Human Papilloma VirusNCT05736718
Engaging Clinical Champions to Improve HPV Vaccination
A study testing Champion Announcement Approach Training and Traditional Announcement Approach Training in people with Human Papilloma Virus, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- Champion Announcement Approach Training and Traditional Announcement Approach Training
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Mar 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Wisconsin - Madison
Madison, Wisconsin, 53726
About this study
Official title: Engaging Clinical Champions to Improve HPV Vaccine Communication and Uptake in Healthcare Systems
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.
Read the 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.
- Conditions
- Human Papilloma Virus
- Being tested
- Champion Announcement Approach Training, Traditional Announcement Approach Training
- Keywords
- Human Papilloma Virus, vaccination, adolescent medicine, primary care, clinical champions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Champion Announcement Approach TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Champion AAT | Experimental | 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. Receives: Behavioral: Champion Announcement Approach Training |
| Traditional AAT | Experimental | Staff in clinics randomized to this arm will also receive Announcement Approach Training (AAT). The training will be organized and delivered by outside experts. Receives: Behavioral: Traditional Announcement Approach Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from baseline to 12 months
Secondary outcomes (1)
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
Measured: from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start8 Mar 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized design in which clinics will be randomized within healthcare systems
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noel T Brewer, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736718
- Sponsor's protocol ID
- IMPACTP3CHAMP
- Other IDs
- 1P01CA250989-01A1
- Status last verified
- Jul 2025
- First submitted
- 10 Feb 2023
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Clinical Champions to Improve HPV Vaccine Communication and Uptake in Healthcare Systems
- ClinicalTrials.gov ID
- NCT05736718
- Acronym / sponsor ID
- IMPACTP3CHAMP
- Conditions
- Human Papilloma Virus
- Keywords
- Human Papilloma Virus, vaccination, adolescent medicine, primary care, clinical champions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Wisconsin, Madison
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster randomized design in which clinics will be randomized within healthcare systems
| Arm | Type | Receives |
|---|---|---|
| Champion AAT | Experimental | Behavioral: Champion Announcement Approach TrainingStaff 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. |
| Traditional AAT | Experimental | Behavioral: Traditional Announcement Approach TrainingStaff in clinics randomized to this arm will also receive Announcement Approach Training (AAT). The training will be organized and delivered by outside experts. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- provide primary care to children ages 9-12
- specialize in pediatrics or family medicine
- are between the ages of 9-12 years at baseline
- are attributed to a participating clinic at 12-month follow-up
Key exclusion criteria (7 listed)
- do not provide primary care to children ages 9-12
- have a specialty other than pediatrics or family medicine
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Champion Announcement Approach TrainingAAT 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. | Behavioural | Champion AAT |
| Traditional Announcement Approach TrainingAAT 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. | Behavioural | Traditional AAT |
Primary outcome
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
1 secondary outcome
HPV vaccination (2 doses), 9-12 year olds
Time frame: from baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel T Brewer, PhD principal investigator
University of North Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Champion Announcement Approach Training and Traditional Announcement Approach Training in people with Human Papilloma Virus, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV vaccination (≥1 dose), 9-12 year olds (time frame: from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.