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A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208269
Recruitment Status : Completed
First Posted : December 23, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Our project will assess the feasibility and estimate preliminary efficacy of a multilevel intervention to improve HPV vaccine series initiation among adolescents in Medicaid and CHIP. The investigators will use two intervention components: postcards and an iPad survey system. To estimate efficacy the investigators will select potential participants from Florida Medicaid and CHIP. The investigators will assess their claims for the HPV vaccine before and after the intervention.

Condition or disease Intervention/treatment Phase
Human Papilloma Virus Other: postcard campaign Other: Health Information Technology system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5663 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3
Actual Study Start Date : August 1, 2013
Actual Primary Completion Date : April 1, 2014
Actual Study Completion Date : March 30, 2015

Arm Intervention/treatment
Active Comparator: Postcard campaign Other: postcard campaign
Post card sent to parent only

Active Comparator: Provider-only intervention Other: Health Information Technology system
Accessed by adolescent and provider only

Active Comparator: Patient and provider intervention Other: postcard campaign
Post card sent to parent only

Other: Health Information Technology system
Accessed by adolescent and provider only

No Intervention: Standard care



Primary Outcome Measures :
  1. The number of participants receiving HPV vaccine [ Time Frame: Up to 5 months ]
    The percent age eligible participants who initiate HPV vaccination.

  2. Number of preventive care visits [ Time Frame: Up to 3 months ]
    The percent age eligible participants received a preventive care visit



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrolled in Florida Medicaid
  • Not initiated the HPV vaccine series at the start of the study period.

Exclusion Criteria:

  • Anyone who has a severe (life threatening) allergy to any component of HPV vaccine, esp yeast
  • Pregnant
  • Not enrolled in Florida Medicaid

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): NCT04208269


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Stephanie Staras, PhD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04208269    
Other Study ID Numbers: IRB201200143
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
preventative
postcard
vaccinate
Additional relevant MeSH terms:
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Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms