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

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial explores ways to improve HPV vaccination rates among 9-17 year-olds. It tests whether allowing healthcare staff to administer the vaccine without a doctor's order (known as "Standing Orders"), combined with training on vaccine communication, is more effective than training alone. The trial takes place in Western New York and involves 40 different healthcare practices. Suitable participants are those receiving care at these practices, except at locations with already high HPV vaccination rates or very few 11-12 year-olds needing the vaccine. As an unphased trial, this study provides a unique opportunity to enhance public health strategies for increasing HPV vaccination rates.

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 prior data suggests that standing orders for HPV vaccination are safe?

Research has shown that standing orders can increase vaccination rates, including for the HPV vaccine. Standing orders are guidelines that allow healthcare staff to administer vaccines without a doctor's approval for each patient. This method has been safely used for other vaccines, such as those for tetanus and whooping cough.

No specific safety concerns exist with using standing orders for the HPV vaccine. They primarily change the administration process, not the vaccines themselves. The FDA has already approved the HPV vaccine, confirming its safety.

Training healthcare staff to communicate about vaccines is also safe. It enhances their ability to discuss vaccines with patients and parents, improving understanding and acceptance.

In summary, both standing orders and communication training are safe for clinical trial participants. They help increase vaccination rates without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to boost HPV vaccination rates through improved communication and streamlined processes. Unlike the standard approach, which often relies on healthcare providers remembering to recommend the vaccine during visits, this trial tests the impact of communication training for providers and nurses. Additionally, it examines the use of standing orders, which allow vaccinations to be administered without a direct physician order each time, potentially making the process more efficient and increasing vaccination rates. By improving how healthcare teams discuss and administer the vaccine, the trial aims to enhance vaccination uptake and ultimately reduce the prevalence of HPV-related diseases.

What evidence suggests that this trial's treatments could be effective for increasing HPV vaccination rates?

Research has shown that standing orders can increase HPV vaccination rates, but the readiness of clinical staff to use them remains unclear. One study found that about half of healthcare providers felt comfortable using standing orders for the HPV vaccine. Quality improvement coaching, often including standing orders, has led to small increases in vaccination rates. In this trial, one group will receive only communication training, while another will receive both communication training and training in implementing standing orders. Training and communication programs for providers have effectively encouraged HPV vaccination. Overall, combining standing orders with communication training could improve vaccination rates among teenagers. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11242613/

HPV Vaccine Standing Orders and Communication in ...

Standing orders may improve HPV vaccination rates, but clinical staff's readiness to use them has not been well-explored.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05742386

NCT05742386 | Impact of Standing Orders Optimization

This trial will look at the impact of optimizing human papillomavirus (HPV) vaccine standing orders. The research team will work with primary care clinics.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0264410X15002339

Acceptability of using standing orders to deliver human ...

Results. The response rate was 44%. Receipt of prior HPV vaccine doses was reported by 67% of respondents. Approximately half (53%) were comfortable ...

4.

cdc.gov

cdc.gov/pcd/issues/2020/19_0410.htm

A Process Evaluation in 3 States, 2018–2019

Quality improvement (QI) coaching is effective in improving clinic human papillomavirus (HPV) vaccination coverage; however, improvements are generally small.

5.

publications.aap.org

publications.aap.org/pediatrics/article/151/5/e2022058029/191043/Provider-Based-HPV-Vaccine-Promotion-Interventions

Provider-Based HPV Vaccine Promotion Interventions

This systematic review assessed the effects and costs of provider-based interventions designed to increase HPV vaccination coverage.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27687213/

Facilitators and barriers to the use of standing orders for ...

Results: All study practices achieved partial to full implementation of vaccine standing orders for human papillomavirus, tetanus diphtheria pertussis, and ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06380114

Study Details | NCT06380114 | Stand Up 2 HPV: ...

Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0264410X25011624

Impact and lessons learned from an HPV vaccination ...

Surveys and interviews occurred from December 2022 to April 2024. Progress reports consisted of process and outcome metrics including HPV vaccination initiation ...