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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04279964
Other study ID # 18-0338
Secondary ID 1R21CA230878-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date May 8, 2020
Est. completion date August 31, 2024

Study information

Verified date February 2024
Source University of Colorado, Denver
Contact Sarah Brewer, PhD
Phone 303-724-6927
Email sarah.brewer@cuanschutz.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 9 Years to 26 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Colorado Hospital Aurora Colorado

Sponsors (3)

Lead Sponsor Collaborator
University of Colorado, Denver National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Initiation of HPV vaccination series, 9-17 Percent of 9-17 year olds who have received >=1 dose of the HPV vaccine by September 29, 2021 Up to 12 months
Secondary Differences in initiation rates between intervention vs. control, 9-10 Comparison of boys vs. girls who have received >1=dose of HPV vaccine by September 29, 2021 12 months
Secondary Differences in initiation rates between intervention vs. control, 11-12 Comparison of boys vs. girls who have received >1=dose of HPV vaccine by September 29, 2021 12 months
Secondary Differences in initiation rates between intervention vs. control, 13-17 Comparison of boys vs. girls who have received >1=dose of HPV vaccine by September 29, 2021 12 months
Secondary Differences in initiation rates between intervention vs. control, 18-26 Percent of 18-26 year olds who have received >=1 dose of the HPV vaccine by September 29, 2021 12 months
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