Engaging Clinical Champions to Improve HPV Vaccination

UNC Lineberger Comprehensive Cancer Center47 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Human Papilloma Virus

Interventions

Champion Announcement Approach TrainingBEHAVIORAL

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 TrainingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 9 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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

Time frame: from baseline to 12 months

Secondary Outcomes

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

Time frame: from baseline to 12 months

Data from ClinicalTrials.gov

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