Impact of Financial Incentives

Not Applicable

Recruiting

• Conditions: Human Papilloma Virus
• Interventions: Behavioral: Communication training; Behavioral: financial Incentive

• Registration Number: NCT05744960
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief 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. 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 Timeline

• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Study Start: 2023-02-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-07-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPV vaccine communication training.	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.
HPV vaccine communication training and clinic-level financial incentive program	Communication training	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.
HPV vaccine communication training and clinic-level financial incentive program	financial Incentive	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.

Primary Outcome Measures

Name	Time	Method
HPV vaccination (≥1 dose), 9-12 year olds	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 Outcome Measures

Name	Time	Method
HPV vaccination (≥1 dose), 9-12 year olds	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.
HPV vaccination (≥2 doses), 9-12 year olds	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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States