Recruiting

HPV Vaccination

Sponsor:

Kaiser Permanente

Code:

NCT05365048

Conditions

Human Papillomavirus

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Local Tailoring implementation strategy

Prescribed Strategy

Study Details

Brief 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.

Conditions

Human Papillomavirus

Study ID

NCT05365048

Start date

Mar 21, 2022

Status verified date

May, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All KPSC pediatric clinics.
  • All providers (physicians, nurses, and medical assistants) and department administrators from the pediatric department.
  • Parents of HPV vaccine-eligible children (9-12 years old).

Exclusion Criteria:

  • Providers and administrators who do not work for the pediatric department
  • Parents of children older than 12 years and/or who did not have a clinic visit in the study period.

Study Design

Enrollment

301201 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Local Tailoring

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.

experimental: Prescribed Strategy

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.

no intervention: Usual Care

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.

Interventions

Local Tailoring implementation strategy

The "local-tailored" approach will be guided by a structured process involving the following: (1) convening a local HPV vaccine project team, (2) conducting a local diagnostic process to identify top barriers, (3) selecting from a menu of intervention options that will be offered in this study, categorized by core function (i.e., the forms and functions menu) that address top local barriers, and (4) deploying the selected interventions. The barrier assessment and intervention customization are key processes for the local-tailored strategy, which allow clinics to devote resources to respond to unique local barriers in addition to common barriers.

Prescribed Strategy

The prescribed strategy is the standard implementation approach used by most health systems. Our prescribed approach will be guided by the evidence-based, award-winning 4 Pillars™ Practice Transformation Program for improving vaccination rates in the outpatient setting. The 4 Pillars™ address 4 main "functions", i.e., convenience, communication, office systems, and motivation to guide the selection of interventions. For adolescent HPV vaccination, the 4 Pillars has demonstrated moderate effectiveness.

Primary outcome measure

  • Proportion of children 9-12 years old who received the first dose of the HPV vaccine -EMR [ Time Frame: Year 1 ]
  • Proportion of children 9-12 years old who received the first dose of the HPV vaccine - EMR [ Time Frame: Year 4 ]

Central Contacts and Locations

Central contacts

Nancy Takahashi Cannnizzaro, PhD

626-564-7663Nancy.Takahashi@kp.org

Locations

Kaiser Permanente Southern California

Recruiting

Pasadena, California, United States, 91101

Contacts

Nancy Takahashi Cannizzaro, PhD

626-564-7663Nancy.Takahashi@kp.org

More Information

Sponsor

Kaiser Permanente

Last update posted

May 20, 2025

Last verified

May, 2025

Keywords

  • Human Papillomavirus
  • Vaccine
  • Local Tailoring
  • 4 Pillars
  • Prescribed Strategy
  • Implementation Strategy
  • Provider Recommendation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2025-05-20.