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/NCT05964842</url>
    </required_header>
    <id_info>
      <org_study_id>MILEAGE4TB</org_study_id>
      <nct_id>NCT05964842</nct_id>
    </id_info>
    <brief_title>Using SMS Reminders, Phone Calls and Money Incentives to Enhance Linkage to Care of Presumptive TB Patients in Uganda</brief_title>
    <acronym>MILEAGE4TB</acronym>
    <official_title>Using Short Message Service Reminders, Phone Calls and Mobile Money Incentives to Enhance Linkage to Care of Presumptive Tuberculosis Patients in Uganda: a Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Makerere University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Makerere University</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>
        The major challenge in meeting the WHO's End TB Strategy- reducing tuberculosis (TB) deaths&#xD;
        by 90% and incidence by 80% is the cascading patient loss-to-follow-up (LTFU) along the&#xD;
        continuum of TB care. A systematic review found high levels of pre-treatment LTFU-ranging&#xD;
        from 4 to 38%, and was higher in sub-Saharan Africa (18%) compared to Asia (13%).&#xD;
        Consequences of pre-diagnosis and pre-treatment LTFU are; untreated TB patients are&#xD;
        infectious and can transmit TB to others and not starting TB treatment at all, causes high&#xD;
        morbidity and mortality. Therefore, monitoring outcomes of presumptive TB patients is equally&#xD;
        important as monitoring treatment outcomes. Short message service (SMS), phone calls and&#xD;
        mobile money (MM) incentives have shown promise by improving health outcomes such as uptake&#xD;
        of immunization, adherence to TB treatment and antiretroviral therapy (ART). However, there&#xD;
        is limited knowledge their effect in increasing linkage to care and treatment for presumptive&#xD;
        TB patients in Uganda and sub-Saharan Africa. The aim of this study is therefore to leverage&#xD;
        SMS reminders, phone call and MM incentives in improving linkage to care of presumptive TB&#xD;
        patients.&#xD;
  &#xD;
        This will be a five arm multi-center individual randomized controlled trial implemented in&#xD;
        selected high-volume health facilities in Uganda among 1548 presumptive TB patients. The&#xD;
        study population will be presumptive TB patients aged 18 years and above identified within&#xD;
        the study facilities who do not complete TB diagnosis same day. Completion of TB diagnosis&#xD;
        will refer to submitting a sample and obtaining results from the test. Our hypothesis is that&#xD;
        using SMS reminders, phone call and Mobile Money incentives will result in increase in the&#xD;
        proportion of presumptive TB patients that complete diagnosis and pre-treatment TB cases that&#xD;
        initiate treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The major challenge in meeting the WHO's End TB Strategy- reducing TB deaths by 90% and&#xD;
        incidence by 80% is the cascading patient loss-to-follow-up (LTFU) along the continuum of TB&#xD;
        care. Patients can be lost to follow-up after being identified as presumptive TB cases and&#xD;
        never get to test for TB (pre-diagnosis LTFU) or those who test and are confirmed to have TB,&#xD;
        can also be lost and never start TB treatment (pre-treatment LTFU). A systematic review found&#xD;
        high levels of pre-treatment LTFU-ranging from 4 to 38%, and was higher in sub-Saharan Africa&#xD;
        (18%) compared to Asia (13%). Consequences of pre-diagnosis and pre-treatment LTFU are;&#xD;
        untreated TB patients are infectious and can transmit TB to others and not starting TB&#xD;
        treatment at all, causes high morbidity and mortality. Therefore, monitoring outcomes of&#xD;
        presumptive TB patients is equally important as monitoring treatment outcomes. Short message&#xD;
        service (SMS), phone calls and mobile money (MM) incentives have shown promise by improving&#xD;
        health outcomes such as uptake of immunization, adherence to TB treatment and ART. However,&#xD;
        there is limited knowledge their effect in increasing linkage to care and treatment for&#xD;
        presumptive TB patients in Uganda and sub-Saharan Africa. The aim of this study is therefore&#xD;
        to leverage SMS reminders, phone call and MM incentives in improving linkage to care of&#xD;
        presumptive TB patients.&#xD;
  &#xD;
        This will be a five arm multi-center individual randomized controlled trial implemented in&#xD;
        selected high-volume health facilities in Uganda among 1548 presumptive TB patients. The&#xD;
        study population will be presumptive TB patients aged 18 years and above identified within&#xD;
        the study facilities who do not complete TB diagnosis same day. Completion of TB diagnosis&#xD;
        will refer to submitting a sample and obtaining results from the test.&#xD;
  &#xD;
        The study arms will include; i) Standard of care (SOC - control group) ii) SMS only iii)&#xD;
        phone call only iv) SMS and MM incentive v) Phone call and MM incentive&#xD;
  &#xD;
        Our hypothesis is that using SMS reminders, phone call and Mobile Money incentives will&#xD;
        result in increase in the proportion of presumptive TB patients that complete diagnosis and&#xD;
        pre-treatment TB cases that initiate treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 24, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</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>This will be an individual randomized controlled trial with five arms. The study arms will include; i) Standard of care (SOC - control group) ii) SMS only iii) phone call only iv) SMS and mobile money incentive v) Phone call and mobile money incentive</intervention_model_description>
      <primary_purpose>Screening</primary_purpose>
      <masking>Double (Care Provider, Outcomes Assessor)</masking>
      <masking_description>Due to the nature of the intervention, participants will not be blinded to the study arm though data analysis will be blindly conducted.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Completion of TB diagnosis</measure>
      <time_frame>30 days (from being identified as presumptive TB patient)</time_frame>
      <description>This will include completing TB diagnosis using laboratory investigations (GeneXpert) 30 days after being identified as presumptive. This will also include the patient receiving results when ready.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Median time to completing TB diagnosis</measure>
      <time_frame>Up to 30 days. Determined as Time from when the patient is enrolled on the study to when they complete TB diagnosis</time_frame>
      <description>The time a participant took to complete diagnosis from when they were presumed for TB.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Initiation of TB treatment</measure>
      <time_frame>30 days after being confirmed with TB</time_frame>
      <description>This will include initiating treatment within 30 days after being confirmed with TB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median time to initiating treatment</measure>
      <time_frame>Up to 30 days. Determined as Time from when the patient is confirmed to have TB to when they initiate TB treatment</time_frame>
      <description>The time a participant took to initiate treatment once confirmed to have TB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability of the intervention</measure>
      <time_frame>Through study completion, an average of two months</time_frame>
      <description>This will refer to how acceptable the short message service, phone call and mobile money incentives intervention is in terms of performance, effort, social norms, and facilitating conditions. This will be a post intervention qualitative evaluation</description>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">1548</enrollment>
    <condition>Tuberculosis</condition>
    <arm_group>
      <arm_group_label>Standard of care (Control)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients in this arm will receive the routine TB care, according to the Uganda Ministry of Health guidelines, that is; i) Patient screened for TB ii) Patient identified as presumptive and registered in the presumptive TB register iii) Patient referred for TB testing iv) Patient expected to return and pick results on their own drive vi) Positive TB patients initiated on treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SMS only</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to standard of care, participants in this arm will receive three SMS reminders. The first SMS will be sent on day one after enrollment into the study. The second SMS will be sent once participant results are ready. If two days after the second SMS the patient has not returned to complete TB diagnosis, a third SMS will be sent. Messages will be automatically sent in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Phone call only</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to standard of care, participants in this arm will receive three phone call reminders to complete TB diagnosis. The first phone call will be made on day one after enrollment into the study. The second phone call will be made once participant results are ready. If two days after the second phone call the patient has not returned to complete TB diagnosis, a third phone call will be made. Phone calls will be made in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SMS and mobile money incentives</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to standard of care, participants in this arm will receive three SMS reminders and a transport refund once they complete TB diagnosis. The first SMS will be sent on day one after enrollment into the study. The second SMS will be sent once participant results are ready. If two days after the second SMS the patient has not returned to complete TB diagnosis, a third SMS will be sent. Messages will be automatically sent in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.&#xD;
  Once participants in this study arm complete TB diagnosis by submitting a sputum sample and collecting back results, a money incentive worth 20,000/= (Twenty thousand shillings only) will be given as a transport refund sent via mobile money.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Phone call and mobile money incentives</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to standard of care, participants in this arm will receive three phone call reminders and a transport refund once they complete TB diagnosis. The first phone call will be made on day one after enrollment into the study. The second phone call will be made once participant results are ready. If two days after the second phone call the patient has not returned to complete TB diagnosis, a third phone call will be made. Phone calls will be made in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.&#xD;
  Once participants in this study arm complete TB diagnosis by submitting a sputum sample and collecting back results, a money incentive worth 20,000/= (Twenty thousand shillings only) will be given as a transport refund sent via mobile money.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SMS</intervention_name>
      <description>Participants in this arm will receive three SMS reminders. The first SMS will be sent on day one after enrollment into the study. The second SMS will be sent once participant results are ready. If two days after the second SMS the patient has not returned to complete TB diagnosis, a third SMS will be sent. Messages will be automatically sent in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.</description>
      <arm_group_label>SMS and mobile money incentives</arm_group_label>
      <arm_group_label>SMS only</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Phone call</intervention_name>
      <description>Participants in this arm will receive three phone call reminders. The first phone call will be made on day one after enrollment into the study. The second phone call will be made once participant results are ready. If two days after the second phone call the patient has not returned to complete TB diagnosis, a third phone call will be made. Phone calls will be made in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.</description>
      <arm_group_label>Phone call and mobile money incentives</arm_group_label>
      <arm_group_label>Phone call only</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mobile money incentive</intervention_name>
      <description>Once participants in the study arms with mobile money complete TB diagnosis by submitting a sputum sample and collecting back results, a money incentive worth 20,000/= (Twenty thousand shillings only) will be given as a transport refund sent via mobile money.</description>
      <arm_group_label>Phone call and mobile money incentives</arm_group_label>
      <arm_group_label>SMS and mobile money incentives</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Presumptive TB patient (cough, fever, night sweats, weight loss)&#xD;
  &#xD;
            -  Requested to have GeneXpert testing&#xD;
  &#xD;
            -  Aged between 18 and 65 years&#xD;
  &#xD;
            -  Current resident in the study districts&#xD;
  &#xD;
            -  Willing to sign informed consent&#xD;
  &#xD;
            -  Owning a mobile phone&#xD;
  &#xD;
            -  Able to read&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant plans to move out of the study area in the next 3 months&#xD;
  &#xD;
            -  Participation in another related study such as SMS, phone call or mobile money&#xD;
               incentive and others&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Esther Buregyeya, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Makerere University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Esther Buregyeya, PhD</last_name>
      <phone>0752420555</phone>
      <email>eburegyeya@musph.ac.ug</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rebecca Nuwematsiko, MPH</last_name>
      <phone>0781507824</phone>
      <email>rnuwematsiko@musph.ac.ug</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Luwero General Hospital</name>
        <address>
          <city>Luwero</city>
          <state>Kasana</state>
          <country>Uganda</country>
        </address>
      </facility>
      <contact>
        <last_name>Rebecca Nuwematsiko, MPH</last_name>
        <phone>0781507824</phone>
        <email>rnuwematsiko@musph.ac.ug</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Kojja Health Center IV</name>
        <address>
          <city>Mukono</city>
          <state>Ntenjeru</state>
          <country>Uganda</country>
        </address>
      </facility>
      <contact>
        <last_name>Rebecca Nuwematsiko, MPH</last_name>
        <phone>0781507824</phone>
        <email>rnuwematsiko@musph.ac.ug</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Kawolo General Hospital</name>
        <address>
          <city>Lugazi</city>
          <country>Uganda</country>
        </address>
      </facility>
      <contact>
        <last_name>Rebecca Nuwematsiko, MPH</last_name>
        <phone>0781507824</phone>
        <email>rnuwematsiko@musph.ac.ug</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Mityana General Hospital</name>
        <address>
          <city>Mityana</city>
          <country>Uganda</country>
        </address>
      </facility>
      <contact>
        <last_name>Rebecca Nuwematsiko, MPH</last_name>
        <phone>0781507824</phone>
        <email>rnuwematsiko@musph.ac.ug</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Mukono General Hospital</name>
        <address>
          <city>Mukono</city>
          <country>Uganda</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Uganda</country>
    </location_countries>
    <link>
      <url>https://sph.mak.ac.ug/research-innovations/projects/mileage4tb-using-short-message-service-reminders-and-mobile-money</url>
      <description>MILEAGE4TB: Using short message service reminders and mobile money incentives to enhance linkage to care of presumptive tuberculosis patients in Uganda: a randomised controlled trial</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Tuberculosis</keyword>
    <keyword>Presumptive TB</keyword>
    <keyword>Loss to follow-up</keyword>
    <keyword>SMS</keyword>
    <keyword>Phone call</keyword>
    <keyword>Cash incentives</keyword>
    <keyword>Mobile health (mHealth)</keyword>
    <keyword>Pre-treatment loss to follow-up</keyword>
    <keyword>Pre-diagnosis loss to follow-up</keyword>
    <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>
      <ipd_description>Individual participant data will be made available to other researchers upon a written request with justification. The study team will review the request and either approve or deny as they deem necessary. Approved requests will only receive patient de-identified data.</ipd_description>
    </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/NCT05964842
  org study id: MILEAGE4TB
  nct id: NCT05964842
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The major challenge in meeting the WHO's End TB Strategy- reducing tuberculosis (TB) deaths
        by 90% and incidence by 80% is the cascading patient loss-to-follow-up (LTFU) along the
        continuum of TB care. A systematic review found high levels of pre-treatment LTFU-ranging
        from 4 to 38%, and was higher in sub-Saharan Africa (18%) compared to Asia (13%).
        Consequences of pre-diagnosis and pre-treatment LTFU are; untreated TB patients are
        infectious and can transmit TB to others and not starting TB treatment at all, causes high
        morbidity and mortality. Therefore, monitoring outcomes of presumptive TB patients is equally
        important as monitoring treatment outcomes. Short message service (SMS), phone calls and
        mobile money (MM) incentives have shown promise by improving health outcomes such as uptake
        of immunization, adherence to TB treatment and antiretroviral therapy (ART). However, there
        is limited knowledge their effect in increasing linkage to care and treatment for presumptive
        TB patients in Uganda and sub-Saharan Africa. The aim of this study is therefore to leverage
        SMS reminders, phone call and MM incentives in improving linkage to care of presumptive TB
        patients.
  
        This will be a five arm multi-center individual randomized controlled trial implemented in
        selected high-volume health facilities in Uganda among 1548 presumptive TB patients. The
        study population will be presumptive TB patients aged 18 years and above identified within
        the study facilities who do not complete TB diagnosis same day. Completion of TB diagnosis
        will refer to submitting a sample and obtaining results from the test. Our hypothesis is that
        using SMS reminders, phone call and Mobile Money incentives will result in increase in the
        proportion of presumptive TB patients that complete diagnosis and pre-treatment TB cases that
        initiate treatment.
  The major challenge in meeting the WHO's End TB Strategy- reducing TB deaths by 90% and
        incidence by 80% is the cascading patient loss-to-follow-up (LTFU) along the continuum of TB
        care. Patients can be lost to follow-up after being identified as presumptive TB cases and
        never get to test for TB (pre-diagnosis LTFU) or those who test and are confirmed to have TB,
        can also be lost and never start TB treatment (pre-treatment LTFU). A systematic review found
        high levels of pre-treatment LTFU-ranging from 4 to 38%, and was higher in sub-Saharan Africa
        (18%) compared to Asia (13%). Consequences of pre-diagnosis and pre-treatment LTFU are;
        untreated TB patients are infectious and can transmit TB to others and not starting TB
        treatment at all, causes high morbidity and mortality. Therefore, monitoring outcomes of
        presumptive TB patients is equally important as monitoring treatment outcomes. Short message
        service (SMS), phone calls and mobile money (MM) incentives have shown promise by improving
        health outcomes such as uptake of immunization, adherence to TB treatment and ART. However,
        there is limited knowledge their effect in increasing linkage to care and treatment for
        presumptive TB patients in Uganda and sub-Saharan Africa. The aim of this study is therefore
        to leverage SMS reminders, phone call and MM incentives in improving linkage to care of
        presumptive TB patients.
  
        This will be a five arm multi-center individual randomized controlled trial implemented in
        selected high-volume health facilities in Uganda among 1548 presumptive TB patients. The
        study population will be presumptive TB patients aged 18 years and above identified within
        the study facilities who do not complete TB diagnosis same day. Completion of TB diagnosis
        will refer to submitting a sample and obtaining results from the test.
  
        The study arms will include; i) Standard of care (SOC - control group) ii) SMS only iii)
        phone call only iv) SMS and MM incentive v) Phone call and MM incentive
  
        Our hypothesis is that using SMS reminders, phone call and Mobile Money incentives will
        result in increase in the proportion of presumptive TB patients that complete diagnosis and
        pre-treatment TB cases that initiate treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This will be an individual randomized controlled trial with five arms. The study arms will include; i) Standard of care (SOC - control group) ii) SMS only iii) phone call only iv) SMS and mobile money incentive v) Phone call and mobile money incentive
  primary purpose: Screening
  masking: Double (Care Provider, Outcomes Assessor)
  masking description: Due to the nature of the intervention, participants will not be blinded to the study arm though data analysis will be blindly conducted.
  measure: Completion of TB diagnosis
  time frame: 30 days (from being identified as presumptive TB patient)
  description: This will include completing TB diagnosis using laboratory investigations (GeneXpert) 30 days after being identified as presumptive. This will also include the patient receiving results when ready.
  measure: Median time to completing TB diagnosis
  time frame: Up to 30 days. Determined as Time from when the patient is enrolled on the study to when they complete TB diagnosis
  description: The time a participant took to complete diagnosis from when they were presumed for TB.
  measure: Initiation of TB treatment
  time frame: 30 days after being confirmed with TB
  description: This will include initiating treatment within 30 days after being confirmed with TB
  measure: Median time to initiating treatment
  time frame: Up to 30 days. Determined as Time from when the patient is confirmed to have TB to when they initiate TB treatment
  description: The time a participant took to initiate treatment once confirmed to have TB
  measure: Acceptability of the intervention
  time frame: Through study completion, an average of two months
  description: This will refer to how acceptable the short message service, phone call and mobile money incentives intervention is in terms of performance, effort, social norms, and facilitating conditions. This will be a post intervention qualitative evaluation
  arm group label: Standard of care (Control)
  arm group type: No Intervention
  description: Patients in this arm will receive the routine TB care, according to the Uganda Ministry of Health guidelines, that is; i) Patient screened for TB ii) Patient identified as presumptive and registered in the presumptive TB register iii) Patient referred for TB testing iv) Patient expected to return and pick results on their own drive vi) Positive TB patients initiated on treatment.
  arm group label: SMS only
  arm group type: Experimental
  description: In addition to standard of care, participants in this arm will receive three SMS reminders. The first SMS will be sent on day one after enrollment into the study. The second SMS will be sent once participant results are ready. If two days after the second SMS the patient has not returned to complete TB diagnosis, a third SMS will be sent. Messages will be automatically sent in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.
  arm group label: Phone call only
  arm group type: Experimental
  description: In addition to standard of care, participants in this arm will receive three phone call reminders to complete TB diagnosis. The first phone call will be made on day one after enrollment into the study. The second phone call will be made once participant results are ready. If two days after the second phone call the patient has not returned to complete TB diagnosis, a third phone call will be made. Phone calls will be made in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.
  arm group label: SMS and mobile money incentives
  arm group type: Experimental
  description: In addition to standard of care, participants in this arm will receive three SMS reminders and a transport refund once they complete TB diagnosis. The first SMS will be sent on day one after enrollment into the study. The second SMS will be sent once participant results are ready. If two days after the second SMS the patient has not returned to complete TB diagnosis, a third SMS will be sent. Messages will be automatically sent in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.
  Once participants in this study arm complete TB diagnosis by submitting a sputum sample and collecting back results, a money incentive worth 20,000/= (Twenty thousand shillings only) will be given as a transport refund sent via mobile money.
  arm group label: Phone call and mobile money incentives
  arm group type: Experimental
  description: In addition to standard of care, participants in this arm will receive three phone call reminders and a transport refund once they complete TB diagnosis. The first phone call will be made on day one after enrollment into the study. The second phone call will be made once participant results are ready. If two days after the second phone call the patient has not returned to complete TB diagnosis, a third phone call will be made. Phone calls will be made in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.
  Once participants in this study arm complete TB diagnosis by submitting a sputum sample and collecting back results, a money incentive worth 20,000/= (Twenty thousand shillings only) will be given as a transport refund sent via mobile money.
  intervention type: Behavioral
  intervention name: SMS
  description: Participants in this arm will receive three SMS reminders. The first SMS will be sent on day one after enrollment into the study. The second SMS will be sent once participant results are ready. If two days after the second SMS the patient has not returned to complete TB diagnosis, a third SMS will be sent. Messages will be automatically sent in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.
  arm group label: SMS and mobile money incentives
  arm group label: SMS only
  intervention type: Behavioral
  intervention name: Phone call
  description: Participants in this arm will receive three phone call reminders. The first phone call will be made on day one after enrollment into the study. The second phone call will be made once participant results are ready. If two days after the second phone call the patient has not returned to complete TB diagnosis, a third phone call will be made. Phone calls will be made in either English or Luganda, the commonly spoken local language in the study area. The preferred language of the participant will be determined at enrollment.
  arm group label: Phone call and mobile money incentives
  arm group label: Phone call only
  intervention type: Behavioral
  intervention name: Mobile money incentive
  description: Once participants in the study arms with mobile money complete TB diagnosis by submitting a sputum sample and collecting back results, a money incentive worth 20,000/= (Twenty thousand shillings only) will be given as a transport refund sent via mobile money.
  arm group label: Phone call and mobile money incentives
  arm group label: SMS and mobile money incentives
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Esther Buregyeya, PhD
  role: Principal Investigator
  affiliation: Makerere University
  last name: Esther Buregyeya, PhD
  phone: 0752420555
  email: eburegyeya@musph.ac.ug
  last name: Rebecca Nuwematsiko, MPH
  phone: 0781507824
  email: rnuwematsiko@musph.ac.ug
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  country: Uganda
  url: https://sph.mak.ac.ug/research-innovations/projects/mileage4tb-using-short-message-service-reminders-and-mobile-money
  description: MILEAGE4TB: Using short message service reminders and mobile money incentives to enhance linkage to care of presumptive tuberculosis patients in Uganda: a randomised controlled trial
  responsible party type: Sponsor
  mesh term: Tuberculosis
  sharing ipd: No
  ipd description: Individual participant data will be made available to other researchers upon a written request with justification. The study team will review the request and either approve or deny as they deem necessary. Approved requests will only receive patient de-identified data.