Communication Strategies for HPV Vaccination

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the most effective way for clinics to discuss HPV vaccination, which protects against certain types of cancer. Clinics will receive training either from outside experts (Traditional Announcement Approach Training) or from vaccine champions within their healthcare system (Champion Announcement Approach Training). The trial will examine how these training styles affect vaccination rates among children. Clinics that provide primary care for children aged 9-12 and specialize in pediatrics or family medicine are well-suited for participation. As an unphased trial, this study presents a unique opportunity to enhance public health communication strategies.

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 prior data suggests that these communication strategies are safe?

Research has shown that Announcement Approach Training (AAT) helps doctors discuss the HPV vaccine more effectively, aiming to enhance vaccine recommendations.

In the Champion Announcement Approach Training, healthcare staff learn from a vaccine expert within their system. In the Traditional Announcement Approach Training, outside experts lead the sessions. Both methods aim to strengthen doctors' vaccine recommendations.

These trainings focus on communication skills, not on a new drug or medical procedure, so there are no direct safety concerns for participants. The main goal is to improve how vaccines are discussed in clinics.

Past studies found that healthcare workers who completed this training improved in recommending the HPV vaccine. No negative effects were reported from the training itself, indicating that the trainings are safe and well-received by clinic staff. ^{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 boost HPV vaccination rates. Unlike traditional methods that rely on standard announcement approaches, this study includes a Champion Announcement Approach Training. This unique method leverages vaccine champions from healthcare systems to deliver training, potentially leading to more persuasive and personalized conversations about HPV vaccination. By improving how healthcare providers discuss vaccinations, the trial aims to increase vaccine uptake and protect more people from HPV-related diseases.

What evidence suggests that this trial's communication strategies could be effective for improving HPV vaccination rates?

This trial will compare two communication strategies for increasing HPV vaccination rates: the Champion Announcement Approach Training and the Traditional Announcement Approach Training. Research has shown that both methods help increase HPV vaccination rates. In the Champion approach, studies have found that using vaccine champions to assist healthcare providers can greatly improve how they discuss the HPV vaccine. This method has been linked to more people starting the vaccination. In the Traditional approach, training providers to make clear announcements has led to more young adolescents getting vaccinated. Both methods enable healthcare professionals to recommend the vaccine more effectively, resulting in higher vaccination rates. ^{3 5 6 7 8}

Who Is on the Research Team?

Noel T Brewer, PhD

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8217248/

Easing Human Papillomavirus Vaccine Hesitancy CONCLUSIONS. The Announcement Approach gives providers an effective way to communicate about HPV vaccine that saves time during clinical encounters39 and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11180554/

HPV Multilevel Intervention Strategies Targeting Immunization ... This session provides a brief overview of the Announcement Approach, discusses how Vaccine Champions can support providers at their health ...

3. publications.aap.org publications.aap.org/pediatrics/article/155/3/e2024066742/200812/Cost-Analysis-of-a-Scalable-Clinician

Cost Analysis of a Scalable Clinician Communication ... Online communication training reduced missed opportunities (MOs) for initial human papillomavirus (HPV) vaccination at well-child care (WCC) ...

4. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10266271&term=CA250989

Division of Cancer Control & Population Sciences - Grant Details The projects will work together to enhance the impact of the Announcement Approach Training (AAT), an HPV vaccine communication training for primary care ...

5. withpower.com withpower.com/trial/phase-papilloma-2-2023-d0c3b

Communication Strategies for HPV Vaccination Training providers to use presumptive 'announcements' significantly increased HPV vaccination initiation by 5.4% among adolescents aged 11 or 12 years compared ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8522013/

HPV Vaccination Champions: Evaluating a Technology ... The goals of the 3-month online training were to help HPV vaccination champions explain HPV vaccination recommendations, discuss the importance of HPV ...

7. wicancer.org wicancer.org/hpv-vaccine-improvement-project-recruiting-health-systems-for-spring-2024/

HPV Vaccine Improvement Project Recruiting Health ... The communication workshop, called The Announcement Approach, is for all clinical staff who have a role in adolescent vaccination. Content ...

8. hpviq.org hpviq.org/train/the-announcement-approach-training

The Announcement Approach Training The training teaches health care professionals how to make and support strong HPV vaccine recommendations.