NCT05744960

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Feb 2023Aug 2026

First Submitted

Initial submission to the registry

February 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2026

Expected
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

February 15, 2023

Last Update Submit

January 2, 2026

Conditions

Keywords

financial incentivespediatric medicinevaccinationpay-for-performance

Outcome Measures

Primary Outcomes (1)

  • 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.

    from baseline to 12 months

Secondary Outcomes (3)

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

    from 13 months to 24 months

  • HPV vaccination (≥2 doses), 9-12 year olds

    from baseline to 12 months

  • HPV vaccination (≥2 doses), 9-12 year olds

    from 13 months to 24 months

Study Arms (2)

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.

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.

Behavioral: Communication trainingBehavioral: financial Incentive

Interventions

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.

HPV vaccine communication training and clinic-level financial incentive programHPV vaccine communication training.

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.

HPV vaccine communication training and clinic-level financial incentive program

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7590, United States

Location

Study Officials

  • Justin G Trogdon, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster randomized design in which clinics will be randomized within healthcare systems
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 27, 2023

Study Start

February 28, 2023

Primary Completion

April 30, 2026

Study Completion (Estimated)

August 29, 2026

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations