Clinical trial NCT03429413: Maximizing HPV Vaccination: Real-time Reminders, Guidance, and Recommendations - Part 4: Feasibility Trial
Official title: Maximizing HPV Vaccination: Real-time Reminders, Guidance, and Recommendations - Part 4: Feasibility Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Human Papillomavirus (HPV) Vaccines
Keywords: Health Information Technology (HIT)
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Patient-Centered Outcomes Research Institute
First posted: 2018-02-12
Enrollment: 1296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinics are randomly assigned to use the intervention app or not. A 5th clinic, will use the app, but has not been involved in the app development.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Reach - Feasibility
timeFrame: After month 9
measure: Adoption - Feasibility
timeFrame: After month 9
measure: Provider-level Implementation - Feasibility
timeFrame: After month 9
measure: Parent-level Implementation - Feasibility
timeFrame: After month 9
measure: Maintenance - Feasibility
timeFrame: Months 7-9
measure: Acceptability - Feasibility
timeFrame: Month 6, Month 9
Secondary outcomes:
measure: Data Collection Strategy
timeFrame: After month 9
measure: Efficacy Measurements
timeFrame: After month 9
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Stephanie Staras, PhD
role: PRINCIPAL_INVESTIGATOR
References: