1500 Participants Needed

HPV Vaccination Strategies for Cervical Cancer Prevention

(IVaccinate Trial)

Recruiting at 3 trial locations
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies how well a multi-level health system-based intervention works in improving human papillomavirus (HPV) vaccine initiation and completion among children in health systems in four Appalachian states. Utilizing educational and promotional materials and electronic health record reminders, may improve the uptake of the HPV vaccine in children and young adults, ultimately preventing the development of cervical cancer.

Who Is on the Research Team?

Electra D. Paskett, PhD | College of ...

Electra D. Paskett, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for healthcare providers and office staff in certain Appalachian states who care for patients aged 11-26, provide immunizations, and are involved in the vaccine process. Participants must be able to speak, read, and write English.

Inclusion Criteria

The trial does not include healthcare providers, such as doctors, nurses, and office staff.
People who work with the vaccine at the clinic.
You are able to communicate in English through speaking, reading, and writing.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Intervention

Health systems receive educational materials, providers complete surveys and educational sessions, and patients receive educational materials and reminder letters for HPV vaccination.

12 months
Multiple visits for educational sessions and material distribution

Delayed Intervention

Health systems, providers, and patients receive usual care for 12 months, then receive the multi-level intervention as in the early intervention phase.

12 months
Multiple visits for educational sessions and material distribution

Follow-up

Participants are monitored for changes in HPV vaccination rates, knowledge, and attitudes of providers.

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Educational Intervention
  • HPV Vaccine
  • Reminder
Trial Overview The study tests if using educational materials, promotional efforts, and electronic health record reminders can increase HPV vaccination rates among children and young adults within four Appalachian state health systems.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: ARM II (DELAYED INTERVENTION)(education, reminder, usual care)Experimental Treatment4 Interventions
Group II: ARM I (EARLY INTERVENTION) (educational material, reminders)Experimental Treatment4 Interventions

HPV Vaccine is already approved in United States, European Union, Canada, Switzerland for the following indications:

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Approved in United States as Gardasil 9 for:
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Approved in European Union as Gardasil 9 for:
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Approved in Canada as Gardasil 9 for:
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Approved in Switzerland as Gardasil 9 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Unbiased ResultsWe believe in providing patients with all the options.
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