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

September 27, 2023 updated by: Electra Paskett, Ohio State University Comprehensive Cancer Center

Improving Uptake of Cervical Cancer Prevention Services in Appalachia; Testing Multi-Level Interventions to Improve HPV Vaccination: The "I Vaccinate" Program

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

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.

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark Dingnan, PhD, MPH
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Electra D. Paskett
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • Melissa Little, PhD, MPH
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University
        • Contact:
        • Principal Investigator:
          • Stephenie K Kennedy-Rea, EdD, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Questionnaire Administration
Ancillary studies
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: 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: Questionnaire Administration
Ancillary studies
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: Reminder
Receive reminder letter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in rate of human papillomavirus (HPV) vaccination initiation among 11-12 year olds
Time Frame: 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.
Baseline up to 24 months
Change in rate of HPV vaccination initiation among those 13-26
Time Frame: 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.
Baseline up to 24 months
Sustainability
Time Frame: 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.
Up to 24 months
Cost-effectiveness
Time Frame: 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.
Up to 60 months
Change in knowledge of providers
Time Frame: 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.
Baseline up to 60 months
Change in attitudes of providers
Time Frame: Baseline up to 60 months
Will compare changes in attitudes of providers via educational session pre-post survey.
Baseline up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2020

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

June 26, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-20058
  • NCI-2020-01225 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • P01CA229143 (U.S. NIH Grant/Contract)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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