- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05744960
Impact of Financial Incentives
The Impact of Clinic-level Financial Incentives on HPV Vaccine Communication and Uptake
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599-7590
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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.
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.
Exclusion Criteria:
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$
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HPV vaccine communication training.
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.
|
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.
|
|
Experimental: HPV vaccine communication training and clinic-level financial incentive program
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.
|
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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from baseline to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HPV vaccination (≥1 dose), 9-12 year olds
Time Frame: from 13 months to 24 months
|
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.
|
from 13 months to 24 months
|
|
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.
|
from baseline to 12 months
|
|
HPV vaccination (≥2 doses), 9-12 year olds
Time Frame: from 13 months to 24 months
|
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.
|
from 13 months to 24 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Justin G Trogdon, PhD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMPACTP2FI
- 1P01CA250989-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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