Maximizing HPV Vaccination: Real-time Reminders, Guidance, and Recommendations - Part 4: Feasibility Trial
NCT ID: NCT03429413
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1296 participants
INTERVENTIONAL
2026-09-15
2027-09-15
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Parents
Parents of 11-12 year old children who visit participating interventional clinics during study period.
Protect Me 4 Application + External Quality Improvement Support
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
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.
Health Care Provider
Health care providers and clinic staff for 11-12 year old patients at 4 participating pediatric clinics.
Protect Me 4 Application + External Quality Improvement Support
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
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.
Adolescents at Intervention clinics
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.
No interventions assigned to this group
Adolescents at Control Clinic
Parents of 11-12 year old children who visit participating control clinics during study period.
No interventions assigned to this group
Health Care Provider at Control Clinic
Health care providers and clinic staff for 11-12 year old patients at 3 participating pediatric control clinics.
No interventions assigned to this group
Interventions
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Protect Me 4 Application + External Quality Improvement Support
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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/Parents/Providers unwilling to consent to participation
* Adolescents/Parents that can NOT read and speak English
18 Years
99 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Patient-Centered Outcomes Research Institute
OTHER
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Stephanie Staras, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Central Contacts
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Other Identifiers
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OCR19940
Identifier Type: OTHER
Identifier Source: secondary_id
IRB201701537 -N
Identifier Type: -
Identifier Source: org_study_id
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