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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to encourage more teenagers to receive the HPV vaccine, which helps prevent certain types of cancer. It will test two communication strategies used by healthcare providers to boost vaccination rates during clinic visits. One group will receive training on effective ways to discuss the vaccine, while the other will also use reminders for parents who initially decline the vaccine. The trial seeks parents of teens aged 11-17 who haven't started the HPV vaccine and are seen at participating clinics in Pennsylvania. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance public health strategies.

Do I need to stop my current medications to participate in the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on communication strategies for HPV vaccination, so it's unlikely that your current medications would be affected.

What prior data suggests that these communication strategies are safe for increasing HPV vaccine uptake?

Research has shown that the HPV vaccine is safe and effective. The FDA approved it to prevent certain cancers caused by the human papillomavirus, indicating it is generally well-tolerated. Previous studies have found that the ECHO model, a program that trains healthcare providers to discuss vaccines, helps increase vaccination rates. Although specific safety data for the ECHO program itself is not available, it focuses on improving communication and does not impact the safety of the HPV vaccine. In summary, while the ECHO and ECHO+ programs are new methods being tested to encourage vaccination, the HPV vaccine itself has a proven safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative communication strategies to increase HPV vaccine uptake among adolescents. Unlike standard approaches that focus solely on vaccine availability and recommendation, this trial examines the effectiveness of real-time, interactive videoconferencing and personalized communication strategies. The use of the ECHO model, enhanced with a systems communication strategy for recall notices, aims to engage parents and clinics more effectively. By focusing on communication enhancements, this trial seeks to address vaccine hesitancy and improve public health outcomes through better vaccine adherence.

What evidence suggests that this trial's communication strategies could be effective for increasing HPV vaccine uptake?

Studies have shown that the HPV vaccine effectively prevents infections from the human papillomavirus, which can lead to cervical and other cancers. In this trial, the HPV ECHO program is one strategy under evaluation. It trains providers to strongly recommend the vaccine, a method that has increased vaccination rates in previous research. Another strategy, the HPV ECHO+ program, includes reminders for parents who initially declined the vaccine, encouraging reconsideration and further boosting vaccine uptake. These reminder systems have reduced missed vaccination opportunities, making them a promising tool for increasing HPV vaccination rates. ^{1 2 3 4 6}

Who Is on the Research Team?

William A Calo, PhD, JD, MPH

Principal Investigator

Penn State College of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10528011/

The HPV ECHO study protocol for a cluster randomized ... This trial uses a hybrid effectiveness-implementation design (type II) to evaluate two ECHO-delivered interventions intended to increase HPV vaccination rates.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423001891

The HPV ECHO study protocol for a cluster randomized ... This trial uses a hybrid effectiveness-implementation design (type II) to evaluate two ECHO-delivered interventions intended to increase HPV vaccination rates.

3. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10398939&term=CA253279

Division of Cancer Control & Population Sciences - Grant Details Our expected outcome is to demonstrate the effectiveness of a highly efficient and scalable implementation strategy, ECHO, to support HPV vaccination in rural ...

4. stjude.org stjude.org/research/comprehensive-cancer-center/hpv-cancer-prevention-program/resources/news-hpv-program/wos/wos-hpv-echo-for-providers.html

HPV ECHO for Providers | St. Jude Research Read about a study using the Extension for Community Healthcare Outcomes (ECHO) Model to provide HPV vaccine communication training to rural clinics.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37301468/

The HPV ECHO study protocol for a cluster randomized ... Never tested in supporting HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) model is a proven implementation strategy to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11281520/

“That Was an Eye Opener for Me”: Mixed-Methods ... Human papillomavirus (HPV) is known to cause six different types of cancer. HPV vaccination can prevent over 90% of these cancers.