Multi-component Interventions to Increase HPV Vaccination in a Network of Pediatric Clinics

Human Papillomavirus (HPV) Clinical Trial

Official title:

Multi-component Interventions for Patients and Providers to Increase HPV Vaccination in a Network of Pediatric Clinics in Houston, TX

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111251
• Other study ID #: HSC-SPH-15-0202
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: February 28, 2019

Study information

• Verified date: May 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria:

• Patient at a Texas Children's Pediatrics clinic

• Patient had not initiated the HPV vaccination series at baseline

Exclusion Criteria:

• Patient had completed the HPV vaccination series at baseline

Related Conditions & MeSH terms

• Human Papillomavirus (HPV)

Intervention

Behavioral:
• Provider assessment and feedback
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 reminders
An EHR-based reminder system informs providers when patients are due or overdue for HPV vaccination.
• Provider education
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.
• Patient reminders
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.
• Parent education
The parent education intervention (currently in development) will employ innovative strategies to identify and overcome barriers to HPV vaccination.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Baylor College of Medicine, Cancer Prevention Research Institute of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percent of HPV vaccination initiation		baseline, 3 years