<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/NCT02993965</url>
  </required_header>
  <id_info>
    <org_study_id>15-1560</org_study_id>
    <secondary_id>1R01CA187707-01A1</secondary_id>
    <nct_id>NCT02993965</nct_id>
  </id_info>
  <brief_title>State Immunization Information Systems to Improve HPV Vaccination Rates</brief_title>
  <official_title>State Immunization Information Systems to Improve HPV Vaccination Rates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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 overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and&#xD;
      sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct&#xD;
      centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates&#xD;
      among adolescents ages 11-17 (with a more focused look at the new two dose series for 11-14&#xD;
      year olds).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and&#xD;
      sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct&#xD;
      centralized reminder/recall (R/R) to improve HPV vaccination rates among adolescents ages&#xD;
      11-17, and additionally look at the 11-14 year old subset for whom a new 2 dose series has&#xD;
      recently been recommended. The investigators will extend previous research on effectiveness&#xD;
      of centralized R/R to a new population--adolescents due for HPV vaccine-- and test the use of&#xD;
      centralized R/R as a cancer-prevention strategy. Investigators will assess the effect of&#xD;
      centralized R/R in two states--one with and one without mandated reporting of vaccinations to&#xD;
      IISs, and disseminate IIS R/R to other states. Investigators will implement, evaluate (using&#xD;
      the RE-AIM framework 31-36), and disseminate a collaborative, IIS-based centralized HPV&#xD;
      vaccine R/R model in which partnerships of public health systems and primary care practices&#xD;
      in two states (NY, CO) collaborate to remind parents about HPV vaccination.&#xD;
&#xD;
      Specific Aims and hypotheses:&#xD;
&#xD;
      Aim #1: Adapt IIS messages and delivery systems (e.g., algorithms) previously developed for&#xD;
      centralized R/R for other vaccines to fit HPV vaccine IIS R/R.&#xD;
&#xD;
      Aim #2: Assess the impact and cost-effectiveness of centralized IIS-based (IIS-C) autodialer&#xD;
      (phone) R/R in increasing vaccine rates [initial dose (HPV#1) and a complete series (HPV#2 or&#xD;
      #3)] among teens.&#xD;
&#xD;
      Conduct a pragmatic trial, to assess the impact and cost effectiveness of centralized&#xD;
      IIS-based (IIS-C) autodialer (phone) R/R in increasing initiation and completion rates for&#xD;
      the HPV vaccine series in adolescents ages 11-17 years. The investigators will use a&#xD;
      within-practice design, randomizing patients within randomly selected primary care practices&#xD;
      to IIS-C R/R (1, 2, or 3 reminders per dose) compared to usual care (0 reminders from this&#xD;
      study). The investigators will apply the RE-AIM framework to evaluate the reach,&#xD;
      effectiveness/cost effectiveness, adoption, and implementation of IIS-C R/R.&#xD;
&#xD;
      Hypothesis 2a: IIS-C R/R will result in higher HPV vaccination rates than usual care.&#xD;
&#xD;
      Hypothesis 2b: IIS-C R/R will result in higher HPV vaccination rates than usual care in key&#xD;
      subgroups (males and females, younger and older teens, urban//rural teens).&#xD;
&#xD;
      Hypothesis 2c: IIS-C R/R will be more cost-effective (cost/vaccine received) than usual care.&#xD;
&#xD;
      Aim #3: Assess the impact and cost-effectiveness of centralized IIS-based (IIS-C) R/R using&#xD;
      autodialer (phone) or mail in increasing vaccine rates [initial dose (HPV#1) and a complete&#xD;
      series (HPV#2)] and decreasing time to completion among teens 11-14.&#xD;
&#xD;
      Conduct a pragmatic trial, to assess the impact and cost effectiveness of centralized&#xD;
      IIS-based (IIS-C) R/R using either autodialer (phone) or postcard (mail) in increasing&#xD;
      initiation and completion rates for the newly implemented HPV vaccine 2 dose series in&#xD;
      adolescents ages 11-14 years. We will use a within-practice design, randomizing patients&#xD;
      within randomly selected primary care practices to IIS-C R/R using either an autodailer or&#xD;
      postcards (up to 2 reminders per dose needed) compared to usual care (0 reminders from this&#xD;
      study). We will apply the RE-AIM framework to evaluate the reach, effectiveness/cost&#xD;
      effectiveness, adoption, and implementation of IIS-C R/R.&#xD;
&#xD;
      Hypothesis 3a: IIS-C R/R (either modality) will result in higher HPV vaccination rates than&#xD;
      usual care.&#xD;
&#xD;
      Hypothesis 3b: IIS-C R/R (either modality) will result in higher HPV vaccination rates than&#xD;
      usual care in key subgroups (males and females, younger and older teens, urban//rural teens).&#xD;
&#xD;
      Hypothesis 3c: IIS-C R/R will be more cost-effective (cost/vaccine received) than usual care.&#xD;
      IIS-C R/R using autodialer will be more cost effective than IIS-C R/R using postcards.&#xD;
&#xD;
      Aim #4: Disseminate IIS-C R/R across NY and CO and pilot in four IISs: (a) Develop an IIS-C&#xD;
      HPV R/R toolkit, (b) Use a technical advisory group, (c) Initiate IIS-C R/R in four other&#xD;
      IISs [Yr. 4].&#xD;
&#xD;
      By the end of the study investigators will have a feasible, sustainable, cost-effective model&#xD;
      for HPV vaccine reminders that can be used nationally to prevent cervical cancer and other&#xD;
      HPV-related cancers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 15, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry)</measure>
    <time_frame>5 months</time_frame>
    <description>Did the adolescent initiate the HPV vaccine series? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Completion of the HPV vaccine series (receipt and documentation of final dose of vaccine series within immunization registry)</measure>
    <time_frame>5 months</time_frame>
    <description>Did those eligible to complete the HPV vaccine series within the time frame of the study do so? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences between arms - initiation</measure>
    <time_frame>5 months</time_frame>
    <description>Is 1, 2, or 3 reminders per arm most effective and cost effective for initiation. Only those who need an initial dose at baseline will be eligible for this outcome. Adolescents in each arm will be allowed up to 5 months after the first recall notice to get a vaccine. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested in the 11-17 year old group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between arms - completion</measure>
    <time_frame>20 months</time_frame>
    <description>Is 1, 2, or 3 reminders per arm most effective and cost effective for completion. Because the second or third dose of the series is dependent on when the adolescent receives their initial dose, the investigators will be following eligible adolescents for 20 months to allow time for those who did not respond to the recall for the initial dose right away to be able to complete the series within the time frame. However, receipt of the completion dose will only be attributed to the recall if it was received within 5 months of the 1st recall for the completion dose. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested in the 11-17 year old group. For 11-14 year olds, completion is 2 doses. For 15-17 year olds, completion is 3 doses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between modalities - initiation</measure>
    <time_frame>5 months</time_frame>
    <description>Are mail or phone reminders most effective and cost effective for initiation. Only those who need an initial dose at baseline will be eligible for this outcome. Adolescents in each arm will be allowed up to 5 months after the first recall notice to get a vaccine. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested with the 11-14 year old group only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between modalities - completion</measure>
    <time_frame>5 months</time_frame>
    <description>Are mail or phone reminders most effective and cost effective for completion. This will be tested only in the 11-14 year old group, so completion will equal 2nd dose. Because the second dose of the series is dependent on when the adolescent receives their initial dose, the investigators will be following eligible adolescents for 17 months to allow time for those who did not respond to the recall for the initial dose right away to be able to complete the series within the time frame. However, receipt of the completion dose will only be attributed to the recall if it was received within 5 months of the 1st recall for the completion dose. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">77716</enrollment>
  <condition>Vaccine</condition>
  <condition>Human Papiloma Virus Vaccine</condition>
  <condition>HPV Vaccine</condition>
  <condition>Immunization</condition>
  <condition>Health Registry</condition>
  <condition>Adolescent Health</condition>
  <condition>Reproductive Health</condition>
  <condition>Preventive Health Services</condition>
  <arm_group>
    <arm_group_label>Control 11-17</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No additional intervention done aside from usual care for 11-17 year olds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1 R/R per Dose 11-17</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sending up to one recall notice per dose of HPV vaccine needed for 11-17 year olds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 R/R per Dose 11-17</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sending up to two recall notices per dose of HPV vaccine needed for 11-17 year olds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 R/R per Dose 11-17</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sending up to three recall notices per dose of HPV vaccine needed for 11-17 year olds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control 11-14</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No additional intervention done aside from usual care for 11-14 year olds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phone R/R 11-14</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sending up to two recall notices per dose of HPV vaccine needed via autodialer for 11-14 year olds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mail R/R 11-14</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sending up to two recall notices per dose of HPV vaccine needed via mailed postcards for 11-14 year olds</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vaccine Reminder/Recall</intervention_name>
    <description>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.</description>
    <arm_group_label>1 R/R per Dose 11-17</arm_group_label>
    <arm_group_label>2 R/R per Dose 11-17</arm_group_label>
    <arm_group_label>3 R/R per Dose 11-17</arm_group_label>
    <arm_group_label>Mail R/R 11-14</arm_group_label>
    <arm_group_label>Phone R/R 11-14</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  11 through 17 years of age (trial 1)&#xD;
&#xD;
          -  11 through 14 years of age (trial 2)&#xD;
&#xD;
          -  defaulted to our selected clinics within CIIS&#xD;
&#xD;
          -  is either due for an HPV dose at baseline according to Advisory Committee on&#xD;
             Immunization Practices (ACIP) guidelines, or&#xD;
&#xD;
          -  has initiated but not yet completed the HPV series at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has completed the HPV vaccine series according to Advisory Committee on Immunization&#xD;
             Practices (ACIP) guidelines&#xD;
&#xD;
          -  Any child whose parents have requested removal from the immunization registry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allison Kempe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>August 19, 2020</last_update_submitted>
  <last_update_submitted_qc>August 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will not be sharing individual data with other researchers</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/NCT02993965
org study id: 15-1560
secondary id: 1R01CA187707-01A1
nct id: NCT02993965
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry)
time frame: 5 months
description: Did the adolescent initiate the HPV vaccine series? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.
measure: Completion of the HPV vaccine series (receipt and documentation of final dose of vaccine series within immunization registry)
time frame: 5 months
description: Did those eligible to complete the HPV vaccine series within the time frame of the study do so? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.
measure: Differences between arms - initiation
time frame: 5 months
description: Is 1, 2, or 3 reminders per arm most effective and cost effective for initiation. Only those who need an initial dose at baseline will be eligible for this outcome. Adolescents in each arm will be allowed up to 5 months after the first recall notice to get a vaccine. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested in the 11-17 year old group.
measure: Differences between arms - completion
time frame: 20 months
description: Is 1, 2, or 3 reminders per arm most effective and cost effective for completion. Because the second or third dose of the series is dependent on when the adolescent receives their initial dose, the investigators will be following eligible adolescents for 20 months to allow time for those who did not respond to the recall for the initial dose right away to be able to complete the series within the time frame. However, receipt of the completion dose will only be attributed to the recall if it was received within 5 months of the 1st recall for the completion dose. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested in the 11-17 year old group. For 11-14 year olds, completion is 2 doses. For 15-17 year olds, completion is 3 doses.
measure: Differences between modalities - initiation
time frame: 5 months
description: Are mail or phone reminders most effective and cost effective for initiation. Only those who need an initial dose at baseline will be eligible for this outcome. Adolescents in each arm will be allowed up to 5 months after the first recall notice to get a vaccine. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested with the 11-14 year old group only.
measure: Differences between modalities - completion
time frame: 5 months
description: Are mail or phone reminders most effective and cost effective for completion. This will be tested only in the 11-14 year old group, so completion will equal 2nd dose. Because the second dose of the series is dependent on when the adolescent receives their initial dose, the investigators will be following eligible adolescents for 17 months to allow time for those who did not respond to the recall for the initial dose right away to be able to complete the series within the time frame. However, receipt of the completion dose will only be attributed to the recall if it was received within 5 months of the 1st recall for the completion dose. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.
arm group label: Control 11-17
arm group type: No Intervention
description: No additional intervention done aside from usual care for 11-17 year olds
arm group label: 1 R/R per Dose 11-17
arm group type: Experimental
description: Sending up to one recall notice per dose of HPV vaccine needed for 11-17 year olds
arm group label: 2 R/R per Dose 11-17
arm group type: Experimental
description: Sending up to two recall notices per dose of HPV vaccine needed for 11-17 year olds
arm group label: 3 R/R per Dose 11-17
arm group type: Experimental
description: Sending up to three recall notices per dose of HPV vaccine needed for 11-17 year olds
arm group label: Control 11-14
arm group type: No Intervention
description: No additional intervention done aside from usual care for 11-14 year olds
arm group label: Phone R/R 11-14
arm group type: Experimental
description: Sending up to two recall notices per dose of HPV vaccine needed via autodialer for 11-14 year olds
arm group label: Mail R/R 11-14
arm group type: Experimental
description: Sending up to two recall notices per dose of HPV vaccine needed via mailed postcards for 11-14 year olds
intervention type: Other
intervention name: Vaccine Reminder/Recall
description: 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.
arm group label: 1 R/R per Dose 11-17
arm group label: 2 R/R per Dose 11-17
arm group label: 3 R/R per Dose 11-17
arm group label: Mail R/R 11-14
arm group label: Phone R/R 11-14
criteria: 
gender: All
minimum age: 11 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Allison Kempe, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: We will not be sharing individual data with other researchers