Primary PreventionNCT04279964
Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake
A study testing Boot Camp Translation in people with Primary Prevention, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The overarching goal of this project is to implement Boot Camp Translation (BCT) methodology to translate the guidelines and evidence for human papillomavirus (HPV) vaccine into a practice and provider level intervention designed to improve its acceptability and uptake. Read more about this study
- Who is it for?
- Ages 9 to 26 years
- Conditions the study is for
- Primary Prevention
- What is being tested?
- Boot Camp Translation
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2020to 31 Aug 2024
- 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 9 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All child patients who have received health supervision at participating practices during the 12 month prior to intervention and the 12 month following intervention implementation, who are ages 9-26 years, and whose parents have not requested removal from the Colorado Immunization Information System (CIIS) will be eligible for the assessment of practice immunization rates in the pre and post periods.
Who cannot join
- No subjects will be excluded because of gender, ethnicity, or insurance status.
- Any child whose parents have requested removal from the immunization registry; any child with hypersensitivity to any component of one of the recommended vaccines; any child who has moved to a primary care provider other than one at the study clinics.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
The overarching goal of this project is to implement Boot Camp Translation (BCT) methodology to translate the guidelines and evidence for human papillomavirus (HPV) vaccine into a practice and provider level intervention designed to improve its acceptability and uptake.
Read the detailed description
As a community engagement approach, Boot Camp Translation (BCT), is a 6-9-month iterative process that brings together multiple stakeholders, including patients, parents, and community members, to translate evidence-based guidelines and recommendations into locally relevant and meaningful messages, materials, and programs.
Aim 1: Implement BCT in three geographically distinct Colorado communities to translate the current evidence for HPV vaccination into locally relevant interventions designed to increase vaccine uptake.
Aim 2: Evaluate the impact of the BCT- designed intervention on practice-level HPV vaccination initiation rates.
The long-term goal is to develop a replicable approach and low-cost method of increasing HPV vaccine uptake that is easily adaptable to different settings and sociodemographic contexts.
- Conditions
- Primary Prevention
- Being tested
- Boot Camp Translation, Control
- Keywords
- Immunization, Boot Camp Translation, Adolescent, Human Papillomavirus, Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boot Camp TranslationBehavioural
Practices in the intervention arm will participate in the Boot Camp Translation process, where BCT Community Advisory group members will come together to develop and implement practice relevant materials to promote adolescent vaccination.
ControlOther
No intervention. Practices will continue to behave as usual.
| Study group | Role | What they receive |
|---|---|---|
| Boot Camp Translation | Experimental | Intervention practices will undergo the Boot Camp Translation process. Receives: Behavioral: Boot Camp Translation |
| Control | Active comparator | Control practice will behave as usual. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of HPV vaccination series, 9-17
Percent of 9-17 year olds who have received >=1 dose of the HPV vaccine by September 29, 2021
Measured: Up to 12 months
Secondary outcomes (4)
Differences in initiation rates between intervention vs. control, 9-10
Comparison of boys vs. girls who have received >1=dose of HPV vaccine by September 29, 2021
Measured: 12 months
Differences in initiation rates between intervention vs. control, 11-12
Comparison of boys vs. girls who have received >1=dose of HPV vaccine by September 29, 2021
Measured: 12 months
Differences in initiation rates between intervention vs. control, 13-17
Comparison of boys vs. girls who have received >1=dose of HPV vaccine by September 29, 2021
Measured: 12 months
Differences in initiation rates between intervention vs. control, 18-26
Percent of 18-26 year olds who have received >=1 dose of the HPV vaccine by September 29, 2021
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start8 May 2020
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary PreventionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sean O'Leary, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279964
- Sponsor's protocol ID
- 18-0338
- Other IDs
- 1R21CA230878-01A1
- Status last verified
- Apr 2025
- First submitted
- 19 Feb 2020
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brewer SE, Simpson MJ, Rice JD, Skenadore A, O'Leary ST. Engaging practices and communities in the development of interventions to promote HPV vaccine uptake: a protocol for implementing Boot Camp Translation in the private practice setting. BMJ Open. 2020 Dec 12;10(12):e041685. doi: 10.1136/bmjopen-2020-041685.
PubMed 33310806
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake
- ClinicalTrials.gov ID
- NCT04279964
- Acronym / sponsor ID
- 18-0338
- Conditions
- Primary Prevention
- Keywords
- Immunization, Boot Camp Translation, Adolescent, Human Papillomavirus, Vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 8 May 2020 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this project is to implement Boot Camp Translation (BCT) methodology to translate the guidelines and evidence for human papillomavirus (HPV) vaccine into a practice and provider level intervention designed to improve its acceptability and uptake.
Detailed description
As a community engagement approach, Boot Camp Translation (BCT), is a 6-9-month iterative process that brings together multiple stakeholders, including patients, parents, and community members, to translate evidence-based guidelines and recommendations into locally relevant and meaningful messages, materials, and programs.
Aim 1: Implement BCT in three geographically distinct Colorado communities to translate the current evidence for HPV vaccination into locally relevant interventions designed to increase vaccine uptake.
Aim 2: Evaluate the impact of the BCT- designed intervention on practice-level HPV vaccination initiation rates.
The long-term goal is to develop a replicable approach and low-cost method of increasing HPV vaccine uptake that is easily adaptable to different settings and sociodemographic contexts.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boot Camp Translation | Experimental | Behavioral: Boot Camp TranslationIntervention practices will undergo the Boot Camp Translation process. |
| Control | Active comparator | Other: ControlControl practice will behave as usual. |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All child patients who have received health supervision at participating practices during the 12 month prior to intervention and the 12 month following intervention implementation, who are ages 9-26 years, and whose parents have not requested removal from the Colorado Immunization Information System (CIIS) will be eligible for the assessment of practice immunization rates in the pre and post periods.
Key exclusion criteria (2 listed)
- No subjects will be excluded because of gender, ethnicity, or insurance status.
- Any child whose parents have requested removal from the immunization registry; any child with hypersensitivity to any component of one of the recommended vaccines; any child who has moved to a primary care provider other than one at the study clinics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boot Camp TranslationPractices in the intervention arm will participate in the Boot Camp Translation process, where BCT Community Advisory group members will come together to develop and implement practice relevant materials to promote adolescent vaccination. | Behavioural | Boot Camp Translation |
| ControlNo intervention. Practices will continue to behave as usual. | Other | Control |
Primary outcome
Initiation of HPV vaccination series, 9-17
Time frame: Up to 12 months
Percent of 9-17 year olds who have received >=1 dose of the HPV vaccine by September 29, 2021
4 secondary outcomes
Differences in initiation rates between intervention vs. control, 9-10
Time frame: 12 months
Differences in initiation rates between intervention vs. control, 11-12
Time frame: 12 months
Differences in initiation rates between intervention vs. control, 13-17
Time frame: 12 months
Differences in initiation rates between intervention vs. control, 18-26
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Derived from this study: PubMed 33310806Brewer SE, Simpson MJ, Rice JD, Skenadore A, O'Leary ST. Engaging practices and communities in the development of interventions to promote HPV vaccine uptake: a protocol for implementing Boot Camp Translation in the private practice setting. BMJ Open. 2020 Dec 12;10(12):e041685. doi: 10.1136/bmjopen-2020-041685.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean O'Leary, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
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 2 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: finished, as of the sponsor's last update on 15 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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, 9-17 (time frame: Up to 12 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 NCT04279964, 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 15 Apr 2025.