- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03604393
Increasing HPV Immunization Rates: The Rural Adolescent Vaccine Enterprise (RAVE)
March 17, 2022 updated by: Lyle J. Fagnan, Oregon Health and Science University
Increasing Human Papillomavirus (HPV) Immunization Rates: The Rural Adolescent Vaccine Enterprise (RAVE)
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
22000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oregon
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Portland, Oregon, United States, 97239
- ORPRN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lyle J Fagnan, MD, Oregon Health and Science University
- Principal Investigator: Patty Carney, PhD, Oregon Health and Science University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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- Westfall JM, Mold J, Fagnan L. Practice-based research--"Blue Highways" on the NIH roadmap. JAMA. 2007 Jan 24;297(4):403-6. doi: 10.1001/jama.297.4.403. No abstract available.
- Briss PA, Rodewald LE, Hinman AR, Shefer AM, Strikas RA, Bernier RR, Carande-Kulis VG, Yusuf HR, Ndiaye SM, Williams SM. Reviews of evidence regarding interventions to improve vaccination coverage in children, adolescents, and adults. The Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):97-140. doi: 10.1016/s0749-3797(99)00118-x.
- Recommendations regarding interventions to improve vaccination coverage in children, adolescents, and adults. Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):92-6. No abstract available.
- Munoz N, Castellsague X, Berrington de Gonzalez A, Gissmann L. Chapter 1: HPV in the etiology of human cancer. Vaccine. 2006 Aug 31;24 Suppl 3:S3/1-10. doi: 10.1016/j.vaccine.2006.05.115. Epub 2006 Jun 23.
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- Koutsky L. The epidemiology behind the HPV vaccine discovery. Ann Epidemiol. 2009 Apr;19(4):239-44. doi: 10.1016/j.annepidem.2009.01.023.
- Centers for Disease Control and Prevention (CDC). National and state vaccination coverage among adolescents aged 13-17 years--United States, 2011. MMWR Morb Mortal Wkly Rep. 2012 Aug 31;61(34):671-7. Erratum In: MMWR Morb Mortal Wkly Rep. 2012 Oct 19;61(41):844.
- Reagan-Steiner S, Yankey D, Jeyarajah J, Elam-Evans LD, Singleton JA, Curtis CR, MacNeil J, Markowitz LE, Stokley S. National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13-17 Years--United States, 2014. MMWR Morb Mortal Wkly Rep. 2015 Jul 31;64(29):784-92. doi: 10.15585/mmwr.mm6429a3.
- Oster NV, McPhillips-Tangum CA, Averhoff F, Howell K. Barriers to adolescent immunization: a survey of family physicians and pediatricians. J Am Board Fam Pract. 2005 Jan-Feb;18(1):13-9. doi: 10.3122/jabfm.18.1.13.
- Niccolai LM, Hansen CE. Practice- and Community-Based Interventions to Increase Human Papillomavirus Vaccine Coverage: A Systematic Review. JAMA Pediatr. 2015 Jul;169(7):686-92. doi: 10.1001/jamapediatrics.2015.0310.
- Smulian EA, Mitchell KR, Stokley S. Interventions to increase HPV vaccination coverage: A systematic review. Hum Vaccin Immunother. 2016 Jun 2;12(6):1566-88. doi: 10.1080/21645515.2015.1125055. Epub 2016 Feb 2.
- Petrosky E, Bocchini JA Jr, Hariri S, Chesson H, Curtis CR, Saraiya M, Unger ER, Markowitz LE; Centers for Disease Control and Prevention (CDC). Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the advisory committee on immunization practices. MMWR Morb Mortal Wkly Rep. 2015 Mar 27;64(11):300-4.
- Meites E, Kempe A, Markowitz LE. Use of a 2-Dose Schedule for Human Papillomavirus Vaccination - Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2016 Dec 16;65(49):1405-1408. doi: 10.15585/mmwr.mm6549a5.
- Jacobson RM, Rogacki B, Thompson DM, Roberts JR, Margolis B, Darden PM. Vaccination Rates among Adolescents in Minnesota as Compared with the United States: Not "Above Average". Minn Med. 2015 Nov-Dec;98(11-12):38-43.
- Kepka D, Spigarelli MG, Warner EL, Yoneoka Y, McConnell N, Balch A. Statewide analysis of missed opportunities for human papillomavirus vaccination using vaccine registry data. Papillomavirus Res. 2016 Dec;2:128-132. doi: 10.1016/j.pvr.2016.06.002.
- Roberts JR, Naifeh M, Jacobson RM, Hinton E, O'Brien E, Rogacki B, Thompson D, Margolis B, Darden PM. Adolescent Vaccination Performance in South Carolina Compared to the United States. J S C Med Assoc. 2015 Dec-2016 Jan;111(4):117-21.
- Brewer NT, Fazekas KI. Predictors of HPV vaccine acceptability: a theory-informed, systematic review. Prev Med. 2007 Aug-Sep;45(2-3):107-14. doi: 10.1016/j.ypmed.2007.05.013. Epub 2007 Jun 2.
- Marlow LA, Waller J, Wardle J. Parental attitudes to pre-pubertal HPV vaccination. Vaccine. 2007 Mar 1;25(11):1945-52. doi: 10.1016/j.vaccine.2007.01.059. Epub 2007 Jan 22.
- Roberts JR, Thompson D, Rogacki B, Hale JJ, Jacobson RM, Opel DJ, Darden PM. Vaccine hesitancy among parents of adolescents and its association with vaccine uptake. Vaccine. 2015 Mar 30;33(14):1748-55. doi: 10.1016/j.vaccine.2015.01.068. Epub 2015 Feb 7.
- Katz ML, Reiter PL, Heaner S, Ruffin MT, Post DM, Paskett ED. Acceptance of the HPV vaccine among women, parents, community leaders, and healthcare providers in Ohio Appalachia. Vaccine. 2009 Jun 19;27(30):3945-52. doi: 10.1016/j.vaccine.2009.04.040. Epub 2009 May 3.
- Coyne CA, Demian-Popescu C, Friend D. Social and cultural factors influencing health in southern West Virginia: a qualitative study. Prev Chronic Dis. 2006 Oct;3(4):A124. Epub 2006 Sep 15.
- Ferrer HB, Trotter C, Hickman M, Audrey S. Barriers and facilitators to HPV vaccination of young women in high-income countries: a qualitative systematic review and evidence synthesis. BMC Public Health. 2014 Jul 9;14:700. doi: 10.1186/1471-2458-14-700.
- Lyttle NL, Stadelman K. Assessing awareness and knowledge of breast and cervical cancer among Appalachian women. Prev Chronic Dis. 2006 Oct;3(4):A125. Epub 2006 Sep 15.
- Elnicki DM, Morris DK, Shockcor WT. Patient-perceived barriers to preventive health care among indigent, rural Appalachian patients. Arch Intern Med. 1995 Feb 27;155(4):421-4.
- Thomas T, Blumling A, Delaney A. The Influence of Religiosity and Spirituality on Rural Parents' Health Decision Making and Human Papillomavirus Vaccine Choices. ANS Adv Nurs Sci. 2015 Oct-Dec;38(4):E1-E12. doi: 10.1097/ANS.0000000000000094.
- Darden PM, Thompson DM, Roberts JR, Hale JJ, Pope C, Naifeh M, Jacobson RM. Reasons for not vaccinating adolescents: National Immunization Survey of Teens, 2008-2010. Pediatrics. 2013 Apr;131(4):645-51. doi: 10.1542/peds.2012-2384. Epub 2013 Mar 18.
- Darden PM, Taylor JA, Brooks DA, Hendricks JW, Massoudi M, Stevenson JM, Bocian AB. How should immunization rates be measured in the office setting? A study from PROS and NMA PedsNet. Clin Pediatr (Phila). 2008 Apr;47(3):252-60. doi: 10.1177/0009922807308743. Epub 2007 Dec 5.
- Slora EJ, Steffes JM, Harris D, Clegg HW, Norton D, Darden PM, Sullivan SA, Wasserman RC. Improving pediatric practice immunization rates through distance-based quality improvement: a feasibility trial from PROS. Clin Pediatr (Phila). 2008 Jan;47(1):25-36. doi: 10.1177/0009922807304597. Epub 2007 Aug 10.
- McElligott JT, Darden PM. Are patient-held vaccination records associated with improved vaccination coverage rates? Pediatrics. 2010 Mar;125(3):e467-72. doi: 10.1542/peds.2009-0835. Epub 2010 Feb 15.
- Mennito SH, Darden PM. Impact of practice policies on pediatric immunization rates. J Pediatr. 2010 Apr;156(4):618-22. doi: 10.1016/j.jpeds.2009.10.046. Epub 2010 Jan 13.
- Darden PM, Gustafson KK, Nietert PJ, Jacobson RM. Extra-immunization as a clinical indicator for fragmentation of care. Public Health Rep. 2011 Jul-Aug;126 Suppl 2(Suppl 2):48-59. doi: 10.1177/00333549111260S207.
- Fagnan LJ, Dorr DA, Davis M, McGinnis P, Mahler J, King MM, Michaels L. Turning on the care coordination switch in rural primary care: voices from the practices--clinician champions, clinician partners, administrators, and nurse care managers. J Ambul Care Manage. 2011 Jul-Sep;34(3):304-18. doi: 10.1097/JAC.0b013e31821c63ee.
- Carney PA, Cook AJ, Miglioretti DL, Feig SA, Bowles EA, Geller BM, Kerlikowske K, Kettler M, Onega T, Elmore JG. Use of clinical history affects accuracy of interpretive performance of screening mammography. J Clin Epidemiol. 2012 Feb;65(2):219-30. doi: 10.1016/j.jclinepi.2011.06.010. Epub 2011 Oct 15.
- Fagnan LJ, Morris C, Shipman SA, Holub J, King A, Angier H. Characterizing a practice-based research network: Oregon Rural Practice-Based Research Network (ORPRN) survey tools. J Am Board Fam Med. 2007 Mar-Apr;20(2):204-19. doi: 10.3122/jabfm.2007.02.060140.
- Dietrich AJ, Carney PA, Winchell CW, Sox CH, Reed SC. An office systems approach to cancer prevention in primary care. Cancer Pract. 1997 Nov-Dec;5(6):375-81.
- Dietrich AJ, Woodruff CB, Carney PA. Changing office routines to enhance preventive care. The preventive GAPS approach. Arch Fam Med. 1994 Feb;3(2):176-83. doi: 10.1001/archfami.3.2.176.
- Dietrich AJ, O'Connor GT, Keller A, Carney PA, Levy D, Whaley FS. Cancer: improving early detection and prevention. A community practice randomised trial. BMJ. 1992 Mar 14;304(6828):687-91. doi: 10.1136/bmj.304.6828.687.
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- Cates JR, Diehl SJ, Crandell JL, Coyne-Beasley T. Intervention effects from a social marketing campaign to promote HPV vaccination in preteen boys. Vaccine. 2014 Jul 16;32(33):4171-8. doi: 10.1016/j.vaccine.2014.05.044. Epub 2014 Jun 2.
- Cates JR, Shafer A, Diehl SJ, Deal AM. Evaluating a County-Sponsored Social Marketing Campaign to Increase Mothers' Initiation of HPV Vaccine for their Pre-teen Daughters in a Primarily Rural Area. Soc Mar Q. 2011 Spring;17(1):4-26. doi: 10.1080/15245004.2010.546943.
- Moss JL, Gilkey MB, Rimer BK, Brewer NT. Disparities in collaborative patient-provider communication about human papillomavirus (HPV) vaccination. Hum Vaccin Immunother. 2016 Jun 2;12(6):1476-83. doi: 10.1080/21645515.2015.1128601. Epub 2016 Jan 19.
- Keating KM, Brewer NT, Gottlieb SL, Liddon N, Ludema C, Smith JS. Potential barriers to HPV vaccine provision among medical practices in an area with high rates of cervical cancer. J Adolesc Health. 2008 Oct;43(4 Suppl):S61-7. doi: 10.1016/j.jadohealth.2008.06.015.
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- Pope CA, Escobar-Gomez M, Davis BH, Roberts JR, O'Brien ES, Hinton E, Darden PM. The challenge of tetradic relationships in medically interpreted pediatric primary care visits: A descriptive study of communication practices. Patient Educ Couns. 2016 Apr;99(4):542-548. doi: 10.1016/j.pec.2015.10.032. Epub 2015 Dec 8.
- Stone EG, Morton SC, Hulscher ME, Maglione MA, Roth EA, Grimshaw JM, Mittman BS, Rubenstein LV, Rubenstein LZ, Shekelle PG. Interventions that increase use of adult immunization and cancer screening services: a meta-analysis. Ann Intern Med. 2002 May 7;136(9):641-51. doi: 10.7326/0003-4819-136-9-200205070-00006.
- Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Greene MA, Sox CH, Beach ML, DuHamel KN, Younge RG. Telephone care management to improve cancer screening among low-income women: a randomized, controlled trial. Ann Intern Med. 2006 Apr 18;144(8):563-71. doi: 10.7326/0003-4819-144-8-200604180-00006.
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- Fagnan LJ, Shipman SA, Gaudino JA, Mahler J, Sussman AL, Holub J. To give or not to give: Approaches to early childhood immunization delivery in Oregon rural primary care practices. J Rural Health. 2011 Winter;27(4):385-93. doi: 10.1111/j.1748-0361.2010.00356.x. Epub 2011 Jan 11.
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- Miller WL, Crabtree BF, McDaniel R, Stange KC. Understanding change in primary care practice using complexity theory. J Fam Pract. 1998 May;46(5):369-76.
- Carney PA, Hatch B, Stock I, Dickinson C, Davis M, Larsen R, Valenzuela S, Marino M, Darden PM, Gunn R, Ferrara L, Fagnan LJ. A stepped-wedge cluster randomized trial designed to improve completion of HPV vaccine series and reduce missed opportunities to vaccinate in rural primary care practices. Implement Sci. 2019 Mar 14;14(1):30. doi: 10.1186/s13012-019-0871-9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2019
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
July 11, 2018
First Submitted That Met QC Criteria
July 19, 2018
First Posted (Actual)
July 27, 2018
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 17, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18660
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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