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

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.

Study Overview

• Status: Completed
• Conditions: Primary Prevention
• Intervention / Treatment: Behavioral: Boot Camp Translation; Other: Control

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 Type: Interventional
• Enrollment (Actual): 2400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sean O'Leary, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• Brewer SE, Simpson MJ, Rice JD, Skenadore A, O'Leary ST. Engaging practices and communities in the development of interventions to promote HPV vaccine uptake: a protocol for implementing Boot Camp Translation in the private practice setting. BMJ Open. 2020 Dec 12;10(12):e041685. doi: 10.1136/bmjopen-2020-041685.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2020
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Adolescent; Vaccine; Human Papillomavirus; Immunization; Boot Camp Translation
• Other Study ID Numbers: 18-0338; 1R21CA230878-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No