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

Primary Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04279964
• Other study ID #: 18-0338
• Secondary ID: 1R21CA230878-01A
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Primary Prevention

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