NCT03111251

Brief Summary

The purpose of the study is to determine the comparative effectiveness of a provider-only intervention and a parent plus provider intervention to increase initiation of HPV vaccination among male and female patients ages 11-17 in a large pediatric clinic network in the greater Houston area. The hypothesis is that HPV vaccine initiation will be higher in clinics randomized to the parent plus provider intervention compared with clinics randomized to the provider-only intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

4 years

First QC Date

April 6, 2017

Last Update Submit

May 20, 2020

Conditions

Human Papillomavirus (HPV)

Outcome Measures

Primary Outcomes (1)

  • Change in percent of HPV vaccination initiation

    baseline, 3 years

Study Arms (2)

Provider-only intervention

EXPERIMENTAL

New provider- and system-level evidence-based strategies for increasing HPV vaccination rates are being implemented throughout the entire clinic network. This includes provider assessment and feedback, provider reminders, provider education, and patient reminders.

Behavioral: Provider assessment and feedbackBehavioral: Provider remindersBehavioral: Provider educationBehavioral: Patient reminders

Provider plus parent intervention

EXPERIMENTAL

Clinics randomized to the provider plus parent intervention will receive both the provider intervention and the parent education intervention.

Behavioral: Provider assessment and feedbackBehavioral: Provider remindersBehavioral: Provider educationBehavioral: Patient remindersBehavioral: Parent education

Interventions

Provider assessment and feedbackBEHAVIORAL

Tailored immunization reports highlighting adolescent vaccination rates at the individual, clinic and network levels are distributed by clinic champions every quarter. Reports track vaccination rates over time and allow physicians to compare their rates to the national goal.

Provider plus parent interventionProvider-only intervention
Provider remindersBEHAVIORAL

An EHR-based reminder system informs providers when patients are due or overdue for HPV vaccination.

Provider plus parent interventionProvider-only intervention
Provider educationBEHAVIORAL

Provider education is being delivered through a comprehensive online continuing education activity that is tailored specifically to physicians, nurses, and clinical staff at TCP practices. It focuses on HPV vaccination best practices and communicating with parents about the HPV vaccine.

Provider plus parent interventionProvider-only intervention
Patient remindersBEHAVIORAL

Patient reminders are delivered through MyChart, the clinics' online personal health record system, to inform patients (parents) that they are due or overdue for HPV vaccination.

Provider plus parent interventionProvider-only intervention
Parent educationBEHAVIORAL

The parent education intervention (currently in development) will employ innovative strategies to identify and overcome barriers to HPV vaccination.

Provider plus parent intervention

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patient at a Texas Children's Pediatrics clinic
  • Patient had not initiated the HPV vaccination series at baseline

You may not qualify if:

  • \- Patient had completed the HPV vaccination series at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Study Officials

  • Sally W Vernon, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
◦Blair Justice, PhD Professorship in Mind-Body Medicine and Public Health and Director, Division of Health Promotion and Behavioral Sciences

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 12, 2017

Study Start

March 1, 2015

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations

US(1)