Engaging Clinical Champions to Improve HPV Vaccination

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

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.

Study Overview

• Status: Completed
• Conditions: Human Papilloma Virus
• Intervention / Treatment: Behavioral: Champion Announcement Approach Training; Behavioral: Traditional Announcement Approach Training

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina at Chapel Hill
  • Wisconsin
    • Madison, Wisconsin, United States, 53726
      • University of Wisconsin - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Champion Announcement Approach Training; AAT is a one-hour communication workshop that trains clinical staff how to recommend HPV vaccine for children ages 9-12. In the champion arm, vaccine champions will deliver the training using slides and a standardized script. They will also conduct outreach and sustainability planning.
Experimental: 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.	Behavioral: Traditional Announcement Approach Training; AAT is a one-hour communication workshop that trains clinical staff how to recommend HPV vaccine for children ages 9-12. In the traditional arm, outside experts will deliver the training using the same slides and script.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV vaccination (≥1 dose), 9-12 year olds	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	from baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV vaccination (2 doses), 9-12 year olds	Proportion of unvaccinated children who complete the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline	from baseline to 12 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); University of Wisconsin, Madison
• Investigators: Principal Investigator: Noel T Brewer, PhD, University of North Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: primary care; vaccination; Human Papilloma Virus; adolescent medicine; clinical champions
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: IMPACTP3CHAMP; 1P01CA250989-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No