Clinical trial NCT03604393: Increasing HPV Immunization Rates: The Rural Adolescent Vaccine Enterprise
Official title: Increasing Human Papillomavirus (HPV) Immunization Rates: The Rural Adolescent Vaccine Enterprise (RAVE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Human Papilloma Virus
Keywords: Immunization
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Oregon Health Authority
name: University of Arkansas
First posted: 2018-07-27
Enrollment: 22000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Aims II and III are interventional, using a randomized stepped-wedge design with the practice as the unit of randomization.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: HPV vaccine series completion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: ORPRN
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Lyle J Fagnan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Patty Carney, PhD
role: PRINCIPAL_INVESTIGATOR
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