<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/NCT02236273</url>
  </required_header>
  <id_info>
    <org_study_id>AAAM3960</org_study_id>
    <nct_id>NCT02236273</nct_id>
  </id_info>
  <brief_title>Interactive, Health Literacy Promoting Text Messages and HPV Vaccine Completion In Minority Adolescents</brief_title>
  <official_title>Comparative Effectiveness of Interactive, Health Literacy Promoting Text Messages on HPV Vaccine Completion In Minority Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <brief_summary>
    <textblock>
      Emerging communication technologies, such as text messaging offer low-cost, scalable&#xD;
      opportunities to improve health literacy and promote healthy behaviors, such as vaccination.&#xD;
      While the investigators reported the success of text message vaccine reminders, effects were&#xD;
      limited by their untailored approach. The trans-theoretical model of behavior change supports&#xD;
      tailoring interventions to an individual's stage of decision-making. Human papillomavirus&#xD;
      (HPV) is the most prevalent sexually transmitted virus in the U.S. and can lead to genital&#xD;
      warts, and cervical, anal and penile cancer. The three-dose vaccine is 90-100% efficacious.&#xD;
      Minorities are at greatest risk for such cancers but have low HPV vaccine completion rates.&#xD;
      Limited health literacy regarding the vaccine can affect series completion. The investigators&#xD;
      will compare the effects of enhancing text message vaccination reminders with interactive,&#xD;
      vaccine health literacy-promoting information tailored to vaccine decision making-stage on&#xD;
      HPV vaccine series completion. The effects of these messages represent a new paradigm in&#xD;
      interactive health communications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HPV vaccine series completion</measure>
    <time_frame>12 months</time_frame>
    <description>receipt of 3 doses of HPV vaccine by 12 months after initiation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time between 1st and 2nd dose</measure>
    <time_frame>2 months</time_frame>
    <description>Time elapsed in weeks between first and second dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time between 1st and 3rd dose</measure>
    <time_frame>6 months</time_frame>
    <description>Time elapsed (in months) between 1st and 3rd dose</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">956</enrollment>
  <condition>Human Papillomavirus</condition>
  <arm_group>
    <arm_group_label>Conventional Text Message</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conventional text message reminder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced reminders</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enhanced text message reminders</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional text message reminder</intervention_name>
    <description>Receipt of conventional text message notifying when due for next dose</description>
    <arm_group_label>Conventional Text Message</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced text message reminders</intervention_name>
    <description>Receipt of enhanced text messages notifying when due for next dose coupled with educational information</description>
    <arm_group_label>Enhanced reminders</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parenting adult of adolescent age 11-17 years&#xD;
&#xD;
          -  Adolescent received 1st dose of HPV at a study site within the last 2 weeks.&#xD;
&#xD;
          -  Eligible parent's cell phone has text message capability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Language other than English or Spanish only&#xD;
&#xD;
          -  Parent already in the study&#xD;
&#xD;
          -  Intends to move away from the New York City area in &lt;12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa S Stockwell, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Melissa Stockwell</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics and Population and Family Health</investigator_title>
  </responsible_party>
  <keyword>Human papillomavirus</keyword>
  <keyword>vaccination</keyword>
  <keyword>text message</keyword>
  <keyword>reminder</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT02236273
org study id: AAAM3960
nct id: NCT02236273
lead sponsor: 
collaborator: 
Emerging communication technologies, such as text messaging offer low-cost, scalable
      opportunities to improve health literacy and promote healthy behaviors, such as vaccination.
      While the investigators reported the success of text message vaccine reminders, effects were
      limited by their untailored approach. The trans-theoretical model of behavior change supports
      tailoring interventions to an individual's stage of decision-making. Human papillomavirus
      (HPV) is the most prevalent sexually transmitted virus in the U.S. and can lead to genital
      warts, and cervical, anal and penile cancer. The three-dose vaccine is 90-100% efficacious.
      Minorities are at greatest risk for such cancers but have low HPV vaccine completion rates.
      Limited health literacy regarding the vaccine can affect series completion. The investigators
      will compare the effects of enhancing text message vaccination reminders with interactive,
      vaccine health literacy-promoting information tailored to vaccine decision making-stage on
      HPV vaccine series completion. The effects of these messages represent a new paradigm in
      interactive health communications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: HPV vaccine series completion
time frame: 12 months
description: receipt of 3 doses of HPV vaccine by 12 months after initiation
measure: Time between 1st and 2nd dose
time frame: 2 months
description: Time elapsed in weeks between first and second dose
measure: Time between 1st and 3rd dose
time frame: 6 months
description: Time elapsed (in months) between 1st and 3rd dose
arm group label: Conventional Text Message
arm group type: Experimental
description: Conventional text message reminder
arm group label: Enhanced reminders
arm group type: Experimental
description: Enhanced text message reminders
intervention type: Behavioral
intervention name: Conventional text message reminder
description: Receipt of conventional text message notifying when due for next dose
arm group label: Conventional Text Message
intervention type: Behavioral
intervention name: Enhanced text message reminders
description: Receipt of enhanced text messages notifying when due for next dose coupled with educational information
arm group label: Enhanced reminders
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Melissa S Stockwell, MD MPH
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Melissa Stockwell
investigator title: Assistant Professor of Pediatrics and Population and Family Health
sharing ipd: Undecided