Pragmatic Trial Evaluation of a Multilevel Intervention to Increase Human Papillomavirus Vaccination Rates

LILA J. FINNEY RUTTEN, PhD
Mayo Clinic

Despite the availability of an effective and safe vaccine, the human papillomavirus (HPV) causes nearly 36,000 cancers each year in the U.S. HPV vaccination rates remain well below public health goals. Our team is conducting a pragmatic trial with process evaluation to evaluate a multilevel intervention to improve clinician recommendations of the HPV vaccine and increase HPV vaccination rates.

Our trial is being conducted in six Mayo Clinic primary care practices in southeastern Minnesota that employ salaried pediatricians, family physicians, and advanced practice providers. Children aged 11 and 12 years empaneled to the participating practices who in the previous calendar month became due for a dose of the HPV vaccine are eligible.

We are conducting a stepped wedge cluster randomized trial with a factorial design to evaluate the independent and combined impact of parent reminder-recall letters and provider audit-and-feedback interventions on HPV vaccination rates. The audit and feedback reports sent to clinicians on a monthly basis include a web address and QR code to access a strong recommendations toolkit that teaches evidence-based methods for offering strong recommendations and addressing vaccine hesitancy. Following a 12-month baseline assessment, sites were block randomized to the interventions in three subsequent steps, each 12 months in duration to account for seasonal variation in vaccination. During the baseline period, we collected baseline vaccination rates and developed and refined our intervention materials based on feedback from focus groups involving parents of children in our target age group and clinicians who care for patients in the target age group. Throughout the trial we are conducting a process evaluation which involves mailing questionnaires to parents to evaluate their awareness of and response to the reminder-recall intervention and to assess their attitudes and beliefs about HPV vaccination. The process evaluation also includes sending electronic questionnaires to all participating healthcare providers to assess their exposure to and experience with receipt of the monthly audit-and-feedback reports. We initiated step 3 of our pragmatic trial in September of 2020; all six clinical practices are now receiving at least one of the two interventions.

Critical improvements were made to the intervention materials based on feedback from parents and from key stakeholders in the clinical practice. Ongoing assessment of implementation outcomes through process evaluation efforts will provide insight into intervention fidelity and individual, provider, and clinic-level factors that may be associated with observed outcomes. Results of this pragmatic trial and process evaluation will quantify the impact of these practice- and provider-level interventions on HPV vaccination rates and will provide guidance on the factors associated.