Engaging Clinical Champions to Improve HPV Vaccination

NCT ID: NCT05736718

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2025-07-01

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.

Conditions

Human Papilloma Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Champion Announcement Approach Training

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Traditional Announcement Approach Training

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noel T Brewer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1P01CA250989-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IMPACTP3CHAMP

Identifier Type: -

Identifier Source: org_study_id