Using Boot Camp Translation to Address Rural Disparities in Adolescent Vaccination (RADVax)

The overall goal of this project is to implement the Boot Camp Translation process to develop a replicable approach for increasing adolescent vaccine uptake that can be adaptable and feasible to use in rural settings more broadly.

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Prevention
• Intervention / Treatment: Behavioral: Boot Camp Translation; Other: Control

Detailed Description

Boot Camp Translation (BCT) is a process to identify strategies that help communities improve health. It is a 6-month, facilitated, iterative community engagement process that brings together relevant stakeholders to develop and implement locally meaningful messages, materials, and strategies for health topics of interest.

This is a novel community engagement process that has a proven ability to result in meaningful and impactful strategies to improve compliance with recommended health behaviors in rural communities. The investigators will expand this work by testing BCT on its ability to improve vaccination with all recommend adolescent vaccines (Tdap, MenACWY, HPV, Flu).

The investigators will conduct a randomized, controlled trial in which 4 rural communities in Western Colorado will undergo BCT to develop and implement strategies to increase adolescent vaccination. Vaccination rates will be compared to 4 control communities that do not undergo BCT.

• Study Type: Interventional
• Enrollment (Anticipated): 6000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must live in one of the designated Colorado communities

Exclusion Criteria:

• Does not live in one of the designated Colorado communities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Boot Camp Translation; Intervention communities will undergo the Boot Camp Translation process.	Behavioral: Boot Camp Translation; Communities in the intervention arm will participate in the Boot Camp translation process, where stakeholders will come together to develop and implement locally relevant materials to promote adolescent vaccination.
ACTIVE_COMPARATOR: Control; Control communities will behave as usual	Other: Control; No intervention. Communities 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, 11-12 year olds	Percent of 11-12 year olds who have received >=1 dose of the HPV vaccine by May 31,2021	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of HPV vaccination series, 11-12 year olds	Percent of 11-12 year olds with >=2 doses of the HPV vaccine by May 31,2021	Up to 24 months
Initiation of HPV vaccination series, 13-17 year olds	Percent of 13-17 year olds who have received >=1 dose of the HPV vaccine by May 31,2021	Up to 24 months
Completion of HPV vaccination series, 13-17 year olds	Percent of 13-17 year olds who have completed the HPV vaccine series (2 or 3 doses, depending on age of initiation) by May 31,2021	Up to 24 months
Receipt of Tdap vaccine, 11-12 year olds	Percent of 11-12 year olds who have received Tdap vaccine by May 31,2021	Up to 24 months
Receipt of Tdap vaccine, 13-17 year olds	Percent of 13-17 year olds who have received Tdap vaccine by May 31,2021	Up to 24 months
Receipt of MCV vaccine, 11-12 year olds	Percent of 11-12 year olds who have received >=1 dose of MCV vaccine by May 31,2021	Up to 24 months
Receipt of MCV vaccine, 13-17 year olds	Percent of 13-17 year olds who have received >=1 dose of MCV vaccine by May 31,2021	Up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of influenza vaccine	Percent of 11-17 year olds who receive the influenza vaccine between Sept 2020 and May 2021	Up to 24 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Sean T O'Leary, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ANTICIPATED): August 31, 2022
• Study Completion (ANTICIPATED): August 31, 2022

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (ACTUAL): May 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Adolescent; Immunization; Boot Camp Translation
• Other Study ID Numbers: 18-1588; U01IP001091 (NIH)

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