<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/NCT03002324</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00087211a</org_study_id>
    <nct_id>NCT03002324</nct_id>
  </id_info>
  <brief_title>Tailoring of Vaccine-Focused Messages: Disease Salience</brief_title>
  <official_title>Tailoring of Vaccine-Focused Messages: Moral Foundations and Disease Salience - Part 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is the second phase of a trial examining decision making about vaccines. For this&#xD;
      phase of this study, the researchers will conduct a 3-arm randomized trial to compare the&#xD;
      current Centers for Disease Control and Prevention (CDC) human papillomavirus (HPV) message,&#xD;
      a new cervical cancer focused message developed by the study team, and a non-vaccine related&#xD;
      control passage among parents of adolescent females. The goal of the trial will be to&#xD;
      determine if the new cervical cancer framed message has an increased impact on intent to have&#xD;
      daughters receive the HPV vaccine over the trial period as compared to the current CDC&#xD;
      message used in the field. Additionally, the researchers will examine the impact both the CDC&#xD;
      message and the new message individually have on intent to vaccinate when compared to the&#xD;
      non-vaccine related control message.&#xD;
&#xD;
      The participant's vaccine beliefs and intent to vaccinate will be assessed through an online&#xD;
      survey at baseline. Two weeks later, participants will be randomized to view one of the three&#xD;
      messages: the current CDC message, the cervical cancer framed message, or a non-vaccine&#xD;
      related control message. Immediately afterwards, vaccine beliefs and intent to vaccinate will&#xD;
      be assessed to determine the impact of the message.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Genital human papillomavirus (HPV) is the most common sexually transmitted infection in the&#xD;
      United States. Most HPV infections are asymptomatic and clear on their own within 2 years but&#xD;
      persistent infections can lead to diseases, including several cancers. Cervical cancer is the&#xD;
      most common cancer caused by HPV infection, and virtually all cervical cancers can be&#xD;
      attributed to HPV infection. There is no cure for HPV, but HPV can be prevented through&#xD;
      vaccination. Current recommendations from the Advisory Committee on Immunization Practices&#xD;
      (ACIP) state that the HPV vaccine may be given starting at 11-12 years of age for boys and&#xD;
      girls, through age 26. Despite the safety and efficacy of this vaccine, the coverage among&#xD;
      adolescents aged 11-17 years old remains low. Attaining high vaccination rates among&#xD;
      adolescents is essential to decreasing the burden of disease due to cervical cancer, and&#xD;
      other cancers caused by HPV.&#xD;
&#xD;
      Parental decision to vaccinate their children, specifically with the HPV vaccine, can be tied&#xD;
      to multiple constructs of the Health Belief Model. These include perceived susceptibility of&#xD;
      HPV infection (is my child at risk of infection), perceived benefit, and perceived severity&#xD;
      (of disease, and of vaccine related adverse events). This would suggest that messaging&#xD;
      surrounding the HPV vaccination should be highly salient within these constructs. The current&#xD;
      message tied to the HPV vaccine presented by the Centers for Disease Control (CDC) has a&#xD;
      focus on HPV as an infection and is clinical in nature. In a randomized trial, parents given&#xD;
      information about HPV were no more likely to be accepting of an HPV vaccine and no more&#xD;
      likely to get their child vaccinated. Based on this literature, the researchers hypothesize&#xD;
      that reframing the message to promote HPV vaccination as a means of protection against&#xD;
      cervical cancer will impact intent to vaccinate among parents of adolescent females (aged&#xD;
      11-17 years old).&#xD;
&#xD;
      In the first phase of this study the researchers assessed how appealing to different moral&#xD;
      foundations impacted attitudes towards vaccination and intent to vaccinate. For this phase of&#xD;
      this study, the researchers will conduct a 3-arm randomized trial to compare the current CDC&#xD;
      HPV, a cervical cancer focused message developed by the study team, and a non-vaccine related&#xD;
      control passage among parents of adolescent females. The goal of the trial will be to&#xD;
      determine if the new cervical cancer framed message has an increased impact on intent to have&#xD;
      daughters receive the HPV vaccine over the trial period as compared to the current CDC&#xD;
      message. Additionally, the researchers will examine the impact both the CDC message and the&#xD;
      new message have on intent to vaccinate when compared to the non-vaccine related control&#xD;
      message.&#xD;
&#xD;
      The participant's vaccine beliefs and intent to vaccinate will be assessed through an online&#xD;
      survey at baseline. Two weeks later, participants will be randomized to view one of the three&#xD;
      messages: the current CDC message, the cervical cancer framed message, or a non-vaccine&#xD;
      related control message. Immediately afterwards, vaccine beliefs and intent to vaccinate will&#xD;
      be assessed to determine the impact of the message.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 1, 2017</completion_date>
  <primary_completion_date type="Actual">May 1, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall change in attitude towards the human papilloma virus (HPV) vaccine</measure>
    <time_frame>Week 2</time_frame>
    <description>Number of caregivers experiencing a change in attitude towards the HPV vaccine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intent to have their child vaccinated against HPV</measure>
    <time_frame>Week 2</time_frame>
    <description>Number of caregivers intending to have their daughter(s) receive the HPV vaccine</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1320</enrollment>
  <condition>Human Papillomavirus</condition>
  <arm_group>
    <arm_group_label>Current CDC Message Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this arm will receive a message developed to directly follow the current message on the CDC's website.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical Cancer Message Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm will receive a message focused on cervical cancer risks and prevention and framed to highlight perceived susceptibility, perceived benefit, and self-efficacy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Message</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants randomized to the control arm will be provided with a short message about the costs and benefits of bird feeding.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Baseline Survey</intervention_name>
    <description>The baseline survey is a combination of the Vaccine Confidence Scale, and a short form of the Parents' Attitudes about Childhood Vaccines (PACV) Scale. Participants will be asked an additional 10 questions developed as a part of a behavioral phenotyping questionnaire to assess behavioral biases at baseline within the study population. Demographic information and intent to vaccinate will also be collected.</description>
    <arm_group_label>Cervical Cancer Message Arm</arm_group_label>
    <arm_group_label>Control Message</arm_group_label>
    <arm_group_label>Current CDC Message Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Current CDC Message</intervention_name>
    <description>Participants randomized to the current CDC message arm will read a message taken almost directly from the CDC Vaccine Information Sheet (VIS) on HPV. This message was minimally altered for length and clarity.</description>
    <arm_group_label>Current CDC Message Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cervical Cancer Message</intervention_name>
    <description>Participants randomized to the cervical cancer messaging arm will receive a message developed by the study team to appeal tenants of the Health Belief Model (self-efficacy, perceived benefit) and on the purity tenant of the moral foundations theory.</description>
    <arm_group_label>Cervical Cancer Message Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control Message</intervention_name>
    <description>Participants randomized to the non-vaccine related control arm will read a bird-feeding passage.</description>
    <arm_group_label>Control Message</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Post-Intervention Survey</intervention_name>
    <description>The immediate post-intervention survey will include questions from the Vaccine Confidence Scale and the PACV short scale. Intent to vaccinate will be assessed.</description>
    <arm_group_label>Cervical Cancer Message Arm</arm_group_label>
    <arm_group_label>Control Message</arm_group_label>
    <arm_group_label>Current CDC Message Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have at least one daughter between 9 and 17 years of age (inclusive)&#xD;
&#xD;
          -  Reside in the United States&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have previously participated in the disease salience phase of this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saad B Omer, BBS, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>May 9, 2017</last_update_submitted>
  <last_update_submitted_qc>May 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Saad B. Omer, MBBS, MPH, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Vaccines</keyword>
  <keyword>Childhood Vaccination</keyword>
  <keyword>Decision Making</keyword>
  <keyword>Health Belief Model</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03002324
org study id: IRB00087211a
nct id: NCT03002324
lead sponsor: 
has dmc: No
This study is the second phase of a trial examining decision making about vaccines. For this
      phase of this study, the researchers will conduct a 3-arm randomized trial to compare the
      current Centers for Disease Control and Prevention (CDC) human papillomavirus (HPV) message,
      a new cervical cancer focused message developed by the study team, and a non-vaccine related
      control passage among parents of adolescent females. The goal of the trial will be to
      determine if the new cervical cancer framed message has an increased impact on intent to have
      daughters receive the HPV vaccine over the trial period as compared to the current CDC
      message used in the field. Additionally, the researchers will examine the impact both the CDC
      message and the new message individually have on intent to vaccinate when compared to the
      non-vaccine related control message.

      The participant's vaccine beliefs and intent to vaccinate will be assessed through an online
      survey at baseline. Two weeks later, participants will be randomized to view one of the three
      messages: the current CDC message, the cervical cancer framed message, or a non-vaccine
      related control message. Immediately afterwards, vaccine beliefs and intent to vaccinate will
      be assessed to determine the impact of the message.
Genital human papillomavirus (HPV) is the most common sexually transmitted infection in the
      United States. Most HPV infections are asymptomatic and clear on their own within 2 years but
      persistent infections can lead to diseases, including several cancers. Cervical cancer is the
      most common cancer caused by HPV infection, and virtually all cervical cancers can be
      attributed to HPV infection. There is no cure for HPV, but HPV can be prevented through
      vaccination. Current recommendations from the Advisory Committee on Immunization Practices
      (ACIP) state that the HPV vaccine may be given starting at 11-12 years of age for boys and
      girls, through age 26. Despite the safety and efficacy of this vaccine, the coverage among
      adolescents aged 11-17 years old remains low. Attaining high vaccination rates among
      adolescents is essential to decreasing the burden of disease due to cervical cancer, and
      other cancers caused by HPV.

      Parental decision to vaccinate their children, specifically with the HPV vaccine, can be tied
      to multiple constructs of the Health Belief Model. These include perceived susceptibility of
      HPV infection (is my child at risk of infection), perceived benefit, and perceived severity
      (of disease, and of vaccine related adverse events). This would suggest that messaging
      surrounding the HPV vaccination should be highly salient within these constructs. The current
      message tied to the HPV vaccine presented by the Centers for Disease Control (CDC) has a
      focus on HPV as an infection and is clinical in nature. In a randomized trial, parents given
      information about HPV were no more likely to be accepting of an HPV vaccine and no more
      likely to get their child vaccinated. Based on this literature, the researchers hypothesize
      that reframing the message to promote HPV vaccination as a means of protection against
      cervical cancer will impact intent to vaccinate among parents of adolescent females (aged
      11-17 years old).

      In the first phase of this study the researchers assessed how appealing to different moral
      foundations impacted attitudes towards vaccination and intent to vaccinate. For this phase of
      this study, the researchers will conduct a 3-arm randomized trial to compare the current CDC
      HPV, a cervical cancer focused message developed by the study team, and a non-vaccine related
      control passage among parents of adolescent females. The goal of the trial will be to
      determine if the new cervical cancer framed message has an increased impact on intent to have
      daughters receive the HPV vaccine over the trial period as compared to the current CDC
      message. Additionally, the researchers will examine the impact both the CDC message and the
      new message have on intent to vaccinate when compared to the non-vaccine related control
      message.

      The participant's vaccine beliefs and intent to vaccinate will be assessed through an online
      survey at baseline. Two weeks later, participants will be randomized to view one of the three
      messages: the current CDC message, the cervical cancer framed message, or a non-vaccine
      related control message. Immediately afterwards, vaccine beliefs and intent to vaccinate will
      be assessed to determine the impact of the message.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Overall change in attitude towards the human papilloma virus (HPV) vaccine
time frame: Week 2
description: Number of caregivers experiencing a change in attitude towards the HPV vaccine
measure: Intent to have their child vaccinated against HPV
time frame: Week 2
description: Number of caregivers intending to have their daughter(s) receive the HPV vaccine
arm group label: Current CDC Message Arm
arm group type: Active Comparator
description: Participants randomized to this arm will receive a message developed to directly follow the current message on the CDC's website.
arm group label: Cervical Cancer Message Arm
arm group type: Experimental
description: Participants randomized to this arm will receive a message focused on cervical cancer risks and prevention and framed to highlight perceived susceptibility, perceived benefit, and self-efficacy.
arm group label: Control Message
arm group type: Sham Comparator
description: Participants randomized to the control arm will be provided with a short message about the costs and benefits of bird feeding.
intervention type: Behavioral
intervention name: Baseline Survey
description: The baseline survey is a combination of the Vaccine Confidence Scale, and a short form of the Parents' Attitudes about Childhood Vaccines (PACV) Scale. Participants will be asked an additional 10 questions developed as a part of a behavioral phenotyping questionnaire to assess behavioral biases at baseline within the study population. Demographic information and intent to vaccinate will also be collected.
arm group label: Cervical Cancer Message Arm
arm group label: Control Message
arm group label: Current CDC Message Arm
intervention type: Behavioral
intervention name: Current CDC Message
description: Participants randomized to the current CDC message arm will read a message taken almost directly from the CDC Vaccine Information Sheet (VIS) on HPV. This message was minimally altered for length and clarity.
arm group label: Current CDC Message Arm
intervention type: Behavioral
intervention name: Cervical Cancer Message
description: Participants randomized to the cervical cancer messaging arm will receive a message developed by the study team to appeal tenants of the Health Belief Model (self-efficacy, perceived benefit) and on the purity tenant of the moral foundations theory.
arm group label: Cervical Cancer Message Arm
intervention type: Behavioral
intervention name: Control Message
description: Participants randomized to the non-vaccine related control arm will read a bird-feeding passage.
arm group label: Control Message
intervention type: Behavioral
intervention name: Post-Intervention Survey
description: The immediate post-intervention survey will include questions from the Vaccine Confidence Scale and the PACV short scale. Intent to vaccinate will be assessed.
arm group label: Cervical Cancer Message Arm
arm group label: Control Message
arm group label: Current CDC Message Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Saad B Omer, BBS, MPH, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Saad B. Omer, MBBS, MPH, PhD
investigator title: Professor
sharing ipd: No