Feasibility Trial for Protect Me 4 Application to Increase HPV Vaccination

This study is testing a new electronic application (app) called Protect Me 4. This app is designed to help parents and healthcare providers have better conversations about the Human Papillomavirus (HPV) vaccine, which can prevent certain cancers. The study wants to see if the Protect Me 4 app can be successfully used in clinics and if it helps more adolescents get their first HPV vaccine dose. You can join if you are a parent of an 11-12 year old, a healthcare provider, or an adolescent in that age range, and can speak English. The study will measure how easy the app is to use and how many people start the HPV vaccine after using it. The current status of this study is unclear.

Study design
This study plans to enroll 1296 participants and involves clinics using the Protect Me 4 app, either with or without extra support. Some clinics will not use the app and will act as a comparison group.
What's involved
Participants will interact with the Protect Me 4 application using an iPad tablet. Providers will complete audit and feedback reports to assess HPV vaccination rates.
Compensation
Not stated in the trial record.
Follow-up
The primary goals of the study are measured after 9 months.

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NCT03429413

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

Not Yet Recruiting
NAAges 18–99InterventionalHealth services
University of Florida
~1,296 participants
Updated 2025-08-17 on ClinicalTrials.gov
What's tested:Protect Me 4 Application + External Quality Improvement SupportProtect Me 4 Application Alone

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reach - Feasibility
Measured over After month 9
+5 more outcomes measured
Human Papillomavirus (HPV) Vaccines
1 sites across 1 states
Florida1
  • Stephanie Staras, PhD · PRINCIPAL_INVESTIGATOR · University of Florida

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Eligibility criteria

Inclusion

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

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
  • Reach - FeasibilityAfter month 9

    Goal will be to have 80% of the parents of 11-12 year olds offered the Protect Me 4 app.

  • Adoption - FeasibilityAfter month 9

    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 - FeasibilityAfter month 9

    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 - FeasibilityAfter month 9

    Goal will be to have 95% of people who start the app successfully enter the app and 80% agree to participate (consent and assent.)

  • Maintenance - FeasibilityMonths 7-9

    During months 7-9, the study team will assess clinic and provider maintenance of use of the Protect Me 4 app

  • Acceptability - FeasibilityMonth 6, Month 9

    At both the end of the implementation and the maintenance period, providers will complete the Post Intervention Survey.