xml: <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/NCT06002282</url>
    </required_header>
    <id_info>
      <org_study_id>Pro2022001385</org_study_id>
      <secondary_id>K22CA258675</secondary_id>
      <nct_id>NCT06002282</nct_id>
    </id_info>
    <brief_title>HPV Vaccine Confident Families</brief_title>
    <official_title>HPV Vaccine Confident Families</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rutgers, The State University of New Jersey</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Rutgers, The State University of New Jersey</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 objectives of the study are to pilot test a tailored text message intervention among&#xD;
        Black families with adolescents. The hypotheses are that the study protocol will be feasible&#xD;
        and text messages tailored to parents' needs will increase vaccine confidence and intention&#xD;
        to vaccinate.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 2024</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">May 2025</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility - Recruitment</measure>
      <time_frame>After enrollment completion, 6 months</time_frame>
      <description>ratio of parents recruited to potential parents approached to participate in study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility - Retention</measure>
      <time_frame>Post intervention completion, 1 year</time_frame>
      <description>ratio of parents completing post-intervention surveys to the number enrolled</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility - Intervention Delivery</measure>
      <time_frame>Two weeks after intervention begins</time_frame>
      <description>ratio of parents receiving HPV message to the number enrolled</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility - Intervention response</measure>
      <time_frame>Two weeks after intervention completion</time_frame>
      <description>assessment of how often participants completed hesitancy questions across the intervention period</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility - Intervention utility</measure>
      <time_frame>Two weeks after intervention completion</time_frame>
      <description>Perceived ease of use, likeability, helpfulness, impact of texts- Mobile App Rating Scale</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Vaccine Intention</measure>
      <time_frame>Immediately post-intervention (6 months)</time_frame>
      <description>Parent reported intention to vaccinate adolescent in next 6 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vaccine Confidence</measure>
      <time_frame>Immediately post-intervention (6 months)</time_frame>
      <description>Parent-reported response to scale assessing benefits of vaccination, harms of vaccination, and trust in health care providers</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Human Papillomavirus Vaccines</condition>
    <arm_group>
      <arm_group_label>Tailored Messaging</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Tailored text messages based on parents' HPV vaccine hesitancy and perceived barriers to vaccination.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Messaging</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard (untailored) text messages about HPV vaccination reminder/recall.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Tailored text messages</intervention_name>
      <description>Text messages will be individually tailored to parents' responses to a baseline survey (child gender, vaccination status) and real-time responses to interactive prompts about vaccine hesitancy determinants with links to additional information (e.g., CDC, NJ Department of Health) and community resources to overcome barriers.</description>
      <arm_group_label>Tailored Messaging</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard text messages</intervention_name>
      <description>Generic reminder/recall HPV vaccination text messages.</description>
      <arm_group_label>Standard Messaging</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  parent or legal guardian of at least one child aged 9-13 years who has received 0 or 1&#xD;
               dose of HPV vaccine;&#xD;
  &#xD;
            -  identify as Black or African American adult;&#xD;
  &#xD;
            -  have access to personal mobile phone and agree to send/receive MMS messages;&#xD;
  &#xD;
            -  able to speak and understand English; and&#xD;
  &#xD;
            -  able to provide informed consent to participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  parent or legal guardian of child outside of participation age range or who has&#xD;
               completed multiple doses of HPV vaccine;&#xD;
  &#xD;
            -  does not identify as Black or African American adult;&#xD;
  &#xD;
            -  does not have personal mobile phone;&#xD;
  &#xD;
            -  unable to speak and understand English;&#xD;
  &#xD;
            -  not willing to consent to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Racquel Kohler, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rutgers</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Racquel E Kohler, PhD</last_name>
      <phone>732.258.6031</phone>
      <email>kelly.kohler@rutgers.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rachel Wagner</last_name>
      <phone>732.853.6036</phone>
      <email>r.wagner@rutgers.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
      <investigator_full_name>Racquel Kohler, PhD, MSPH</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002282
  org study id: Pro2022001385
  secondary id: K22CA258675
  nct id: NCT06002282
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objectives of the study are to pilot test a tailored text message intervention among
        Black families with adolescents. The hypotheses are that the study protocol will be feasible
        and text messages tailored to parents' needs will increase vaccine confidence and intention
        to vaccinate.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Feasibility - Recruitment
  time frame: After enrollment completion, 6 months
  description: ratio of parents recruited to potential parents approached to participate in study
  measure: Feasibility - Retention
  time frame: Post intervention completion, 1 year
  description: ratio of parents completing post-intervention surveys to the number enrolled
  measure: Feasibility - Intervention Delivery
  time frame: Two weeks after intervention begins
  description: ratio of parents receiving HPV message to the number enrolled
  measure: Feasibility - Intervention response
  time frame: Two weeks after intervention completion
  description: assessment of how often participants completed hesitancy questions across the intervention period
  measure: Feasibility - Intervention utility
  time frame: Two weeks after intervention completion
  description: Perceived ease of use, likeability, helpfulness, impact of texts- Mobile App Rating Scale
  measure: Vaccine Intention
  time frame: Immediately post-intervention (6 months)
  description: Parent reported intention to vaccinate adolescent in next 6 months
  measure: Vaccine Confidence
  time frame: Immediately post-intervention (6 months)
  description: Parent-reported response to scale assessing benefits of vaccination, harms of vaccination, and trust in health care providers
  arm group label: Tailored Messaging
  arm group type: Experimental
  description: Tailored text messages based on parents' HPV vaccine hesitancy and perceived barriers to vaccination.
  arm group label: Standard Messaging
  arm group type: Active Comparator
  description: Standard (untailored) text messages about HPV vaccination reminder/recall.
  intervention type: Behavioral
  intervention name: Tailored text messages
  description: Text messages will be individually tailored to parents' responses to a baseline survey (child gender, vaccination status) and real-time responses to interactive prompts about vaccine hesitancy determinants with links to additional information (e.g., CDC, NJ Department of Health) and community resources to overcome barriers.
  arm group label: Tailored Messaging
  intervention type: Behavioral
  intervention name: Standard text messages
  description: Generic reminder/recall HPV vaccination text messages.
  arm group label: Standard Messaging
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Racquel Kohler, PhD
  role: Principal Investigator
  affiliation: Rutgers
  last name: Racquel E Kohler, PhD
  phone: 732.258.6031
  email: kelly.kohler@rutgers.edu
  last name: Rachel Wagner
  phone: 732.853.6036
  email: r.wagner@rutgers.edu
  responsible party type: Principal Investigator
  investigator affiliation: Rutgers, The State University of New Jersey
  investigator full name: Racquel Kohler, PhD, MSPH
  investigator title: Assistant Professor