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

Conditions

• Human Papillomavirus (HPV) Vaccines

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Accepted

Interventions

• Protect Me 4 Application + External Quality Improvement Support — BEHAVIORAL
  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 — BEHAVIORAL
  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.

Study Details

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).

Key Dates

Start date

Sep 15, 2026

Status verified

Aug 2025

Primary completion

Sep 15, 2027

Completion

Sep 15, 2027

Study Design

Enrollment

1,296 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Active Comparator: Parents
  Parents of 11-12 year old children who visit participating interventional clinics during study period.
• Active Comparator: Health Care Provider
  Health care providers and clinic staff for 11-12 year old patients at 4 participating pediatric clinics.
• 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.

Primary Outcome Measure

Reach - Feasibility [ Time Frame: After month 9 ]

Central Contacts

• Stephanie Staras, PhD
  352-294 8299
  [email protected]
• Marta Hansen
  [email protected]

Locations (1)

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