Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Prevention	Behavioral: Boot Camp Translation Other: Control	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

5000 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake

Actual Study Start Date :

May 8, 2020

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Control No intervention. Practices will continue to behave as usual.

Arm

Intervention/Treatment

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.

Other: Control

No intervention. Practices will continue to behave as usual.

Outcome Measures

Primary Outcome Measures

Initiation of HPV vaccination series, 9-17 [Up to 12 months]
Percent of 9-17 year olds who have received >=1 dose of the HPV vaccine by September 29, 2021

Secondary Outcome Measures

Differences in initiation rates between intervention vs. control, 9-10 [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 [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 [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 [12 months]
Percent of 18-26 year olds who have received >=1 dose of the HPV vaccine by September 29, 2021

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 26 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.