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

Not Applicable

Recruiting

• Conditions: Primary Prevention
• Interventions: Other: Control; Behavioral: Boot Camp Translation

• Registration Number: NCT04279964
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Study Start: 2020-05-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Control practice will behave as usual.
Boot Camp Translation	Boot Camp Translation	Intervention practices will undergo the Boot Camp Translation process.

Primary Outcome Measures

Name	Time	Method
Initiation of HPV vaccination series, 9-17	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

Name	Time	Method
Differences in initiation rates between intervention vs. control, 11-12	12 months	Comparison of boys vs. girls who have received \>1=dose of HPV vaccine by September 29, 2021
Differences in initiation rates between intervention vs. control, 9-10	12 months	Comparison of boys vs. girls who have received \>1=dose of HPV vaccine by September 29, 2021
Differences in initiation rates between intervention vs. control, 13-17	12 months	Comparison of boys vs. girls who have received \>1=dose of HPV vaccine by September 29, 2021
Differences in initiation rates between intervention vs. control, 18-26	12 months	Percent of 18-26 year olds who have received \>=1 dose of the HPV vaccine by September 29, 2021

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States