<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/NCT04438291</url>
  </required_header>
  <id_info>
    <org_study_id>14606919</org_study_id>
    <nct_id>NCT04438291</nct_id>
  </id_info>
  <brief_title>HPV Vaccination Health-promotion Programme on Vaccine Acceptance and Uptake Among Female Adolescents</brief_title>
  <official_title>Effects of a Multidisciplinary Team-led School-based Human Papillomavirus Vaccination Health-promotion Programme (MDL-SHPVP) on Improving Vaccine Acceptance and Uptake Among Female Adolescents: A Cluster Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MDL-SHPVP will be developed and a clustered randomised controlled trial will be conducted&#xD;
      to evaluate the effects of the MDL-SHPVP and to examine whether the effect of the MDL-SHPVP&#xD;
      on the rate of HPV vaccine uptake 1 year after intervention is mediated by&#xD;
      parents'/guardians' and female adolescents' HPV knowledge, attitudes and beliefs,&#xD;
      adolescents' intention to receive HPV vaccination and vaccine acceptance among their&#xD;
      parents/guardians.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2520 adolescents and their parents or guardians from 18 local secondary day schools will be&#xD;
      recruited. Multicomponent interventions will be offered to the intervention schools. To build&#xD;
      and strengthen the community capacity in health promotion, a team of volunteers will be&#xD;
      established to raise awareness of HPV, cervical cancer and HPV vaccine.&#xD;
&#xD;
      Data will be collected at baseline, 1 month and 1 year after intervention. The mixed-effects&#xD;
      model will be used to compare the differential changes for each of the primary and secondary&#xD;
      outcomes across time between the two groups.&#xD;
&#xD;
      The project is expected to instil a more accurate understanding of HPV and HPV vaccination&#xD;
      and support the decision to undergo vaccination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Female adolescents' uptake of the HPV vaccine</measure>
    <time_frame>1 year post-intervention</time_frame>
    <description>Self report uptake of the HPV vaccine by the female adolescents in the past 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of female adolescents' intention to receive HPV vaccination</measure>
    <time_frame>baseline, 1 month post-intervention</time_frame>
    <description>A 10-point Likert scale will be used to measure the intention indicates &quot;Definitely&quot;. 1 indicates &quot;Definitely not&quot; and 10 indicates &quot;Definitely&quot;. Higher value means higher intention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of vaccine acceptance among parents/guardians</measure>
    <time_frame>baseline, 1 month post-intervention</time_frame>
    <description>Precaution Adoption Process Model will be used to measure the vaccine acceptance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of female adolescents' and parents'/ guardians' HPV knowledge</measure>
    <time_frame>baseline, 1 month post-intervention</time_frame>
    <description>HPV General and HPV Vaccine Knowledge Scale will be used to measure the knowledge.1 point will be given to each correct answer and 0 points will be given to each incorrect or &quot;Don't know&quot; answer. Higher scores mean more HPV knowledge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of female adolescents' HPV attitudes and beliefs</measure>
    <time_frame>baseline, 1 month post-intervention</time_frame>
    <description>Carolina HPV Immunisation Attitudes and Beliefs Scale will be used to measure the attitudes and belief.&#xD;
An 11-point Likert scale will be used, with 0, 5, 7 and 10 indicate &quot;strongly disagree,&quot; &quot;somewhat disagree,&quot; &quot;somewhat agree&quot; and &quot;strongly agree&quot; respectively, or indicate &quot;extremely ineffective, &quot;somewhat ineffective,&quot; &quot;somewhat effective&quot; and &quot;extremely effective&quot; respectively. Higher values mean stronger agreement with the statement and less agreement with or endorsement of HPV vaccination. Five items will be reverse-coded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of parents'/ guardians' HPV attitudes and beliefs</measure>
    <time_frame>baseline, 1 month post-intervention</time_frame>
    <description>Carolina HPV Immunisation Attitudes and Beliefs Scale will be used to measure the attitudes and belief.&#xD;
A 4-point Likert scale will be used. 1,2,3 and 4 indicate &quot;strongly disagree,&quot; &quot;somewhat disagree,&quot; somewhat agree,&quot; and &quot;strongly agree&quot; respectively. Higher values indicate stronger agreement with the statement.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2520</enrollment>
  <condition>HPV Infection</condition>
  <condition>Health Behavior</condition>
  <condition>Health Attitude</condition>
  <arm_group>
    <arm_group_label>Intervention schools</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 2-hour education session with multicomponent interventions including education sessions with small group dialogues with a registered nurse and trained healthcare and lay volunteers and educational computer games</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control schools</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control and usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MDL-SHPVP</intervention_name>
    <description>A 2-hour education session with multicomponent interventions including education sessions with small group dialogues with a registered nurse and trained healthcare and lay volunteers and educational computer games</description>
    <arm_group_label>Intervention schools</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>30-minute educational video</intervention_name>
    <description>A 30-minute education video (DVD) on HPV, cervical cancer and the HPV vaccine that is designed to enhance HPV vaccine acceptance</description>
    <arm_group_label>Control schools</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female;&#xD;
&#xD;
          -  Age 14-17 years;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have received the HPV vaccination before&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The HPV vaccination mainly targets at female in Hong Kong, with the inclusion in Hong Kong Child Immunisation Programme to eligible female students at Primary 5 and 6 from 2019/2020 school year.</gender_description>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pak Chun Janita Chau, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pak Chun Janita Chau, PhD</last_name>
    <phone>+852 3949 6226</phone>
    <email>janitachau@cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Shatin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>July 29, 2021</last_update_submitted>
  <last_update_submitted_qc>July 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Chau Pak Chun Janita</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papillomavirus Infections</mesh_term>
  </condition_browse>
  <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/NCT04438291
org study id: 14606919
nct id: NCT04438291
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The MDL-SHPVP will be developed and a clustered randomised controlled trial will be conducted
      to evaluate the effects of the MDL-SHPVP and to examine whether the effect of the MDL-SHPVP
      on the rate of HPV vaccine uptake 1 year after intervention is mediated by
      parents'/guardians' and female adolescents' HPV knowledge, attitudes and beliefs,
      adolescents' intention to receive HPV vaccination and vaccine acceptance among their
      parents/guardians.
2520 adolescents and their parents or guardians from 18 local secondary day schools will be
      recruited. Multicomponent interventions will be offered to the intervention schools. To build
      and strengthen the community capacity in health promotion, a team of volunteers will be
      established to raise awareness of HPV, cervical cancer and HPV vaccine.

      Data will be collected at baseline, 1 month and 1 year after intervention. The mixed-effects
      model will be used to compare the differential changes for each of the primary and secondary
      outcomes across time between the two groups.

      The project is expected to instil a more accurate understanding of HPV and HPV vaccination
      and support the decision to undergo vaccination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Female adolescents' uptake of the HPV vaccine
time frame: 1 year post-intervention
description: Self report uptake of the HPV vaccine by the female adolescents in the past 12 months.
measure: Change of female adolescents' intention to receive HPV vaccination
time frame: baseline, 1 month post-intervention
description: A 10-point Likert scale will be used to measure the intention indicates "Definitely". 1 indicates "Definitely not" and 10 indicates "Definitely". Higher value means higher intention.
measure: Change of vaccine acceptance among parents/guardians
time frame: baseline, 1 month post-intervention
description: Precaution Adoption Process Model will be used to measure the vaccine acceptance.
measure: Change of female adolescents' and parents'/ guardians' HPV knowledge
time frame: baseline, 1 month post-intervention
description: HPV General and HPV Vaccine Knowledge Scale will be used to measure the knowledge.1 point will be given to each correct answer and 0 points will be given to each incorrect or "Don't know" answer. Higher scores mean more HPV knowledge.
measure: Change of female adolescents' HPV attitudes and beliefs
time frame: baseline, 1 month post-intervention
description: Carolina HPV Immunisation Attitudes and Beliefs Scale will be used to measure the attitudes and belief.
An 11-point Likert scale will be used, with 0, 5, 7 and 10 indicate "strongly disagree," "somewhat disagree," "somewhat agree" and "strongly agree" respectively, or indicate "extremely ineffective, "somewhat ineffective," "somewhat effective" and "extremely effective" respectively. Higher values mean stronger agreement with the statement and less agreement with or endorsement of HPV vaccination. Five items will be reverse-coded.
measure: Change of parents'/ guardians' HPV attitudes and beliefs
time frame: baseline, 1 month post-intervention
description: Carolina HPV Immunisation Attitudes and Beliefs Scale will be used to measure the attitudes and belief.
A 4-point Likert scale will be used. 1,2,3 and 4 indicate "strongly disagree," "somewhat disagree," somewhat agree," and "strongly agree" respectively. Higher values indicate stronger agreement with the statement.
arm group label: Intervention schools
arm group type: Experimental
description: A 2-hour education session with multicomponent interventions including education sessions with small group dialogues with a registered nurse and trained healthcare and lay volunteers and educational computer games
arm group label: Control schools
arm group type: Other
description: Control and usual care
intervention type: Other
intervention name: MDL-SHPVP
description: A 2-hour education session with multicomponent interventions including education sessions with small group dialogues with a registered nurse and trained healthcare and lay volunteers and educational computer games
arm group label: Intervention schools
intervention type: Other
intervention name: 30-minute educational video
description: A 30-minute education video (DVD) on HPV, cervical cancer and the HPV vaccine that is designed to enhance HPV vaccine acceptance
arm group label: Control schools
criteria: 
gender: Female
gender based: Yes
gender description: The HPV vaccination mainly targets at female in Hong Kong, with the inclusion in Hong Kong Child Immunisation Programme to eligible female students at Primary 5 and 6 from 2019/2020 school year.
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pak Chun Janita Chau, PhD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: Pak Chun Janita Chau, PhD
phone: +852 3949 6226
email: janitachau@cuhk.edu.hk
facility: 
status: Recruiting
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Chau Pak Chun Janita
investigator title: Professor
mesh term: Papillomavirus Infections
sharing ipd: No