<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/NCT03787914</url>
  </required_header>
  <id_info>
    <org_study_id>H-02-J-002-00877</org_study_id>
    <nct_id>NCT03787914</nct_id>
  </id_info>
  <brief_title>Effect of Community Mobile Outreach Approach Compared to Facility Based Directly Observed Treatment Short Course on Treatment Outcome Among Tuberculosis Patients in Jeddah: A Randomized Controlled Trial</brief_title>
  <official_title>Community Outreach Mobile Teams Impact on Tuberculosis Treatment Outcome in Jeddah Region: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ministry of Health, Saudi Arabia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ministry of Health, Saudi Arabia</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To compare the effectiveness of the community mobile outreach approach in improving treatment&#xD;
      outcomes (success rate) among tuberculosis patients with those being treated with facility&#xD;
      based directly observed treatment short course (DOTS) in Jeddah region.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2018</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>The investigators conducted a two-arm, parallel design[1:1], single blind randomized control trial in 200 newly diagnosed TB patients</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Success rate</measure>
    <time_frame>6 to 8 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention arm patients were served by outreach mobile teams for oral anti-TB treatment under DOTS at the place of their convenience by health care professionals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control arm patients were given the traditional facility based DOTS treatment. Control arm was not served by the outreach mobile teams.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mobile Outreach Approach</intervention_name>
    <description>TB patients in intervention arm were served by outreach mobile teams for DOTS (i.e. administration of anti-TB medicines orally at the place and time of their choice and convenience under mobile teams direct supervision</description>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed TB cases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visitors having TB especially pilgrims&#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>Abdullah AlSahafi, MBBS, SBFM</last_name>
    <role>Study Director</role>
    <affiliation>Director of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ministry of Health</name>
      <address>
        <city>Jeddah</city>
        <state>Makkah</state>
        <zip>21577</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 25, 2018</last_update_submitted>
  <last_update_submitted_qc>December 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Health, Saudi Arabia</investigator_affiliation>
    <investigator_full_name>Hassan Bin Usman</investigator_full_name>
    <investigator_title>Public Health Specialist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</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/NCT03787914
org study id: H-02-J-002-00877
nct id: NCT03787914
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare the effectiveness of the community mobile outreach approach in improving treatment
      outcomes (success rate) among tuberculosis patients with those being treated with facility
      based directly observed treatment short course (DOTS) in Jeddah region.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators conducted a two-arm, parallel design[1:1], single blind randomized control trial in 200 newly diagnosed TB patients
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Treatment Success rate
time frame: 6 to 8 months
arm group label: Intervention arm
arm group type: Experimental
description: Intervention arm patients were served by outreach mobile teams for oral anti-TB treatment under DOTS at the place of their convenience by health care professionals
arm group label: Control arm
arm group type: Active Comparator
description: Control arm patients were given the traditional facility based DOTS treatment. Control arm was not served by the outreach mobile teams.
intervention type: Procedure
intervention name: Mobile Outreach Approach
description: TB patients in intervention arm were served by outreach mobile teams for DOTS (i.e. administration of anti-TB medicines orally at the place and time of their choice and convenience under mobile teams direct supervision
arm group label: Control arm
arm group label: Intervention arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abdullah AlSahafi, MBBS, SBFM
role: Study Director
affiliation: Director of Public Health
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: Ministry of Health, Saudi Arabia
investigator full name: Hassan Bin Usman
investigator title: Public Health Specialist
mesh term: Tuberculosis
sharing ipd: No