<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/NCT01733537</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00034415</org_study_id>
    <secondary_id>1R25TW009337-01</secondary_id>
    <nct_id>NCT01733537</nct_id>
  </id_info>
  <brief_title>Improving Motorcycle Taxi Driver Visibility in Tanzania</brief_title>
  <official_title>Improving Motorcycle Taxi Driver Visibility in Tanzania-A Cluster Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kilimanjaro Christian Medical Centre, Tanzania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fogarty International Center of the National Institute of Health</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether providing motorcycle taxi drivers with a&#xD;
      free reflective fluorescent vest will result in increased use of reflective or fluorescent&#xD;
      clothing compared to education about wearing reflective or fluorescent clothing alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Road traffic injuries are the 4th leading cause of death among individuals in the&#xD;
      economically productive age group (age 15 to 59) in low and middle income countries. The&#xD;
      Africa region currently has some of the world's highest traffic injury rates, with vulnerable&#xD;
      road users, including motorcycle riders, bearing a disproportionate share of the injury&#xD;
      burden.&#xD;
&#xD;
      Motorcycles are a rapidly growing form of transport in Africa, both for personal and&#xD;
      commercial transportation. Conspicuity measures-factors that increase a motorcycle rider's&#xD;
      visibility-for the prevention of motorcycle crash have been previously studied and found to&#xD;
      be associated with a decreased risk of crash.&#xD;
&#xD;
      Motorcycle taxi drivers are a particularly high risk population for motorcycle crash as they&#xD;
      operate a motorcycle for several hours a day. Reflective, fluorescent safety vests are a&#xD;
      common article worn by motorcycle drivers in some locations; however, penetration of such&#xD;
      clothing in Moshi is currently low. This study aims to increase use of reflective vests among&#xD;
      commercial motorcycle drivers. We will test whether provision of a free reflective,&#xD;
      fluorescent vest increases use of reflective, fluorescent clothing compared to education&#xD;
      about wearing reflective, fluorescent clothing alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Use of reflective or fluorescent clothing</measure>
    <time_frame>3-5 months</time_frame>
    <description>The use of reflective or fluorescent clothing will be compared between the intervention and control groups over the observation period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wearing White Helmet</measure>
    <time_frame>3-5 months</time_frame>
    <description>The use of white helmets will be compared between the intervention and control groups over the observation period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daytime Running Headlights</measure>
    <time_frame>3-5 months</time_frame>
    <description>The use of daytime running headlights will be compared between the intervention and control groups over the observation period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Accidents, Traffic</condition>
  <arm_group>
    <arm_group_label>Vest and Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Motorcycle Taxi Drivers provided with a reflective, fluorescent vest and basic education about recommended measures to increase their visibility</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education Alone</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Motorcycle Taxi Drivers provided with basic education about recommended measures to increase their visibility</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Free reflective, fluorescent vest</intervention_name>
    <description>Motorcycle taxi drivers in the intervention arm will receive a free reflective, fluorescent vest</description>
    <arm_group_label>Vest and Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Both arms will receive brief, basic education about recommended measures to increase their visibility</description>
    <arm_group_label>Education Alone</arm_group_label>
    <arm_group_label>Vest and Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  motorcycle riders who identify themselves as motorcycle taxi drivers&#xD;
&#xD;
          -  individuals must work at least 2 days a week as a motorcycle taxi driver&#xD;
&#xD;
          -  have a telephone number for ride solicitation&#xD;
&#xD;
          -  have a license plate that is able to be recorded&#xD;
&#xD;
          -  are at least 18 years old&#xD;
&#xD;
          -  are willing to have us contact them in the future for repeat surveys&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  motorcycle riders who do not meet the above criteria&#xD;
&#xD;
          -  motorcycle riders who do not consent to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan M Thielman, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steven A Sumner, MD</last_name>
    <role>Study Director</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kilimanjaro Region, Tanzania</name>
      <address>
        <city>Kilimanjaro Region</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>August 6, 2013</last_update_submitted>
  <last_update_submitted_qc>August 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 9, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>traffic accidents, motorcycle, injury, conspicuity</keyword>
  <!-- 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/NCT01733537
org study id: Pro00034415
secondary id: 1R25TW009337-01
nct id: NCT01733537
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether providing motorcycle taxi drivers with a
      free reflective fluorescent vest will result in increased use of reflective or fluorescent
      clothing compared to education about wearing reflective or fluorescent clothing alone.
Road traffic injuries are the 4th leading cause of death among individuals in the
      economically productive age group (age 15 to 59) in low and middle income countries. The
      Africa region currently has some of the world's highest traffic injury rates, with vulnerable
      road users, including motorcycle riders, bearing a disproportionate share of the injury
      burden.

      Motorcycles are a rapidly growing form of transport in Africa, both for personal and
      commercial transportation. Conspicuity measures-factors that increase a motorcycle rider's
      visibility-for the prevention of motorcycle crash have been previously studied and found to
      be associated with a decreased risk of crash.

      Motorcycle taxi drivers are a particularly high risk population for motorcycle crash as they
      operate a motorcycle for several hours a day. Reflective, fluorescent safety vests are a
      common article worn by motorcycle drivers in some locations; however, penetration of such
      clothing in Moshi is currently low. This study aims to increase use of reflective vests among
      commercial motorcycle drivers. We will test whether provision of a free reflective,
      fluorescent vest increases use of reflective, fluorescent clothing compared to education
      about wearing reflective, fluorescent clothing alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Use of reflective or fluorescent clothing
time frame: 3-5 months
description: The use of reflective or fluorescent clothing will be compared between the intervention and control groups over the observation period
measure: Wearing White Helmet
time frame: 3-5 months
description: The use of white helmets will be compared between the intervention and control groups over the observation period
measure: Daytime Running Headlights
time frame: 3-5 months
description: The use of daytime running headlights will be compared between the intervention and control groups over the observation period
arm group label: Vest and Education
arm group type: Experimental
description: Motorcycle Taxi Drivers provided with a reflective, fluorescent vest and basic education about recommended measures to increase their visibility
arm group label: Education Alone
arm group type: Other
description: Motorcycle Taxi Drivers provided with basic education about recommended measures to increase their visibility
intervention type: Other
intervention name: Free reflective, fluorescent vest
description: Motorcycle taxi drivers in the intervention arm will receive a free reflective, fluorescent vest
arm group label: Vest and Education
intervention type: Behavioral
intervention name: Education
description: Both arms will receive brief, basic education about recommended measures to increase their visibility
arm group label: Education Alone
arm group label: Vest and Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathan M Thielman, MD, MPH
role: Principal Investigator
affiliation: Duke University
last name: Steven A Sumner, MD
role: Study Director
affiliation: Duke University
facility: 
country: Tanzania
responsible party type: Sponsor