Local Tailoring for Human Papilloma Virus (HPV)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kaiser Permanente Southern California, Pasadena, CA
Human Papilloma Virus (HPV)
Prescribed Strategy - Other
Eligibility
18+
All Sexes
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Study Summary

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.

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Year 1 through Year 4

Month 12
Fidelity - survey
Year 1
Proportion of children 9-12 years old who received the first dose of the HPV vaccine -EMR
Year 4
HPV vaccine series completion - EMR
Year 4
Parent satisfaction with HPV vaccine communication - survey
Perceived comfort/distress in discussing HPV vaccination with parents - survey
Proportion of children 9-12 years old who received the first dose of the HPV vaccine - EMR
Provider Recommendation - survey
Sustainment of study interventions - survey
Time taken to recommend the HPV vaccine - survey

Trial Safety

Trial Design

3 Treatment Groups

Usual Care
1 of 3
Local Tailoring
1 of 3
Prescribed Strategy
1 of 3
Active Control
Experimental Treatment

90000 Total Participants · 3 Treatment Groups

Primary Treatment: Local Tailoring · No Placebo Group · N/A

Local Tailoring
Other
Experimental Group · 1 Intervention: Local Tailoring implementation strategy · Intervention Types: Other
Prescribed Strategy
Other
Experimental Group · 1 Intervention: Prescribed Strategy · Intervention Types: Other
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: year 1 through year 4

Trial Background

Chun Chao, Research Scientist
Principal Investigator
Kaiser Permanente
Closest Location: Kaiser Permanente Southern California · Pasadena, CA
2009First Recorded Clinical Trial
2 TrialsResearching Human Papilloma Virus (HPV)
11 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a physician, nurse, or medical assistant from the pediatric department.
Parents of HPV vaccine-eligible children (9-12 years old).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.