Back to resultsA Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3
Primary Purpose
Human Papilloma Virus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
postcard campaign
Health Information Technology system
Sponsored by
About this trial
This is an interventional health services research trial for Human Papilloma Virus focused on measuring preventative, postcard, vaccinate
Eligibility 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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
Postcard campaign
Provider-only intervention
Patient and provider intervention
Standard care
Arm Description
Outcomes
Primary Outcome Measures
The number of participants receiving HPV vaccine
The percent age eligible participants who initiate HPV vaccination.
Number of preventive care visits
The percent age eligible participants received a preventive care visit
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04208269
Brief Title
A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3
Official Title
A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2013 (Actual)
Primary Completion Date
April 1, 2014 (Actual)
Study Completion Date
March 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
preventative, postcard, vaccinate
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5663 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Postcard campaign
Arm Type
Active Comparator
Arm Title
Provider-only intervention
Arm Type
Active Comparator
Arm Title
Patient and provider intervention
Arm Type
Active Comparator
Arm Title
Standard care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
postcard campaign
Intervention Description
Post card sent to parent only
Intervention Type
Other
Intervention Name(s)
Health Information Technology system
Intervention Description
Accessed by adolescent and provider only
Primary Outcome Measure Information:
Title
The number of participants receiving HPV vaccine
Description
The percent age eligible participants who initiate HPV vaccination.
Time Frame
Up to 5 months
Title
Number of preventive care visits
Description
The percent age eligible participants received a preventive care visit
Time Frame
Up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Staras, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32953426
Citation
Staras SAS, Vadaparampil ST, Thompson LA, Scherr C, Gurka MJ, Filipp SL, Shenkman EA. Postcard reminders for HPV vaccination mainly primed parents for providers' recommendations. Prev Med Rep. 2020 Aug 26;20:101188. doi: 10.1016/j.pmedr.2020.101188. eCollection 2020 Dec.
Results Reference
derived
Learn more about this trial
A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3
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