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OpenTrials
Completed

NCT Number: NCT05736718

Engaging Clinical Champions to Improve HPV Vaccination

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.

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Key information

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Champion Announcement Approach Training

Behavioral

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 Training

Behavioral

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 outcomes

  1. HPV vaccination (≥1 dose), 9-12 year olds

    Time frame: from baseline to 12 months

    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 outcomes

  1. HPV vaccination (2 doses), 9-12 year olds

    Time frame: from baseline to 12 months

    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

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Wisconsin, Madison

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2023
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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