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

Not Applicable

Not yet recruiting

• Conditions: Human Papillomavirus (HPV) Vaccines
• Interventions: Behavioral: Protect Me 4 Application + External Quality Improvement Support; Behavioral: Protect Me 4 Application Alone

• Registration Number: NCT03429413
• Lead Sponsor: University of Florida

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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Study Start: 2026-09-15
• Primary Completion: 2027-09-15
• Study Completion: 2027-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1296

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parents	Protect Me 4 Application + External Quality Improvement Support	Parents of 11-12 year old children who visit participating interventional clinics during study period.
Health Care Provider	Protect Me 4 Application Alone	Health care providers and clinic staff for 11-12 year old patients at 4 participating pediatric clinics.
Parents	Protect Me 4 Application Alone	Parents of 11-12 year old children who visit participating interventional clinics during study period.
Health Care Provider	Protect Me 4 Application + External Quality Improvement Support	Health care providers and clinic staff for 11-12 year old patients at 4 participating pediatric clinics.

Primary Outcome Measures

Name	Time	Method
Reach - Feasibility	After month 9	Goal will be to have 80% of the parents of 11-12 year olds offered the Protect Me 4 app.
Adoption - Feasibility	After 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.
Maintenance - Feasibility	Months 7-9	During months 7-9, the study team will assess clinic and provider maintenance of use of the Protect Me 4 app
Acceptability - Feasibility	Month 6, Month 9	At both the end of the implementation and the maintenance period, providers will complete the Post Intervention Survey.
Provider-level Implementation - Feasibility	After 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 - Feasibility	After 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.)

Secondary Outcome Measures

Name	Time	Method
Data Collection Strategy	After month 9	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.
Efficacy Measurements	After month 9	Determination of HPV vaccine initiation using Current Procedural Terminology (CPT) and Current Vaccine Administered (CVX) codes

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States