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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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