NCT05365048 Provider Recommendation and HPV Vaccination
| NCT ID | NCT05365048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kaiser Permanente |
| Condition | Human Papillomavirus |
| Study Type | INTERVENTIONAL |
| Enrollment | 301,201 participants |
| Start Date | 2022-03-21 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 301,201 participants in total. It began in 2022-03-21 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Erin Hahn, PhD
PRINCIPAL INVESTIGATOR
KPSC Department of Research and Evaluation
Frequently Asked Questions
Who can join the NCT05365048 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 70 Years, studying Human Papillomavirus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05365048 currently recruiting?
Yes, NCT05365048 is actively recruiting participants. Contact the research team at Nancy.Takahashi@kp.org for enrollment information.
Where is the NCT05365048 trial being conducted?
This trial is being conducted at Pasadena, United States.
Who is sponsoring the NCT05365048 clinical trial?
NCT05365048 is sponsored by Kaiser Permanente. The principal investigator is Erin Hahn, PhD at KPSC Department of Research and Evaluation. The trial plans to enroll 301,201 participants.