State Immunization Information Systems to Improve HPV Vaccination Rates
NCT ID: NCT02993965
Last Updated: 2020-08-20
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
77716 participants
INTERVENTIONAL
2017-02-21
2020-07-31
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 \[initial dose (HPV#1) and a complete series (HPV#2 or #3)\] 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: Assess the impact and cost-effectiveness of centralized IIS-based (IIS-C) R/R using autodialer (phone) or mail in increasing vaccine rates \[initial dose (HPV#1) and a complete series (HPV#2)\] and decreasing time to completion among teens 11-14.
Conduct a pragmatic trial, to assess the impact and cost effectiveness of centralized IIS-based (IIS-C) R/R using either autodialer (phone) or postcard (mail) in increasing initiation and completion rates for the newly implemented HPV vaccine 2 dose series in adolescents ages 11-14 years. We will use a within-practice design, randomizing patients within randomly selected primary care practices to IIS-C R/R using either an autodailer or postcards (up to 2 reminders per dose needed) compared to usual care (0 reminders from this study). We will apply the RE-AIM framework to evaluate the reach, effectiveness/cost effectiveness, adoption, and implementation of IIS-C R/R.
Hypothesis 3a: IIS-C R/R (either modality) will result in higher HPV vaccination rates than usual care.
Hypothesis 3b: IIS-C R/R (either modality) will result in higher HPV vaccination rates than usual care in key subgroups (males and females, younger and older teens, urban//rural teens).
Hypothesis 3c: IIS-C R/R will be more cost-effective (cost/vaccine received) than usual care. IIS-C R/R using autodialer will be more cost effective than IIS-C R/R using postcards.
Aim #4: 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 11-17
No additional intervention done aside from usual care for 11-17 year olds
No interventions assigned to this group
1 R/R per Dose 11-17
Sending up to one recall notice per dose of HPV vaccine needed for 11-17 year olds
Vaccine Reminder/Recall
The investigators will be sending recall notices via phone call or postcard to 11-17 year olds or 11-14 year olds who are eligible but lacking HPV vaccine doses recorded in the Colorado Immunization Information System (CIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention) for bringing children 11-17 years old up to date on HPV vaccination. They will also be testing the effectiveness and cost effectiveness of using mail vs. phone call reminder notices (as compared to no intervention) for bringing 11-14 year olds up to date on HPV vaccination.
2 R/R per Dose 11-17
Sending up to two recall notices per dose of HPV vaccine needed for 11-17 year olds
Vaccine Reminder/Recall
The investigators will be sending recall notices via phone call or postcard to 11-17 year olds or 11-14 year olds who are eligible but lacking HPV vaccine doses recorded in the Colorado Immunization Information System (CIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention) for bringing children 11-17 years old up to date on HPV vaccination. They will also be testing the effectiveness and cost effectiveness of using mail vs. phone call reminder notices (as compared to no intervention) for bringing 11-14 year olds up to date on HPV vaccination.
3 R/R per Dose 11-17
Sending up to three recall notices per dose of HPV vaccine needed for 11-17 year olds
Vaccine Reminder/Recall
The investigators will be sending recall notices via phone call or postcard to 11-17 year olds or 11-14 year olds who are eligible but lacking HPV vaccine doses recorded in the Colorado Immunization Information System (CIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention) for bringing children 11-17 years old up to date on HPV vaccination. They will also be testing the effectiveness and cost effectiveness of using mail vs. phone call reminder notices (as compared to no intervention) for bringing 11-14 year olds up to date on HPV vaccination.
Control 11-14
No additional intervention done aside from usual care for 11-14 year olds
No interventions assigned to this group
Phone R/R 11-14
Sending up to two recall notices per dose of HPV vaccine needed via autodialer for 11-14 year olds
Vaccine Reminder/Recall
The investigators will be sending recall notices via phone call or postcard to 11-17 year olds or 11-14 year olds who are eligible but lacking HPV vaccine doses recorded in the Colorado Immunization Information System (CIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention) for bringing children 11-17 years old up to date on HPV vaccination. They will also be testing the effectiveness and cost effectiveness of using mail vs. phone call reminder notices (as compared to no intervention) for bringing 11-14 year olds up to date on HPV vaccination.
Mail R/R 11-14
Sending up to two recall notices per dose of HPV vaccine needed via mailed postcards for 11-14 year olds
Vaccine Reminder/Recall
The investigators will be sending recall notices via phone call or postcard to 11-17 year olds or 11-14 year olds who are eligible but lacking HPV vaccine doses recorded in the Colorado Immunization Information System (CIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention) for bringing children 11-17 years old up to date on HPV vaccination. They will also be testing the effectiveness and cost effectiveness of using mail vs. phone call reminder notices (as compared to no intervention) for bringing 11-14 year olds up to date on HPV vaccination.
Interventions
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Vaccine Reminder/Recall
The investigators will be sending recall notices via phone call or postcard to 11-17 year olds or 11-14 year olds who are eligible but lacking HPV vaccine doses recorded in the Colorado Immunization Information System (CIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention) for bringing children 11-17 years old up to date on HPV vaccination. They will also be testing the effectiveness and cost effectiveness of using mail vs. phone call reminder notices (as compared to no intervention) for bringing 11-14 year olds up to date on HPV vaccination.
Eligibility Criteria
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Inclusion Criteria
* 11 through 14 years of age (trial 2)
* defaulted to our selected clinics within CIIS
* is either due for an HPV dose at baseline according to Advisory Committee on Immunization Practices (ACIP) guidelines, or
* has initiated but not yet completed the HPV series at baseline
Exclusion Criteria
* Any child whose parents have requested removal from the immunization registry
11 Years
17 Years
ALL
Yes
Sponsors
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University of California, Los Angeles
OTHER
National Cancer Institute (NCI)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Allison Kempe, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado
Aurora, Colorado, United States
Countries
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References
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Gurfinkel D, Kempe A, Albertin C, Breck A, Zhou X, Vangala S, Beaty B, Rice J, Tseng CH, Campbell JD, Valderrama R, Rand C, Humiston SG, Roth H, Arora S, Szilagyi P. Centralized Reminder/Recall for Human Papillomavirus Vaccination: Findings From Two States-A Randomized Clinical Trial. J Adolesc Health. 2021 Oct;69(4):579-587. doi: 10.1016/j.jadohealth.2021.02.023. Epub 2021 Apr 10.
Other Identifiers
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15-1560
Identifier Type: -
Identifier Source: org_study_id
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