HPV Vaccine Communication Strategies for Adolescent Vaccine Uptake

Overseen By Erica Francis, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Outside Pennsylvania, Prior HPV research, others

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: 10

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US; only 51% of 13- to 17-year-old girls and boys were up-to-date by 2018. The Announcement Approach Training is effective in increasing HPV vaccine uptake during the clinic visit by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communication like recall notifications also improve vaccination by reducing missed clinical opportunities. Although never tested to support HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) Model is a proven implementation strategy to promote capacity exchange between health care experts at academic centers and primary care providers at the front line of rural community health care. The trial will test the effectiveness of two ECHO-delivered HPV vaccination communication interventions versus control: HPV ECHO will provide Announcement Approach training, and HPV ECHO+ will provide training plus recall notices to communicate with parents who initially decline vaccination.

Research Team

William A Calo, PhD, JD, MPH

Principal Investigator

Penn State College of Medicine

Eligibility Criteria

This trial is for family medicine or pediatric clinics in Pennsylvania with at least 100 active patients aged 11-14. It's also for parents or guardians of adolescents aged 11-17 who have not started the HPV vaccine and receive care at participating clinics. Clinics outside PA, those involved in recent HPV research, or patients already vaccinated are excluded.

Inclusion Criteria

Adolescent has not yet started HPV vaccination

Adolescent receive primary care at participating clinic

I am between 11 and 14 years old.

Exclusion Criteria

Participated in HPV vaccine communication or quality improvement research either through Penn State or another institution in the last 12 months

Adolescent does not receive primary care at participating clinic

I have started the HPV vaccination series.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinics receive HPV ECHO training via videoconferencing, focusing on the Announcement Approach over 10 sessions

16 weeks

10 sessions (virtual)

Follow-up

Participants are monitored for changes in HPV vaccination rates among 11- to 17-year-olds

12 months

Treatment Details

Interventions

• Announcement Approach Training
• HPV Vaccine
• Project ECHO
• Recall notices

Trial Overview The trial tests two strategies to increase HPV vaccination rates delivered via ECHO: one provides Announcement Approach training to providers; the other adds recall notices for parents who decline vaccines. The effectiveness of these interventions compared to a control group will be evaluated.

Participant Groups

Group I: HPV ECHO+ Experimental Treatment 3 Interventions

Clinics randomly assigned to this arm will receive the HPV ECHO intervention plus a systems communication strategy to deliver recall notices to parents who initially decline HPV vaccination. This arm includes 12 primary care clinics in Pennsylvania.

Group II: HPV ECHO Experimental Treatment 2 Interventions

Clinics randomly assigned to this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. The intervention has a curriculum of 10 sessions focused on the evidence-based Announcement Approach. Sessions will be 60 minutes in duration and held every other weekly for 4 months at regularly scheduled times.

Group III: Control Active Control 1 Intervention

Clinics randomly assigned to this arm will receive no ECHO interventions. This arm includes 12 primary care clinics in Pennsylvania.

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?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+