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 an electronic application (app), Protect Me 4, to help parents and providers assess and have more productive conversations about needed vaccines.
The specific aims of this study are to: (1) evaluate the feasibility of implementing Protect Me 4, and (2) estimate preliminary efficacy of Protect Me 4 to increase HPV vaccine initiation (receipt of first dose).
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
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
Parallel
Protect Me 4 Application + External Quality Improvement Support
BehavioralParticipants will be asked to interact with the Protect Me 4 application, using an iPad tablet. 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). Providers from intervention clinics will complete audit and feedback reports to assess HPV vaccination rates with the assistance of the practice facilitator. Providers at the intervention clinic will complete a pre-intervention survey to obtain background information (demographics, approximate HPV vaccination rates, comfort with the use of technology etc.)
Protect Me 4 Application Alone
BehavioralDuring the maintenance period (months 7-9), intervention clinics will receive Protect Me 4 without external support (practice facilitation and external provider peer opinion leaders). Providers from intervention clinics will complete audit and feedback reports to assess HPV vaccination rates without the assistance of the practice facilitator. Providers at the intervention clinic will complete a post-intervention survey to gain provider feedback regarding the feasibility of Protect Me 4 and changes in perceptions regarding the use of technology.
Reach - Feasibility
Goal will be to have 80% of the parents of 11-12 year olds offered the Protect Me 4 app.
Adoption - Feasibility
Goal will be to have 70% of parents complete the Protect Me 4 app for each provider. App will be considered feasible of 80% or more of providers use the app during the study.
Provider-level Implementation - Feasibility
Goal will be to have providers report using the discussion tips approximately half the time they are provided and offering HPV vaccine 75% of the time it is due. App will be considered feasible if providers view shot lists for 60% of their patients with screens indicating that shots are due. Will aim for providers to look at specific hesitations reported by parents 60% of the time they login to the app and hesitations are reported.
Parent-level Implementation - Feasibility
Goal will be to have 95% of people who start the app successfully enter the app and 80% agree to participate (consent and assent.)
Data Collection Strategy
Analysis of de-identified participant datasets linked to clinic records, HIT participation date, and vaccinations from the Florida Medicaid and CHIP claims or the Florida Immunization Registry data.
Efficacy Measurements
Determination of HPV vaccine initiation using Current Procedural Terminology (CPT) and Current Vaccine Administered (CVX) codes
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University of Florida
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
