HPV Vaccine Strategies for Human Papillomavirus

(HPVV Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Erin Hahn, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kaiser Permanente

Disqualifiers: Non-pediatric staff, Children over 12, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

In the United State, there are millions of US teens who are not vaccinated against the human papillomavirus (HPV) putting them at risk of getting HPV-related cancers. Although there are clinical guidelines recommending the HPV vaccine and interventions encouraging parents to vaccinate their children to prevent HPV-related cancers, the vaccination rate for teens remains low according to a 2018 national survey. Survey data shows that HPV vaccine complete series coverage for teens aged 13-15 years was 50%, far below the 80% target of Healthy People 2020. Receiving a strong provider recommendation is the most powerful strategy for improving HPV vaccine rates. Yet, little is known about how to include provider recommendations and other important factors into an intervention to improve the HPV vaccination rates. Studies show there are provider, patient and system-level barriers in the initiation and completion of HPV vaccine series among 9-12 years old children. Barriers to the HPV vaccine also differ across demographic subgroups, communities, and clinics. Interventions that address only one component are not responsive to site barriers and as effective as one that addresses multiple components and site-specific barriers. This study uses a 3-arm cluster randomized controlled trial (RCT) to compare three implementation strategies to improve provider recommendations on the HPV vaccine. Two of the implementation strategies (local-tailored and prescribed strategy) utilize a multilevel approach. The three implementation strategies of interest are (1) a "local-tailored" implementation strategy, co-designed with local care teams to address local barriers and contexts (2) A "prescribed" strategy, most commonly used by health systems, that involves pre-specified interventions addressing pre-selected vaccination barriers and (3) usual standard of care where there are no research-led activities. We will use surveys, interviews, and electronic health records to evaluate the three implementation strategies and their impact on improving HPV vaccination rates. The study surveys and interviews will include pediatric providers, nurses, administrators, staff members, and parents of HPV vaccine-eligible children (9-12 years old). Successful implementation will be defined as improvement in HPV vaccination rates (primary outcome), strengthening provider recommendation (secondary outcome), and the cost-effectiveness of the implementation strategy.

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

The trial protocol does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the HPV vaccine treatment?

Research shows that training healthcare providers to make strong vaccine recommendations and using communication strategies like recall notices can effectively increase HPV vaccine uptake. Additionally, the HPV vaccine has been used successfully in managing conditions like recurrent respiratory papillomatosis, indicating its broader effectiveness. ^{1 2 3 4 5}

Is the HPV vaccine, including Gardasil 9, generally safe for humans?

The HPV vaccines, including Gardasil 9, have been studied extensively and are generally considered safe. Some adverse events (unwanted effects) have been reported, but they are typically mild and similar to those seen with other vaccines. ^{6 7 8 9 10}

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

The HPV vaccine strategy, particularly with the nonavalent (9-valent) vaccine Gardasil 9, is unique because it covers nine HPV types, including five additional high-risk types beyond the original vaccines, increasing protection from about 70% to 90% against cervical cancer. This vaccine can be administered in a simplified two-dose regimen for younger individuals, making it more accessible and cost-effective compared to the traditional three-dose schedule. ^{8 11 12 13 14}

Eligibility Criteria

This trial is for pediatric clinics, their staff including physicians, nurses, and administrators, as well as parents of children aged 9-12 eligible for the HPV vaccine. It excludes healthcare workers outside pediatrics and parents of children over 12 or without a clinic visit in the study period.

Inclusion Criteria

I am a parent of a child aged 9-12, eligible for the HPV vaccine.

All KPSC pediatric clinics

All providers (physicians, nurses, and medical assistants) and department administrators from the pediatric department

Exclusion Criteria

Providers and administrators who do not work for the pediatric department

My child is older than 12 years and/or hasn't visited the clinic during the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Examine baseline associations between patient-, provider-, and clinic-level factors and variations in HPV vaccination rates and provider recommendations

Year 1

Intervention

Conduct a cluster RCT comparing the effectiveness of a 'tailored' multilevel implementation strategy to a 'prescribed' multilevel implementation strategy and to usual care in improving HPV vaccination rates

Year 1 through Year 4

Follow-up

Participants are monitored for the sustainment of study interventions and provider recommendations

12 months after intervention period

Treatment Details

Interventions

• Local Tailoring implementation strategy (Behavioural Intervention)
• Prescribed Strategy (Behavioural Intervention)

Trial Overview The trial compares three strategies to improve HPV vaccination rates: a 'local-tailored' strategy addressing local barriers; a 'prescribed' strategy targeting pre-selected barriers; and usual care with no research-led activities.

Participant Groups

Group I: Prescribed Strategy Experimental Treatment 1 Intervention

The intervention arm will include 20 clinics randomly assigned to the intervention arm.. All physicians, nurses, department administrator,s and other staff members from the pediatric departments randomized to this arm will be included in the study, as well as parents of HPV vaccine eligible children (9-12 years old) who had one or more visits with their pediatric provider during the data collection period.

Group II: Local Tailoring Experimental Treatment 1 Intervention

The intervention arm will include 20 clinics randomly assigned to the intervention arm. All physicians, nurses, department administrator and other staff members from the pediatric departments randomized to this arm will be included in the study, as well as parents of HPV vaccine eligible children (9-12 years old) who had one or more visits with their pediatric provider during the data collection period.

Group III: Usual Care Active Control 1 Intervention

The intervention arm will include 20 clinics randomly assigned to the usual care arm. All physicians, nurses, department administrators,s and other staff members from the pediatric departments randomized to this arm will be included in the study, as well as parents of HPV vaccine eligible children (9-12 years old) who had one or more visits with their pediatric provider during the data collection period.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Kaiser Permanente Southern California Pasadena, CA

Who Is Running the Clinical Trial?

Kaiser Permanente Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

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

Implementing Evidence-Based Strategies to Improve HPV Vaccine Delivery. [2020] High-quality evidence indicates that intervening with health care providers improves human papillomavirus (HPV) vaccine delivery. However, scaling up evidence-based strategies in real-world clinical practice remains challenging. We sought to improve the reach and impact of strategies for HPV vaccination quality improvement (QI) through local adaptation and implementation in a large, not-for-profit health care system.

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

Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt. [2022] To improve human papillomavirus (HPV) vaccination rates, we studied the effectiveness of targeting automated decision support to families, clinicians, or both.

3. 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] The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US. The Announcement Approach Training (AAT) has been shown to effectively increase HPV vaccine uptake by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communications, like recall notices, can further improve HPV vaccination by reducing missed clinical opportunities for vaccination. Never tested in supporting HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) model is a proven implementation strategy to increase best practices among healthcare providers. This trial uses a hybrid effectiveness-implementation design (type II) to evaluate two ECHO-delivered interventions intended to increase HPV vaccination rates.

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

The use of the quadrivalent human papillomavirus vaccine (gardasil) as adjuvant therapy in the treatment of recurrent respiratory papilloma. [2015] To examine the effect of the quadrivalent human papillomavirus vaccine, Gardasil, on the disease course of patients with recurrent respiratory papillomatosis (RRP).

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

Implementation of Routine HPV Vaccination in the Management of Recurrent Respiratory Papillomatosis. [2019] To investigate vaccine compliance and clinical outcomes after implementation of an initiative to provide the human papillomavirus (HPV) vaccine to all patients with recurrent respiratory papillomatosis (RRP).

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

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. [2023] The nine-valent human papillomavirus vaccine (HPV9, Gardasil®9) was licensed in the USA in December 2014. This study was a multiyear post-licensure study to assess HPV9 safety following routine administration.

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

Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel. [2015] Multinational phase III trials of a human papillomavirus vaccine, Gardasil, have shown the vaccine to be generally well-tolerated, efficacious, and immunogenic. We evaluated the immunogenicity and safety of Gardasil administered concomitantly with Menactra and Adacel.

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

HPV16/18 Antibody Responses After a Single Dose of Nonavalent HPV Vaccine. [2023] A single dose of human papillomavirus (HPV) vaccine would simplify logistics and reduce costs of vaccination programs worldwide. We conducted a phase IIa trial to determine the stability of HPV type-specific antibody responses after a single dose of the nonavalent HPV vaccine, Gardasil9.

9. Italy pubmed.ncbi.nlm.nih.gov

[Human papillomavirus vaccine register]. [2013] We carried out an active surveillance of common adverse events occurring among women (9 to 26 years old) receiving human papillomavirus vaccine (Gardasil® and Cervarix®) in 9 Italian Regions.

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

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022] Three licensed human papillomavirus (HPV) vaccines (Cervarix, Gardasil, and Gardasil 9) have been effectively used to prevent infection with oncogenic HPV types; however, many adverse events (AEs) have also been reported following their vaccinations. We assessed AE profiles after receiving the HPV vaccines based on the reported data from Vaccine Adverse Event Reporting System (VAERS).

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

Population-level impact of the bivalent, quadrivalent, and nonavalent human papillomavirus vaccines: a model-based analysis. [2022] Bivalent and quadrivalent human papillomavirus (HPV) vaccines are now licensed in several countries. Furthermore, clinical trials examining the efficacy of a nonavalent vaccine are underway. We aimed to compare the potential population-level effectiveness of the bivalent, quadrivalent, and candidate nonavalent HPV vaccines.

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

Human papillomavirus vaccine update. [2020] With the approval of Gardasil (Merck and Co., Inc., Whitehouse Station, NJ) in June of 2006 and the pending approval of Cervarix (GlaxoSmithKline, London, UK), two prophylactic human papillomavirus (HPV) vaccines will be available for clinical use. Randomized controlled trials have shown that both vaccines are safe and highly effective in preventing persistent infection and lesions caused by HPV 16 and 18--the types responsible for 70% of cervical cancers worldwide. Determining an effective vaccination strategy is now the most pressing issue facing clinicians, parents, public health officials, and policy makers. We discuss the appropriate age of vaccination, vaccine acceptance, implementation strategies in low resource settings, and the future of screening.

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

Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. [2019] Human papillomavirus is considered the causative factor for cervical cancer, which accounts for approximately 5% of the global cancer burden and more than 600,000 new cases annually that are attributable to HPV infection worldwide. The first-generation prophylactic HPV vaccines, Gardasil® and Cervarix®, were licensed approximately a decade ago. Both vaccines contain the most prevalent high-risk types, HPV16 and 18, which are associated with 70% of cervical cancer. To further increase the type coverage, 5 additional oncogenic HPV types (31, 33, 45, 52 and 58) were added to the existing Gardasil-4 to develop a 9-valent HPV vaccine (9vHPV), Gardasil 9®, increasing the potential level of protection from ∼70% to ∼90%. The efficacy of the vaccine lies primarily in its ability to elicit type-specific and neutralizing antibodies to fend off the viral infection. Therefore, type-specific and neutralizing murine monoclonal antibodies (mAbs) were used to quantitate the antigenicity of the individual vaccine antigens and to measure the antibody levels in the serum samples from vaccinees in a type- and epitope-specific manner in a competitive immunoassay. Assays for 9vHPV are extended from the proven platform used for 4vHPV by developing and adding new mAbs against the additional types. In Phase III clinical trials, comparable safety profile and immunogenicity against the original 4 types were demonstrated for the 9vHPV vaccine, and these were comparable to the 4vHPV vaccine. The efficacy of the 9vHPV vaccine was established in trials with young women. Immunobridging for younger boys and girls was performed, and the results showed higher immunogenicity in the younger age group. In a subsequent clinical trial, the 2-dose regimen of the 9vHPV vaccine used among girls and boys aged 9-14 y showed non-inferior immunogenicity to the regular 3-dose regimen for young women (aged 16-26 years). Overall, the clinical data and cost-effectiveness analysis for the 9vHPV vaccine support its widespread use to maximize the impact of this important, life-saving vaccine.

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

Prevalence and Incidence of Anal and Cervical High-Risk Human Papillomavirus (HPV) Types Covered by Current HPV Vaccines Among HIV-Infected Women in the SUN Study. [2019] Nonavalent (9v) human papilloma virus vaccine targets high-risk human papillomavirus (HR-HPV) types 16, 18, 31, 33, 45, 52, 58, and low-risk 6, 11. We examined prevalence, incidence, and clearance of anal and cervical HR-HPV in HIV-infected women.