Engaging Clinical Champions to Improve HPV Vaccination

Human Papilloma Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05736718
• Other study ID #: IMPACTP3CHAMP
• Secondary ID: 1P01CA250989-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 8, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Papilloma Virus
• Papilloma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI), University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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