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

Overview

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.

Interventions

• 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
• 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 chang

Primary outcome measures

• Reach - Feasibility [Time frame: After month 9]
• Adoption - Feasibility [Time frame: After month 9]
• Provider-level Implementation - Feasibility [Time frame: After month 9]
• Parent-level Implementation - Feasibility [Time frame: After month 9]
• Maintenance - Feasibility [Time frame: Months 7-9]
• Acceptability - Feasibility [Time frame: Month 6, Month 9]

Secondary outcome measures (2)

• Data Collection Strategy [Time frame: After month 9]
• Efficacy Measurements [Time frame: After month 9]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 1 center

• University of Florida — Gainesville

Identifiers

NCT: NCT03429413 · IRB201701537 -N · R21CA202011 · OCR19940

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗