Maximizing HPV Vaccination: Real-time Reminders, Guidance, and Recommendations - Part 4: Feasibility Trial
3 other identifiers
interventional
1,296
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2018
CompletedFirst Posted
Study publicly available on registry
February 12, 2018
CompletedStudy Start
First participant enrolled
September 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2027
Study Completion
Last participant's last visit for all outcomes
September 15, 2027
August 17, 2025
August 1, 2025
1 year
February 5, 2018
August 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
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
Secondary Outcomes (2)
Data Collection Strategy
After month 9
Efficacy Measurements
After month 9
Study Arms (5)
Parents
ACTIVE COMPARATORParents of 11-12 year old children who visit participating interventional clinics during study period.
Health Care Provider
ACTIVE COMPARATORHealth care providers and clinic staff for 11-12 year old patients at 4 participating pediatric clinics.
Adolescents at Intervention clinics
NO INTERVENTIONAdolescents 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.
Adolescents at Control Clinic
NO INTERVENTIONParents of 11-12 year old children who visit participating control clinics during study period.
Health Care Provider at Control Clinic
NO INTERVENTIONHealth care providers and clinic staff for 11-12 year old patients at 3 participating pediatric control clinics.
Interventions
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.)
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- National Cancer Institute (NCI)collaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Staras, PhD
University of Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The statistical team is blinded to the clinic assignment.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2018
First Posted
February 12, 2018
Study Start (Estimated)
September 15, 2026
Primary Completion (Estimated)
September 15, 2027
Study Completion (Estimated)
September 15, 2027
Last Updated
August 17, 2025
Record last verified: 2025-08