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

Primary Purpose

Human Papilloma Virus

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Practice facilitation

About this trial

This is an interventional health services research trial for Human Papilloma Virus focused on measuring Immunization

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

ORPRN

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Practice Facilitation, Cluster 1

Practice Facilitation, Cluster 2

Practice Facilitation, Cluster 3

Practice Facilitation, Cluster 4

Practice Facilitation, Cluster 5

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03604393

First Posted

July 11, 2018

Last Updated

March 17, 2022

Sponsor

Oregon Health and Science University

Collaborators

American Cancer Society, Inc., Oregon Health Authority, University of Arkansas

1. Study Identification

Unique Protocol Identification Number

NCT03604393

Brief Title

Increasing HPV Immunization Rates: The Rural Adolescent Vaccine Enterprise

Acronym

RAVE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 1, 2019 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

Collaborators

American Cancer Society, Inc., Oregon Health Authority, University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Papilloma Virus

Keywords

Immunization

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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)

Allocation

Randomized

Enrollment

22000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Practice Facilitation, Cluster 1

Arm Type

Experimental

Arm Description

Arm Title

Practice Facilitation, Cluster 2

Arm Type

Experimental

Arm Description

Arm Title

Practice Facilitation, Cluster 3

Arm Type

Experimental

Arm Description

Arm Title

Practice Facilitation, Cluster 4

Arm Type

Experimental

Arm Description

Arm Title

Practice Facilitation, Cluster 5

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Practice facilitation

Intervention Description

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.

Primary Outcome Measure Information:

Title

HPV vaccine series completion

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lyle J Fagnan, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Patty Carney, PhD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

Facility Information:

Facility Name

ORPRN

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Increasing HPV Immunization Rates: The Rural Adolescent Vaccine Enterprise

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