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

NCT04279964 | Completed

• 2 other identifiers: 18-03381R21CA230878-01A1
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Prevention

Keywords

Immunization; Boot Camp Translation; Adolescent; Human Papillomavirus; Vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Differences in initiation rates between intervention vs. control, 9-10

  12 months

• Differences in initiation rates between intervention vs. control, 11-12

  12 months

• Differences in initiation rates between intervention vs. control, 13-17

  12 months

• Differences in initiation rates between intervention vs. control, 18-26

  12 months

Study Arms (2)

Boot Camp Translation

EXPERIMENTAL

Intervention practices will undergo the Boot Camp Translation process.

Behavioral: Boot Camp Translation

Control

ACTIVE COMPARATOR

Control practice will behave as usual.

Other: Control

Interventions

Boot Camp Translation BEHAVIORAL

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.

Boot Camp Translation

Control OTHER

No intervention. Practices will continue to behave as usual.

Control

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 33310806 DERIVED

Study Officials

• Sean O'Leary, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: May 8, 2020
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)