State Immunization Information Systems to Improve HPV Vaccination Rates
Condition: Vaccine; Human Papiloma Virus Vaccine; HPV Vaccine; Immunization; Health Registry; Adolescent Health; Reproductive Health; Preventive Health Services
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Vaccine Reminder/Recall
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research