Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30616 participants
INTERVENTIONAL
2017-02-27
2019-01-17
Brief Summary
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Detailed Description
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Specific Aims and hypotheses:
Aim #1: Adapt IIS messages and delivery systems (e.g., algorithms) previously developed for centralized R/R for other vaccines to fit HPV vaccine IIS R/R.
Aim #2: Assess the impact and cost-effectiveness of centralized IIS-based (IIS-C) autodialer (phone) R/R in increasing vaccine rates \[initial dose (HPV#1) and a complete series (HPV#3)\] among teens.
Conduct a pragmatic trial, to assess the impact and cost effectiveness of centralized IIS-based (IIS-C) autodialer (phone) R/R in increasing initiation and completion rates for the HPV vaccine series in adolescents ages 11-17 years. The investigators will use a within-practice design, randomizing patients within randomly selected primary care practices to IIS-C R/R (1, 2, or 3 reminders per dose) compared to usual care (0 reminders from this study). The investigators will apply the RE-AIM framework to evaluate the reach, effectiveness/cost effectiveness, adoption, and implementation of IIS-C R/R.
Hypothesis 2a: IIS-C R/R will result in higher HPV vaccination rates than usual care.
Hypothesis 2b: IIS-C R/R will result in higher HPV vaccination rates than usual care in key subgroups (males and females, younger and older teens, urban//rural teens).
Hypothesis 2c: IIS-C R/R will be more cost-effective (cost/vaccine received) than usual care.
Aim #3: Disseminate IIS-C R/R across NY and CO and pilot in four IISs: (a) Develop an IIS-C HPV R/R toolkit, (b) Use a technical advisory group, (c) Initiate IIS-C R/R in four other IISs \[Yr. 4\].
By the end of the study investigators will have a feasible, sustainable, cost-effective model for HPV vaccine reminders that can be used nationally to prevent cervical cancer and other HPV-related cancers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Control arm
Usual source of care
No interventions assigned to this group
1 R/R per Dose
Sending up to one recall notice per dose of HPV vaccine needed
Vaccine Reminder Recall
The investigators will be sending recall notices via phone call to 11-17 year olds who are eligible but lacking HPV vaccine doses recorded in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention)
2 R/R per dose
Sending up to two recall notice per dose of HPV vaccine needed
Vaccine Reminder Recall
The investigators will be sending recall notices via phone call to 11-17 year olds who are eligible but lacking HPV vaccine doses recorded in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention)
3 R/R per dose
Sending up to three recall notice per dose of HPV vaccine needed
Vaccine Reminder Recall
The investigators will be sending recall notices via phone call to 11-17 year olds who are eligible but lacking HPV vaccine doses recorded in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention)
Interventions
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Vaccine Reminder Recall
The investigators will be sending recall notices via phone call to 11-17 year olds who are eligible but lacking HPV vaccine doses recorded in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention)
Eligibility Criteria
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Inclusion Criteria
* patient of a participating practice (practices randomly selected)
* is either due for an HPV dose at baseline, or
* has initiated but not yet completed the HPV series at baseline
Exclusion Criteria
11 Years
17 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Colorado, Denver
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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Peter G Szilagyi, MD MPH
Professor of Pediatrics
Locations
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University of California LA
Los Angeles, California, United States
Countries
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Other Identifiers
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16-002040
Identifier Type: -
Identifier Source: org_study_id
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