Maximizing HPV Vaccination: Real-time Reminders, Guidance, and Recommendations - Part 4: Feasibility Trial

Human papillomavirus (HPV) vaccines have potential to prevent an average of 26,900 cancer
cases each year in the United States, but vaccine coverage rates remain low. The study team
has developed a health information technology (HIT) electronic application (app), Protect Me
4, to help parents and providers assess and have more productive conversations about needed
vaccines.

In past studies, Protect Me 4 users have demonstrated three times higher chances of
initiating the HPV vaccine. Despite this promise, Protect Me 4 system implementation suffered
from very low reach within clinics. In this phase of the project, the investigators will
assess the feasibility of implementing Protect Me 4 in community clinics, as well as test
vaccination rate data collection strategies and estimate the preliminary efficacy of Protect
Me 4 to increase HPV vaccine initiation. Seven clinics will participate in the study, and
three will be randomly assigned the use of Protect Me 4. Three of the clinics will act as
controls and will not receive Protect Me 4. The final clinic will receive the intervention
(but has not participated in any of the intervention development. This clinic will s as a
demonstration clinic for the subsequent R01.

For evaluation, vaccination records will be grouped in three-month periods [initial (months
1-3), implementation (months 4-6) and maintenance (months 7-9)] from Medicaid and CHIP
(Children's Health Insurance Program) claims and Florida Immunization Registry data. During
the implementation period (months 4-6), intervention clinics will receive the Protect Me 4
app and External Quality Improvement Support (practice facilitation and external and internal
provider peer opinion leaders and provider incentives). During the maintenance period (months
7-9), intervention clinics will receive Protect Me 4 without external support (practice
facilitation and external provider peer opinion leaders).

To evaluate effectiveness at the individual-level, the study team will compare vaccination
rates between eligible adolescents who visited intervention and control clinics across the
three time periods.

Inclusion Criteria:

- Must be parent of an adolescent aged 11-12 years old.

- Providers working with age appropriate for study adolescents at the intervention
clinics

- Adolescents/Parents/Providers willing to consent to participation

- Adolescents/Parents that can read and speak English

Exclusion Criteria:

- Adolescents out of the age range for participation

- Adolescents/Parents/Providers unwilling to consent to participation

- Adolescents/Parents that can NOT read and speak English