I Vaccinate: Testing Multi-Level Interventions to Improve HPV Vaccination
IVaccinate
Improving Uptake of Cervical Cancer Prevention Services in Appalachia; Testing Multi-Level Interventions to Improve HPV Vaccination: The "I Vaccinate" Program
3 other identifiers
interventional
372
1 country
4
Brief Summary
This trial studies how well a multi-level health system-based intervention works in improving human papillomavirus (HPV) vaccine initiation and completion among children in health systems in four Appalachian states. Utilizing educational and promotional materials and electronic health record reminders, may improve the uptake of the HPV vaccine in children and young adults, ultimately preventing the development of cervical cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedStudy Start
First participant enrolled
October 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedAugust 26, 2025
August 1, 2025
4.7 years
June 26, 2020
August 19, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
Change in rate of human papillomavirus (HPV) vaccination initiation among 11-12 year olds
The effectiveness of the intervention will be assessed by comparing early vs delayed intervention clinics at the end of the first implementation phase adjusting for baseline rates and pre- versus (vs) post implementation rates in the delayed implementation clinics.
Baseline up to 24 months
Change in rate of HPV vaccination initiation among those 13-26
The effectiveness of the intervention will be assessed by comparing early vs delayed intervention clinics at the end of the first implementation phase adjusting for baseline rates and pre- versus (vs) post implementation rates in the delayed implementation clinics.
Baseline up to 24 months
Sustainability
Will use logistic regression models with random health systems effects to compare odds of vaccination at the end of sustainability period to odds of vaccination at the end of the implementation period.
Up to 24 months
Cost-effectiveness
Will conduct the cost-effectiveness analyses of using the multi-level intervention (MLI) intervention to promote HPV vaccination in three broad steps.
Up to 60 months
Change in knowledge of providers
Will compare changes in knowledge of providers via educational session pre-post survey. Changes in Knowledge following the educational session will be assessed using linear mixed models containing random health system effects.
Baseline up to 60 months
Change in attitudes of providers
Will compare changes in attitudes of providers via educational session pre-post survey.
Baseline up to 60 months
Study Arms (2)
ARM I (EARLY INTERVENTION) (educational material, reminders)
EXPERIMENTALHealth 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
ARM II (DELAYED INTERVENTION)(education, reminder, usual care)
EXPERIMENTALHealth systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I.
Interventions
Receive usual care
Receive educational materials
Ancillary studies
Receive reminder letter
Eligibility Criteria
You may qualify if:
- CLINIC
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Electra D Paskett
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 26, 2020
First Posted
June 30, 2020
Study Start
October 21, 2020
Primary Completion
June 26, 2025
Study Completion
September 1, 2025
Last Updated
August 26, 2025
Record last verified: 2025-08