<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/NCT03800888</url>
  </required_header>
  <id_info>
    <org_study_id>MUST-16/10-16</org_study_id>
    <nct_id>NCT03800888</nct_id>
  </id_info>
  <brief_title>Real-time Tuberculosis Medication Adherence Intervention in Rural Southwestern Uganda</brief_title>
  <acronym>MAT K43</acronym>
  <official_title>Real-time Tuberculosis Medication Adherence Intervention in Rural Southwestern Uganda</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mbarara University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mbarara University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</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>
      With an estimated 60,000 people diagnosed with TB (Tuberculosis) annually, Uganda holds the&#xD;
      16th position of the 22 countries with highest cases of TB in the world. The Uganda national&#xD;
      target of utilizing the DOTS (Direct Observed Treatment Short Course) to successfully treat&#xD;
      85% of patients diagnosed with TB has not been met. Currently, the country only detects 49.6%&#xD;
      TB case detection, of which it successfully treats 73%. The DOTS strategy has suffered many&#xD;
      socioeconomic challenges, which have resulted into its abandonment by many of the Ugandan&#xD;
      hospitals. Poor TB medication adherence greatly attribute to the many cases of TB in Uganda.&#xD;
      Causes of non-adherence to TB medication include lack of patient follow-up, patients' lack of&#xD;
      transport to go to the clinics to pick up drugs, patients' forgetfulness. There is evidence&#xD;
      that real time adherence monitoring linked with SMS reminders and social support&#xD;
      notifications can address barriers to sustained ART (antiretroviral therapy) adherence. Such&#xD;
      novel interventions addressing TB medication adherence challenges in low resource settings to&#xD;
      date are limited. The prevailing SMS-based studies for TB medication adherence report mixed&#xD;
      results, do not strategically link interventions with missed doses, and have largely been&#xD;
      implemented in developed countries. To date, little is known about the use of real-time&#xD;
      adherence monitoring technologies for TB medication adherence in resource-limited settings.&#xD;
&#xD;
      The goal of this research is to investigate the use of real time adherence monitoring&#xD;
      technology linked with SMS reminders and notifications for TB medication adherence in rural&#xD;
      southwestern Uganda.&#xD;
&#xD;
      The investigator will develop and quantitatively test a real-time adherence monitoring&#xD;
      intervention with 60 individuals initiating TB treatment, and 40 social supporters. The&#xD;
      investigator will randomize participants (1:1:1) to the following arms: 1) Fixed and linked&#xD;
      SMS reminders, 2) SMS notifications to social supporters, and 3) no SMS (control). All&#xD;
      participants will have adherence monitored in real-time for 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has three major aims (Aims 1, 2 and 3)&#xD;
&#xD;
      Aim 1: Carry out a formative qualitative study to assess barriers and facilitators to TB&#xD;
      medication adherence, and identify optimal SMS reminders, notifications, and initial&#xD;
      feasibility of real time adherence monitoring. 35 TB patients will be recruited from the TB&#xD;
      clinic in Mbarara Regional Referral Hospital (MRRH), and up to 15 social supporters specified&#xD;
      by the TB patients (one per TB patient). Drawing from technology adoption and behavioral&#xD;
      change models, the investigator will use semi-structured interviews to assess the initial&#xD;
      feasibility and acceptability of the intervention, as well the barriers and facilitators to&#xD;
      TB medication adherence, and how they can be addressed using the proposed intervention. The&#xD;
      purpose will be to inform the development the technology necessary to conduct a real-time&#xD;
      intervention involving a wireless monitor and SMS reminders and notifications (Aim 2 and 3).&#xD;
&#xD;
      Aim 2: Develop a TB medication adherence intervention based on SMS reminders (fixed and/or&#xD;
      linked to real-time detection of missed doses) and assess its acceptability, feasibility and&#xD;
      preliminary impact on adherence.&#xD;
&#xD;
      The Investigators will use real-time electronic adherence monitoring (i.e., Wisepill) to&#xD;
      follow 60 TB-infected individuals initiating TB treatment in Mbarara Regional Referral&#xD;
      Hospital (MRRH) for six months. Using a 1:1:1 manner, participants will be randomized to one&#xD;
      of the following three study arms (details of each intervention will be informed by the data&#xD;
      collected in Aim 1):&#xD;
&#xD;
        1. Intervention Arm A: SMS reminders on a fixed schedule&#xD;
&#xD;
        2. Intervention Arm B: SMS reminders linked to missed doses&#xD;
&#xD;
        3. Control: No SMS reminders.&#xD;
&#xD;
      Qualitative interviews to understand the patients experiences with Wisepill adherence&#xD;
      monitoring and the SMS reminders will be carried out, depending on the study arm to which&#xD;
      they are assigned. The first set of interviews for Arms A and B will be conducted at the end&#xD;
      of Month 3 of the study. The second set of interviews is planned to be conducted within two&#xD;
      weeks after the first 24+ hour lapse in Wisepill signal for the participants in the&#xD;
      intervention arms (A and B). If there is no 24+ hour lapse, the interview will take place at&#xD;
      the end of the study. The control participants in Arm C's interview will occur at a&#xD;
      convenient time during Months 3-6. The effect sizes will be estimated by comparing adherence&#xD;
      at the end of six months between each intervention group and the control group. The primary&#xD;
      outcome will be percent adherence.&#xD;
&#xD;
      Treatment outcomes will be defined according to WHO definitions, where cure and completed&#xD;
      treatment are defined as successful treatment outcomes (WHO 2014). Unsuccessful treatment&#xD;
      outcomes for active TB treatment will include death ascertained from hospital death registry,&#xD;
      treatment failure (sputum smear positive at 6 months) and loss to follow-up. Treatment&#xD;
      outcomes will be compared for both intervention and control arms.&#xD;
&#xD;
      Aim 3: Develop a social support intervention linked to real-time adherence monitoring and&#xD;
      assess its acceptability, feasibility and preliminary impact on adherence. Members of&#xD;
      pre-existing social support networks for the same 40 TB-infected individuals in the two&#xD;
      intervention arms described in Aim 2 above will be recruited to receive real-time SMS&#xD;
      notification of sustained non-adherence (i.e., gaps of &gt;24 hours) over the latter four months&#xD;
      of follow-up. The investigators will continue to follow the 20 TB-infected individuals in the&#xD;
      control group (i.e., electronic monitoring alone) to estimate the effect size of the&#xD;
      intervention on adherence at the end of the six-month period. Qualitative interviews to&#xD;
      understand the experiences of participants in each study arm and the social supporters with&#xD;
      special emphasis on understanding mechanisms of effects of the SMS reminders, forms and&#xD;
      dynamics of support, experiences with the SMS reminders/notifications, and technical problems&#xD;
      encountered will be conducted. The results of Aim 3 will be used to determine the types of&#xD;
      SMS (fixed versus linked SMS), and the nature of social support that shows the most promise&#xD;
      for real time intervention on anti-TB medication adherence and cure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>Participants will be randomized using the 1:1:1 allocation ratio to the following arms: 1) Fixed and linked SMS reminders, 2) SMS notifications to social supporters, and 3) no SMS (control). All participants will have adherence monitored in real-time for 6 months.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent adherence</measure>
    <time_frame>12 Weeks</time_frame>
    <description>SPSS (statistical package for social scientists) will be used, to determine the mean (standard deviation), median (interquartile range), number of late doses, number of missed doses, and number of hour gaps in adherence as determined by Wisepill for each stage of the intervention, as well as for the control group. The Investigator will compare adherence during each type of SMS reminder with adherence during the matched time period for the control group using T-tests (or Mann-Whitney U tests, depending on the normality of the data) for continuous data and chi-squared tests for categorical data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment success rate.</measure>
    <time_frame>24 Weeks</time_frame>
    <description>The Investigator will determine the mechanisms of effect and context of an integrated adherence monitoring, SMS reminders and social support interventions.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Arm A will receive a Wisepill device for Real- time monitoring plus Daily SMS reminders plus Social Supporter notifications (for 3 months) sent according to participant's preferred time and then shall receive Linked SMS for missed dose (Right after missed dose) plus Social Support notifications (3 months).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Arm B will receive a wisepill device for Real-time monitoring plus Weekly SMS reminders plus Social support notifications (for 3 months) sent according to participant's preferred time and date and then shall receive Linked SMS for missed dose (Right after missed dose) plus Social Support notifications (3 months).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in Arm C will receive only the Wise pill device (No SMS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Daily SMS reminders for TB patients</intervention_name>
    <description>Daily SMS Medication reminders will be sent to TB patients to remind them take their medications.</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMS Notifications for social supporters</intervention_name>
    <description>SMS Notifications will be sent to social supporters to assit TB patients take their medication</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Weekly SMS remiders</intervention_name>
    <description>Weekly SMS reminders sent to TB patients to remind them take medication</description>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria for Wisepill participants:&#xD;
&#xD;
          -  Newly diagnosed with TB per the clinic records&#xD;
&#xD;
          -  Starting TB treatment now or within the next two weeks&#xD;
&#xD;
          -  Age 18 years and older&#xD;
&#xD;
          -  Live in the Mbarara District (20 km from MRRH)&#xD;
&#xD;
          -  Own a cell phone for personal use and have reliable cellular phone reception at home&#xD;
             on networks (MTN or Airtel) supported by the technology used in this study&#xD;
&#xD;
          -  Know how to use SMS&#xD;
&#xD;
          -  Willing and able to give consent&#xD;
&#xD;
          -  Willing and able to name one or two social supporters who are able to use SMS and have&#xD;
             cellular phones using network provider (MTN or Airtel) supported by the technology&#xD;
             used in this study.&#xD;
&#xD;
        Exclusion Criteria for Wisepill Participants:&#xD;
&#xD;
          -  Unable to use SMS (The investigators will train and test this skill at recruitment)&#xD;
&#xD;
          -  Unwilling to receive SMS reminder&#xD;
&#xD;
          -  Severe mental condition limiting the ability to provide consent&#xD;
&#xD;
          -  Cellular phone reception is not reliable&#xD;
&#xD;
        Inclusion Criteria for Social Supporters&#xD;
&#xD;
          -  Know a Wisepill participant and be aware s/he has TB&#xD;
&#xD;
          -  Have provided help to that Wisepill participant at least once, i.e,&#xD;
&#xD;
               -  Helping him/her get to clinic by loaning or giving money, driving the patient ,&#xD;
                  or taking care of his/her job or children while he/she is away&#xD;
&#xD;
               -  Helping the patient take medicines through encouragement or reminders&#xD;
&#xD;
               -  Motivating the patient to take medicines, including addressing cognitive and&#xD;
                  behavioral barriers such as depression and alcohol use&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Live in Mbarara District (within 20 KM from MRRH)&#xD;
&#xD;
          -  Willing and able to provide consent.&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Unable to use SMS (Investigators will train and test this skill at recruitment)&#xD;
&#xD;
          -  Unwilling to receive SMS reminder&#xD;
&#xD;
          -  Severe mental condition limiting the ability to provide consent&#xD;
&#xD;
          -  Cellular phone reception is not reliable&#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_contact>
    <last_name>Angella Musiimenta, PhD</last_name>
    <phone>+256776820598</phone>
    <email>amusiimenta@must.ac.ug</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mbarara Regional Referral Hospital</name>
      <address>
        <city>Mbarara</city>
        <country>Uganda</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aaron Mugaba, BSc</last_name>
      <phone>+256772865984</phone>
      <email>aaronmugabaam@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <reference>
    <citation>Musiimenta A. Social and Institutional issues in the Adoption of School-based Technology-aided Sexual Health Education Program. Online J Public Health Inform. 2013 Jul 1;5(2):213. doi: 10.5210/ojphi.v5i2.4654. Print 2013.</citation>
    <PMID>23923098</PMID>
  </reference>
  <reference>
    <citation>Musiimenta A. A Controlled Pre-Post Evaluation of a Computer-based HIV/AIDS Education on Students' Sexual Behaviors, Knowledge and Attitudes. Online J Public Health Inform. 2012;4(1):ojphi.v4i1.4017. doi: 10.5210/ojphi.v4i1.4017. Epub 2012 May 17.</citation>
    <PMID>23569630</PMID>
  </reference>
  <reference>
    <citation>Musiimenta A. Contextual Mediators influencing the Effectiveness of Behavioural Change Interventions: A Case of HIV/AIDS Prevention Behaviours. Online J Public Health Inform. 2012;4(2):ojphi.v4i2.3988. doi: 10.5210/ojphi.v4i2.3988. Epub 2012 Sep 14.</citation>
    <PMID>23569636</PMID>
  </reference>
  <reference>
    <citation>Liu X, Lewis JJ, Zhang H, Lu W, Zhang S, Zheng G, Bai L, Li J, Li X, Chen H, Liu M, Chen R, Chi J, Lu J, Huan S, Cheng S, Wang L, Jiang S, Chin DP, Fielding KL. Effectiveness of Electronic Reminders to Improve Medication Adherence in Tuberculosis Patients: A Cluster-Randomised Trial. PLoS Med. 2015 Sep 15;12(9):e1001876. doi: 10.1371/journal.pmed.1001876. eCollection 2015 Sep.</citation>
    <PMID>26372470</PMID>
  </reference>
  <reference>
    <citation>Nglazi MD, Bekker LG, Wood R, Hussey GD, Wiysonge CS. Mobile phone text messaging for promoting adherence to anti-tuberculosis treatment: a systematic review. BMC Infect Dis. 2013 Dec 2;13:566. doi: 10.1186/1471-2334-13-566.</citation>
    <PMID>24295439</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Real-time</keyword>
  <keyword>Medication Adherence</keyword>
  <keyword>Tuberculosis</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>
  </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/NCT03800888
org study id: MUST-16/10-16
nct id: NCT03800888
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With an estimated 60,000 people diagnosed with TB (Tuberculosis) annually, Uganda holds the
      16th position of the 22 countries with highest cases of TB in the world. The Uganda national
      target of utilizing the DOTS (Direct Observed Treatment Short Course) to successfully treat
      85% of patients diagnosed with TB has not been met. Currently, the country only detects 49.6%
      TB case detection, of which it successfully treats 73%. The DOTS strategy has suffered many
      socioeconomic challenges, which have resulted into its abandonment by many of the Ugandan
      hospitals. Poor TB medication adherence greatly attribute to the many cases of TB in Uganda.
      Causes of non-adherence to TB medication include lack of patient follow-up, patients' lack of
      transport to go to the clinics to pick up drugs, patients' forgetfulness. There is evidence
      that real time adherence monitoring linked with SMS reminders and social support
      notifications can address barriers to sustained ART (antiretroviral therapy) adherence. Such
      novel interventions addressing TB medication adherence challenges in low resource settings to
      date are limited. The prevailing SMS-based studies for TB medication adherence report mixed
      results, do not strategically link interventions with missed doses, and have largely been
      implemented in developed countries. To date, little is known about the use of real-time
      adherence monitoring technologies for TB medication adherence in resource-limited settings.

      The goal of this research is to investigate the use of real time adherence monitoring
      technology linked with SMS reminders and notifications for TB medication adherence in rural
      southwestern Uganda.

      The investigator will develop and quantitatively test a real-time adherence monitoring
      intervention with 60 individuals initiating TB treatment, and 40 social supporters. The
      investigator will randomize participants (1:1:1) to the following arms: 1) Fixed and linked
      SMS reminders, 2) SMS notifications to social supporters, and 3) no SMS (control). All
      participants will have adherence monitored in real-time for 6 months.
This study has three major aims (Aims 1, 2 and 3)

      Aim 1: Carry out a formative qualitative study to assess barriers and facilitators to TB
      medication adherence, and identify optimal SMS reminders, notifications, and initial
      feasibility of real time adherence monitoring. 35 TB patients will be recruited from the TB
      clinic in Mbarara Regional Referral Hospital (MRRH), and up to 15 social supporters specified
      by the TB patients (one per TB patient). Drawing from technology adoption and behavioral
      change models, the investigator will use semi-structured interviews to assess the initial
      feasibility and acceptability of the intervention, as well the barriers and facilitators to
      TB medication adherence, and how they can be addressed using the proposed intervention. The
      purpose will be to inform the development the technology necessary to conduct a real-time
      intervention involving a wireless monitor and SMS reminders and notifications (Aim 2 and 3).

      Aim 2: Develop a TB medication adherence intervention based on SMS reminders (fixed and/or
      linked to real-time detection of missed doses) and assess its acceptability, feasibility and
      preliminary impact on adherence.

      The Investigators will use real-time electronic adherence monitoring (i.e., Wisepill) to
      follow 60 TB-infected individuals initiating TB treatment in Mbarara Regional Referral
      Hospital (MRRH) for six months. Using a 1:1:1 manner, participants will be randomized to one
      of the following three study arms (details of each intervention will be informed by the data
      collected in Aim 1):

        1. Intervention Arm A: SMS reminders on a fixed schedule

        2. Intervention Arm B: SMS reminders linked to missed doses

        3. Control: No SMS reminders.

      Qualitative interviews to understand the patients experiences with Wisepill adherence
      monitoring and the SMS reminders will be carried out, depending on the study arm to which
      they are assigned. The first set of interviews for Arms A and B will be conducted at the end
      of Month 3 of the study. The second set of interviews is planned to be conducted within two
      weeks after the first 24+ hour lapse in Wisepill signal for the participants in the
      intervention arms (A and B). If there is no 24+ hour lapse, the interview will take place at
      the end of the study. The control participants in Arm C's interview will occur at a
      convenient time during Months 3-6. The effect sizes will be estimated by comparing adherence
      at the end of six months between each intervention group and the control group. The primary
      outcome will be percent adherence.

      Treatment outcomes will be defined according to WHO definitions, where cure and completed
      treatment are defined as successful treatment outcomes (WHO 2014). Unsuccessful treatment
      outcomes for active TB treatment will include death ascertained from hospital death registry,
      treatment failure (sputum smear positive at 6 months) and loss to follow-up. Treatment
      outcomes will be compared for both intervention and control arms.

      Aim 3: Develop a social support intervention linked to real-time adherence monitoring and
      assess its acceptability, feasibility and preliminary impact on adherence. Members of
      pre-existing social support networks for the same 40 TB-infected individuals in the two
      intervention arms described in Aim 2 above will be recruited to receive real-time SMS
      notification of sustained non-adherence (i.e., gaps of >24 hours) over the latter four months
      of follow-up. The investigators will continue to follow the 20 TB-infected individuals in the
      control group (i.e., electronic monitoring alone) to estimate the effect size of the
      intervention on adherence at the end of the six-month period. Qualitative interviews to
      understand the experiences of participants in each study arm and the social supporters with
      special emphasis on understanding mechanisms of effects of the SMS reminders, forms and
      dynamics of support, experiences with the SMS reminders/notifications, and technical problems
      encountered will be conducted. The results of Aim 3 will be used to determine the types of
      SMS (fixed versus linked SMS), and the nature of social support that shows the most promise
      for real time intervention on anti-TB medication adherence and cure.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized using the 1:1:1 allocation ratio to the following arms: 1) Fixed and linked SMS reminders, 2) SMS notifications to social supporters, and 3) no SMS (control). All participants will have adherence monitored in real-time for 6 months.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Percent adherence
time frame: 12 Weeks
description: SPSS (statistical package for social scientists) will be used, to determine the mean (standard deviation), median (interquartile range), number of late doses, number of missed doses, and number of hour gaps in adherence as determined by Wisepill for each stage of the intervention, as well as for the control group. The Investigator will compare adherence during each type of SMS reminder with adherence during the matched time period for the control group using T-tests (or Mann-Whitney U tests, depending on the normality of the data) for continuous data and chi-squared tests for categorical data.
measure: Treatment success rate.
time frame: 24 Weeks
description: The Investigator will determine the mechanisms of effect and context of an integrated adherence monitoring, SMS reminders and social support interventions.
arm group label: Arm A
arm group type: Experimental
description: Participants in Arm A will receive a Wisepill device for Real- time monitoring plus Daily SMS reminders plus Social Supporter notifications (for 3 months) sent according to participant's preferred time and then shall receive Linked SMS for missed dose (Right after missed dose) plus Social Support notifications (3 months).
arm group label: Arm B
arm group type: Experimental
description: Participants in Arm B will receive a wisepill device for Real-time monitoring plus Weekly SMS reminders plus Social support notifications (for 3 months) sent according to participant's preferred time and date and then shall receive Linked SMS for missed dose (Right after missed dose) plus Social Support notifications (3 months).
arm group label: Arm C
arm group type: No Intervention
description: Participants in Arm C will receive only the Wise pill device (No SMS)
intervention type: Other
intervention name: Daily SMS reminders for TB patients
description: Daily SMS Medication reminders will be sent to TB patients to remind them take their medications.
arm group label: Arm A
intervention type: Other
intervention name: SMS Notifications for social supporters
description: SMS Notifications will be sent to social supporters to assit TB patients take their medication
arm group label: Arm A
arm group label: Arm B
intervention type: Other
intervention name: Weekly SMS remiders
description: Weekly SMS reminders sent to TB patients to remind them take medication
arm group label: Arm B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Angella Musiimenta, PhD
phone: +256776820598
email: amusiimenta@must.ac.ug
facility: 
status: Recruiting
contact: 
country: Uganda
citation: Musiimenta A. Social and Institutional issues in the Adoption of School-based Technology-aided Sexual Health Education Program. Online J Public Health Inform. 2013 Jul 1;5(2):213. doi: 10.5210/ojphi.v5i2.4654. Print 2013.
PMID: 23923098
citation: Musiimenta A. A Controlled Pre-Post Evaluation of a Computer-based HIV/AIDS Education on Students' Sexual Behaviors, Knowledge and Attitudes. Online J Public Health Inform. 2012;4(1):ojphi.v4i1.4017. doi: 10.5210/ojphi.v4i1.4017. Epub 2012 May 17.
PMID: 23569630
citation: Musiimenta A. Contextual Mediators influencing the Effectiveness of Behavioural Change Interventions: A Case of HIV/AIDS Prevention Behaviours. Online J Public Health Inform. 2012;4(2):ojphi.v4i2.3988. doi: 10.5210/ojphi.v4i2.3988. Epub 2012 Sep 14.
PMID: 23569636
citation: Liu X, Lewis JJ, Zhang H, Lu W, Zhang S, Zheng G, Bai L, Li J, Li X, Chen H, Liu M, Chen R, Chi J, Lu J, Huan S, Cheng S, Wang L, Jiang S, Chin DP, Fielding KL. Effectiveness of Electronic Reminders to Improve Medication Adherence in Tuberculosis Patients: A Cluster-Randomised Trial. PLoS Med. 2015 Sep 15;12(9):e1001876. doi: 10.1371/journal.pmed.1001876. eCollection 2015 Sep.
PMID: 26372470
citation: Nglazi MD, Bekker LG, Wood R, Hussey GD, Wiysonge CS. Mobile phone text messaging for promoting adherence to anti-tuberculosis treatment: a systematic review. BMC Infect Dis. 2013 Dec 2;13:566. doi: 10.1186/1471-2334-13-566.
PMID: 24295439
responsible party type: Sponsor
mesh term: Tuberculosis
sharing ipd: No