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Trial record 44 of 1373 for:    rural

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

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ClinicalTrials.gov Identifier: NCT03604393
Recruitment Status : Active, not recruiting
First Posted : July 27, 2018
Last Update Posted : June 10, 2019
Sponsor:
Collaborators:
American Cancer Society, Inc.
Oregon Health Authority
University of Oklahoma
Information provided by (Responsible Party):
Lyle J. Fagnan, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE July 11, 2018
First Posted Date  ICMJE July 27, 2018
Last Update Posted Date June 10, 2019
Actual Study Start Date  ICMJE September 19, 2018
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03604393 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increasing HPV Immunization Rates: The Rural Adolescent Vaccine Enterprise
Official Title  ICMJE Increasing Human Papillomavirus (HPV) Immunization Rates: The Rural Adolescent Vaccine Enterprise (RAVE)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Health Services Research
Condition  ICMJE Human Papilloma Virus
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Practice Facilitation, Cluster 1
    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: Behavioral: Practice facilitation
  • Experimental: Practice Facilitation, Cluster 2
    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: Behavioral: Practice facilitation
  • Experimental: Practice Facilitation, Cluster 3
    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: Behavioral: Practice facilitation
  • Experimental: Practice Facilitation, Cluster 4
    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: Behavioral: Practice facilitation
  • Experimental: Practice Facilitation, Cluster 5
    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.
    Intervention: Behavioral: Practice facilitation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 19, 2018)
22000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03604393
Other Study ID Numbers  ICMJE 18660
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lyle J. Fagnan, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE
  • American Cancer Society, Inc.
  • Oregon Health Authority
  • University of Oklahoma
Investigators  ICMJE
Principal Investigator: Lyle J Fagnan, MD Oregon Health and Science University
Principal Investigator: Patty Carney, PhD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP