Engaging Clinical Champions to Improve HPV Vaccination

NCT05736718 | Completed

• 2 other identifiers: IMPACTP3CHAMP1P01CA250989-01A1
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

Human Papilloma Virus

Keywords

Human Papilloma Virus; vaccination; adolescent medicine; primary care; clinical champions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• HPV vaccination (2 doses), 9-12 year olds

  from baseline to 12 months

Study Arms (2)

Champion AAT

EXPERIMENTAL

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

Traditional AAT

EXPERIMENTAL

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

Interventions

Champion Announcement Approach Training BEHAVIORAL

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.

Champion AAT

Traditional Announcement Approach Training BEHAVIORAL

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.

Traditional AAT

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (2)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53726, United States

Location

Study Officials

• Noel T Brewer, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster randomized design in which clinics will be randomized within healthcare systems

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: March 8, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 9, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)