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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Human Papillomavirus (HPV) Vaccines
• Intervention / Treatment: Behavioral: Protect Me 4 Application + External Quality Improvement Support; Behavioral: Protect Me 4 Application Alone

Detailed Description

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 a health information technology (HIT) electronic application (app), Protect Me 4, to help parents and providers assess and have more productive conversations about needed vaccines.

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.

• Study Type: Interventional
• Enrollment (Estimated): 1296
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Staras, PhD; Phone Number: 352-294 8299; Email: sstaras@ufl.edu
• Study Contact Backup: Name: Marta Hansen; Email: m.hansen1@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Parents; Parents of 11-12 year old children who visit participating interventional clinics during study period.	Behavioral: 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.); Behavioral: 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 Names: Enhanced HIT System Intervention
Active Comparator: Health Care Provider; Health care providers and clinic staff for 11-12 year old patients at 4 participating pediatric clinics.	Behavioral: 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.); Behavioral: 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 Names: Enhanced HIT System Intervention
No Intervention: 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 Intervention: Adolescents at Control Clinic; Parents of 11-12 year old children who visit participating control clinics during study period.
No Intervention: Health Care Provider at Control Clinic; Health care providers and clinic staff for 11-12 year old patients at 3 participating pediatric control clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data Collection Strategy	Analysis of de-identified participant datasets linked to clinic records, HIT participation date, and vaccinations from the Florida Medicaid and CHIP claims or the Florida Immunization Registry data.	After month 9
Efficacy Measurements	Determination of HPV vaccine initiation using Current Procedural Terminology (CPT) and Current Vaccine Administered (CVX) codes	After month 9

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Patient-Centered Outcomes Research Institute; National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stephanie Staras, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Health Information Technology (HIT)
• Other Study ID Numbers: IRB201701537 -N; R21CA202011 (U.S. NIH Grant/Contract); OCR19940 (Other Identifier: UF OnCore)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No