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

NCT ID: NCT04208269

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5663 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-01

Study Completion Date

2015-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Human Papilloma Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Postcard campaign

Group Type ACTIVE_COMPARATOR

postcard campaign

Intervention Type OTHER

Post card sent to parent only

Provider-only intervention

Group Type ACTIVE_COMPARATOR

Health Information Technology system

Intervention Type OTHER

Accessed by adolescent and provider only

Patient and provider intervention

Group Type ACTIVE_COMPARATOR

postcard campaign

Intervention Type OTHER

Post card sent to parent only

Health Information Technology system

Intervention Type OTHER

Accessed by adolescent and provider only

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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postcard campaign

Post card sent to parent only

Intervention Type OTHER

Health Information Technology system

Accessed by adolescent and provider only

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Staras, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32953426 (View on PubMed)

Other Identifiers

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IRB201200143

Identifier Type: -

Identifier Source: org_study_id

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