<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03294551</url>
  </required_header>
  <id_info>
    <org_study_id>17-001559</org_study_id>
    <secondary_id>5R01CA187707-02</secondary_id>
    <nct_id>NCT03294551</nct_id>
  </id_info>
  <brief_title>HPV Centralized R/R RCT #2 - New York State</brief_title>
  <official_title>Enhancing HPV Vaccination Rates for 11-14 Year Old Adolescents Using New York State's Immunization Information System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New York State Department of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The work done in this trial builds off of the work previously conducted by this same research&#xD;
      group in clinicaltrials.gov ID: NCT03057379. Due to some changes in study design, protocol,&#xD;
      and cohort of interest, a new registration was warranted.&#xD;
&#xD;
      The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness, and&#xD;
      sustainability of utilizing statewide immunization information systems (IISs) to conduct&#xD;
      centralized reminder recall (R/R) to improve human papillomavirus (HPV) vaccination rates&#xD;
      among adolescents 11-14 years of age.&#xD;
&#xD;
      The latest recommendations from the ACIP, as of February 2017, modified the vaccination&#xD;
      schedule for the HPV series for eligible adolescents ages 11-14. Adolescents who receive dose&#xD;
      #1 between the ages of 11 and 14 are now eligible for their second and final dose 6-12 months&#xD;
      after their initial dose. Despite U.S. guidelines for vaccinating all adolescents starting at&#xD;
      age 11 with the HPV vaccine, in 2012 only 53% of 13-17 year old females had &gt;1 dose and 35%&#xD;
      had 3 doses; 21% of teen males had a vaccination. Modeling studies predict marked reduction&#xD;
      in HPV associated cancers and in disparities in these cancers if high HPV vaccination rates&#xD;
      can be achieved.&#xD;
&#xD;
      With this new dosing schedule for adolescents, the research team proposes to conduct a&#xD;
      randomized control trial (RCT) utilizing the capabilities of the State Immunization&#xD;
      Information System (IIS), and create a HPV-specific R/R autodialer and text message to be&#xD;
      delivered to the parents of patients ages 11-14 of randomly selected practices within New&#xD;
      York State (excluding NYC). Upon conclusion of this trial, researchers will develop a toolkit&#xD;
      for dissemination so that other state IIS systems may replicate these centralized reminder&#xD;
      recall procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overarching goal is to evaluate the effectiveness, cost effectiveness, and sustainability&#xD;
      of statewide immunization systems (IISs) to conduct reminder/recall (R/R) to improve human&#xD;
      papillomarvirus (HPV) vaccination rates among adolescents ages 11-14.&#xD;
&#xD;
      Each year, 6.2 million persons are newly infected with HPV and 26,000 new HPV-related&#xD;
      cervical, genital, and oropharyngeal cancers are diagnosed, resulting in &gt;$4 billion in&#xD;
      annual medical costs. Despite U.S. guidelines for vaccinating all adolescents starting at age&#xD;
      11 with the HPV vaccine, in 2012 only 53% of 13-17 year old females had &gt;1 dose and 35% had 3&#xD;
      doses; 21% of teen males had a vaccination.&#xD;
&#xD;
      The most effective strategy for improving vaccination rates is patient reminder/recall (R/R).&#xD;
      Recent literature from Melissa Stockwell found that utilization of a new R/R modality, i.e.&#xD;
      text messaging, positively impacted influenza vaccination rates among the adolescents&#xD;
      enrolled in the study. Although R/R is already considered a &quot;best practice&quot; for improving&#xD;
      vaccination rates, very few practices use reminder/recall for any vaccinations because of&#xD;
      costs and lack of personnel time; and even fewer use reminder/recall for HPV vaccine.&#xD;
&#xD;
      Furthermore, since the Advisory Committee on Immunization Practices (ACIP) modified the&#xD;
      schedule for the HPV series for adolescents' age 11-14 years, those who receive dose #1&#xD;
      between ages of 11 and 14 years are now eligible for their second and final dose 6-12 months&#xD;
      after their initial dose. This change in dosing schedule could influence HPV vaccine visit&#xD;
      scheduling procedures within Family Practice and/or Pediatric Clinics, and would therefore&#xD;
      effect timing and frequency of any R/R strategies currently in place. Therefore, the UCLA&#xD;
      (overseeing the work to be done in NY) and University of Colorado at Denver research teams&#xD;
      unite to understand how the use of centralized R/R to disseminate reminders, via text&#xD;
      messages and autodialer calls, to patients eligible for the 2-dose HPV vaccine could impact&#xD;
      vaccination rates among adolescents ages 11-14. This will be the first head-to-head RCT&#xD;
      comparing text message vs. autodialer reminders to standard of care control&#xD;
&#xD;
      The aim of the study is as follows:&#xD;
&#xD;
      To assess the impact and cost-effectiveness of autodialer IIS R/R versus text message based&#xD;
      IIS R/R versus standard-of-care control (no reminder recall) in increasing initiation and&#xD;
      completion of the 2-dose HPV vaccine series among adolescents 11-14 years of age. The&#xD;
      investigators will use a within-practice randomized control trial, randomizing patients&#xD;
      within 150 practices to the aforementioned intervention arms.&#xD;
&#xD;
      Hypothesis 1: All centralized IIS R/R modalities will be more effective than usual care&#xD;
&#xD;
      Hypothesis 2: Text messaging will be more cost-effective than other modalities&#xD;
&#xD;
      Upon completion of the study, the investigators will have a feasible, sustainable,&#xD;
      cost-effective model for HPV vaccination reminders that could be scaled up on the national&#xD;
      level to help prevent HPV-related cancers. Additionally, this research will be adding&#xD;
      significant new knowledge to the field as no such studies exist examining the impact of&#xD;
      educational text message R/R on HPV vaccination rates among adolescents eligible for the&#xD;
      2-dose series.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2017</start_date>
  <completion_date type="Actual">November 5, 2019</completion_date>
  <primary_completion_date type="Actual">November 5, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Initiation of the HPV 2-dose series</measure>
    <time_frame>5 months from the first reminder received for the first dose of HPV vaccine</time_frame>
    <description>Receipt and documentation of the initial dose of the vaccine within the series as recorded in the NYSIIS database. Investigators are allowing 5 months after the initial reminder recall was sent as the timeline of attributing vaccination status to the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Completion of the HPV 2-dose series</measure>
    <time_frame>5 months from the first reminder received for the last dose of HPV vaccine</time_frame>
    <description>Receipt and documentation of the final dose of the vaccine series as recorded within the NYSIIS database. Investigators are allowing up to 5 months after the first reminder recall for the second dose was received. If vaccination is received after that 5 month period, investigators will not attribute change in vaccination status to the reminder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost of the R/R intervention - autodialers and texting</measure>
    <time_frame>17 months - entirety of the trial</time_frame>
    <description>A cost-effectiveness analysis will be conducted to determine which modality of R/R (autodialer or text message) is the most cost-effective in relation to improving HPV vaccination rates among 11-14 year old adolescents as compared to the control, as well as comparing the two interventions arms to one another.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">37003</enrollment>
  <condition>Vaccines</condition>
  <arm_group>
    <arm_group_label>Standard of Care Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual source of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HPV Vaccine Reminder Recall - Autodialer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HPV Vaccine Reminder Recall - Autodialer: Receive up to 4 reminders via telephone (live call or voicemail) - includes brief educational message + providers name + providers telephone number</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HPV Vaccine Reminder Recall - Texting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HPV Vaccine Reminder Recall - Texting: Receive up to 4 reminders via text message - includes brief educational message + providers name + providers telephone number</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HPV Vaccine Reminder Recall - Autodialer</intervention_name>
    <description>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)</description>
    <arm_group_label>HPV Vaccine Reminder Recall - Autodialer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HPV Vaccine Reminder Recall - Texting</intervention_name>
    <description>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)</description>
    <arm_group_label>HPV Vaccine Reminder Recall - Texting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  11 to 14 years of age&#xD;
&#xD;
          -  patient of a participating practice in New York State (practices were randomly&#xD;
             selected)&#xD;
&#xD;
          -  is due for an HPV dose at baseline, or&#xD;
&#xD;
          -  has initiated but not yet completed the HPV series at baseline&#xD;
&#xD;
          -  immunization record within the New York State Immunization Information System (NYSIIS)&#xD;
             database&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  is not a patient of a participating practice that was randomly selected in New York&#xD;
             State&#xD;
&#xD;
          -  has completed the HPV vaccination series&#xD;
&#xD;
          -  does not have a valid record within the NYSIIS database&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Szilagyi, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>May 26, 2021</last_update_submitted>
  <last_update_submitted_qc>May 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Peter G Szilagyi, MD MPH</investigator_full_name>
    <investigator_title>Vice Chair Clinical Research, Pediatrics</investigator_title>
  </responsible_party>
  <keyword>HPV Vaccine</keyword>
  <keyword>immunization registry</keyword>
  <keyword>Reminder recall (R/R)</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The aggregate results will be published in a peer reviewed journal.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03294551
org study id: 17-001559
secondary id: 5R01CA187707-02
nct id: NCT03294551
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Initiation of the HPV 2-dose series
time frame: 5 months from the first reminder received for the first dose of HPV vaccine
description: Receipt and documentation of the initial dose of the vaccine within the series as recorded in the NYSIIS database. Investigators are allowing 5 months after the initial reminder recall was sent as the timeline of attributing vaccination status to the intervention
measure: Completion of the HPV 2-dose series
time frame: 5 months from the first reminder received for the last dose of HPV vaccine
description: Receipt and documentation of the final dose of the vaccine series as recorded within the NYSIIS database. Investigators are allowing up to 5 months after the first reminder recall for the second dose was received. If vaccination is received after that 5 month period, investigators will not attribute change in vaccination status to the reminder.
measure: Cost of the R/R intervention - autodialers and texting
time frame: 17 months - entirety of the trial
description: A cost-effectiveness analysis will be conducted to determine which modality of R/R (autodialer or text message) is the most cost-effective in relation to improving HPV vaccination rates among 11-14 year old adolescents as compared to the control, as well as comparing the two interventions arms to one another.
arm group label: Standard of Care Control
arm group type: No Intervention
description: Usual source of care
arm group label: HPV Vaccine Reminder Recall - Autodialer
arm group type: Experimental
description: HPV Vaccine Reminder Recall - Autodialer: Receive up to 4 reminders via telephone (live call or voicemail) - includes brief educational message + providers name + providers telephone number
arm group label: HPV Vaccine Reminder Recall - Texting
arm group type: Experimental
description: HPV Vaccine Reminder Recall - Texting: Receive up to 4 reminders via text message - includes brief educational message + providers name + providers telephone number
intervention type: Behavioral
intervention name: HPV Vaccine Reminder Recall - Autodialer
description: 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)
arm group label: HPV Vaccine Reminder Recall - Autodialer
intervention type: Behavioral
intervention name: HPV Vaccine Reminder Recall - Texting
description: 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)
arm group label: HPV Vaccine Reminder Recall - Texting
criteria: 
gender: All
minimum age: 11 Years
maximum age: 14 Years
healthy volunteers: No
last name: Peter Szilagyi, MD MPH
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Peter G Szilagyi, MD MPH
investigator title: Vice Chair Clinical Research, Pediatrics
mesh term: Vaccines
sharing ipd: No
ipd description: The aggregate results will be published in a peer reviewed journal.