<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/NCT03808597</url>
  </required_header>
  <id_info>
    <org_study_id>DigI</org_study_id>
    <nct_id>NCT03808597</nct_id>
  </id_info>
  <brief_title>Digital Health Promotion in Iringa, Tanzania</brief_title>
  <official_title>Free Digital Health Education for Diseases of Public Health Importance (HIV, Tuberculosis and Taenia Solium Cysticercosis/Taeniosis) in Iringa, Tanzania</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Medical Research, Tanzania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sokoine University of Agriculture</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oslo</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>
      Increased health education has the potential to facilitate better use of health care services&#xD;
      and to promote early treatment, thus it can strengthen the health care system, and ultimately&#xD;
      reduce morbidity and mortality. In this study, we will develop and test the effect of digital&#xD;
      health messages related to HIV, Tuberculosis (TB) and Taenia solium cysticercosis/taeniosis&#xD;
      (TSCT) (the intervention diseases) in Migoli and Izazi (the intervention villages), in&#xD;
      Iringa, Tanzania (TZ).&#xD;
&#xD;
      The intervention is planned as follows: A digital platform, providing the intervention&#xD;
      villages with digital health messages related to the above-mentioned diseases, will be&#xD;
      implemented in TZ in 2019. The platform will be accessible free of charge, through own&#xD;
      devices and tablets based in the local Wi-Fi spots in the villages.&#xD;
&#xD;
      In the first part of this project, the doctoral research fellow will participate in&#xD;
      developing the digital health messages, together with experts from the medical and teaching&#xD;
      environments in Tanzania, Norway, Germany and USA.&#xD;
&#xD;
      The second part of the PhD-project consists of a cluster non-randomised controlled trial and&#xD;
      semi-structured interviews in Tanzania. The digital health messages will be physically shown&#xD;
      to the participants in the intervention group. The study is planned to investigate the&#xD;
      knowledge related to the intervention diseases, before the intervention, immediately after&#xD;
      exposure to the intervention, and at follow-up points throughout one year, after the&#xD;
      intervention has been implemented. Semi-structured interviews with clients (users of the&#xD;
      intervention) from each of the intervention villages are included, to explore the perception&#xD;
      and reception of the intervention.&#xD;
&#xD;
      The baseline study and the immediate after survey will take place in Tanzania in Q1 2019,&#xD;
      while the other follow-up studies and interviews (3, 6 and 12 months after baseline) will be&#xD;
      undertaken throughout one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction This protocol is registered in Helseforsk, University of Oslo, and the project&#xD;
      has been assessed by Norwegian Centre for Research Data (NSD), ref. number 59643. Ethical&#xD;
      approval from the National Institute for Medical Research (NIMR), Tanzania, has been granted&#xD;
      with the reference number NIMR/HQ/R.8a/Vol IX/2947.&#xD;
&#xD;
      The PhD-project consist of three work packages (WPs): WP1: A systematic review and&#xD;
      meta-analysis, WP2: A cluster non-randomised controlled trial and WP3: Semi-structured&#xD;
      interviews with clients in the intervention group. Only WP2 and WP3 are elaborated upon in&#xD;
      this protocol.&#xD;
&#xD;
      The planned research project will be included as a health-research component in the Norwegian&#xD;
      Government- and Norwegian Research Council- funded innovation project &quot;Non-discriminating&#xD;
      access for Digital Inclusion&quot; (DigI). The project runs from January 2017 to September 2020.&#xD;
      Altogether 11 partners from eight countries are collaborating on the project. Professor Josef&#xD;
      Noll from the Dept. of Technology Systems (ITS), University of Oslo (UiO), is the project&#xD;
      owner, and the doctoral research fellow's co- supervisor. Responsible for the health-research&#xD;
      component and main supervisor of the doctoral research fellow, is Professor Dr. Andrea&#xD;
      Winkler at the Institute of Health and Society, UiO. Head in TZ, is Dr. Bernard Ngowi&#xD;
      (HIV/AIDS and TB specialist) from NIMR and Associate professor Helena Ngowi (TSCT specialist)&#xD;
      from Sokoine University of Agriculture (SUA). Associate professor Maurice Isabwe from Dept.&#xD;
      of Information and Communication Technology at University of Agder is head of developing the&#xD;
      digital health messages. This study is thus multicentre with several institutions responsible&#xD;
      for research.&#xD;
&#xD;
      In Tanzania, DigI will facilitate a digital health education platform, where digital health&#xD;
      messages related to HIV / AIDS, Tuberculosis (TB) and Taenia solium cysticercosis/taeniosis&#xD;
      (TSCT) will be transferred to the community; hereby called clients, defined by the World&#xD;
      Health Organization (2017) as &quot;members of the public that are potential or current users of&#xD;
      health services, including promotion activities&quot; .&#xD;
&#xD;
      The digital health messages will be accessible at a Wi-Fi spot in the local village close to&#xD;
      the local health post. The digital health messages will also be shown face-to-face to each of&#xD;
      the participants in the intervention group, by enumerators in the research team from SUA and&#xD;
      the doctoral research fellow. The intervention will be available for all clients in the&#xD;
      intervention villages, not only for the participants in the study described in this protocol.&#xD;
&#xD;
      The intervention will be maintained by NIMR Muhimbili Centre in Dar es Salaam during the&#xD;
      first phase, but is going to be managed as a sustainable business model where a local sales&#xD;
      man or woman is selling vouchers to access the World Wide Web. NIMR have close contact with&#xD;
      the village authorities and health workers in the intervention villages, and will be alerted&#xD;
      if the intervention for some reason is not functioning. The Wi-Fi network that provides the&#xD;
      access to the digital health education platform, reaches within a radius of 50 meters, and is&#xD;
      driven by a solar panel. This means that the intervention will be accessible even if the&#xD;
      electricity locally shuts down.&#xD;
&#xD;
      Background and Rationale Today's education channels are changing, thus health education&#xD;
      interventions must meet the target population at their own level of technology, and further&#xD;
      do rely upon the characteristics of the technology available. A useful tool to deliver&#xD;
      education and improve health seeking behaviour and health-related lifestyle decisions, is&#xD;
      mobile technologies, because they make people more contactable. Health seeking behaviour may&#xD;
      change after the target group has been exposed to adequate health messages that provide&#xD;
      relevant information to the target population, , thus digital health information can&#xD;
      contribute to prevention and management of diseases.&#xD;
&#xD;
      Digital health and digital health education Digital health is defined by World Health&#xD;
      Organization (2016) as &quot;The use of digital, mobile and wireless technologies to support the&#xD;
      achievement of health objectives. Digital health describes the general use of information and&#xD;
      communications technologies (ICT) for health and is inclusive of both mHealth (mobile health)&#xD;
      and eHealth (electronic health)&quot; . eHealth is defined by the WHO (2005) as &quot;the&#xD;
      cost-effective and secure use of information and communications technologies in support of&#xD;
      health and health-related fields, including health-care services, health surveillance, health&#xD;
      literature, and health education, knowledge and research&quot; . mHealth is a component of&#xD;
      eHealth, and commonly referred to as the use of mobile and wireless technologies for health.&#xD;
      WHO (2011) defines it as: &quot;medical and public health practice supported by mobile devices,&#xD;
      such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and&#xD;
      other wireless devices&quot; .&#xD;
&#xD;
      Health behaviour change may reduce the burden of preventable disease and death around the&#xD;
      world, &quot;as health education covers the continuum from disease prevention and promotion of&#xD;
      optimal health to the detection of illness to treatment, rehabilitation, and long-term care&quot;&#xD;
      .&#xD;
&#xD;
      The use of eHealth is now understood as central in order to provide more care and better care&#xD;
      to more people, especially those most in need. A key part of the Sustainable Development Goal&#xD;
      3 relates to reaching people with the information they need in order to live healthier lives,&#xD;
      and eHealth is regarded as a tool to reach the public with health messages and support, as&#xD;
      well as encouraging clients to take active roles in their health and wellbeing (ibid).&#xD;
&#xD;
      The use of smart devices and mobile data services are rapidly changing, and it is likely that&#xD;
      an increasingly part of the population in for example Sub-Saharan Africa will have access to&#xD;
      both in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Baseline Health knowledge score</measure>
    <time_frame>One day</time_frame>
    <description>Score calculated from the questionnaire with questions related to HIV, TB and TSCT. The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Health knowledge score, immediately after exposure</measure>
    <time_frame>One day</time_frame>
    <description>Score calculated from the questionnaire with questions related to HIV, TB and TSCT. Comparison between baseline score and immediate post intervention score.&#xD;
The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Health knowledge score at 3 months</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Score calculated from the questionnaire with questions related to HIV, TB and TSCT. Comparison between baseline score and post intervention (3 months) score.&#xD;
The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Health knowledge score at 6 months</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Score calculated from the questionnaire with questions related to HIV, TB and TSCT. Comparison between baseline score and post intervention (6 months) score.&#xD;
The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Health knowledge score at 12 months</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Score calculated from the questionnaire with questions related to HIV, TB and TSCT. Comparison between baseline score and post intervention (12 months) score.&#xD;
The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participants own perspectives on the intervention (qualitative)</measure>
    <time_frame>One hour</time_frame>
    <description>In order to get complimentary qualitative data, 8-10 semi-structured interviews with clients from the intervention villages will be conducted. The main aim is to get people to reveal their own perspectives related to the intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>HIV Infections</condition>
  <condition>Tuberculosis</condition>
  <condition>Cysticercosis</condition>
  <condition>Tapeworm Pork</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in this group will be exposed to digital health promotion. Please note that the participants are not randomly chosen, but stratified after the project villages. The participants in this group belong to the villages: Izazi and Migoli.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants in this group will be not be exposed to digital health promotion, but the villages will receive the intervention after one year. Please note that the participants are not randomly chosen, but stratified after the project villages.&#xD;
The participants in this group belong to the villages: Kimande and Idodi.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Digital health promotion intervention</intervention_name>
    <description>Digital health promition related to HIV, Tuberculosis and TSCT in a digital format.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Living in the selected household (15-70 years), at least for the past six months, and&#xD;
             at least planning to not move the next 12 months.&#xD;
&#xD;
          -  Must be capable and willing to sign written informed consent and thumb-print for&#xD;
             illiterate participants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planning to be out of the village for more than 6 weeks in the next 12 months&#xD;
&#xD;
          -  Those above 71 or under 15&#xD;
&#xD;
          -  Not capable of signing consent letter (very sick)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea S Winkler, M, PhdD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute for Medical Research / Muhimbili University</name>
      <address>
        <city>Dar es Salaam</city>
        <state>Dar</state>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Idodi</name>
      <address>
        <city>Iringa</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Izazi</name>
      <address>
        <city>Iringa</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kimande</name>
      <address>
        <city>Iringa</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Migoli</name>
      <address>
        <city>Iringa</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sokoine University of Agriculture</name>
      <address>
        <city>Morogoro</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <link>
    <url>https://www.med.uio.no/helsam/english/research/projects/free-digital-health-information-tanzania/index.html</url>
    <description>Research project site University of Oslo</description>
  </link>
  <link>
    <url>https://its-wiki.no/wiki/DigI:Home</url>
    <description>Overarching project site</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Christine Holst</investigator_full_name>
    <investigator_title>Doctoral Research Fellow</investigator_title>
  </responsible_party>
  <keyword>digital health</keyword>
  <keyword>digital health promotion</keyword>
  <keyword>health promotion</keyword>
  <keyword>disease prevention</keyword>
  <keyword>HIV</keyword>
  <keyword>Tuberculosis</keyword>
  <keyword>Cysticercosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Cysticercosis</mesh_term>
    <mesh_term>Taeniasis</mesh_term>
    <mesh_term>Neurocysticercosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>2020</ipd_time_frame>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03808597/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03808597
org study id: DigI
nct id: NCT03808597
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Increased health education has the potential to facilitate better use of health care services
      and to promote early treatment, thus it can strengthen the health care system, and ultimately
      reduce morbidity and mortality. In this study, we will develop and test the effect of digital
      health messages related to HIV, Tuberculosis (TB) and Taenia solium cysticercosis/taeniosis
      (TSCT) (the intervention diseases) in Migoli and Izazi (the intervention villages), in
      Iringa, Tanzania (TZ).

      The intervention is planned as follows: A digital platform, providing the intervention
      villages with digital health messages related to the above-mentioned diseases, will be
      implemented in TZ in 2019. The platform will be accessible free of charge, through own
      devices and tablets based in the local Wi-Fi spots in the villages.

      In the first part of this project, the doctoral research fellow will participate in
      developing the digital health messages, together with experts from the medical and teaching
      environments in Tanzania, Norway, Germany and USA.

      The second part of the PhD-project consists of a cluster non-randomised controlled trial and
      semi-structured interviews in Tanzania. The digital health messages will be physically shown
      to the participants in the intervention group. The study is planned to investigate the
      knowledge related to the intervention diseases, before the intervention, immediately after
      exposure to the intervention, and at follow-up points throughout one year, after the
      intervention has been implemented. Semi-structured interviews with clients (users of the
      intervention) from each of the intervention villages are included, to explore the perception
      and reception of the intervention.

      The baseline study and the immediate after survey will take place in Tanzania in Q1 2019,
      while the other follow-up studies and interviews (3, 6 and 12 months after baseline) will be
      undertaken throughout one year.
Introduction This protocol is registered in Helseforsk, University of Oslo, and the project
      has been assessed by Norwegian Centre for Research Data (NSD), ref. number 59643. Ethical
      approval from the National Institute for Medical Research (NIMR), Tanzania, has been granted
      with the reference number NIMR/HQ/R.8a/Vol IX/2947.

      The PhD-project consist of three work packages (WPs): WP1: A systematic review and
      meta-analysis, WP2: A cluster non-randomised controlled trial and WP3: Semi-structured
      interviews with clients in the intervention group. Only WP2 and WP3 are elaborated upon in
      this protocol.

      The planned research project will be included as a health-research component in the Norwegian
      Government- and Norwegian Research Council- funded innovation project "Non-discriminating
      access for Digital Inclusion" (DigI). The project runs from January 2017 to September 2020.
      Altogether 11 partners from eight countries are collaborating on the project. Professor Josef
      Noll from the Dept. of Technology Systems (ITS), University of Oslo (UiO), is the project
      owner, and the doctoral research fellow's co- supervisor. Responsible for the health-research
      component and main supervisor of the doctoral research fellow, is Professor Dr. Andrea
      Winkler at the Institute of Health and Society, UiO. Head in TZ, is Dr. Bernard Ngowi
      (HIV/AIDS and TB specialist) from NIMR and Associate professor Helena Ngowi (TSCT specialist)
      from Sokoine University of Agriculture (SUA). Associate professor Maurice Isabwe from Dept.
      of Information and Communication Technology at University of Agder is head of developing the
      digital health messages. This study is thus multicentre with several institutions responsible
      for research.

      In Tanzania, DigI will facilitate a digital health education platform, where digital health
      messages related to HIV / AIDS, Tuberculosis (TB) and Taenia solium cysticercosis/taeniosis
      (TSCT) will be transferred to the community; hereby called clients, defined by the World
      Health Organization (2017) as "members of the public that are potential or current users of
      health services, including promotion activities" .

      The digital health messages will be accessible at a Wi-Fi spot in the local village close to
      the local health post. The digital health messages will also be shown face-to-face to each of
      the participants in the intervention group, by enumerators in the research team from SUA and
      the doctoral research fellow. The intervention will be available for all clients in the
      intervention villages, not only for the participants in the study described in this protocol.

      The intervention will be maintained by NIMR Muhimbili Centre in Dar es Salaam during the
      first phase, but is going to be managed as a sustainable business model where a local sales
      man or woman is selling vouchers to access the World Wide Web. NIMR have close contact with
      the village authorities and health workers in the intervention villages, and will be alerted
      if the intervention for some reason is not functioning. The Wi-Fi network that provides the
      access to the digital health education platform, reaches within a radius of 50 meters, and is
      driven by a solar panel. This means that the intervention will be accessible even if the
      electricity locally shuts down.

      Background and Rationale Today's education channels are changing, thus health education
      interventions must meet the target population at their own level of technology, and further
      do rely upon the characteristics of the technology available. A useful tool to deliver
      education and improve health seeking behaviour and health-related lifestyle decisions, is
      mobile technologies, because they make people more contactable. Health seeking behaviour may
      change after the target group has been exposed to adequate health messages that provide
      relevant information to the target population, , thus digital health information can
      contribute to prevention and management of diseases.

      Digital health and digital health education Digital health is defined by World Health
      Organization (2016) as "The use of digital, mobile and wireless technologies to support the
      achievement of health objectives. Digital health describes the general use of information and
      communications technologies (ICT) for health and is inclusive of both mHealth (mobile health)
      and eHealth (electronic health)" . eHealth is defined by the WHO (2005) as "the
      cost-effective and secure use of information and communications technologies in support of
      health and health-related fields, including health-care services, health surveillance, health
      literature, and health education, knowledge and research" . mHealth is a component of
      eHealth, and commonly referred to as the use of mobile and wireless technologies for health.
      WHO (2011) defines it as: "medical and public health practice supported by mobile devices,
      such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and
      other wireless devices" .

      Health behaviour change may reduce the burden of preventable disease and death around the
      world, "as health education covers the continuum from disease prevention and promotion of
      optimal health to the detection of illness to treatment, rehabilitation, and long-term care"
      .

      The use of eHealth is now understood as central in order to provide more care and better care
      to more people, especially those most in need. A key part of the Sustainable Development Goal
      3 relates to reaching people with the information they need in order to live healthier lives,
      and eHealth is regarded as a tool to reach the public with health messages and support, as
      well as encouraging clients to take active roles in their health and wellbeing (ibid).

      The use of smart devices and mobile data services are rapidly changing, and it is likely that
      an increasingly part of the population in for example Sub-Saharan Africa will have access to
      both in the future.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Baseline Health knowledge score
time frame: One day
description: Score calculated from the questionnaire with questions related to HIV, TB and TSCT. The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.
measure: Change from Baseline Health knowledge score, immediately after exposure
time frame: One day
description: Score calculated from the questionnaire with questions related to HIV, TB and TSCT. Comparison between baseline score and immediate post intervention score.
The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.
measure: Change from Baseline Health knowledge score at 3 months
time frame: Up to 3 months
description: Score calculated from the questionnaire with questions related to HIV, TB and TSCT. Comparison between baseline score and post intervention (3 months) score.
The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.
measure: Change from Baseline Health knowledge score at 6 months
time frame: Up to 6 months
description: Score calculated from the questionnaire with questions related to HIV, TB and TSCT. Comparison between baseline score and post intervention (6 months) score.
The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.
measure: Change from Baseline Health knowledge score at 12 months
time frame: Up to 12 months
description: Score calculated from the questionnaire with questions related to HIV, TB and TSCT. Comparison between baseline score and post intervention (12 months) score.
The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.
measure: Participants own perspectives on the intervention (qualitative)
time frame: One hour
description: In order to get complimentary qualitative data, 8-10 semi-structured interviews with clients from the intervention villages will be conducted. The main aim is to get people to reveal their own perspectives related to the intervention.
arm group label: Intervention group
arm group type: Experimental
description: The participants in this group will be exposed to digital health promotion. Please note that the participants are not randomly chosen, but stratified after the project villages. The participants in this group belong to the villages: Izazi and Migoli.
arm group label: Control group
arm group type: No Intervention
description: The participants in this group will be not be exposed to digital health promotion, but the villages will receive the intervention after one year. Please note that the participants are not randomly chosen, but stratified after the project villages.
The participants in this group belong to the villages: Kimande and Idodi.
intervention type: Other
intervention name: Digital health promotion intervention
description: Digital health promition related to HIV, Tuberculosis and TSCT in a digital format.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 15 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrea S Winkler, M, PhdD
role: Study Chair
affiliation: University of Oslo
facility: 
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country: Tanzania
url: https://www.med.uio.no/helsam/english/research/projects/free-digital-health-information-tanzania/index.html
description: Research project site University of Oslo
url: https://its-wiki.no/wiki/DigI:Home
description: Overarching project site
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Christine Holst
investigator title: Doctoral Research Fellow
mesh term: Tuberculosis
mesh term: Cysticercosis
mesh term: Taeniasis
mesh term: Neurocysticercosis
sharing ipd: Yes
ipd info type: Analytic Code
ipd time frame: 2020
provided document: 