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Human Papillomavirus (HPV) VaccinesDigital healthSTIsBehavioralBehavioral

What this study is

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).

What's being tested

  • Protect Me 4 Application + External Quality Improvement Support

    Intervention · BEHAVIORAL

    Participants 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

    Intervention · BEHAVIORAL

    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). 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.

Study details

Sponsor
University of Florida
Conditions
Human Papillomavirus (HPV) Vaccines
Enrolling
1,296 people
Starts
2027-09-15
Est. completion
2028-09-15
Design
Single-blind, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗