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Clinical Trials/NCT03604393
NCT03604393
Unknown
Not Applicable

Increasing Human Papillomavirus (HPV) Immunization Rates: The Rural Adolescent Vaccine Enterprise (RAVE)

Oregon Health and Science University1 site in 1 country22,000 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Papilloma Virus
Sponsor
Oregon Health and Science University
Enrollment
22000
Locations
1
Primary Endpoint
HPV vaccine series completion
Last Updated
4 years ago

Overview

Brief Summary

The goal of this study is to engage rural primary care clinics and community organizations to test interventions designed to increase HPV vaccinations in both male and female patients aged 9-26 years.

Detailed Description

The overarching goal of this study is to engage rural primary care clinics and community organizations to test interventions designed to increase HPV vaccinations in both male and female patients aged 9-26 years. Using a step-wedge randomized controlled trial, we will design and test the effectiveness of multi-component primary care practice-based interventions on the completion of the HPV vaccine series and will explore implementation timing in high and low functioning practices to determine how specific characteristics affect the delivery of the full series. Additionally, we will design and test the impact of a community organization-based intervention intended to educate the public about HPV and cancer risk and risk reduction via vaccination.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
June 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lyle J. Fagnan

Director, Oregon Rural Practice-based Research Network (ORPRN)

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

  • Oregon family medicine and pediatric clinics located in rural communities that see adequate numbers of patients in the age range we are studying (age 11-17 years).

Exclusion Criteria

  • We will not include neonates, decisionally impaired adults, and prisoners in this study.

Outcomes

Primary Outcomes

HPV vaccine series completion

Time Frame: 3 months

A primary outcome variable is the receipt rate of the full series of HPV vaccine among males and females aged 11-17 years. Practices will be block randomized in five waves every six months. Outcomes will be measured every three months in all clusters at every period, so that each cluster provides data points in both the control and intervention conditions. Practices in each wave will be stratified based on designation of pediatric or family medicine clinic to balance pediatric/family medicine clinics at each wave. Outcome data collection will be collected from Oregon's ALERT Immunization System beginning in quarter four and up to 17, for 14 longitudinal data collection points per practice.

Study Sites (1)

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