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Clinical Trials/NCT05736718
NCT05736718
Completed
Not Applicable

Engaging Clinical Champions to Improve HPV Vaccine Communication and Uptake in Healthcare Systems

UNC Lineberger Comprehensive Cancer Center2 sites in 1 country47 target enrollmentMarch 8, 2023

Overview

Phase
Not Applicable
Intervention
Champion Announcement Approach Training
Conditions
Human Papilloma Virus
Sponsor
UNC Lineberger Comprehensive Cancer Center
Enrollment
47
Locations
2
Primary Endpoint
HPV vaccination (≥1 dose), 9-12 year olds
Status
Completed
Last Updated
last month

Overview

Brief Summary

This trial will compare two ways to improve communication about HPV vaccination in primary care. The research team will work with primary care clinics. Some clinics will receive communication training from an outside expert. Other clinics will receive the same training from a vaccine champion from their healthcare system.

Detailed Description

The researchers will conduct a cluster randomized non-inferiority trial. The trial will compare two ways of delivering a communication workshop called Announcement Approach Training (AAT). AAT is designed to improve communication about HPV vaccination in primary care. The researchers will randomize clinics within participating healthcare systems. Some clinics will receive the training from an outside expert. Other clinics will receive the same training from a vaccine champion from their own system. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 12 months. The study will engage clinical staff. Researchers will not have direct contact with children or their families.

Registry
clinicaltrials.gov
Start Date
March 8, 2023
End Date
July 1, 2025
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children to evaluate intervention effectiveness. We will not enroll children or interact with them directly.
  • Inclusion Criteria
  • Clinics are eligible if they:
  • provide primary care to children ages 9-12
  • specialize in pediatrics or family medicine
  • Children's medical records will be eligible to be included in the dataset if children:
  • are between the ages of 9-12 years at baseline
  • are attributed to a participating clinic at 12-month follow-up

Exclusion Criteria

  • Clinics are excluded if they:
  • do not provide primary care to children ages 9-12
  • have a specialty other than pediatrics or family medicine
  • Children's medical records will be excluded if children:
  • are not between the ages of 9-12 years at baseline
  • are not attributed to a participating clinic at 12-month follow-up
  • are receiving hospice/palliative care, are pregnant, or have a history of HPV vaccine contraindications

Arms & Interventions

Champion AAT

Staff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination. The training will be organized and delivered by vaccine champions from participating healthcare systems.

Intervention: Champion Announcement Approach Training

Traditional AAT

Staff in clinics randomized to this arm will also receive Announcement Approach Training (AAT). The training will be organized and delivered by outside experts.

Intervention: Traditional Announcement Approach Training

Outcomes

Primary Outcomes

HPV vaccination (≥1 dose), 9-12 year olds

Time Frame: from baseline to 12 months

Proportion of unvaccinated children who initiate the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline

Secondary Outcomes

  • HPV vaccination (2 doses), 9-12 year olds(from baseline to 12 months)

Study Sites (2)

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