Randomized Controlled Trial to Evaluate an Implementation Strategy to Increase Optimal Use of HPV Vaccine in Primary Care
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Human Papillomavirus Vaccines
- Sponsor
- Washington University School of Medicine
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Initiation of the HPV Vaccine 2-dose Series.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Washington University will evaluate the effectiveness of a multi-component implementation strategy to increase use of HPV vaccine in primary care practices.
Detailed Description
The investigators at Washington University will complete a cluster-randomized trial to evaluate the effectiveness of a multi-component implementation strategy (the intervention) to increase use of the HPV vaccine according to CDC guidelines. The unit of randomization is a community-based, primary care pediatric practice. Twenty practices will be randomized into two groups, the intervention group (n=10) or a wait-list control group (n=10). The intervention will be implemented over 2-years and includes: 1) an educational video for providers; 2) audit and feedback of vaccine coverage; 3) a communication strategy; and 4) practice facilitation. The primary outcome of HPV vaccination by age 13 will be assessed at 24 months, and at 36 months to assess if change is sustained.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Initiation of the HPV Vaccine 2-dose Series.
Time Frame: 24 months
The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization
Completion of the HPV Vaccine 2-dose Series.
Time Frame: 24 months
The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization.
Secondary Outcomes
- Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine.(36 months)
- Sustainability of the Intervention Benefit for Completion of the HPV Vaccine.(36 months)