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 Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1500 Participants Needed

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.

Research Team

Electra D. Paskett, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: ARM II (DELAYED INTERVENTION)(education, reminder, usual care) Experimental Treatment 4 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 Treatment 4 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, 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 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

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+