the vaccine; however, they have a significantly less likelihood of completing the vaccine series. Past research with Latino and African American populations determined the following patient-level barriers to vaccine completion: caregivers' lack of awareness to receive additional vaccine doses, lack of time to attend an additional vaccine-only primary care clinic appointment, and other structural barriers that prohibit caregivers and their children from returning to primary care clinics for additional vaccine doses. Pharmacists are licensed to vaccinate against the HPV virus. However, they are less likely to administer the vaccine. Although past research has recommended incorporating pharmacists to increase adolescent vaccination, no intervention studies, to our knowledge, have tested a healthcare delivery model that incorporates pharmacists to complete the HPV vaccine series. We propose a randomized controlled pilot study titled Community Pharmacists Vaccinate Against Cancer (CPVAC). In CPVAC, the PI will oversample for ethnic minority (particularly African American and Hispanic) HPV vaccine age-eligible children and their caregivers to take part in the study. Patients will be randomized to the Pharmacist-Administered HPV Vaccine Series Completion group or Primary Care Provider HPV Vaccine Series Completion (control) group. After enrolling in the study, primary care providers (PCPs) of patients in the Pharmacist-Administered HPV Vaccine Series Completion group will contact the patients' community pharmacy 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' caregivers when it is time to complete additional HPV vaccine dose(s). Primary Care Provider HPV Vaccine Series Completion group participants will receive usual care, returning to their PCPs to complete the additional HPV vaccine doses. The aims of this study are to 1) determine the preliminary efficacy of CPVAC to increase HPV vaccine series completion with the community pharmacist vs. with the primary care provider among racially/ethnically diverse participants, and 2) assess perceived intervention feasibility and acceptability of CPVAC among intervention participants and primary care clinic staff. Findings from this pilot study can be used to inform a larger randomized controlled trial to examine intervention effectiveness and analyze the cost-benefit of working with community pharmacies to enhance HPV vaccine completion among diverse children.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85201
      • Adelante Healthcare Mesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion 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
• Receives care at Adelante Healthcare Mesa
• Fluent in English and/or Spanish
• Willing to provide informed consent

Exclusion Criteria:

• Caregivers whose child has completed additional HPV vaccine doses
• Child is over age 18 years (no caregiver consent needed)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist-Administered HPV Vaccine Series Completion group; For the Pharmacist-Administered HPV Vaccine Series Completion group (intervention group), primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacies. Patients between ages 9-14 will need to receive one additional HPV vaccine dose with their community pharmacist 6-12 months after receiving Dose 1. Patients aged 15 and older will need to receive the 2nd dose 1-2 months after receiving the first HPV vaccine dose and the 3rd dose 6-months after receiving the initial dose.	Behavioral: Community Pharmacists Vaccinating Against Cancer; Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant. A sample (n=30) of intervention and control group participants will be invited to participate in an in-depth interview to gauge both parents' and children's' acceptability of this intervention.
No Intervention: Primary Care Provider HPV Vaccine Series Completion; Participant in the Primary Care Provider HPV Vaccine Series Completion (control group) will receive standard care and will be scheduled to return to the clinic for the remaining HPV vaccine doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Completed HPV Vaccine Series(Preliminary Efficacy)	Whether child completed HPV vaccine series with pharmacist (self-report on post-test and patient medical record)	6 months post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility in Participant Enrollment/Study Completion	Ability to enroll 90 participants into study and retain study participants, ability to retain 90 participants post-intervention (as evidenced by collecting intervention and control group post-tests) - Compare recruitment/enrollment and intervention completion	1 year after intervention baseline (March 2020)

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Adelante Healthcare

Publications and helpful links

General Publications

• Koskan A, Zittel ME, Lee C, Sanchez O, Alvarez L, Helitzer DL. The feasibility and acceptability of a pilot randomized controlled trial testing pharmacy-based HPV vaccine completion. Res Social Adm Pharm. 2022 Jun;18(6):3038-3045. doi: 10.1016/j.sapharm.2021.08.002. Epub 2021 Aug 8.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00007938; 5U54MD002316-12 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Yes Deidentified data related to patient vaccine completion (number of vaccines completed) will be shared. A Microsoft Excel file of deidentified survey results will be shared. When the qualitative data has removed all identifying information, interview data can be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No