301201 Participants Needed

HPV Vaccine Strategies for Human Papillomavirus

(HPVV Trial)

NT
CH
Overseen ByChunyi Hsu, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Kaiser Permanente
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.36789

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.1011121314

Who Is on the Research Team?

EH

Erin Hahn, PhD

Principal Investigator

KPSC Department of Research and Evaluation

CR

Chun R Chao, PhD

Principal Investigator

KPSC Department of Research and Evaluation

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Local Tailoring implementation strategy
  • Prescribed Strategy
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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Prescribed StrategyExperimental Treatment1 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 TailoringExperimental Treatment1 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 CareActive Control1 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

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials
563
Recruited
27,400,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

The HPV vaccination quality improvement (QI) program successfully trained 95% of participating physicians, demonstrating effective implementation of training and feedback strategies in a large health care system.
While the overall increase in HPV vaccination coverage was modest (8.6% in the QI arm vs. 6.4% in the control), a significant improvement of 3.3 percentage points was observed when excluding data from physicians with poor reporting, indicating potential for greater impact with refined implementation.
Implementing Evidence-Based Strategies to Improve HPV Vaccine Delivery.Gilkey, MB., Parks, MJ., Margolis, MA., et al.[2020]
A study involving 22,486 girls aged 11 to 17 showed that a combined intervention targeting both clinicians and families significantly increased HPV vaccination rates by 9, 8, and 13 percentage points for doses 1, 2, and 3, respectively.
The clinician-focused approach was particularly effective for starting the HPV vaccination series, while the family-focused approach helped in completing the series, highlighting the importance of a dual strategy for optimal vaccination outcomes.
Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt.Fiks, AG., Grundmeier, RW., Mayne, S., et al.[2022]
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.
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]

Citations

Implementing Evidence-Based Strategies to Improve HPV Vaccine Delivery. [2020]
Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt. [2022]
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 use of the quadrivalent human papillomavirus vaccine (gardasil) as adjuvant therapy in the treatment of recurrent respiratory papilloma. [2015]
Implementation of Routine HPV Vaccination in the Management of Recurrent Respiratory Papillomatosis. [2019]
Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. [2023]
Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel. [2015]
HPV16/18 Antibody Responses After a Single Dose of Nonavalent HPV Vaccine. [2023]
[Human papillomavirus vaccine register]. [2013]
OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Population-level impact of the bivalent, quadrivalent, and nonavalent human papillomavirus vaccines: a model-based analysis. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Human papillomavirus vaccine update. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. [2019]
14.United Statespubmed.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]
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