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

NCT ID: NCT04279964

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-08

Study Completion Date

2024-08-31

Brief Summary

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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

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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.

Conditions

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Primary Prevention

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Boot Camp Translation

Intervention practices will undergo the Boot Camp Translation process.

Group Type EXPERIMENTAL

Boot Camp Translation

Intervention Type 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.

Control

Control practice will behave as usual.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

No intervention. Practices will continue to behave as usual.

Interventions

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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.

Intervention Type BEHAVIORAL

Control

No intervention. Practices will continue to behave as usual.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean O'Leary, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33310806 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1R21CA230878-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-0338

Identifier Type: -

Identifier Source: org_study_id

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