Engaging Clinical Champions to Improve HPV Vaccination

Trial Title: Engaging Clinical Champions to Improve HPV Vaccination

NCT ID: NCT05736718

Condition: Human Papilloma Virus

Conditions: Official terms:
Papilloma

Conditions: Keywords:
Human Papilloma Virus
vaccination
adolescent medicine
primary care
clinical champions

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: cluster randomized design in which clinics will be randomized within healthcare systems

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Champion Announcement Approach Training
Description: 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.
Arm group label: Champion AAT

Intervention type: Behavioral
Intervention name: Traditional Announcement Approach Training
Description: 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.
Arm group label: Traditional AAT

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 9 Years

Maximum age: 12 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: The University of North Carolina at Chapel Hill

Address:
City: Chapel Hill
Zip: 27599
Country: United States

Facility:
Name: University of Wisconsin - Madison

Address:
City: Madison
Zip: 53726
Country: United States

Start date: March 8, 2023

Completion date: June 30, 2026

Lead sponsor:
Agency: UNC Lineberger Comprehensive Cancer Center
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Collaborator:
Agency: University of Wisconsin, Madison
Agency class: Other

Source: UNC Lineberger Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05736718