Vaccine Clinical Trial
Official title:
State Immunization Information Systems to Improve HPV Vaccination Rates
The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates among adolescents ages 11-17 (with a more focused look at the new two dose series for 11-14 year olds).
The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and
sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct
centralized reminder/recall (R/R) to improve HPV vaccination rates among adolescents ages
11-17, and additionally look at the 11-14 year old subset for whom a new 2 dose series has
recently been recommended. The investigators will extend previous research on effectiveness
of centralized R/R to a new population--adolescents due for HPV vaccine-- and test the use of
centralized R/R as a cancer-prevention strategy. Investigators will assess the effect of
centralized R/R in two states--one with and one without mandated reporting of vaccinations to
IISs, and disseminate IIS R/R to other states. Investigators will implement, evaluate (using
the RE-AIM framework 31-36), and disseminate a collaborative, IIS-based centralized HPV
vaccine R/R model in which partnerships of public health systems and primary care practices
in two states (NY, CO) collaborate to remind parents about HPV vaccination.
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.
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