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Community Pharmacists Vaccinate Against Cancer

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04072159
Acronym
CPVAC
Enrollment
33
Registered
2019-08-28
Start date
2019-04-01
Completion date
2021-02-01
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus Vaccines

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.

Interventions

BEHAVIORALCommunity 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.

Sponsors

Adelante Healthcare
CollaboratorUNKNOWN
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Completed HPV Vaccine Series(Preliminary Efficacy)6 months post baselineWhether child completed HPV vaccine series with pharmacist (self-report on post-test and patient medical record)

Secondary

MeasureTime frameDescription
Intervention Feasibility in Participant Enrollment/Study Completion1 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Pharmacist-Administered HPV Vaccine Series Completion Group
For the Pharmacist-Administered HPV Vaccine Series Completion group, primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacy. 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.
16
Primary Care Provider HPV Vaccine Series Completion
Primary Care Provider HPV Vaccine Series Completion group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care).
17
Total33

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up66
Overall StudyWithdrawal by Subject20

Baseline characteristics

CharacteristicPharmacist-Administered HPV Vaccine Series Completion GroupTotalPrimary Care Provider HPV Vaccine Series Completion
Age, Continuous37.8 years37.4 years37.1 years
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants16 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants17 Participants9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants6 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants14 Participants7 Participants
Race (NIH/OMB)
White
6 Participants12 Participants6 Participants
Region of Enrollment
United States
16 participants33 participants17 participants
Sex: Female, Male
Sex: Female, Male
Female
15 Participants30 Participants15 Participants
Sex: Female, Male
Sex: Female, Male
Male
1 Participants3 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 17
other
Total, other adverse events
0 / 160 / 17
serious
Total, serious adverse events
0 / 160 / 17

Outcome results

Primary

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)

Time frame: 6 months post baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pharmacist-Administered HPV Vaccine Series Completion GroupNumber of Participants Who Completed HPV Vaccine Series(Preliminary Efficacy)8 Participants
Primary Care Provider HPV Vaccine Series CompletionNumber of Participants Who Completed HPV Vaccine Series(Preliminary Efficacy)11 Participants
Secondary

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

Time frame: 1 year after intervention baseline (March 2020)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pharmacist-Administered HPV Vaccine Series Completion GroupIntervention Feasibility in Participant Enrollment/Study Completion8 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026