Standing Orders for Human Papillomavirus

Overseen By Robin Bender

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: High vaccination rate, Low eligible patients

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

Compensation: Varies

Number of Visits: Unknown

16000 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Communication, Standing Orders for Human Papillomavirus?

Research shows that improving communication and using standing orders can increase HPV vaccination rates. For example, a study found that using electronic medical record prompts and nurse protocols significantly improved vaccination rates in postpartum patients. Additionally, educating healthcare providers about HPV and enhancing their communication skills led to better vaccine recommendations and higher vaccination rates. ^{1 2 3 4 5}

Is the human papillomavirus (HPV) vaccine safe for humans?

The HPV vaccine has been monitored for safety in various studies, including in Italy and Australia, and through global databases. These studies have shown that the vaccine is generally safe, with common side effects being mild, such as soreness at the injection site. ^{6 7 8 9 10}

How does the HPV vaccine treatment differ from other treatments for HPV?

The HPV vaccine is unique because it is a preventive measure rather than a treatment for existing HPV infections. It is administered in a series of doses to prevent HPV-related diseases, such as cervical cancer, by targeting specific strains of the virus before exposure. This approach contrasts with treatments that address symptoms or complications after infection has occurred. ^{11 12 13 14 15}

What is the purpose of this trial?

Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time. Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 9-17 year-olds.

Eligibility Criteria

This trial is for active patients within a specific healthcare network in Western New York, aged between 9 and 17 years old. It aims to improve HPV vaccination rates among adolescents who are often at the primary target age for receiving this vaccine.

Inclusion Criteria

I am currently seeing a doctor in the AHP network.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Practice personnel receive training in communication about HPV vaccination and implementation of standing orders

12 months

Ongoing practice visits

Maintenance

Practices continue to implement standing orders and communication strategies

12 months

Follow-up

Participants are monitored for vaccination uptake and effectiveness of interventions

12 months

Treatment Details

Interventions

• Communication
• Standing Orders

Trial Overview The study is testing whether 'standing orders' plus an HPV communication education program can increase vaccination rates compared to just the education program alone. Standing orders allow certain healthcare team members to vaccinate without a direct physician order.

Participant Groups

Group I: Communication Training + Standing Orders Training/Implementation Experimental Treatment 2 Interventions

Practice personnel (providers and nurses) receive training in communication about HPV vaccination and training in the implementation of standing orders for HPV vaccination.

Group II: Communication Training Active Control 1 Intervention

Practice personnel (providers and nurses) receive training in communication about HPV vaccination.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A multi-component intervention, including communication training, significantly improved providers' beliefs about the HPV vaccine, with the percentage of providers considering it a key adolescent vaccine rising from 71% to 100%.

The intervention also enhanced recommendation practices, as evidenced by an increase in the use of a presumptive recommendation style from 62.5% to 79.6%, indicating a more effective approach to discussing the HPV vaccine with parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a multi-component intervention on providers' HPV vaccine communication. Perkins, RB., Banigbe, B., Fenton, AT., et al.[2021]

A quality improvement initiative successfully increased HPV vaccine completion rates among adolescents from 50.9% to 61.7%, with significant improvements for both males and females.

The study demonstrated that enhancing provider recommendations and ensuring consistent vaccine availability at visits led to a notable rise in vaccination rates, with one-dose rates reaching 88.4% for males and 91.5% for females.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing HPV Vaccination Coverage Through Provider-Based Interventions. Krantz, L., Ollberding, NJ., Beck, AF., et al.[2019]

In a study involving postpartum patients at two hospitals, an electronic medical record (EMR) prompt significantly increased HPV vaccination rates, with 66% of eligible patients receiving the vaccine compared to only 32% with a nurse-based protocol.

Patients at the hospital using the EMR prompt were nearly 6 times more likely to receive the HPV vaccine than those at the hospital using the nurse protocol, highlighting the effectiveness of integrating technology into vaccination strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Success of an EMR-Driven Postpartum Intervention to Improve HPV Vaccination Rates. Park, SK., Holschneider, CH., Chen, J., et al.[2021]

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]

The study estimated background rates of potential adverse events following immunization (AEFI) in adolescent boys, finding rates of 252.9 neurological events and 175.2 allergic events per 100,000 person-years, which helps establish a baseline for safety monitoring after the quadrivalent HPV vaccination.

After vaccinating approximately 1.44 million boys, the study predicts about 2.4 cases of Guillain-Barré syndrome, 3.9 seizures, and 0.3 anaphylaxis episodes in the first 6 weeks, indicating that while some adverse events may occur, they are expected at low rates relative to the number of vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccine in boys: background rates of potential adverse events. Clothier, HJ., Lee, KJ., Sundararajan, V., et al.[2019]

The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.

The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

References

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

A Clinical Educational Intervention to Increase HPV Vaccination Rates Among Pediatric Patients Through Enhanced Recommendations. [2023]

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

Effect of a multi-component intervention on providers' HPV vaccine communication. [2021]

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

Increasing HPV Vaccination Coverage Through Provider-Based Interventions. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Development of a cervical cancer progress prediction tool for human papillomavirus-positive Koreans: A support vector machine-based approach. [2022]

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

Success of an EMR-Driven Postpartum Intervention to Improve HPV Vaccination Rates. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events following HPV vaccination: 11 years of surveillance in Australia. [2021]

7. Italy pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. [2013]

8. Australia pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccine in boys: background rates of potential adverse events. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. [2015]

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

Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (types 6, 11, 16, and 18) l1 virus-like particle vaccine. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Acceptability of two- versus three-dose human papillomavirus vaccination schedule among providers and mothers of adolescent girls: a mixed-methods study in five countries. [2020]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccines: WHO position paper, October 2014-Recommendations. [2015]

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

Medical societies' recommendations for immunization with Human Papillomavirus vaccine and disclosure of conflicts of interests. [2009]

14. England pubmed.ncbi.nlm.nih.gov

Prophylactic human papillomavirus vaccination and primary prevention of cervical cancer: issues and challenges. [2018]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Vaccine programme stakeholder perspectives on a hypothetical single-dose human papillomavirus (HPV) vaccine schedule in low and middle-income countries. [2019]