<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/NCT01690754</url>
  </required_header>
  <id_info>
    <org_study_id>IRD_IRB_2011_03_002</org_study_id>
    <nct_id>NCT01690754</nct_id>
  </id_info>
  <brief_title>Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes</brief_title>
  <official_title>Monitoring Patient Compliance With Tuberculosis Treatment Regimens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Interactive Research and Development</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Interactive Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating&#xD;
      the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive&#xD;
      Reminders is an interactive SMS reminder system to help patients remember to take their TB&#xD;
      medication. In this system, patients receive daily SMS reminders for the duration of their&#xD;
      treatment at a pre-specified time, reminding them to take their medication. Patients are&#xD;
      asked to reply back to the system, either through SMS or a missed call, with the time they&#xD;
      took their medicine that day. If a response is not received within two hours, a second&#xD;
      reminder is sent. If a response is still not received in a further two hours, a third and&#xD;
      final reminder for the day is sent. Non-responsive patients are followed up with phone calls&#xD;
      and a list of non-responsive patients is shared with clinics based on the parameters of&#xD;
      non-responsiveness that they specify.&#xD;
&#xD;
      IRD seeks to determine the impact of this system on treatment outcomes and compliance to&#xD;
      prescribed medication through administering a randomized control trial among newly diagnosed&#xD;
      TB patients in Karachi, Pakistan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Outcomes</measure>
    <time_frame>After 6 to 8 months of treatment</time_frame>
    <description>The investigators will compare clinically reported treatment outcomes between the intervention and control groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical fitness and mobility</measure>
    <time_frame>Monthly visits for 6 to 8 months of treatment</time_frame>
    <description>The investigators will measure physical fitness and mobility through questionnaires conducted with patients during household visits each month that they are on treatment. The investigators are using two indices. The physical fitness index will record respondents ability to perform certain tasks. The mobility index will record the mobility of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Impacts</measure>
    <time_frame>Monthly visits for 6 to 8 months of treatment</time_frame>
    <description>In order to gauge the psychological impacts of the system, the investigators will be looking at participants' perceptions on the likelihood of being cured, how they feel on a given day using the pain scale, and how supported they feel. This data will be collected through questionnaires conducted at each monthly mid-line visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported medication adherence</measure>
    <time_frame>&quot;Surprise&quot; monthly visits during treatment</time_frame>
    <description>Medication adherence will be measured through self-reports by participants on whether they took their TB medication in the past 24 hours. This data will be collected through monthly &quot;surprise&quot; visits to the participants' houses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sputum conversion</measure>
    <time_frame>At 1, 2, 5, and 6/7 months of treatment</time_frame>
    <description>The investigators will look at sputum test results for patients at months 2, 5, and 6/7 of their treatment to compare when sputum conversion occurs between the intervention and control group at these three periods during their treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2207</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm will receive the regular standard of care given by TB clinics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interactive Reminders</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to this arm will receive Interactive SMS reminders daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interactive Reminders</intervention_name>
    <description>Daily SMS reminders sent to TB patients at a pre-specified time. They are asked to respond to the reminders. If a response is not received within two hours, they are sent another reminder for up to three per day.</description>
    <arm_group_label>Interactive Reminders</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New, smear-positive drug susceptible TB who have been on treatment for less than two&#xD;
             weeks&#xD;
&#xD;
          -  Access to a mobile phone (self-reported)&#xD;
&#xD;
          -  Intending to reside in Karachi for the duration of their treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not have regular access to a mobile phone&#xD;
&#xD;
          -  Patients who have previously received TB treatment&#xD;
&#xD;
          -  Patients who have another member in their household who is already a part of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Glennerster, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts Institute of Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shama Mohammed, MPA/ID</last_name>
    <role>Principal Investigator</role>
    <affiliation>Interactive Research and Development</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aamir J. Khan, MD/PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Interactive Research and Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Civil Hospital</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indus Hospital</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jinnah Postgraduate Medical Center</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landhi Medical Complex</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private GP clinics and Private labs partnering with Interactive Research and Devellopment</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sindh Government Hospital - Liaqatabad</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sindh Government Hospital - New Karachi</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sindh Government Hospital - Qatar</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sindh Government Hospital New Karachi Kaali Market</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UHC-New Karachi</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urban Health Center - Landhi</name>
      <address>
        <city>Karachi</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>March 18, 2015</last_update_submitted>
  <last_update_submitted_qc>March 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Interactive Research and Development</investigator_affiliation>
    <investigator_full_name>Shama Mohammed</investigator_full_name>
    <investigator_title>Associate Researcher</investigator_title>
  </responsible_party>
  <keyword>SMS</keyword>
  <keyword>tuberculosis</keyword>
  <keyword>impact evaluation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01690754
org study id: IRD_IRB_2011_03_002
nct id: NCT01690754
lead sponsor: 
collaborator: 
has dmc: No
In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating
      the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive
      Reminders is an interactive SMS reminder system to help patients remember to take their TB
      medication. In this system, patients receive daily SMS reminders for the duration of their
      treatment at a pre-specified time, reminding them to take their medication. Patients are
      asked to reply back to the system, either through SMS or a missed call, with the time they
      took their medicine that day. If a response is not received within two hours, a second
      reminder is sent. If a response is still not received in a further two hours, a third and
      final reminder for the day is sent. Non-responsive patients are followed up with phone calls
      and a list of non-responsive patients is shared with clinics based on the parameters of
      non-responsiveness that they specify.

      IRD seeks to determine the impact of this system on treatment outcomes and compliance to
      prescribed medication through administering a randomized control trial among newly diagnosed
      TB patients in Karachi, Pakistan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Treatment Outcomes
time frame: After 6 to 8 months of treatment
description: The investigators will compare clinically reported treatment outcomes between the intervention and control groups.
measure: Physical fitness and mobility
time frame: Monthly visits for 6 to 8 months of treatment
description: The investigators will measure physical fitness and mobility through questionnaires conducted with patients during household visits each month that they are on treatment. The investigators are using two indices. The physical fitness index will record respondents ability to perform certain tasks. The mobility index will record the mobility of participants.
measure: Psychological Impacts
time frame: Monthly visits for 6 to 8 months of treatment
description: In order to gauge the psychological impacts of the system, the investigators will be looking at participants' perceptions on the likelihood of being cured, how they feel on a given day using the pain scale, and how supported they feel. This data will be collected through questionnaires conducted at each monthly mid-line visit.
measure: Self-reported medication adherence
time frame: "Surprise" monthly visits during treatment
description: Medication adherence will be measured through self-reports by participants on whether they took their TB medication in the past 24 hours. This data will be collected through monthly "surprise" visits to the participants' houses.
measure: Sputum conversion
time frame: At 1, 2, 5, and 6/7 months of treatment
description: The investigators will look at sputum test results for patients at months 2, 5, and 6/7 of their treatment to compare when sputum conversion occurs between the intervention and control group at these three periods during their treatment.
arm group label: Control
arm group type: No Intervention
description: This arm will receive the regular standard of care given by TB clinics.
arm group label: Interactive Reminders
arm group type: Experimental
description: Patients randomized to this arm will receive Interactive SMS reminders daily.
intervention type: Other
intervention name: Interactive Reminders
description: Daily SMS reminders sent to TB patients at a pre-specified time. They are asked to respond to the reminders. If a response is not received within two hours, they are sent another reminder for up to three per day.
arm group label: Interactive Reminders
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Rachel Glennerster, PhD.
role: Principal Investigator
affiliation: Massachusetts Institute of Technology
last name: Shama Mohammed, MPA/ID
role: Principal Investigator
affiliation: Interactive Research and Development
last name: Aamir J. Khan, MD/PhD.
role: Principal Investigator
affiliation: Interactive Research and Development
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Interactive Research and Development
investigator full name: Shama Mohammed
investigator title: Associate Researcher
mesh term: Tuberculosis