NCT02456077

Brief Summary

The purpose of this study is to determine if a multimodal Human Papillomavirus (HPV) immunization program carried out in pediatric and family medicine practices would be more effective in improving adolescent patients' HPV immunization rates than the usual care provided to adolescents in pediatric and family medicine practices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93,582

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2016

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

12 months

First QC Date

May 26, 2015

Last Update Submit

June 21, 2019

Conditions

HPV Immunization Status

Keywords

MCV4: Meningococcal Conjugate VaccineHPV: Human Papillomavirus

Outcome Measures

Primary Outcomes (1)

  • The percentage of adolescents who initiate the HPV vaccine series

    The percent of eligible patients presenting for care at intervention offices who receive one or more HPV vaccines (using administrative, Electronic Medical Records (EMR), and Colorado Immunization Information System (CIIS) immunization data), during the intervention year, compared to the percent in control offices.

    1 year

Secondary Outcomes (4)

  • The percentage of adolescents who receive MCV4 vaccine

    1 year

  • The percentage of adolescents who receive Tdap vaccine

    1 year

  • Provider HPV vaccine recommendations

    1 year

  • Parents' experiences and preferences regarding provider communication about HPV vaccines

    1 year

Study Arms (2)

Intervention Practices

EXPERIMENTAL

Intervention offices will adopt a multi-modal vaccine program to increase their patients' vaccine rates.

Behavioral: Multimodal Vaccine Program

Control Practices

NO INTERVENTION

Control offices will offer usual health care related to immunizations throughout the duration of the study.

Interventions

Multimodal Vaccine ProgramBEHAVIORAL

Efforts will be made to collaborate with pediatric and family medicine offices to utilize a multimodal intervention to improve adolescents' HPV immunization rates. As part of the overall intervention, four intervention strategies will be used: 1) a tailored website, iVac -HPV , 2) Motivational Interview Training for providers, 3) HPV Fact Sheets and 4) The Decision Aid for HPV Vaccines

Intervention Practices

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older when presenting for care
  • Patients who present for care one year prior to the start of the intervention and up to two years after the start of the intervention

You may not qualify if:

  • Less than 9 years of age when presenting for care
  • Patient is not eligible for HPV immunization
  • Provider survey:
  • Providers who are working at participating practices during the two times a cross-sectional survey is administered.
  • Parent survey:
  • Parents of adolescents who presented for care within one 1 year prior to the two times a cross-sectional survey is administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Dempsey AF, Pyrznawoski J, Lockhart S, Barnard J, Campagna EJ, Garrett K, Fisher A, Dickinson LM, O'Leary ST. Effect of a Health Care Professional Communication Training Intervention on Adolescent Human Papillomavirus Vaccination: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2018 May 7;172(5):e180016. doi: 10.1001/jamapediatrics.2018.0016. Epub 2018 May 7.

    PMID: 29507952DERIVED

Study Officials

  • Amanda Dempsey, MD, PhD, MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

May 28, 2015

Study Start

February 1, 2015

Primary Completion

January 31, 2016

Study Completion

January 31, 2016

Last Updated

June 24, 2019

Record last verified: 2019-06

Locations

US(1)