Engaging Clinical Champions to Improve HPV Vaccination

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Human Papilloma Virus

Intervention / Treatment
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* Behavioral: Champion Announcement Approach Training
* Behavioral: Traditional Announcement Approach Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: cluster randomized design in which clinics will be randomized within healthcare systems
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Champion AAT<br>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<br>* 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.<br>|
| Experimental: Traditional AAT<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papilloma Virus, vaccination, adolescent medicine, primary care, clinical champions