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Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04279964
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : January 26, 2023
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The overarching goal of this project is to implement Boot Camp Translation (BCT) methodology to translate the guidelines and evidence for human papillomavirus (HPV) vaccine into a practice and provider level intervention designed to improve its acceptability and uptake.

Condition or disease Intervention/treatment Phase
Primary Prevention Behavioral: Boot Camp Translation Other: Control Not Applicable

Detailed Description:

As a community engagement approach, Boot Camp Translation (BCT), is a 6-9-month iterative process that brings together multiple stakeholders, including patients, parents, and community members, to translate evidence-based guidelines and recommendations into locally relevant and meaningful messages, materials, and programs.

Aim 1: Implement BCT in three geographically distinct Colorado communities to translate the current evidence for HPV vaccination into locally relevant interventions designed to increase vaccine uptake.

Aim 2: Evaluate the impact of the BCT- designed intervention on practice-level HPV vaccination initiation rates.

The long-term goal is to develop a replicable approach and low-cost method of increasing HPV vaccine uptake that is easily adaptable to different settings and sociodemographic contexts.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake
Actual Study Start Date : May 8, 2020
Estimated Primary Completion Date : December 8, 2023
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: Boot Camp Translation
Intervention practices will undergo the Boot Camp Translation process.
Behavioral: Boot Camp Translation
Practices in the intervention arm will participate in the Boot Camp Translation process, where BCT Community Advisory group members will come together to develop and implement practice relevant materials to promote adolescent vaccination.

Active Comparator: Control
Control practice will behave as usual.
Other: Control
No intervention. Practices will continue to behave as usual.




Primary Outcome Measures :
  1. Initiation of HPV vaccination series, 9-17 [ Time Frame: Up to 12 months ]
    Percent of 9-17 year olds who have received >=1 dose of the HPV vaccine by September 29, 2021


Secondary Outcome Measures :
  1. Differences in initiation rates between intervention vs. control, 9-10 [ Time Frame: 12 months ]
    Comparison of boys vs. girls who have received >1=dose of HPV vaccine by September 29, 2021

  2. Differences in initiation rates between intervention vs. control, 11-12 [ Time Frame: 12 months ]
    Comparison of boys vs. girls who have received >1=dose of HPV vaccine by September 29, 2021

  3. Differences in initiation rates between intervention vs. control, 13-17 [ Time Frame: 12 months ]
    Comparison of boys vs. girls who have received >1=dose of HPV vaccine by September 29, 2021

  4. Differences in initiation rates between intervention vs. control, 18-26 [ Time Frame: 12 months ]
    Percent of 18-26 year olds who have received >=1 dose of the HPV vaccine by September 29, 2021



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All child patients who have received health supervision at participating practices during the 12 month prior to intervention and the 12 month following intervention implementation, who are ages 9-26 years, and whose parents have not requested removal from the Colorado Immunization Information System (CIIS) will be eligible for the assessment of practice immunization rates in the pre and post periods.

Exclusion Criteria:

  • No subjects will be excluded because of gender, ethnicity, or insurance status.
  • Any child whose parents have requested removal from the immunization registry; any child with hypersensitivity to any component of one of the recommended vaccines; any child who has moved to a primary care provider other than one at the study clinics.

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): NCT04279964


Contacts
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Contact: Sarah Brewer, PhD 303-724-6927 sarah.brewer@cuanschutz.edu
Contact: Amanda Skenadore, MPH 303-724-4198 amanda.skenadore@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Sarah Brewer, PhD    303-724-6927    sarah.brewer@cuanschutz.edu   
Contact: Amanda Skenadore, MPH    303-724-4198    amanda.skenadore@cuanschutz.edu   
Principal Investigator: Sean O'Leary, MD         
Sponsors and Collaborators
University of Colorado, Denver
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sean O'Leary, MD University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Informed Consent Form  [PDF] July 3, 2021

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: NCT04279964    
Other Study ID Numbers: 18-0338
1R21CA230878-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Immunization
Boot Camp Translation
Adolescent
Human Papillomavirus
Vaccine