Increasing HPV Immunization Rates: The Rural Adolescent Vaccine Enterprise

Study 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.

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

Conditions
-----------------
Human Papilloma Virus

Intervention / Treatment
-----------------
* Behavioral: Practice facilitation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Aims II and III are interventional, using a randomized stepped-wedge design with the practice as the unit of randomization.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Practice Facilitation, Cluster 1<br>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. | Behavioral: Practice facilitation<br>* For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.<br>|
| Experimental: Practice Facilitation, Cluster 2<br>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. | Behavioral: Practice facilitation<br>* For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.<br>|
| Experimental: Practice Facilitation, Cluster 3<br>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. | Behavioral: Practice facilitation<br>* For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.<br>|
| Experimental: Practice Facilitation, Cluster 4<br>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. | Behavioral: Practice facilitation<br>* For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.<br>|
| Experimental: Practice Facilitation, Cluster 5<br>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. | Behavioral: Practice facilitation<br>* For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV vaccine series completion | 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. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunization