Increasing HPV Immunization Rates: The Rural Adolescent Vaccine Enterprise

Not Applicable

• Conditions: Human Papilloma Virus
• Interventions: Behavioral: Practice facilitation

• Registration Number: NCT03604393
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Study Start: 2019-06-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Practice Facilitation, Cluster 1	Practice facilitation	Intervention Cluster 1 is the first intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
Practice Facilitation, Cluster 2	Practice facilitation	Intervention Cluster 2 is the second intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
Practice Facilitation, Cluster 4	Practice facilitation	Intervention Cluster 4 is the fourth intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
Practice Facilitation, Cluster 3	Practice facilitation	Intervention Cluster 3 is the third intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.
Practice Facilitation, Cluster 5	Practice facilitation	Intervention Cluster 5 is the final intervention arm designed to implement and test the effectiveness of a multi-component primary care practice-based intervention on initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate.

Primary Outcome Measures

Name	Time	Method
HPV vaccine series completion	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.

Trial Locations

Locations (1)

ORPRN; 🇺🇸 Portland, Oregon, United States