Clinical trial NCT04279964: Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake
Official title: Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention
Keywords: Immunization
Boot Camp Translation
Adolescent
Human Papillomavirus
Vaccine
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2020-02-21
Enrollment: 2400
Sex: ALL
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Initiation of HPV vaccination series, 9-17
timeFrame: Up to 12 months
Secondary outcomes:
measure: Differences in initiation rates between intervention vs. control, 9-10
timeFrame: 12 months
measure: Differences in initiation rates between intervention vs. control, 11-12
timeFrame: 12 months
measure: Differences in initiation rates between intervention vs. control, 13-17
timeFrame: 12 months
measure: Differences in initiation rates between intervention vs. control, 18-26
timeFrame: 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sean O'Leary, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.