NCT04208269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,663

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2015

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

December 19, 2019

Last Update Submit

May 15, 2020

Conditions

Human Papilloma Virus

Keywords

preventativepostcardvaccinate

Outcome Measures

Primary Outcomes (2)

  • The number of participants receiving HPV vaccine

    The percent age eligible participants who initiate HPV vaccination.

    Up to 5 months

  • Number of preventive care visits

    The percent age eligible participants received a preventive care visit

    Up to 3 months

Study Arms (4)

Postcard campaign

ACTIVE COMPARATOR
Other: postcard campaign

Provider-only intervention

ACTIVE COMPARATOR
Other: Health Information Technology system

Patient and provider intervention

ACTIVE COMPARATOR
Other: postcard campaignOther: Health Information Technology system

Standard care

NO INTERVENTION

Interventions

postcard campaignOTHER

Post card sent to parent only

Patient and provider interventionPostcard campaign
Health Information Technology systemOTHER

Accessed by adolescent and provider only

Patient and provider interventionProvider-only intervention

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • 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.

    PMID: 32953426DERIVED

Study Officials

  • Stephanie Staras, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2019

First Posted

December 23, 2019

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

March 30, 2015

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)