Educational Intervention for HPV Vaccination

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Cognitive impairment, Prisoners, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

560 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the implementation of evidence based strategies to optimize HPV vaccination in rural primary care settings. Some of the largest disparities in human papillomavirus vaccination (HPVV) rates exist in rural communities, which represent missed opportunities for cancer prevention. Primary care provider visits in these communities serve as a crucial opportunity to communicate the importance of timely vaccination that is essential to effective cancer prevention. This study implements and tests a practice-level intervention (PC TEACH) using practice facilitation of evidence-based strategies to expand reach to rural community-based primary care settings to optimize delivery and increase HPVV rates. PC TEACH program may help rural communities overcome access and awareness factors that keep them from receiving HPVV.

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

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

Is the HPV vaccine safe for humans?

The HPV vaccines, including Gardasil, Cervarix, and Gardasil 9, have been widely used and generally show a favorable safety profile. While some adverse events have been reported, serious ones are rare, and the benefits of vaccination outweigh the risks. ^{1 2 3 4 5}

How does the educational intervention for HPV vaccination differ from other treatments for HPV prevention?

The educational intervention for HPV vaccination is unique because it focuses on increasing awareness and understanding of HPV vaccines like Cervarix and Gardasil, rather than being a vaccine itself. This approach aims to improve vaccination rates by addressing knowledge gaps and misconceptions, which is different from the direct prevention method of administering the vaccines. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment PC TEACH, Gardasil, Cervarix, Gardasil 9 for HPV vaccination?

Research shows that educational interventions, like brochures and reminder systems, can increase the uptake and completion of HPV vaccines. Additionally, training healthcare providers to communicate effectively about HPV vaccination can improve vaccination rates. ^{11 12 13 14 15}

Who Is on the Research Team?

Elisa Rodriguez

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for primary care settings in rural areas that are looking to improve their rates of HPV vaccination. The focus is on implementing a program called PC TEACH, which aims to educate and facilitate better vaccination practices.

Inclusion Criteria

PARTICIPANTS: English speaking

PRACTICES: Are located in the 20-county target region

PARENT/GUARDIAN SURVEY: Presenting to the participating clinic for an outpatient well child visit or regular checkup

Exclusion Criteria

Prisoners

Unwilling or unable to follow protocol requirements

Adults unable to complete study measures in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Primary practice providers sites receive PC TEACH intervention over 3.5 hours for 12 months

12 months

Follow-up

Primary care provider sites are monitored for effectiveness of the intervention

3-6 months

Long-term Evaluation

Evaluate the impact of the PC TEACH intervention on HPV vaccination rates over a long-term period

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• PC TEACH

Trial Overview The study tests the effectiveness of an educational intervention known as PC TEACH designed to optimize HPV vaccine delivery in rural primary care. It evaluates how well this strategy works in increasing vaccination rates against human papillomavirus.

How Is the Trial Designed?

Group I: Health services research (PC TEACH) Experimental Treatment 1 Intervention

Primary practice providers sites receive PC TEACH over 3.5 hours for 12 months

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A stepwise evidence-based practice model significantly increased HPV vaccination rates among youth and adolescents, with all 24 eligible participants receiving the vaccine in 2019 compared to only 4 in the same period in 2018.

The model included strong provider recommendations and targeted education to address parental hesitancy, highlighting the importance of proactive communication in improving vaccination uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Practice Model to Increase Human Papillomavirus Vaccine Uptake: A Stepwise Approach. Beck, A., Bianchi, A., Showalter, D.[2022]

The train-the-trainer model effectively increased provider motivation to recommend HPV vaccination, leading to a significant increase in vaccine uptake among adolescents aged 11-12 (1.9%) and 13-17 (1.5%) in the intervention system compared to a control system.

High participant satisfaction (90%-94%) with the training sessions indicates that this approach is not only effective but also well-received by healthcare providers, suggesting potential for broader implementation in large healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPV vaccine communication training in healthcare systems: Evaluating a train-the-trainer model. Brewer, NT., Mitchell, CG., Alton Dailey, S., et al.[2021]

Combining in-person quality improvement (QI) coaching with remote provider communication training significantly improved HPV vaccination initiation among 11 to 12-year-olds, with a 3.8% increase compared to the control group at 12-month follow-up.

The combined intervention not only enhanced vaccination rates for younger patients but also showed lasting effects at 18 months, while remote communication training alone did not lead to any significant improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coaching and Communication Training for HPV Vaccination: A Cluster Randomized Trial. Gilkey, MB., Grabert, BK., Heisler-MacKinnon, J., et al.[2023]

The electronic medical record (EMR)-based HPV vaccine decision support intervention was well-received by parents, with 46% recalling the reminder call, which encouraged them to seek more information and discuss the vaccine with others.

Parents whose daughters attended practices using the clinician-focused intervention were more likely to have discussions about the HPV vaccine during preventive visits, indicating that the intervention positively influenced clinician engagement and communication about vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation and acceptability of an HPV vaccination decision support system directed at both clinicians and families. Mayne, S., Karavite, D., Grundmeier, RW., et al.[2021]

An evidence-based educational brochure and reminder system significantly increased HPV vaccine uptake among parents of preteen girls, with a 9.4 times higher likelihood of vaccination compared to a historical control group.

The intervention also led to a remarkable 22.5 times increase in dose completion rates, highlighting the effectiveness of structured educational and reminder strategies in improving vaccination outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quality improvement initiative to increase HPV vaccine rates using an educational and reminder strategy with parents of preteen girls. Cassidy, B., Braxter, B., Charron-Prochownik, D., et al.[2015]

A comprehensive analysis of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) identified 3,112 AEs for Cervarix, 31,606 for Gardasil, and 6,872 for Gardasil 9, highlighting the need for ongoing monitoring of vaccine safety.

The study found 46 unique serious adverse events (SAEs) associated with the HPV vaccines, clustered around behavioral, neurological, immune, nervous, and reproductive systems, indicating that while the vaccines are effective, further research is needed to understand the cause-and-effect relationships of these AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. Zi, W., Yang, Q., Su, J., et al.[2022]

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]

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]

In a study of 266,647 doses of Gardasil-9® administered in Puglia, Italy, only 22 adverse events following immunization (AEFIs) were reported, resulting in a low reporting rate of 8.25 per 100,000 doses, indicating a favorable safety profile for the vaccine.

Out of the 22 reported AEFIs, only 5 were classified as serious, with 2 leading to hospitalization; however, only 2 serious AEFIs were consistently associated with the vaccine, suggesting that the benefits of Gardasil-9® outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Life Safety Profile of the 9-Valent HPV Vaccine Based on Data from the Puglia Region of Southern Italy. Di Lorenzo, A., Berardi, P., Martinelli, A., et al.[2022]

Over 4 years of post-licensure safety surveillance of the HPV-16/18 vaccine (Cervarix) showed that the most commonly reported adverse events were consistent with those expected in the general population, indicating a favorable safety profile.

No significant patterns of serious immune-mediated diseases were found, and the incidences of conditions like Bell's palsy and Guillain-Barré syndrome were within expected ranges, reinforcing the vaccine's acceptable benefit-risk profile for adolescent girls and women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. Angelo, MG., Zima, J., Tavares Da Silva, F., et al.[2021]

Cervarix and Gardasil are effective HPV vaccines that prevent infections from HPV types 16 and 18, which cause 70% of cervical cancers, with Gardasil also protecting against HPV types 6 and 11, responsible for most genital warts.

Both vaccines are well tolerated with minimal side effects, primarily at the injection site, and ongoing Phase III trials aim to further assess their long-term efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccines. Schmiedeskamp, MR., Kockler, DR.[2015]

Following the French High Committee of Public Health's recommendation change on January 25, 2011, there was a significant increase in the prescription of Cervarix(®) compared to Gardasil(®), indicating that medical recommendations can directly influence prescribing behavior.

The study suggests that the rapid response of prescribers to the new guidelines may be influenced by the strong involvement of pharmaceutical companies in medical education, highlighting the importance of how information is communicated to healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Did the recommendation of the French public health council modify the antipapillomavirus vaccines' prescription level?]. Birebent, J., Dupouy, J., Lempégnat, J., et al.[2022]

Cervarix and Gardasil are effective prophylactic HPV vaccines that help prevent cervical cancer by targeting different cancer-causing HPV types, with Cervarix covering five types and Gardasil covering three types plus two that cause genital warts.

Cervarix has demonstrated efficacy for 6.4 years, while Gardasil has shown efficacy for 5 years, highlighting the importance of vaccine duration in reducing cervical cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Currently approved prophylactic HPV vaccines. Harper, DM.[2022]

Both Gardasil and Cervarix HPV vaccines have shown outstanding efficacy in preventing infections and related conditions in young women, with excellent safety profiles and only mild to moderate side effects reported.

Neither vaccine is effective in treating existing HPV infections or lesions, but they provide strong protection against specific HPV types for at least four years, with Gardasil also preventing genital warts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update of prophylactic human papillomavirus L1 virus-like particle vaccine clinical trial results. Schiller, JT., Castellsagué, X., Villa, LL., et al.[2022]

The nine-valent HPV vaccine, Gardasil9, significantly increases the efficacy against cervical cancer from 70% to 90% compared to the quadrivalent vaccine, covering a broader range of HPV types.

Gardasil9 also provides high efficacy (97%) against lesions associated with HPV types 31, 33, 45, 52, and 58, while maintaining similar effectiveness against HPV types 6, 11, 16, and 18 as the quadrivalent vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nine-valent HPV vaccine - new generation of HPV vaccine]. Fait, T., Dvořák, V., Pilka, R.[2018]

Citations

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

Evidence-Based Practice Model to Increase Human Papillomavirus Vaccine Uptake: A Stepwise Approach. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

HPV vaccine communication training in healthcare systems: Evaluating a train-the-trainer model. [2021]

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

Coaching and Communication Training for HPV Vaccination: A Cluster Randomized Trial. [2023]

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

The implementation and acceptability of an HPV vaccination decision support system directed at both clinicians and families. [2021]

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

A quality improvement initiative to increase HPV vaccine rates using an educational and reminder strategy with parents of preteen girls. [2015]

6. England pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]

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

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

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

[Human papillomavirus vaccine register]. [2013]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Life Safety Profile of the 9-Valent HPV Vaccine Based on Data from the Puglia Region of Southern Italy. [2022]

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

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. [2021]

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

Human papillomavirus vaccines. [2015]

12. France pubmed.ncbi.nlm.nih.gov

[Did the recommendation of the French public health council modify the antipapillomavirus vaccines' prescription level?]. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Currently approved prophylactic HPV vaccines. [2022]

14. Netherlands pubmed.ncbi.nlm.nih.gov

An update of prophylactic human papillomavirus L1 virus-like particle vaccine clinical trial results. [2022]

15. Czech Republic pubmed.ncbi.nlm.nih.gov

[Nine-valent HPV vaccine - new generation of HPV vaccine]. [2018]