I Vaccinate: Testing Multi-Level Interventions to Improve HPV Vaccination
NCT ID: NCT04452526
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
372 participants
INTERVENTIONAL
2020-10-21
2025-09-30
Brief Summary
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Detailed Description
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I. Test the effectiveness of a multi-level intervention (MLI) directed at clinics, providers, and patients (parents of children aged 11-12) to improve HPV vaccine initiation and completion in health systems in four Appalachian states (Kentucky \[KY\], Ohio \[OH\], West Virginia \[WV,\] and Virginia \[VA\]) among children aged 11-12 and assess the effectiveness of the intervention program among subgroups, e.g., females versus (vs) males.
SECONDARY OBJECTIVES:
I. Assess sustainability of the intervention. II. Assess cost impacts of the intervention III. Assess changes in clinic practices that occur as a result of the intervention in terms of staff responsibilities for the vaccination process and reducing missed opportunities for vaccination.
IV. Assess whether interventions focused on 13-26 year olds increases catch-up vaccination.
V. Examine changes in knowledge and attitudes of providers via educational session pre-post surveys.
VI. Satisfaction with the intervention at the multiple levels.
OUTLINE: Health systems are randomized to 1 of 2 arms.
ARM I (EARLY INTERVENTION): Health systems receive educational materials consisting of posters, brochures and table tents. Providers complete survey about HPV knowledge, participate in educational session over 1 hour and receive educational handouts on the HPV vaccine. Patients receive educational materials about HPV vaccine and reminder letters for HPV vaccination.
ARM II (DELAYED INTERVENTION): Health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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ARM I (EARLY INTERVENTION) (educational material, reminders)
Health systems receive educational materials consisting of posters, brochures and handouts. Providers complete survey about HPV knowledge, participate in educational session over 1 hour and receive educational handouts on the HPV vaccine. Patients receive educational materials about HPV vaccine and reminder letters for HPV vaccination
Best Practice
Receive usual care
Educational Intervention
Receive educational materials
Questionnaire Administration
Ancillary studies
Reminder
Receive reminder letter
ARM II (DELAYED INTERVENTION)(education, reminder, usual care)
Health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I.
Best Practice
Receive usual care
Educational Intervention
Receive educational materials
Questionnaire Administration
Ancillary studies
Reminder
Receive reminder letter
Interventions
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Best Practice
Receive usual care
Educational Intervention
Receive educational materials
Questionnaire Administration
Ancillary studies
Reminder
Receive reminder letter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Located in one of the counties that are part of this program
* Provides care to patients aged 11-26
* Provides immunizations
HEALTH CARE PROVIDERS (PHYSICIANS, NURSES) AND OFFICE STAFF
* Practicing in a clinic in one of the participating health systems
* Personnel involved in the vaccine process (determined by individual clinics)
* Able to speak, read, and write English
11 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Electra Paskett
Principal Investigator
Principal Investigators
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Electra D Paskett
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Virginia
Charlottesville, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2020-01225
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-20058
Identifier Type: -
Identifier Source: org_study_id
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