Community Pharmacists Vaccinate Against Cancer

Not Applicable

Completed

Conditions: Human Papillomavirus Vaccines

Interventions: Behavioral: Community Pharmacists Vaccinating Against Cancer

Registration Number: NCT04072159

Lead Sponsor: Arizona State University

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist-Administered HPV Vaccine Series Completion group	Community Pharmacists Vaccinating Against Cancer	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Intervention Feasibility in Participant Enrollment/Study Completion	1 year after intervention baseline (March 2020)	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