HPV Vaccination Strategies for Cervical Cancer Prevention
(IVaccinate Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

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

Overseen byElectra D. Paskett, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

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.

Eligibility Criteria

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.

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Treatment Details

Interventions

Educational Intervention (Behavioural Intervention)
HPV Vaccine (Cancer Vaccine)
Reminder (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: ARM II (DELAYED INTERVENTION)(education, reminder, usual care)Experimental Treatment4 Interventions

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

Group II: ARM I (EARLY INTERVENTION) (educational material, reminders)Experimental Treatment4 Interventions

Health systems receive educational materials consisting of posters, brochures and handouts. Providers complete survey about HPV knowledge, participate in educational session over 1 hour and receive educational handouts on the HPV vaccine. Patients receive educational materials about HPV vaccine and reminder letters for HPV vaccination

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

🇺🇸 Approved in United States as Gardasil 9 for:

Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

🇪🇺 Approved in European Union as Gardasil 9 for:

Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

🇨🇦 Approved in Canada as Gardasil 9 for:

Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

🇦🇺 Approved in Australia as Gardasil 9 for:

Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11

🇨🇭 Approved in Switzerland as Gardasil 9 for:

Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11