Clinical trial NCT05736718: Engaging Clinical Champions to Improve HPV Vaccination
Official title: Engaging Clinical Champions to Improve HPV Vaccine Communication and Uptake in Healthcare Systems
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Papilloma Virus
Keywords: Human Papilloma Virus
vaccination
adolescent medicine
primary care
clinical champions
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Wisconsin, Madison
First posted: 2023-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized design in which clinics will be randomized within healthcare systems
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: HPV vaccination (≥1 dose), 9-12 year olds
timeFrame: from baseline to 12 months
Secondary outcomes:
measure: HPV vaccination (2 doses), 9-12 year olds
timeFrame: from baseline to 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of North Carolina
name: Noel T Brewer, PhD
role: PRINCIPAL_INVESTIGATOR
References: