Communication Strategies for HPV Vaccination

Recruiting at 1 trial location

Overseen By Melissa B Gilkey, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Hospice, Pregnancy, HPV contraindications, others

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

Compensation: Varies

Number of Visits: 1

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will compare two ways to improve communication about HPV vaccination in primary care. The research team will work with primary care clinics. Some clinics will receive communication training from an outside expert. Other clinics will receive the same training from a vaccine champion from their healthcare system.

Do I have to stop taking my current medications for this trial?

The trial does not specify whether participants need to stop taking their current medications. However, since the trial involves clinics and staff rather than individual patients, it is unlikely that you would need to change your medications.

What data supports the effectiveness of the treatment Champion Announcement Approach Training, Traditional Announcement Approach Training for HPV vaccination?

Research shows that training healthcare providers to use strong, presumptive announcements when recommending the HPV vaccine effectively increases vaccination rates. This approach helps address parents' concerns and boosts their confidence in the vaccine's benefits. ^{1 2 3 4 5}

Is the Announcement Approach Training for HPV vaccination safe for humans?

The Announcement Approach Training is a communication strategy to increase HPV vaccine uptake and does not involve administering a vaccine or medication, so it does not have safety concerns like a medical treatment would. The safety of the HPV vaccines themselves has been well-studied, and they are considered safe based on extensive research and monitoring. ^{1 5 6 7 8}

How does the treatment for HPV vaccination communication differ from other treatments?

This treatment focuses on communication strategies, like the Announcement Approach, to increase HPV vaccine uptake by addressing parents' concerns and encouraging vaccination, which is different from traditional medical treatments that focus on the vaccine itself. ^{1 4 5 9 10}

Research Team

Noel T Brewer, PhD

Principal Investigator

University of North Carolina

Eligibility Criteria

This trial is for primary care clinics that serve children aged 9-12, specializing in pediatrics or family medicine. Clinics will be enrolled and their staff trained to communicate about HPV vaccination; however, children won't be directly involved.

Inclusion Criteria

Clinics that specialize in pediatrics or family medicine

I am between 9 and 12 years old.

My clinic offers primary care to children aged 9-12.

Exclusion Criteria

I am not between 9 and 12 years old.

Children not attributed to a participating clinic at 12-month follow-up

Clinics with a specialty other than pediatrics or family medicine

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Clinics receive Announcement Approach Training (AAT) to improve communication about HPV vaccination

4 weeks

1 visit (in-person)

Follow-up

Clinics are monitored for changes in HPV vaccination rates among children ages 9-12

12 months

Treatment Details

Interventions

• Champion Announcement Approach Training
• Traditional Announcement Approach Training

Trial Overview The study compares two training methods aimed at improving HPV vaccine discussions: one delivered by an external expert and the other by a 'vaccine champion' from within the healthcare system itself.

Participant Groups

Group I: Traditional AAT Experimental Treatment 1 Intervention

Staff in clinics randomized to this arm will also receive Announcement Approach Training (AAT). The training will be organized and delivered by outside experts.

Group II: Champion AAT Experimental Treatment 1 Intervention

Staff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination. The training will be organized and delivered by vaccine champions from participating healthcare systems.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Wisconsin, Madison

Collaborator

Trials

1,249

Recruited

3,255,000+

Findings from Research

This trial will evaluate two ECHO-delivered interventions aimed at increasing HPV vaccination rates among adolescents aged 11-14 in 36 primary care clinics, focusing on the effectiveness of provider training and parent recall notices.

The study aims to demonstrate that these interventions can improve HPV vaccination uptake, ultimately helping to prevent HPV-related cancers by addressing communication needs for both healthcare providers and parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing the adoption of evidence-based communication practices for HPV vaccination in primary care clinics: The HPV ECHO study protocol for a cluster randomized controlled trial. Calo, WA., Shah, PD., Fogel, BN., et al.[2023]

Training providers to use presumptive 'announcements' significantly increased HPV vaccination initiation by 5.4% among adolescents aged 11 or 12 years compared to control clinics, indicating that this approach is effective in improving vaccination rates.

Conversational training did not lead to any significant changes in HPV vaccination coverage, suggesting that the method of recommendation plays a crucial role in influencing parents' decisions to vaccinate their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial. Brewer, NT., Hall, ME., Malo, TL., et al.[2022]

Gardasil-9, the only HPV vaccine available in the U.S., is nearly 100% effective at preventing precancers caused by oncogenic HPV types, yet only about half of adolescents are fully vaccinated.

Strong and presumptive recommendations from healthcare clinicians significantly improve HPV vaccine uptake, highlighting the importance of effective communication strategies in increasing vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician communication strategies associated with increased uptake of the human papillomavirus (HPV) vaccine: A systematic review. Constable, C., Ferguson, K., Nicholson, J., et al.[2022]

There are three licensed HPV vaccines: bivalent, quadrivalent, and nonavalent, with the nonavalent vaccine introduced in 2014, yet vaccination coverage remains low in many developed countries due to safety concerns.

This review aims to clarify the safety profiles of all three HPV vaccines by summarizing data from both pre- and post-licensure studies, particularly focusing on the newer nonavalent vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of HPV vaccines in the age of nonavalent vaccination. Quattrone, F., Canale, A., Filippetti, E., et al.[2018]

Out of 1577 patients referred to the One Access centers for suspected adverse events following HPV vaccination, only 404 (26%) were reported to the Danish Medicines Agency, highlighting significant gaps in AEFI reporting.

The study identified regional differences in reporting completeness and factors influencing physicians' reporting behavior, suggesting that these inconsistencies could affect the reliability of AEFI data used for research and policy decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the contextual nature of vaccine safety monitoring: Adverse events reporting after HPV-vaccination in Denmark, 2015. Schartau, S., Heering Holt, D., Lützen, T., et al.[2020]

In a study involving 12,066 women aged 9 to 26 years who received the HPV vaccines Gardasil® and Cervarix® over three years, 61% reported experiencing mild and transient adverse events after the first dose.

The high rate of reported adverse events is attributed to the study's design, which encouraged participants to document all occurrences, highlighting the importance of ongoing surveillance for vaccine safety, especially for newly marketed vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. Spila-Alegiani, S., Da Cas, R., Giambi, C., et al.[2013]

Over ten years since its introduction, various strategies have been implemented to improve and sustain HPV vaccination rates, involving public health policies, education programs, and clinical practices.

Future efforts to promote HPV vaccination should adopt a multi-level and integrated approach to effectively combat misinformation and enhance vaccination rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective and prospective look at strategies to increase adolescent HPV vaccine uptake in the United States. Head, KJ., Biederman, E., Sturm, LA., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Increasing the adoption of evidence-based communication practices for HPV vaccination in primary care clinics: The HPV ECHO study protocol for a cluster randomized controlled trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Why is announcement training more effective than conversation training for introducing HPV vaccination? A theory-based investigation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinician communication strategies associated with increased uptake of the human papillomavirus (HPV) vaccine: A systematic review. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Easing Human Papillomavirus Vaccine Hesitancy: A Communication Experiment With U.S. Parents. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Safety of HPV vaccines in the age of nonavalent vaccination. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

On the contextual nature of vaccine safety monitoring: Adverse events reporting after HPV-vaccination in Denmark, 2015. [2020]

8. Italy pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

A retrospective and prospective look at strategies to increase adolescent HPV vaccine uptake in the United States. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Designing for dissemination: lessons in message design from "1-2-3 pap". [2022]