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/NCT05962411</url>
    </required_header>
    <id_info>
      <org_study_id>21-430</org_study_id>
      <nct_id>NCT05962411</nct_id>
    </id_info>
    <brief_title>Effects of Dress by Adolescents on Electronic Cigarette Retailer Behaviors in China</brief_title>
    <official_title>A Large-Scale Randomized Control Trial to Determine the Effects of Dress by Adolescents on Electronic Cigarette Retailer Behaviors in Regulation Compliance in China</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>China Medical Board</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking University</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>
        This study is a national-level randomized control trial to measure the effects of dressing in&#xD;
        professional attire by adolescents on regulation compliance-related behaviors of electronic&#xD;
        cigarette (e-cigarette) retailers defined by both age verification and potential underage&#xD;
        sales. The corresponding null hypothesis that will be tested is that dressing in professional&#xD;
        attire by adolescents will have no effect upon retailer behaviors in regulation compliance.&#xD;
        The secondary objectives are to determine the impacts of type of dress by adolescents on&#xD;
        marketing and communication strategies adopted by retailers, as well as to document the&#xD;
        differences in the behaviors between e-cigarette and tobacco retailers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Electronic cigarette (e-cigarette) use has been growing dramatically and poses a significant&#xD;
        public health threat to adolescents in China. After the online sales of these products has&#xD;
        been banned, purchases from brick-and-mortar stores became the only legal option for the&#xD;
        users. However, little research has been conducted to document sales behaviors of the&#xD;
        physical retailers and identify the associated factors. The study will investigate the extent&#xD;
        to which dressing in professional attire by adolescents on regulation compliance in retailer&#xD;
        behaviors, including inquiring about age, requesting identity cards for age verification, and&#xD;
        completing transactions even when identity cards are not presented. Adopting the simulated&#xD;
        client method, the study will collect information on regulation compliance, store&#xD;
        environment, product availability, and marketing strategies through interacting with&#xD;
        retailers across China. Considering that e-cigarette retailers are predominately located in&#xD;
        the most densely populated cities, the investigators will include approximately 1,080&#xD;
        e-cigarette retailers from 36 cities, including 4 municipalities directly under the Central&#xD;
        Government, 27 provincial capital cities, and 5 cities specially designated in the state&#xD;
        plan. Store addresses and contact information will be obtained through web scraping from the&#xD;
        AutoNavi map (the most popular map app in China). The investigators plan to randomly sample&#xD;
        32 retailers in each city if the number allows, and cities with less than 32 retailers&#xD;
        identified will all be included. To capture reality, retailers will not be informed during&#xD;
        visit. The sampled ones within each city will be randomized into the intervention and control&#xD;
        group, with a balance gender ratio of the simulated clients. These clients will be recruited&#xD;
        from university students younger than 20 years old, who can easily be considered as minors&#xD;
        (under 18) when purely judged by their appearance. Clients visiting retailers in the control&#xD;
        group will dress in school uniforms and carry a school bag, while those in the intervention&#xD;
        group will dress in professional attire with a business-style backpack for males or a leather&#xD;
        bag for females. The clients will record retailer responses, including (1) inquiring about&#xD;
        age verbally, (2) requesting identity cards for age verification, and (3) whether retailers&#xD;
        still sell products even when identity cards are not presented. For each e-cigarette&#xD;
        retailer, the nearest tobacco retailer identified through the AutoNavi Map will be used for&#xD;
        comparison to document the differences in the behaviors between the two types of retailers.&#xD;
        Additionally, communication and marketing strategies, e.g., mentioning available flavored&#xD;
        products, dissuading clients not to purchase, are also collected.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Non-compliant sales</measure>
      <time_frame>During visit (day 1)</time_frame>
      <description>The simulated clients will report whether retailers sell e-cigarette products to possible minors even when identity cards are not presented for age verification.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Inquiring about age</measure>
      <time_frame>During visit (day 1)</time_frame>
      <description>The simulated clients will report whether retailers inquire about their age verbally in stores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Requesting identity cards</measure>
      <time_frame>During visit (day 1)</time_frame>
      <description>The simulated clients will report whether retailers request them to show identity cards for the purpose of age verification.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Online contact</measure>
      <time_frame>During visit (day 1)</time_frame>
      <description>The simulated clients will report if they are able to add retailers as WeChat (the online most popular chat app in China) contacts.</description>
    </other_outcome>
    <other_outcome>
      <measure>Delivery service offered</measure>
      <time_frame>During visit (day 1)</time_frame>
      <description>The simulated clients will report if salespersons mention that products ordered online can be delivered to them.</description>
    </other_outcome>
    <other_outcome>
      <measure>Illegal flavored e-cigarette products available</measure>
      <time_frame>During visit (day 1)</time_frame>
      <description>The simulated clients will report if salespersons mention that flavored (non-national-standard) e-cigarette products are available in stores.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1080</enrollment>
    <condition>Regulation Compliance</condition>
    <condition>Electronic Nicotine Delivery Systems</condition>
    <arm_group>
      <arm_group_label>Dress in School Uniforms</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Simulated clients dress in school uniforms, enter e-cigarette stores, and act as minor buyers.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dress in Professional Attire</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Simulated clients dress in business casuals, enter e-cigarette stores, and act as potential &quot;adult e-cigarette buyers&quot;.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dress in Professional Attire</intervention_name>
      <description>&quot;Adolescents&quot; pretend to be &quot;adult e-cigarette buyers&quot; by dressing in professional attire.</description>
      <arm_group_label>Dress in Professional Attire</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Retailers can be identified from the AutoNavi Map through keyword searches&#xD;
  &#xD;
            -  Retailers have reachable contact information&#xD;
  &#xD;
            -  Retailers are contacted and claim being open for business on a regular basis&#xD;
  &#xD;
            -  Include only one retailer if multiple ones have the same contact information&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Retailers that are not located in main districts of the cities (usually old town and&#xD;
               economically developed central areas)&#xD;
  &#xD;
            -  Perceived danger surrounding the retailers (e.g., remote alleys with no pedestrians at&#xD;
               all)&#xD;
  &#xD;
            -  Closed when arriving&#xD;
  &#xD;
            -  Retailers that cannot be located based on map information&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yang Wang, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University Health Science Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hai Fang, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University Health Science Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yang Wang, PhD</last_name>
      <phone>86-010-82805703</phone>
      <email>yang.wang@hsc.pku.edu.cn</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Electronic Cigarette</keyword>
    <keyword>Retailer</keyword>
    <keyword>Adolescent</keyword>
    <keyword>Regulation Compliance</keyword>
    <keyword>China</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
    </patient_data>
    <!-- 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/NCT05962411
  org study id: 21-430
  nct id: NCT05962411
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a national-level randomized control trial to measure the effects of dressing in
        professional attire by adolescents on regulation compliance-related behaviors of electronic
        cigarette (e-cigarette) retailers defined by both age verification and potential underage
        sales. The corresponding null hypothesis that will be tested is that dressing in professional
        attire by adolescents will have no effect upon retailer behaviors in regulation compliance.
        The secondary objectives are to determine the impacts of type of dress by adolescents on
        marketing and communication strategies adopted by retailers, as well as to document the
        differences in the behaviors between e-cigarette and tobacco retailers.
  Electronic cigarette (e-cigarette) use has been growing dramatically and poses a significant
        public health threat to adolescents in China. After the online sales of these products has
        been banned, purchases from brick-and-mortar stores became the only legal option for the
        users. However, little research has been conducted to document sales behaviors of the
        physical retailers and identify the associated factors. The study will investigate the extent
        to which dressing in professional attire by adolescents on regulation compliance in retailer
        behaviors, including inquiring about age, requesting identity cards for age verification, and
        completing transactions even when identity cards are not presented. Adopting the simulated
        client method, the study will collect information on regulation compliance, store
        environment, product availability, and marketing strategies through interacting with
        retailers across China. Considering that e-cigarette retailers are predominately located in
        the most densely populated cities, the investigators will include approximately 1,080
        e-cigarette retailers from 36 cities, including 4 municipalities directly under the Central
        Government, 27 provincial capital cities, and 5 cities specially designated in the state
        plan. Store addresses and contact information will be obtained through web scraping from the
        AutoNavi map (the most popular map app in China). The investigators plan to randomly sample
        32 retailers in each city if the number allows, and cities with less than 32 retailers
        identified will all be included. To capture reality, retailers will not be informed during
        visit. The sampled ones within each city will be randomized into the intervention and control
        group, with a balance gender ratio of the simulated clients. These clients will be recruited
        from university students younger than 20 years old, who can easily be considered as minors
        (under 18) when purely judged by their appearance. Clients visiting retailers in the control
        group will dress in school uniforms and carry a school bag, while those in the intervention
        group will dress in professional attire with a business-style backpack for males or a leather
        bag for females. The clients will record retailer responses, including (1) inquiring about
        age verbally, (2) requesting identity cards for age verification, and (3) whether retailers
        still sell products even when identity cards are not presented. For each e-cigarette
        retailer, the nearest tobacco retailer identified through the AutoNavi Map will be used for
        comparison to document the differences in the behaviors between the two types of retailers.
        Additionally, communication and marketing strategies, e.g., mentioning available flavored
        products, dissuading clients not to purchase, are also collected.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Non-compliant sales
  time frame: During visit (day 1)
  description: The simulated clients will report whether retailers sell e-cigarette products to possible minors even when identity cards are not presented for age verification.
  measure: Inquiring about age
  time frame: During visit (day 1)
  description: The simulated clients will report whether retailers inquire about their age verbally in stores.
  measure: Requesting identity cards
  time frame: During visit (day 1)
  description: The simulated clients will report whether retailers request them to show identity cards for the purpose of age verification.
  measure: Online contact
  time frame: During visit (day 1)
  description: The simulated clients will report if they are able to add retailers as WeChat (the online most popular chat app in China) contacts.
  measure: Delivery service offered
  time frame: During visit (day 1)
  description: The simulated clients will report if salespersons mention that products ordered online can be delivered to them.
  measure: Illegal flavored e-cigarette products available
  time frame: During visit (day 1)
  description: The simulated clients will report if salespersons mention that flavored (non-national-standard) e-cigarette products are available in stores.
  arm group label: Dress in School Uniforms
  arm group type: No Intervention
  description: Simulated clients dress in school uniforms, enter e-cigarette stores, and act as minor buyers.
  arm group label: Dress in Professional Attire
  arm group type: Experimental
  description: Simulated clients dress in business casuals, enter e-cigarette stores, and act as potential "adult e-cigarette buyers".
  intervention type: Other
  intervention name: Dress in Professional Attire
  description: "Adolescents" pretend to be "adult e-cigarette buyers" by dressing in professional attire.
  arm group label: Dress in Professional Attire
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Yang Wang, PhD
  role: Principal Investigator
  affiliation: Peking University Health Science Center
  last name: Hai Fang, PhD
  role: Principal Investigator
  affiliation: Peking University Health Science Center
  last name: Yang Wang, PhD
  phone: 86-010-82805703
  email: yang.wang@hsc.pku.edu.cn
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Analytic Code