Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04279964|
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : January 26, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Primary Prevention||Behavioral: Boot Camp Translation Other: Control||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake|
|Actual Study Start Date :||May 8, 2020|
|Estimated Primary Completion Date :||December 8, 2023|
|Estimated Study Completion Date :||August 31, 2024|
Experimental: Boot Camp Translation
Intervention practices will undergo the Boot Camp Translation process.
Behavioral: Boot Camp Translation
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.
Active Comparator: Control
Control practice will behave as usual.
No intervention. Practices will continue to behave as usual.
- 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
- Differences in initiation rates between intervention vs. control, 9-10 [ Time Frame: 12 months ]Comparison of boys vs. girls who have received >1=dose of HPV vaccine by September 29, 2021
- Differences in initiation rates between intervention vs. control, 11-12 [ Time Frame: 12 months ]Comparison of boys vs. girls who have received >1=dose of HPV vaccine by September 29, 2021
- Differences in initiation rates between intervention vs. control, 13-17 [ Time Frame: 12 months ]Comparison of boys vs. girls who have received >1=dose of HPV vaccine by September 29, 2021
- Differences in initiation rates between intervention vs. control, 18-26 [ Time Frame: 12 months ]Percent of 18-26 year olds who have received >=1 dose of the HPV vaccine by September 29, 2021
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||9 Years to 26 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279964
|Contact: Sarah Brewer, PhDemail@example.com|
|Contact: Amanda Skenadore, MPHfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Sarah Brewer, PhD 303-724-6927 email@example.com|
|Contact: Amanda Skenadore, MPH 303-724-4198 firstname.lastname@example.org|
|Principal Investigator: Sean O'Leary, MD|
|Principal Investigator:||Sean O'Leary, MD||University of Colorado, Denver|
Documents provided by University of Colorado, Denver:
|Responsible Party:||University of Colorado, Denver|
|Other Study ID Numbers:||
1R21CA230878-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||February 21, 2020 Key Record Dates|
|Last Update Posted:||January 26, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Boot Camp Translation