Community Pharmacists Vaccinate Against Cancer

NCT04072159 | Completed Results DMC

• 2 other identifiers: STUDY000079385U54MD002316-12
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus Vaccines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intervention Feasibility in Participant Enrollment/Study Completion

  1 year after intervention baseline (March 2020)

Study Arms (2)

Pharmacist-Administered HPV Vaccine Series Completion group

EXPERIMENTAL

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

Primary Care Provider HPV Vaccine Series Completion

NO INTERVENTION

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.

Interventions

Community Pharmacists Vaccinating Against Cancer BEHAVIORAL

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.

Pharmacist-Administered HPV Vaccine Series Completion group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Arizona State University: lead
• Adelante Healthcare: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Adelante Healthcare Mesa

Mesa, Arizona, 85201, United States

Location

Related Publications (1)

• 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.

  PMID: 34389257 RESULT

Limitations and Caveats

In the protocol, all parents of HPV vaccine age-eligible children were eligible for recruitment. This changed to only parents of adolescents who vaccinated that day. Study providers did not recommend the HPV vaccine to children ages 9 and 10. Once the intervention began, clinic providers decided not fax a prescription for additional vaccine doses since pharmacists can administer all vaccine booster doses without a provider prescription. We ended study recruitment early because of COVID-19.

Results Point of Contact

• Title: Dr. Alexis Koskan (Assistant Professor)
• Organization: Arizona State University, College of Health Solutions

alexis.koskan@asu.edu

602-827-2792

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot intervention is a randomized controlled trial that uses a pre-test/post-test design. Caregivers of HPV vaccine age-eligible minors who are patients of a federally qualified health center, Adelante Healthcare Mesa, will be randomized to Intervention Group (pharmacy), or Control Group (usual care).

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: August 28, 2019
• Study Start: April 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 28, 2024
• Results First Posted: November 9, 2021

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)