ClinicalTrials.gg
CompletedNCT02456077Updated Jun 24, 2019

Strengthening Physician Communication About HPV Vaccines

An interventional study of Multimodal Vaccine Program in HPV Immunization Status, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 9 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-24.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2015, registered May 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
93,582
Allocation
Randomized
Ages
9 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HPV Immunization Status

Keywords

  • MCV4: Meningococcal Conjugate Vaccine
  • HPV: Human Papillomavirus
03

In context

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 318 are open to participants now.

Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria for immunization rate assessment:

  1. 9 years of age or older when presenting for care
  2. 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

Exclusion Criteria:

  1. Less than 9 years of age when presenting for care
  2. 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.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
93,582 participants (actual)

Study arms

  • Experimental
    Intervention Practices

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

    Behavioral: Multimodal Vaccine Program

  • No intervention
    Control Practices

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

Interventions

  • BehavioralMultimodal Vaccine Program

    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

06

What researchers measure

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.

    Time frame: 1 year

Secondary outcomes

  1. The percentage of adolescents who receive MCV4 vaccine

    The percent of eligible patients presenting for care at intervention offices who receive MCV4 vaccine (using administrative, EMR and CIIS immunization data) compared to the percent in control offices.

    Time frame: 1 year

  2. The percentage of adolescents who receive Tdap vaccine

    The percentage of eligible patients presenting for care at intervention offices who receive Tetanus, Diphtheria, Pertussis (Tdap) vaccine (using administrative, EMR and CIIS immunization data) during the intervention year compared to the percent in control offices.

    Time frame: 1 year

  3. Provider HPV vaccine recommendations

    The change in intervention providers' HPV vaccine communication practices compared to control providers' as measured by self-report prior to the intervention and after the intervention.

    Time frame: 1 year

  4. Parents' experiences and preferences regarding provider communication about HPV vaccines

    The change in intervention parents' experiences and preferences regarding provider HPV vaccine communication compared to parents of adolescents attending control practices as measured by self report prior to the intervention and after the intervention.

    Time frame: 1 year

07

Study locations

1 site
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
08

References and documents

Publications

  • 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. PubMed 29507952 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02456077
Responsible party
Sponsor
First posted
May 28, 2015
Start date
Feb 1, 2015
Primary completion
Jan 31, 2016
Completion
Jan 31, 2016
Last update
Jun 24, 2019

Study contacts

Amanda Dempsey, MD, PhD, MPH
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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