NCT03955757

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

3.1 years

First QC Date

May 13, 2019

Last Update Submit

August 12, 2022

Conditions

Keywords

ImmunizationBoot Camp TranslationAdolescent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Completion of HPV vaccination series, 11-12 year olds

    Up to 24 months

  • Initiation of HPV vaccination series, 13-17 year olds

    Up to 24 months

  • Completion of HPV vaccination series, 13-17 year olds

    Up to 24 months

  • Receipt of Tdap vaccine, 11-12 year olds

    Up to 24 months

  • Receipt of Tdap vaccine, 13-17 year olds

    Up to 24 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Receipt of influenza vaccine

    Up to 24 months

Study Arms (2)

Boot Camp Translation

EXPERIMENTAL

Intervention communities will undergo the Boot Camp Translation process.

Behavioral: Boot Camp Translation

Control

ACTIVE COMPARATOR

Control communities will behave as usual

Other: Control

Interventions

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.

Boot Camp Translation
ControlOTHER

No intervention. Communities will continue to behave as usual.

Control

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Must live in one of the designated Colorado communities

You may not qualify if:

  • Does not live in one of the designated Colorado communities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Cataldi JR, Suresh K, Brewer SE, Perreira C, Nederveld A, Skenadore A, Furniss A, Williams C, Severson R, Dempsey AF, O'Leary ST. Boot Camp Translation using Community-Engaged messaging for adolescent Vaccination: A Cluster-Randomized trial. Vaccine. 2024 Feb 15;42(5):1078-1086. doi: 10.1016/j.vaccine.2024.01.042. Epub 2024 Jan 21.

Study Officials

  • Sean T O'Leary, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR
  • Amanda Dempsey, MD, PhD, MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study team data analyst will be provided with blinded data.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 20, 2019

Study Start

August 1, 2019

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

August 16, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations