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IVaccinate: I Vaccinate: Testing Multi-Level Interventions to Improve HPV Vaccination

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04452526
Collaborator
National Cancer Institute (NCI) (NIH)
1,500
Enrollment
3
Locations
2
Arms
38.3
Anticipated Duration (Months)
500
Patients Per Site
13.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice
  • Other: Educational Intervention
  • Other: Questionnaire Administration
  • Other: Reminder
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:

  1. Assess sustainability of the intervention. II. Assess cost impacts of the intervention

  2. 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.

  3. Assess whether interventions focused on 13-26 year olds increases catch-up vaccination.

  4. Examine changes in knowledge and attitudes of providers via educational session pre-post surveys.

  5. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Improving Uptake of Cervical Cancer Prevention Services in Appalachia; Testing Multi-Level Interventions to Improve HPV Vaccination: The "I Vaccinate" Program
Actual Study Start Date :
Oct 21, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy

    • Other: Educational Intervention
    Receive educational materials
    Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

    • Other: Questionnaire Administration
    Ancillary studies

    Other: Reminder
    Receive reminder letter
    Experimental: 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.

    Other: Best Practice
    Receive usual care
    Other Names:
  • standard of care
  • standard therapy

    • Other: Educational Intervention
    Receive educational materials
    Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

    • Other: Questionnaire Administration
    Ancillary studies

    Other: Reminder
    Receive reminder letter

    Outcome Measures

    Primary Outcome Measures

    1. Change in rate of human papillomavirus (HPV) vaccination initiation among 11-12 year olds [Baseline up to 24 months]

      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.

    2. Change in rate of HPV vaccination initiation among those 13-26 [Baseline up to 24 months]

      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.

    3. Sustainability [Up to 24 months]

      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.

    4. Cost-effectiveness [Up to 60 months]

      Will conduct the cost-effectiveness analyses of using the multi-level intervention (MLI) intervention to promote HPV vaccination in three broad steps.

    5. Change in knowledge of providers [Baseline up to 60 months]

      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.

    6. Change in attitudes of providers [Baseline up to 60 months]

      Will compare changes in attitudes of providers via educational session pre-post survey.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    11 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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

    • Are able to speak, read, and write English, as there are very few Spanish-speaking residents in these communities

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    2 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    3 University of Virginia Charlottesville Virginia United States 22908

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Electra D Paskett, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Electra Paskett, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04452526
    Other Study ID Numbers:
    • OSU-20058
    • NCI-2020-01225
    • P01CA229143
    First Posted:
    Jun 30, 2020
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Apr 20, 2022