Engaging Clinical Champions to Improve HPV Vaccination

Not Applicable

Completed

• Conditions: Human Papilloma Virus

• Registration Number: NCT05736718
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-21
• Study Start: 2023-03-08
• Status Verified: 2025-07
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HPV vaccination (≥1 dose), 9-12 year olds	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 Outcome Measures

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

Trial Locations

Locations (2)

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States