Human Papilloma VirusNCT05744960
Impact of Financial Incentives
A study testing Communication training and financial Incentive in people with Human Papilloma Virus, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. Some clinics will receive communication training. 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?
- Communication training and financial Incentive
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 29 Aug 2026
- 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 are a pediatric or family medicine clinic in North Carolina that in the past year had:
- less than 72% HPV vaccine initiation rate,
- greater than or equal to 50 patients ages 9-12
- greater than or equal to 2 HPV vaccine providers
- no clinic or provider-level financial incentive programs to increase system, clinic, or provider HPV vaccination rates among patients aged 9-12 in the past two years, and
- no HPV vaccine provider communication trainings in the past six months.
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- 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 and
- are attributed to a participating clinic at 12- or 24-month follow-up.
Who cannot join
- Clinics are excluded if they:
- do not provide HPV vaccine to children ages 9-12
- have a specialty other than pediatrics or family medicine
- had an HPV vaccine-specific financial incentive program in the past two years
- had a formal HPV vaccine communication training in the past 6 months
- had an HPV initiation rate greater than 72$
Show all 11Show fewer
- had fewer than 49 patients aged 9-12
- had 1 or fewer HPV vaccine providers
- Children's medical records will not be eligible to be included in the dataset if children:
- are not between the ages of 9-12 years at baseline
- are not attributed to a participating clinic at 12- or 24-month follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7590
About this study
Official title: The Impact of Clinic-level Financial Incentives on HPV Vaccine Communication and Uptake
This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake.
Read the detailed description
The researchers will conduct a cluster randomized control trial. This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. The recruitment goal for the trial is 34 clinics in healthcare systems, including 9 rural-serving clinics. The researchers will randomize clinics using simple randomization (1:1). Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 24 months. The study will engage clinical staff. Researchers will not have direct contact with children or their families.
- Conditions
- Human Papilloma Virus
- Being tested
- Communication training, financial Incentive
- Keywords
- financial incentives, pediatric medicine, vaccination, pay-for-performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication trainingBehavioural
Clinics will host an Announcement Approach Training (AAT) workshop. A trained facilitator will use a standard script and slides to deliver workshop in-person or over Zoom; clinical staff who are unavailable will take the workshop later on their own.
financial IncentiveBehavioural
Clinics will host an AAT workshop, as in the other trial arm. Clinics in the intervention arm will then receive a 12-month clinic-level financial incentive program with predetermined targets for HPV vaccine initiation rates (5%, 10%, and 30% increases from baseline). Clinics will be notified of their HPV vaccination rates though a monthly, automated report. Clinic achievement will be assessed and incentives will be paid out to clinics monthly. Incentives will be tiered based on target and sized based on the number of clinic providers. For reaching the highest tier of 30%, clinics will receive an aggregate of $1000 per provider.
| Study group | Role | What they receive |
|---|---|---|
| HPV vaccine communication training. | 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. Receives: Behavioral: Communication training |
| HPV vaccine communication training and clinic-level financial incentive program | Experimental | Staff in clinics randomized to this arm will receive the Announcement Approach Training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake. Receives: Behavioral: Communication training; Behavioral: financial Incentive |
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 (3)
HPV vaccination (≥1 dose), 9-12 year olds
Proportion of unvaccinated children who initiate the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months.
Measured: from 13 months to 24 months
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
HPV vaccination (≥2 doses), 9-12 year olds
Proportion of unvaccinated children who complete the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months.
Measured: from 13 months to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start28 Feb 2023
- Primary completion30 Apr 2026
- Study completion29 Aug 2026
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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Justin G Trogdon, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744960
- Sponsor's protocol ID
- IMPACTP2FI
- Other IDs
- 1P01CA250989-01A1
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2023
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Clinic-level Financial Incentives on HPV Vaccine Communication and Uptake
- ClinicalTrials.gov ID
- NCT05744960
- Acronym / sponsor ID
- IMPACTP2FI
- Conditions
- Human Papilloma Virus
- Keywords
- financial incentives, pediatric medicine, vaccination, pay-for-performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 29 Aug 2026 (actual)
- First posted
- 27 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 look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake.
Detailed description
The researchers will conduct a cluster randomized control trial. This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. The recruitment goal for the trial is 34 clinics in healthcare systems, including 9 rural-serving clinics. The researchers will randomize clinics using simple randomization (1:1). Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 24 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 |
|---|---|---|
| HPV vaccine communication training. | Experimental | Behavioral: Communication 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. |
| HPV vaccine communication training and clinic-level financial incentive program | Experimental | Behavioral: Communication training, Behavioral: financial IncentiveStaff in clinics randomized to this arm will receive the Announcement Approach Training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Clinics are eligible if they are a pediatric or family medicine clinic in North Carolina that in the past year had:
- less than 72% HPV vaccine initiation rate,
- greater than or equal to 50 patients ages 9-12
- greater than or equal to 2 HPV vaccine providers
- no clinic or provider-level financial incentive programs to increase system, clinic, or provider HPV vaccination rates among patients aged 9-12 in the past two years, and
Key exclusion criteria (11 listed)
- do not provide HPV vaccine to children ages 9-12
- have a specialty other than pediatrics or family medicine
- had an HPV vaccine-specific financial incentive program in the past two years
- had a formal HPV vaccine communication training in the past 6 months
- had an HPV initiation rate greater than 72$
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 |
|---|---|---|
| Communication trainingClinics will host an Announcement Approach Training (AAT) workshop. A trained facilitator will use a standard script and slides to deliver workshop in-person or over Zoom; clinical staff who are unavailable will take the workshop later on their own. | Behavioural | HPV vaccine communication training and clinic-level financial incentive program, HPV vaccine communication training. |
| financial IncentiveClinics will host an AAT workshop, as in the other trial arm. Clinics in the intervention arm will then receive a 12-month clinic-level financial incentive program with predetermined targets for HPV vaccine initiation rates (5%, 10%, and 30% increases from baseline). Clinics will be notified of their HPV vaccination rates though a monthly, automated report. Clinic achievement will be assessed and incentives will be paid out to clinics monthly. Incentives will be tiered based on target and sized based on the number of clinic providers. For reaching the highest tier of 30%, clinics will receive an aggregate of $1000 per provider. | Behavioural | HPV vaccine communication training and clinic-level financial incentive program |
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.
3 secondary outcomes
HPV vaccination (≥1 dose), 9-12 year olds
Time frame: from 13 months to 24 months
HPV vaccination (≥2 doses), 9-12 year olds
Time frame: from baseline to 12 months
HPV vaccination (≥2 doses), 9-12 year olds
Time frame: from 13 months to 24 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 30 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- 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.
Justin G Trogdon, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication training and financial Incentive in people with Human Papilloma Virus, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 9 inclusion and 11 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 30 Sep 2026.