AzTrials
AzTrials

Human Papillomavirus VaccinesCPVACNCT04072159

Community Pharmacists Vaccinate Against Cancer

A study testing Community Pharmacists Vaccinating Against Cancer in people with Human Papillomavirus Vaccines, run by Arizona State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Human Papillomavirus Vaccines
What is being tested?
Community Pharmacists Vaccinating Against Cancer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
1 Apr 2019to 1 Feb 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Adelante Healthcare Mesa

    Mesa, Arizona, 85201

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Community Pharmacists Vaccinating Against Cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community Pharmacists Vaccinating Against CancerBehavioural

    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.

Study groups in NCT04072159
Study groupRoleWhat they receive
Pharmacist-Administered HPV Vaccine Series Completion groupExperimentalFor 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.
Receives: Behavioral: Community Pharmacists Vaccinating Against Cancer
Primary Care Provider HPV Vaccine Series CompletionNo interventionParticipant 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 being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 6 months post baseline

Secondary outcomes (1)
  1. 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

    Measured: 1 year after intervention baseline (March 2020)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start1 Apr 2019
  3. Primary completion1 Feb 2021
  4. Study completion1 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04072159
Sponsor's protocol ID
STUDY00007938
Other IDs
5U54MD002316-12
Acronym
CPVAC
Status last verified
Jan 2024
First submitted
28 May 2019
Last updated
28 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34389257

Questions about this trial

What is this clinical trial studying?

A study testing Community Pharmacists Vaccinating Against Cancer in people with Human Papillomavirus Vaccines, run by Arizona State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Completed HPV Vaccine Series(Preliminary Efficacy) (time frame: 6 months post baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04072159, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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