NCT03429413|Not Yet Recruiting
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Sponsor study identifier
Secondary identifiers
NIH
OTHER · UF OnCore
interventional
1,296
1 country
1
Study Start
September 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 5, 2018
Actual (reported)February 12, 2018
Actual (reported)September 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Reach - Feasibility
Goal will be to have 80% of the parents of 11-12 year olds offered the Protect Me 4 app.
After month 9
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.
After month 9
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.
After month 9
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.)
After month 9
Maintenance - Feasibility
Data Collection Strategy
After month 9
Efficacy Measurements
After month 9
Parents of 11-12 year old children who visit participating interventional clinics during study period.
Health care providers and clinic staff for 11-12 year old patients at 4 participating pediatric clinics.
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.)
University of Florida
Gainesville, Florida, 32611, United States
Stephanie Staras, PhD
University of Florida
First Submitted
February 5, 2018
First Posted
February 12, 2018
Study Start
September 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
During months 7-9, the study team will assess clinic and provider maintenance of use of the Protect Me 4 app
Months 7-9
Acceptability - Feasibility
At both the end of the implementation and the maintenance period, providers will complete the Post Intervention Survey.
Month 6, Month 9
Adolescents between 11-12 years of age. Adolescent vaccination data is used in the study, adolescents will assent to participate. The parents, however, use the HIT system.
Parents of 11-12 year old children who visit participating control clinics during study period.
Health care providers and clinic staff for 11-12 year old patients at 3 participating pediatric control clinics.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 14, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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