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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452526
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Electra Paskett, Ohio State University Comprehensive Cancer Center

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
Cervical Carcinoma Human Papillomavirus-Related Malignant Neoplasm Other: Best Practice Other: Educational Intervention Other: Questionnaire Administration Other: Reminder Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452526


Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Contact: Electra D. Paskett    614-293-7520    Electra.Paskett@osumc.edu   
Principal Investigator: Electra D. Paskett         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Electra D Paskett Ohio State University Comprehensive Cancer Center
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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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P01CA229143 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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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:
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Neoplasms