<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/NCT01729429</url>
  </required_header>
  <id_info>
    <org_study_id>PP100047</org_study_id>
    <nct_id>NCT01729429</nct_id>
  </id_info>
  <brief_title>An Intervention Promoting HPV Vaccination in Safety-net Clinics</brief_title>
  <official_title>An Intervention Promoting HPV Vaccination in Safety-net Clinics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cancer Prevention Research Institute of Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Parkland Health and Hospital System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial is designed to evaluate whether a behavioral intervention&#xD;
      that includes three components: 1) reminder letters and education materials delivered before&#xD;
      the clinic visit, 2) telephone recalls after the visit for those who originally decline the&#xD;
      vaccine, and 3) telephone reminders for those who miss the 2nd and/or 3rd doses, increases 1&#xD;
      and 3 dose coverage of the human papillomavirus (HPV) vaccine series among adolescent girls&#xD;
      attending four Parkland primary care clinics in Dallas county.&#xD;
&#xD;
      Hypothesis 1: Investigators expect higher 1 dose HPV vaccine coverage among patients in the&#xD;
      Intervention group than those in the General Adolescent Vaccine Brochure group.&#xD;
&#xD;
      Hypothesis 2: Investigators expect significantly higher 1 dose HPV vaccine coverage among&#xD;
      patients in the Intervention group who initially declined the vaccine than those in the&#xD;
      General Adolescent Vaccine Brochure group who initially declined.&#xD;
&#xD;
      Hypothesis 3: Investigators expect significantly higher 3 dose HPV vaccine coverage among the&#xD;
      Intervention group than those in the General Adolescent Vaccine Brochure group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary research goal is to implement and evaluate evidence-based intervention strategies&#xD;
      targeted to adolescent girls and their parents that stimulate patient demand for the human&#xD;
      papillomavirus (HPV) vaccine and compliment provider-directed strategies already employed by&#xD;
      Parkland clinics.&#xD;
&#xD;
      The project has three specific aims:&#xD;
&#xD;
        -  Aim 1. Determine if a mailed packet with an invitation letter and educational material&#xD;
           (HPV-specific or general brochure about all recommended adolescent vaccines) delivered&#xD;
           prior to clinic visit, increases 1 dose coverage of the HPV vaccine series.&#xD;
&#xD;
        -  Aim 2. Determine if a telephone recall delivered 2 weeks after the clinic visit,&#xD;
           increases 1 dose coverage among parent-patient dyads who decline the vaccine during the&#xD;
           clinic visit.&#xD;
&#xD;
        -  Aim 3. Determine if telephone reminders to those overdue for Dose 2 or 3 of the HPV&#xD;
           vaccine series, increase 3 dose coverage of the series.&#xD;
&#xD;
      Phase 1 - Cognitive interviews: To ensure the usability and cultural appropriateness of all&#xD;
      project materials, investigators will conduct 40 in-person, cognitive interviews with parents&#xD;
      of female patients ages 11-18 attending Parkland clinics.&#xD;
&#xD;
      Phase 2 - Randomized controlled trial. Investigators will select and invite 1200 families&#xD;
      whose daughter has an upcoming appointment at one of four Parkland clinic sites. Eligible&#xD;
      patients will be randomized to either the Intervention group or the General Adolescent&#xD;
      Vaccine Brochure group. The Intervention group participants will be mailed a packet&#xD;
      containing an invitation letter to join the study and HPV vaccine-specific educational&#xD;
      materials; General Adolescent Vaccine Brochure group participants will be mailed a packet&#xD;
      with educational materials on all four of the recommended adolescent vaccines (HPV,&#xD;
      meningococcal, TDAP, and influenza). A few days after the packet has been sent, a research&#xD;
      assistant will call participants to verify that the letter was received and assess interest&#xD;
      in completing a pre-clinic visit survey.&#xD;
&#xD;
      Participants who agree to fill out the in-clinic survey will be asked to come to their clinic&#xD;
      appointment 40 minutes early to obtain verbal informed consent from the parent and verbal&#xD;
      assent from the adolescent female patient. Then, the parent will complete a 20-30 minute&#xD;
      survey about the HPV vaccine and interactions with their daughter's provider. The daughter&#xD;
      will complete a short survey that asks about use of social media and health concerns.&#xD;
&#xD;
      Intervention group participants who complete the in-clinic survey are also eligible to&#xD;
      receive telephone recalls and reminders. If the Intervention group parent refused the vaccine&#xD;
      during the initial clinic visit, a telephone recall will be delivered after 2 weeks offering&#xD;
      to schedule an immunization-only appointment. If the Intervention group participant misses&#xD;
      the 2nd and/or 3rd doses, telephone reminders will be delivered. For participants who&#xD;
      complete the in-clinic survey and are randomized to the General Adolescent Vaccine Brochure&#xD;
      group, parents who refused will be contacted after 2 weeks to assess attitudes and intentions&#xD;
      toward the HPV vaccine.&#xD;
&#xD;
      Participants in both the Intervention and General Adolescent Vaccine Brochure group will have&#xD;
      their medical record reviewed to assess HPV vaccine outcomes, receipt of the other three&#xD;
      recommended adolescent vaccines, and contact with the clinic during the 12 months following&#xD;
      randomization.&#xD;
&#xD;
      Ancillary Analyses&#xD;
&#xD;
      The investigators will perform stratified analyses and multivariate logistic regression&#xD;
      modeling to examine whether certain subgroups were more likely initiate and complete the&#xD;
      series (e.g, vaccine uptake might vary by characteristics such as preferred language,&#xD;
      race/ethnicity, patient age, or parent educational status). The Investigators will use&#xD;
      similar methods to also examine our data for confounding, for example, if initiation differs&#xD;
      by clinic site. If no interactions are found (e.g., outcome estimates are similar for&#xD;
      different subgroups), the investigators will report summary chi-square tests that only adjust&#xD;
      for potential confounders.&#xD;
&#xD;
      The investigators will also use the dates that patients received the 1st, 2nd, and 3rd HPV&#xD;
      doses to run a time-to-recurrent event analysis. The investigators will model the completion&#xD;
      of the 3-dose series as recurrent event data, 72; 73 with event times from intervention to&#xD;
      Dose 1, Dose 1 to 2, and Dose 2 to 3. A proportional means model will be constructed with the&#xD;
      outcome being the recurrent events, and the variables of interest including intervention&#xD;
      group assignment, sociodemographic, clinic site, knowledge, and attitudes. A significant&#xD;
      intervention indicator effect will conclude that the intervention generally shortens the time&#xD;
      between initiation and receipt of all doses.&#xD;
&#xD;
      Secondary Analyses&#xD;
&#xD;
      The investigators will conduct the following secondary analyses to evaluate whether parents&#xD;
      who receive the intervention have greater HPV vaccine knowledge, information seeking, and&#xD;
      PAPM stage progression compared to parents receiving usual care. Among those who consented&#xD;
      for additional contact and completed pre-clinic and follow-up surveys, the investigators will&#xD;
      explore associations among intervention assignment and intermediate factors including&#xD;
      parents' HPV vaccine knowledge, attitudes, perceived risk, information-seeking, and HPV&#xD;
      vaccine decisional stage. Descriptive statistics will be calculated and outliers identified.&#xD;
      A correlation matrix will be run to check for multicollinearity (strong correlations between&#xD;
      intermediate factors). The investigators will run univariate and multivariate logistic&#xD;
      regression models to determine whether intervention assignment is associated with greater&#xD;
      knowledge of the HPV vaccine, more positive attitudes toward and information seeking about&#xD;
      the HPV vaccine, and PAPM stage progression.&#xD;
&#xD;
      To explore generalizability to all safety-net patients in the clinics, the investigators will&#xD;
      compute t tests or chi-square tests and examine whether patients who 1) decline to&#xD;
      participate or 2) do not consent for reminder and recall intervention components differ from&#xD;
      those randomized with respect to variables available in the EMR (patient demographics, health&#xD;
      care utilization patterns, clinic visit characteristics).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>1 Dose Coverage of the HPV vaccine series at End of Study Period</measure>
    <time_frame>12 months</time_frame>
    <description>Receipt of 1 or more doses of the HPV vaccine during 12-month study period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3 Dose Coverage of the HPV vaccine series at End of Study Period</measure>
    <time_frame>12 months</time_frame>
    <description>Receipt of 3 doses of the HPV vaccine during the 12 month study period</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">831</enrollment>
  <condition>Human Papilloma Virus-Related Cervical Carcinoma</condition>
  <arm_group>
    <arm_group_label>General Adolescent Vaccine Brochure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were mailed a brochure describing the 4 recommended adolescent vaccines (HPV, meningococcal, tetanus diptheria acellular pertussis (TDAP), and influenza) 1-2 weeks before a clinic visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HPV brochure, recall, reminders</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HPV-vaccine specific brochure mailed before clinic visit&#xD;
Telephone recalls after visit for those who complete pre-clinic survey and decline the vaccine&#xD;
Telephone reminders for those who complete the pre-clinic survey and are late for receiving the 2nd and/or 3 doses</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HPV brochure, recall, reminders</intervention_name>
    <description>HPV-vaccine specific brochure mailed before clinic visit&#xD;
Telephone recalls after visit for those who complete pre-clinic survey and decline the vaccine&#xD;
Telephone reminders for those who complete the pre-clinic survey and are late for receiving the 2nd and/or 3 doses</description>
    <arm_group_label>HPV brochure, recall, reminders</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>General Adolescent Vaccine Brochure</intervention_name>
    <description>Participants were mailed a brochure describing the 4 recommended adolescent vaccines (HPV, meningococcal, tetanus diptheria acellular pertussis (TDAP), and influenza) 1-2 weeks before a clinic visit</description>
    <arm_group_label>General Adolescent Vaccine Brochure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  11-18 year old female patients and their parent&#xD;
&#xD;
          -  Patient has an upcoming appointment at one of four Parkland clinics&#xD;
&#xD;
          -  Patient has not initiated the HPV vaccine series&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adolescent patient was currently pregnant&#xD;
&#xD;
          -  Parent Participated in Phase 1 Cognitive Interviews&#xD;
&#xD;
          -  Sibling already enrolled in study&#xD;
&#xD;
          -  Parent opted out or was not interested in the study&#xD;
&#xD;
          -  Parent did not have a working address&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jasmin A Tiro, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkland Health &amp; Hospital System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Papillomavirus Vaccines</keyword>
  <keyword>Intervention Studies</keyword>
  <keyword>Health Services Research</keyword>
  <keyword>Cancer of Cervix</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papilloma</mesh_term>
  </condition_browse>
  <!-- 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/NCT01729429
org study id: PP100047
nct id: NCT01729429
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This randomized controlled trial is designed to evaluate whether a behavioral intervention
      that includes three components: 1) reminder letters and education materials delivered before
      the clinic visit, 2) telephone recalls after the visit for those who originally decline the
      vaccine, and 3) telephone reminders for those who miss the 2nd and/or 3rd doses, increases 1
      and 3 dose coverage of the human papillomavirus (HPV) vaccine series among adolescent girls
      attending four Parkland primary care clinics in Dallas county.

      Hypothesis 1: Investigators expect higher 1 dose HPV vaccine coverage among patients in the
      Intervention group than those in the General Adolescent Vaccine Brochure group.

      Hypothesis 2: Investigators expect significantly higher 1 dose HPV vaccine coverage among
      patients in the Intervention group who initially declined the vaccine than those in the
      General Adolescent Vaccine Brochure group who initially declined.

      Hypothesis 3: Investigators expect significantly higher 3 dose HPV vaccine coverage among the
      Intervention group than those in the General Adolescent Vaccine Brochure group.
The primary research goal is to implement and evaluate evidence-based intervention strategies
      targeted to adolescent girls and their parents that stimulate patient demand for the human
      papillomavirus (HPV) vaccine and compliment provider-directed strategies already employed by
      Parkland clinics.

      The project has three specific aims:

        -  Aim 1. Determine if a mailed packet with an invitation letter and educational material
           (HPV-specific or general brochure about all recommended adolescent vaccines) delivered
           prior to clinic visit, increases 1 dose coverage of the HPV vaccine series.

        -  Aim 2. Determine if a telephone recall delivered 2 weeks after the clinic visit,
           increases 1 dose coverage among parent-patient dyads who decline the vaccine during the
           clinic visit.

        -  Aim 3. Determine if telephone reminders to those overdue for Dose 2 or 3 of the HPV
           vaccine series, increase 3 dose coverage of the series.

      Phase 1 - Cognitive interviews: To ensure the usability and cultural appropriateness of all
      project materials, investigators will conduct 40 in-person, cognitive interviews with parents
      of female patients ages 11-18 attending Parkland clinics.

      Phase 2 - Randomized controlled trial. Investigators will select and invite 1200 families
      whose daughter has an upcoming appointment at one of four Parkland clinic sites. Eligible
      patients will be randomized to either the Intervention group or the General Adolescent
      Vaccine Brochure group. The Intervention group participants will be mailed a packet
      containing an invitation letter to join the study and HPV vaccine-specific educational
      materials; General Adolescent Vaccine Brochure group participants will be mailed a packet
      with educational materials on all four of the recommended adolescent vaccines (HPV,
      meningococcal, TDAP, and influenza). A few days after the packet has been sent, a research
      assistant will call participants to verify that the letter was received and assess interest
      in completing a pre-clinic visit survey.

      Participants who agree to fill out the in-clinic survey will be asked to come to their clinic
      appointment 40 minutes early to obtain verbal informed consent from the parent and verbal
      assent from the adolescent female patient. Then, the parent will complete a 20-30 minute
      survey about the HPV vaccine and interactions with their daughter's provider. The daughter
      will complete a short survey that asks about use of social media and health concerns.

      Intervention group participants who complete the in-clinic survey are also eligible to
      receive telephone recalls and reminders. If the Intervention group parent refused the vaccine
      during the initial clinic visit, a telephone recall will be delivered after 2 weeks offering
      to schedule an immunization-only appointment. If the Intervention group participant misses
      the 2nd and/or 3rd doses, telephone reminders will be delivered. For participants who
      complete the in-clinic survey and are randomized to the General Adolescent Vaccine Brochure
      group, parents who refused will be contacted after 2 weeks to assess attitudes and intentions
      toward the HPV vaccine.

      Participants in both the Intervention and General Adolescent Vaccine Brochure group will have
      their medical record reviewed to assess HPV vaccine outcomes, receipt of the other three
      recommended adolescent vaccines, and contact with the clinic during the 12 months following
      randomization.

      Ancillary Analyses

      The investigators will perform stratified analyses and multivariate logistic regression
      modeling to examine whether certain subgroups were more likely initiate and complete the
      series (e.g, vaccine uptake might vary by characteristics such as preferred language,
      race/ethnicity, patient age, or parent educational status). The Investigators will use
      similar methods to also examine our data for confounding, for example, if initiation differs
      by clinic site. If no interactions are found (e.g., outcome estimates are similar for
      different subgroups), the investigators will report summary chi-square tests that only adjust
      for potential confounders.

      The investigators will also use the dates that patients received the 1st, 2nd, and 3rd HPV
      doses to run a time-to-recurrent event analysis. The investigators will model the completion
      of the 3-dose series as recurrent event data, 72; 73 with event times from intervention to
      Dose 1, Dose 1 to 2, and Dose 2 to 3. A proportional means model will be constructed with the
      outcome being the recurrent events, and the variables of interest including intervention
      group assignment, sociodemographic, clinic site, knowledge, and attitudes. A significant
      intervention indicator effect will conclude that the intervention generally shortens the time
      between initiation and receipt of all doses.

      Secondary Analyses

      The investigators will conduct the following secondary analyses to evaluate whether parents
      who receive the intervention have greater HPV vaccine knowledge, information seeking, and
      PAPM stage progression compared to parents receiving usual care. Among those who consented
      for additional contact and completed pre-clinic and follow-up surveys, the investigators will
      explore associations among intervention assignment and intermediate factors including
      parents' HPV vaccine knowledge, attitudes, perceived risk, information-seeking, and HPV
      vaccine decisional stage. Descriptive statistics will be calculated and outliers identified.
      A correlation matrix will be run to check for multicollinearity (strong correlations between
      intermediate factors). The investigators will run univariate and multivariate logistic
      regression models to determine whether intervention assignment is associated with greater
      knowledge of the HPV vaccine, more positive attitudes toward and information seeking about
      the HPV vaccine, and PAPM stage progression.

      To explore generalizability to all safety-net patients in the clinics, the investigators will
      compute t tests or chi-square tests and examine whether patients who 1) decline to
      participate or 2) do not consent for reminder and recall intervention components differ from
      those randomized with respect to variables available in the EMR (patient demographics, health
      care utilization patterns, clinic visit characteristics).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: 1 Dose Coverage of the HPV vaccine series at End of Study Period
time frame: 12 months
description: Receipt of 1 or more doses of the HPV vaccine during 12-month study period
measure: 3 Dose Coverage of the HPV vaccine series at End of Study Period
time frame: 12 months
description: Receipt of 3 doses of the HPV vaccine during the 12 month study period
arm group label: General Adolescent Vaccine Brochure
arm group type: Active Comparator
description: Participants were mailed a brochure describing the 4 recommended adolescent vaccines (HPV, meningococcal, tetanus diptheria acellular pertussis (TDAP), and influenza) 1-2 weeks before a clinic visit
arm group label: HPV brochure, recall, reminders
arm group type: Experimental
description: HPV-vaccine specific brochure mailed before clinic visit
Telephone recalls after visit for those who complete pre-clinic survey and decline the vaccine
Telephone reminders for those who complete the pre-clinic survey and are late for receiving the 2nd and/or 3 doses
intervention type: Behavioral
intervention name: HPV brochure, recall, reminders
description: HPV-vaccine specific brochure mailed before clinic visit
Telephone recalls after visit for those who complete pre-clinic survey and decline the vaccine
Telephone reminders for those who complete the pre-clinic survey and are late for receiving the 2nd and/or 3 doses
arm group label: HPV brochure, recall, reminders
intervention type: Behavioral
intervention name: General Adolescent Vaccine Brochure
description: Participants were mailed a brochure describing the 4 recommended adolescent vaccines (HPV, meningococcal, tetanus diptheria acellular pertussis (TDAP), and influenza) 1-2 weeks before a clinic visit
arm group label: General Adolescent Vaccine Brochure
criteria: 
gender: Female
minimum age: 11 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jasmin A Tiro, PhD
role: Principal Investigator
affiliation: UT Southwestern Medical Center
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Papilloma