NCT04072159|CompletedResultsDMC
Community Pharmacists Vaccinate Against Cancer
CPVAC
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Sponsor study identifier
Secondary identifiers
interventional
33
1 country
1
Study Start
April 1, 2019
Actual (reported)Primary Completion
February 1, 2021
Actual (reported)Study Completion
February 1, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2019
Actual (reported)May 28, 2019
Actual (reported)August 28, 2019
Actual (reported)February 1, 2021
Actual (reported)February 1, 2021
Actual (reported)November 9, 2021
Actual (reported)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
Intervention Feasibility in Participant Enrollment/Study Completion
1 year after intervention baseline (March 2020)
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adelante Healthcare Mesa
Mesa, Arizona, 85201, United States
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.
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.
33 participants (actual enrollment reported by the registry).
First Submitted
May 28, 2019
First Posted
August 28, 2019
Study Start
The STOP-HPV Scale Up Study
Contact the study team to confirm eligibility.
April 1, 2019
Actual (reported)Primary Completion
February 1, 2021
Actual (reported)Study Completion
February 1, 2021
Actual (reported)Last Updated
February 28, 2024
Results First Posted
November 9, 2021
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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