<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/NCT04450940</url>
  </required_header>
  <id_info>
    <org_study_id>H33255</org_study_id>
    <nct_id>NCT04450940</nct_id>
  </id_info>
  <brief_title>Impact of PACV Administration on Vaccine Hesitancy</brief_title>
  <official_title>Examining the Impact of PACV Administration on Vaccine Hesitancy: a Randomized Control Trial, Houston, TX</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</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>
      Our objective is to assess the impact of administering the PACV to parents of newborns. We&#xD;
      also sought to assess the prevalence of vaccine hesitancy among parents of newborns in&#xD;
      Houston, TX and to characterize the demographics of vaccine-hesitant parents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite overwhelming scientific evidence demonstrating the safety and effectiveness of&#xD;
      vaccines, parental immunization concerns continue to increase. Compared to parents who refuse&#xD;
      all vaccines, vaccine-hesitant parents (VHP), defined as parents who are ambivalent towards&#xD;
      vaccines, are of particular interest because they tend to be more amenable to vaccination.&#xD;
      VHPs tend to be part of a larger group of parents with moderate vaccine concerns who seek&#xD;
      additional information from their healthcare provider before deciding whether or not to&#xD;
      immunize. These parents will sometimes immunize after education and reassurance from their&#xD;
      provider. Alternatively, they may choose to delay or refuse certain vaccines. It is important&#xD;
      to identify VHPs early in the medical relationship to provide effective communication and&#xD;
      appropriate education regarding vaccine concerns in order to ensure maximum immunization&#xD;
      coverage for the children of these parents.&#xD;
&#xD;
      The Parent Attitudes about Childhood Vaccines (PACV) survey was previously developed to&#xD;
      identify VHPs. In a follow up study, the survey was validated and found to be a reliable&#xD;
      instrument in identifying VHPs. The PACV survey differs from other survey instruments in that&#xD;
      it seeks to specifically identify VHPs. Moreover, the survey was found to be a reliable&#xD;
      predictor of immunization status with higher total PACV scores associated with&#xD;
      under-immunization.5 It is unknown if administering the PACV survey can have a negative&#xD;
      impact on parental immunization beliefs or if the PACV survey can elicit vaccine concerns&#xD;
      that otherwise would not have been present at that point in time.&#xD;
&#xD;
      Study enrollment will occur among parents/guardians of children who are scheduled at a Texas&#xD;
      Children's Pediatric practice for an 2-week well child visit. Parents/guardians of children&#xD;
      will receive an enrollment packet containing a self-screening form, cover letter, and survey&#xD;
      from the practice staff at their appointment check-in. Parents will be randomized to receive&#xD;
      1 of 2 surveys - either the PACV or a placebo survey about general childhood health topics.&#xD;
      Upon receipt of the enrollment packet, the parent/guardian will be asked to complete a&#xD;
      self-screening form to determine if they meet eligibility criteria. If the parent/guardian&#xD;
      does not meet eligibility criteria the self-screening form will direct them to return the&#xD;
      enrollment packet unopened to the front desk staff. Parents/guardians of children meeting&#xD;
      eligibility criteria will be directed to open the enrollment packet and complete the survey.&#xD;
      The PACV survey will then be administered to all subjects six months following the initial&#xD;
      survey administration.&#xD;
&#xD;
      Prevalence of vaccine hesitancy will be calculated for each group (initial PACV or placebo&#xD;
      survey) separately and then for both groups combined. PACV scores calculated from the second&#xD;
      administration at 6 months will be compared across groups to evaluate if administration of&#xD;
      the PACV increases vaccine hesitancy.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        1. Person must self-identify as English-speaking.&#xD;
&#xD;
        2. Parent of a child less than 3 months of age.&#xD;
&#xD;
        3. Parent must be 18 years of age or older.&#xD;
&#xD;
        4. Parent of a child seeking routine, well-child care at a selected TCP practice site.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        1. Person does not self-identify as English-speaking.&#xD;
&#xD;
        2. Parent of child greater than 3 months of age.&#xD;
&#xD;
        3. Parent is less than 18 years of age.&#xD;
&#xD;
        4. Parent of child not seeking routine, well-child care at a selected TCP practice site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2013</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>
    <intervention_model_description>Participants were randomized to receive 1 of 2 surveys at enrollment - either the PACV (a survey that identifies vaccine hesitant parents) or a placebo survey on general childhood health topics. 6 months following enrollment, all participants received the PACV, regardless of baseline randomization group.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Clinic staff, study authors</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of PACV administration on vaccine hesitancy</measure>
    <time_frame>6 months</time_frame>
    <description>We assessed the change in the proportion of vaccine-hesitant parents between baseline and 6-month follow up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of vaccine hesitancy</measure>
    <time_frame>6 months</time_frame>
    <description>We assessed the proportion of vaccine-hesitant parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summarize characteristics of vaccine-hesitant parents</measure>
    <time_frame>6 months</time_frame>
    <description>We sought to summarize the demographic characteristics of vaccine-hesitant parents and examine associations between vaccine hesitancy and participant characteristics</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1705</enrollment>
  <condition>Evaluating Impact of PACV on Vaccine Hesitancy Among Parents of Newborns</condition>
  <arm_group>
    <arm_group_label>PACV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The PACV arm received the PACV survey at baseline in order to assess the impact of administration on vaccine hesitancy. All participants received the PACV at 6-month follow up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The placebo arm received a placebo survey on general childhood health topics at baseline. All participants received the PACV at 6-month follow up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PACV survey</intervention_name>
    <arm_group_label>PACV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo survey</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Person must self-identify as English-speaking.&#xD;
&#xD;
          2. Parent of a child less than 3 months of age.&#xD;
&#xD;
          3. Parent must be 18 years of age or older.&#xD;
&#xD;
          4. Parent of a child seeking routine, well-child care at a selected TCP practice site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Person does not self-identify as English-speaking.&#xD;
&#xD;
          2. Parent of child greater than 3 months of age.&#xD;
&#xD;
          3. Parent is less than 18 years of age.&#xD;
&#xD;
          4. Parent of child not seeking routine, well-child care at a selected TCP practice site.&#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>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Julie Boom</investigator_full_name>
    <investigator_title>Medical Director, Immunization Project; Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Parental Attitudes about Childhood Vaccines</keyword>
  <keyword>vaccine hesitancy</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/NCT04450940
org study id: H33255
nct id: NCT04450940
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our objective is to assess the impact of administering the PACV to parents of newborns. We
      also sought to assess the prevalence of vaccine hesitancy among parents of newborns in
      Houston, TX and to characterize the demographics of vaccine-hesitant parents.
Despite overwhelming scientific evidence demonstrating the safety and effectiveness of
      vaccines, parental immunization concerns continue to increase. Compared to parents who refuse
      all vaccines, vaccine-hesitant parents (VHP), defined as parents who are ambivalent towards
      vaccines, are of particular interest because they tend to be more amenable to vaccination.
      VHPs tend to be part of a larger group of parents with moderate vaccine concerns who seek
      additional information from their healthcare provider before deciding whether or not to
      immunize. These parents will sometimes immunize after education and reassurance from their
      provider. Alternatively, they may choose to delay or refuse certain vaccines. It is important
      to identify VHPs early in the medical relationship to provide effective communication and
      appropriate education regarding vaccine concerns in order to ensure maximum immunization
      coverage for the children of these parents.

      The Parent Attitudes about Childhood Vaccines (PACV) survey was previously developed to
      identify VHPs. In a follow up study, the survey was validated and found to be a reliable
      instrument in identifying VHPs. The PACV survey differs from other survey instruments in that
      it seeks to specifically identify VHPs. Moreover, the survey was found to be a reliable
      predictor of immunization status with higher total PACV scores associated with
      under-immunization.5 It is unknown if administering the PACV survey can have a negative
      impact on parental immunization beliefs or if the PACV survey can elicit vaccine concerns
      that otherwise would not have been present at that point in time.

      Study enrollment will occur among parents/guardians of children who are scheduled at a Texas
      Children's Pediatric practice for an 2-week well child visit. Parents/guardians of children
      will receive an enrollment packet containing a self-screening form, cover letter, and survey
      from the practice staff at their appointment check-in. Parents will be randomized to receive
      1 of 2 surveys - either the PACV or a placebo survey about general childhood health topics.
      Upon receipt of the enrollment packet, the parent/guardian will be asked to complete a
      self-screening form to determine if they meet eligibility criteria. If the parent/guardian
      does not meet eligibility criteria the self-screening form will direct them to return the
      enrollment packet unopened to the front desk staff. Parents/guardians of children meeting
      eligibility criteria will be directed to open the enrollment packet and complete the survey.
      The PACV survey will then be administered to all subjects six months following the initial
      survey administration.

      Prevalence of vaccine hesitancy will be calculated for each group (initial PACV or placebo
      survey) separately and then for both groups combined. PACV scores calculated from the second
      administration at 6 months will be compared across groups to evaluate if administration of
      the PACV increases vaccine hesitancy.

      Inclusion criteria:

        1. Person must self-identify as English-speaking.

        2. Parent of a child less than 3 months of age.

        3. Parent must be 18 years of age or older.

        4. Parent of a child seeking routine, well-child care at a selected TCP practice site.

      Exclusion criteria:

        1. Person does not self-identify as English-speaking.

        2. Parent of child greater than 3 months of age.

        3. Parent is less than 18 years of age.

        4. Parent of child not seeking routine, well-child care at a selected TCP practice site.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomized to receive 1 of 2 surveys at enrollment - either the PACV (a survey that identifies vaccine hesitant parents) or a placebo survey on general childhood health topics. 6 months following enrollment, all participants received the PACV, regardless of baseline randomization group.
primary purpose: Screening
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: Clinic staff, study authors
measure: Impact of PACV administration on vaccine hesitancy
time frame: 6 months
description: We assessed the change in the proportion of vaccine-hesitant parents between baseline and 6-month follow up
measure: Prevalence of vaccine hesitancy
time frame: 6 months
description: We assessed the proportion of vaccine-hesitant parents
measure: Summarize characteristics of vaccine-hesitant parents
time frame: 6 months
description: We sought to summarize the demographic characteristics of vaccine-hesitant parents and examine associations between vaccine hesitancy and participant characteristics
arm group label: PACV
arm group type: Experimental
description: The PACV arm received the PACV survey at baseline in order to assess the impact of administration on vaccine hesitancy. All participants received the PACV at 6-month follow up.
arm group label: Placebo
arm group type: Sham Comparator
description: The placebo arm received a placebo survey on general childhood health topics at baseline. All participants received the PACV at 6-month follow up.
intervention type: Behavioral
intervention name: PACV survey
arm group label: PACV
intervention type: Behavioral
intervention name: Placebo survey
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Julie Boom
investigator title: Medical Director, Immunization Project; Associate Professor of Pediatrics
sharing ipd: No