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Strengthening Physician Communication About HPV Vaccines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02456077
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
HPV Immunization Status Behavioral: Multimodal Vaccine Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93582 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Strengthening Physician Communication About HPV Vaccines
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : January 31, 2016
Actual Study Completion Date : January 31, 2016

Arm Intervention/treatment
Experimental: Intervention Practices
Intervention offices will adopt a multi-modal vaccine program to increase their patients' vaccine rates.
Behavioral: Multimodal 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

No Intervention: Control Practices
Control offices will offer usual health care related to immunizations throughout the duration of the study.



Primary Outcome Measures :
  1. The percentage of adolescents who initiate the HPV vaccine series [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. The percentage of adolescents who receive MCV4 vaccine [ Time Frame: 1 year ]
    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.

  2. The percentage of adolescents who receive Tdap vaccine [ Time Frame: 1 year ]
    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.

  3. Provider HPV vaccine recommendations [ Time Frame: 1 year ]
    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.

  4. Parents' experiences and preferences regarding provider communication about HPV vaccines [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456077


Locations
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United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Amanda Dempsey, MD, PhD, MPH University of Colorado, Denver
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02456077    
Other Study ID Numbers: 13-2785
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Keywords provided by University of Colorado, Denver:
MCV4: Meningococcal Conjugate Vaccine
HPV: Human Papillomavirus