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Primary PreventionRADVaxNCT03955757

Using Boot Camp Translation to Address Rural Disparities in Adolescent Vaccination

A study testing Boot Camp Translation in people with Primary Prevention, run by University of Colorado, Denver at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 11 to 17 years
Conditions the study is for
Primary Prevention
What is being tested?
Boot Camp Translation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,000 participants
Where
1 siteUnited States
Study dates
1 Aug 2019to 31 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Must live in one of the designated Colorado communities

Who cannot join

  • Does not live in one of the designated Colorado communities

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read the 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.

Being tested
Boot Camp Translation, Control
Keywords
Immunization, Boot Camp Translation, Adolescent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Boot Camp TranslationBehavioural

    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.

  • ControlOther

    No intervention. Communities will continue to behave as usual.

Study groups in NCT03955757
Study groupRoleWhat they receive
Boot Camp TranslationExperimentalIntervention communities will undergo the Boot Camp Translation process.
Receives: Behavioral: Boot Camp Translation
ControlActive comparatorControl communities will behave as usual
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 24 months

Secondary outcomes (7)

  1. 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

    Measured: Up to 24 months

  2. 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

    Measured: Up to 24 months

  3. 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

    Measured: Up to 24 months

  4. Receipt of Tdap vaccine, 11-12 year olds

    Percent of 11-12 year olds who have received Tdap vaccine by May 31,2021

    Measured: Up to 24 months

  5. Receipt of Tdap vaccine, 13-17 year olds

    Percent of 13-17 year olds who have received Tdap vaccine by May 31,2021

    Measured: Up to 24 months

  6. 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

    Measured: Up to 24 months

  7. 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

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2019
  2. Study start1 Aug 2019
  3. Primary completion31 Aug 2022 (estimated)
  4. Study completion31 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03955757
Sponsor's protocol ID
18-1588
Other IDs
U01IP001091
Acronym
RADVax
Status last verified
Aug 2022
First submitted
13 May 2019
Last updated
16 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38253469

Questions about this trial

What is this clinical trial studying?

A study testing Boot Camp Translation in people with Primary Prevention, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Initiation of HPV vaccination series, 11-12 year olds (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03955757, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.

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