HPV Centralized R/R RCT #2 - New York State
Condition: Vaccines
Study type: Interventional

Summary: 
      The work done in this trial builds off of the work previously conducted by this same research
      group in clinicaltrials.gov ID: NCT03057379. Due to some changes in study design, protocol,
      and cohort of interest, a new registration was warranted.

      The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness, and
      sustainability of utilizing statewide immunization information systems (IISs) to conduct
      centralized reminder recall (R/R) to improve human papillomavirus (HPV) vaccination rates
      among adolescents 11-14 years of age.

      The latest recommendations from the ACIP, as of February 2017, modified the vaccination
      schedule for the HPV series for eligible adolescents ages 11-14. Adolescents who receive dose
      #1 between the ages of 11 and 14 are now eligible for their second and final dose 6-12 months
      after their initial dose. Despite U.S. guidelines for vaccinating all adolescents starting at
      age 11 with the HPV vaccine, in 2012 only 53% of 13-17 year old females had >1 dose and 35%
      had 3 doses; 21% of teen males had a vaccination. Modeling studies predict marked reduction
      in HPV associated cancers and in disparities in these cancers if high HPV vaccination rates
      can be achieved.

      With this new dosing schedule for adolescents, the research team proposes to conduct a
      randomized control trial (RCT) utilizing the capabilities of the State Immunization
      Information System (IIS), and create a HPV-specific R/R autodialer and text message to be
      delivered to the parents of patients ages 11-14 of randomly selected practices within New
      York State (excluding NYC). Upon conclusion of this trial, researchers will develop a toolkit
      for dissemination so that other state IIS systems may replicate these centralized reminder
      recall procedures.
    

Detailed description: 
      The overarching goal is to evaluate the effectiveness, cost effectiveness, and sustainability
      of statewide immunization systems (IISs) to conduct reminder/recall (R/R) to improve human
      papillomarvirus (HPV) vaccination rates among adolescents ages 11-14.

      Each year, 6.2 million persons are newly infected with HPV and 26,000 new HPV-related
      cervical, genital, and oropharyngeal cancers are diagnosed, resulting in >$4 billion in
      annual medical costs. Despite U.S. guidelines for vaccinating all adolescents starting at age
      11 with the HPV vaccine, in 2012 only 53% of 13-17 year old females had >1 dose and 35% had 3
      doses; 21% of teen males had a vaccination.

      The most effective strategy for improving vaccination rates is patient reminder/recall (R/R).
      Recent literature from Melissa Stockwell found that utilization of a new R/R modality, i.e.
      text messaging, positively impacted influenza vaccination rates among the adolescents
      enrolled in the study. Although R/R is already considered a "best practice" for improving
      vaccination rates, very few practices use reminder/recall for any vaccinations because of
      costs and lack of personnel time; and even fewer use reminder/recall for HPV vaccine.

      Furthermore, since the Advisory Committee on Immunization Practices (ACIP) modified the
      schedule for the HPV series for adolescents' age 11-14 years, those who receive dose #1
      between ages of 11 and 14 years are now eligible for their second and final dose 6-12 months
      after their initial dose. This change in dosing schedule could influence HPV vaccine visit
      scheduling procedures within Family Practice and/or Pediatric Clinics, and would therefore
      effect timing and frequency of any R/R strategies currently in place. Therefore, the UCLA
      (overseeing the work to be done in NY) and University of Colorado at Denver research teams
      unite to understand how the use of centralized R/R to disseminate reminders, via text
      messages and autodialer calls, to patients eligible for the 2-dose HPV vaccine could impact
      vaccination rates among adolescents ages 11-14. This will be the first head-to-head RCT
      comparing text message vs. autodialer reminders to standard of care control

      The aim of the study is as follows:

      To assess the impact and cost-effectiveness of autodialer IIS R/R versus text message based
      IIS R/R versus standard-of-care control (no reminder recall) in increasing initiation and
      completion of the 2-dose HPV vaccine series among adolescents 11-14 years of age. The
      investigators will use a within-practice randomized control trial, randomizing patients
      within 150 practices to the aforementioned intervention arms.

      Hypothesis 1: All centralized IIS R/R modalities will be more effective than usual care

      Hypothesis 2: Text messaging will be more cost-effective than other modalities

      Upon completion of the study, the investigators will have a feasible, sustainable,
      cost-effective model for HPV vaccination reminders that could be scaled up on the national
      level to help prevent HPV-related cancers. Additionally, this research will be adding
      significant new knowledge to the field as no such studies exist examining the impact of
      educational text message R/R on HPV vaccination rates among adolescents eligible for the
      2-dose series.
    

Intervention name(s): HPV Vaccine Reminder Recall - Autodialer; HPV Vaccine Reminder Recall - Texting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Investigators will send out HPV vaccine reminder recall notices via autodialer message to the parents of adolescents 11-14 years of age who are eligible to receive a dose of the HPV vaccine per the records in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of the various modalities or reminders as compared to the standard of care control (no reminders); Investigators will send out HPV vaccine reminder recall notices via text message to the parents of adolescents 11-14 years of age who are eligible to receive a dose of the HPV vaccine per the records in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of the various modalities or reminders as compared to the standard of care control (no reminders)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: HPV Vaccine; immunization registry; Reminder recall (R/R)