Increasing HPV Immunization Rates: The Rural Adolescent Vaccine Enterprise

Human Papilloma Virus Clinical Trial

— RAVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03604393
• Other study ID #: 18660
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: June 2023

Study information

• Verified date: March 2022
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22000
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Human Papilloma Virus
• Papilloma

Intervention

Behavioral:
• Practice facilitation
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.

Locations

Country	Name	City	State
United States	ORPRN	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Oregon Health and Science University	American Cancer Society, Inc., Oregon Health Authority, University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (52)

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* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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