Using Boot Camp Translation to Address Rural Disparities in Adolescent Vaccination

Primary Prevention Clinical Trial

— RADVax  

Official title:

Using Boot Camp Translation to Address Rural Disparities in Adolescent Vaccination

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03955757
• Other study ID #: 18-1588
• Secondary ID: U01IP001091
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria:

• Must live in one of the designated Colorado communities

Exclusion Criteria:

• Does not live in one of the designated Colorado communities

Related Conditions & MeSH terms

• Primary Prevention

Intervention

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.

Other:
• Control
No intervention. Communities will continue to behave as usual.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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