Back to resultsEngaging Clinical Champions to Improve HPV Vaccination
Primary Purpose
Human Papilloma Virus
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Champion Announcement Approach Training
Traditional Announcement Approach Training
Sponsored by
About this trial
This is an interventional health services research trial for Human Papilloma Virus focused on measuring Human Papilloma Virus, vaccination, adolescent medicine, primary care, clinical champions
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
Sites / Locations
- The University of North Carolina at Chapel Hill
- University of Wisconsin - Madison
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Champion AAT
Traditional AAT
Arm Description
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.
Staff in clinics randomized to this arm will also receive Announcement Approach Training (AAT). The training will be organized and delivered by outside experts.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05736718
First Posted
February 10, 2023
Last Updated
May 18, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI), University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT05736718
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI), University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
Human Papilloma Virus, vaccination, adolescent medicine, primary care, clinical champions
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cluster randomized design in which clinics will be randomized within healthcare systems
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Champion AAT
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional AAT
Arm Type
Experimental
Arm Description
Staff in clinics randomized to this arm will also receive Announcement Approach Training (AAT). The training will be organized and delivered by outside experts.
Intervention Type
Behavioral
Intervention Name(s)
Champion Announcement Approach Training
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Announcement Approach Training
Intervention 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.
Primary Outcome Measure Information:
Title
HPV vaccination (≥1 dose), 9-12 year olds
Description
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 Outcome Measure Information:
Title
HPV vaccination (2 doses), 9-12 year olds
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel T Brewer, PhD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53726
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Engaging Clinical Champions to Improve HPV Vaccination
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