<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/NCT04506918</url>
  </required_header>
  <id_info>
    <org_study_id>00007318 - abc</org_study_id>
    <nct_id>NCT04506918</nct_id>
  </id_info>
  <brief_title>Comparison of SMS and IVR Surveys in Tanzania</brief_title>
  <official_title>Comparison of Short Message Service (SMS) and Interactive Voice Response (IVR) Mobile Phone Surveys for Non-communicable Disease Risk Factor Surveillance in Tanzania</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ifakara Health Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</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>
      This study focuses on mechanisms to adapt the performance of interactive voice response (IVR)&#xD;
      and short message service (SMS) surveys conducted in low-and middle-income (LMIC) setting&#xD;
      (Tanzania) and evaluates how the two survey modalities (IVR and SMS) affect survey metrics,&#xD;
      including response, completion and attrition rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using random digit dialing (RDD) sampling technique, participants will be randomized to one&#xD;
      of two arms : 1) IVR or 2) SMS. Participants in the first study arm will receive an IVR&#xD;
      survey. Participants in the second study arm will receive a SMS survey. The IVR and SMS&#xD;
      questionnaires contain a set of demographic questions and one non-communicable disease (NCD)&#xD;
      module (alcohol, or tobacco, or diet, or physical activity, or blood pressure and diabetes).&#xD;
      We will examine contact, response, refusal and cooperation rates and demographic&#xD;
      representativeness by each study arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 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 to one of two arms : 1) IVR or 2) SMS. Participants in the first study arm will receive an IVR survey. Participants in the second study arm will receive a SMS survey.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cooperation Rate #1</measure>
    <time_frame>Through study completion, an average of one month</time_frame>
    <description>As defined by American Association for Public Opinion Research, cooperation rate is defined as I/(I+P+R) where I is the number of participants with complete interviews, P is the number of participants with partial interviews, and R is the number of participants with refusals and breakoffs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response Rate #4</measure>
    <time_frame>Through study completion, an average of one month</time_frame>
    <description>As defined by American Association for Public Opinion Research, response rate is defined as (I+P)/(I+P+R+eU) where I is the number of participants with complete interviews, P is the number of participants with partial interviews, R is the number of participants with refusals and breakoffs, and eU is the estimated eligible proportion of unknowns</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Refusal Rate #2</measure>
    <time_frame>Through study completion, an average of one month</time_frame>
    <description>As defined by American Association for Public Opinion Research, refusal rate is defined as (R)/(I+P+R+eU) where R is the number of participants with refusals and breakoffs, I is the number of participants with complete interviews, P is the number of participants with partial interviews, and eU is the estimated eligible proportion of unknowns</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contact Rate #2</measure>
    <time_frame>Through study completion, an average of one month</time_frame>
    <description>As defined by American Association for Public Opinion Research, contact rate is defined as (I+P+R)/(I+P+R+eU) where I is the number of participants with complete interviews, P is the number of participants with partial interviews, R is the number of participants with refusals and breakoffs, and eU is the estimated eligible proportion of unknowns</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6483</enrollment>
  <condition>Surveys and Questionnaires</condition>
  <condition>Noncommunicable Diseases</condition>
  <arm_group>
    <arm_group_label>IVR survey</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an IVR survey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMS survey</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an SMS survey</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IVR survey</intervention_name>
    <description>Participants will receive an IVR survey</description>
    <arm_group_label>IVR survey</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMS survey</intervention_name>
    <description>Participants will receive a SMS survey</description>
    <arm_group_label>SMS survey</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Access to a mobile phone&#xD;
&#xD;
          -  Greater or equal to 18 years of age&#xD;
&#xD;
          -  Conversant in the Swahili language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dustin Gibson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University Bloomberg School of Public Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Honorati Masanja, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ifakara Health Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ifakara Health Institute</name>
      <address>
        <city>Dar Es Salaam</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <reference>
    <citation>Gibson DG, Pariyo GW, Wosu AC, Greenleaf AR, Ali J, Ahmed S, Labrique AB, Islam K, Masanja H, Rutebemberwa E, Hyder AA. Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol. JMIR Res Protoc. 2017 May 5;6(5):e81. doi: 10.2196/resprot.7534.</citation>
    <PMID>28476729</PMID>
  </reference>
  <reference>
    <citation>Gibson DG, Pereira A, Farrenkopf BA, Labrique AB, Pariyo GW, Hyder AA. Mobile Phone Surveys for Collecting Population-Level Estimates in Low- and Middle-Income Countries: A Literature Review. J Med Internet Res. 2017 May 5;19(5):e139. doi: 10.2196/jmir.7428.</citation>
    <PMID>28476725</PMID>
  </reference>
  <reference>
    <citation>Gibson DG, Farrenkopf BA, Pereira A, Labrique AB, Pariyo GW. The Development of an Interactive Voice Response Survey for Noncommunicable Disease Risk Factor Estimation: Technical Assessment and Cognitive Testing. J Med Internet Res. 2017 May 5;19(5):e112. doi: 10.2196/jmir.7340.</citation>
    <PMID>28476724</PMID>
  </reference>
  <reference>
    <citation>Hyder AA, Wosu AC, Gibson DG, Labrique AB, Ali J, Pariyo GW. Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda. J Med Internet Res. 2017 May 5;19(5):e133. doi: 10.2196/jmir.7246.</citation>
    <PMID>28476722</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mobile phone surveys</keyword>
  <keyword>interactive voice response</keyword>
  <keyword>short message service</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Noncommunicable Diseases</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/NCT04506918
org study id: 00007318 - abc
nct id: NCT04506918
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study focuses on mechanisms to adapt the performance of interactive voice response (IVR)
      and short message service (SMS) surveys conducted in low-and middle-income (LMIC) setting
      (Tanzania) and evaluates how the two survey modalities (IVR and SMS) affect survey metrics,
      including response, completion and attrition rates.
Using random digit dialing (RDD) sampling technique, participants will be randomized to one
      of two arms : 1) IVR or 2) SMS. Participants in the first study arm will receive an IVR
      survey. Participants in the second study arm will receive a SMS survey. The IVR and SMS
      questionnaires contain a set of demographic questions and one non-communicable disease (NCD)
      module (alcohol, or tobacco, or diet, or physical activity, or blood pressure and diabetes).
      We will examine contact, response, refusal and cooperation rates and demographic
      representativeness by each study arm.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized to one of two arms : 1) IVR or 2) SMS. Participants in the first study arm will receive an IVR survey. Participants in the second study arm will receive a SMS survey.
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Cooperation Rate #1
time frame: Through study completion, an average of one month
description: As defined by American Association for Public Opinion Research, cooperation rate is defined as I/(I+P+R) where I is the number of participants with complete interviews, P is the number of participants with partial interviews, and R is the number of participants with refusals and breakoffs.
measure: Response Rate #4
time frame: Through study completion, an average of one month
description: As defined by American Association for Public Opinion Research, response rate is defined as (I+P)/(I+P+R+eU) where I is the number of participants with complete interviews, P is the number of participants with partial interviews, R is the number of participants with refusals and breakoffs, and eU is the estimated eligible proportion of unknowns
measure: Refusal Rate #2
time frame: Through study completion, an average of one month
description: As defined by American Association for Public Opinion Research, refusal rate is defined as (R)/(I+P+R+eU) where R is the number of participants with refusals and breakoffs, I is the number of participants with complete interviews, P is the number of participants with partial interviews, and eU is the estimated eligible proportion of unknowns
measure: Contact Rate #2
time frame: Through study completion, an average of one month
description: As defined by American Association for Public Opinion Research, contact rate is defined as (I+P+R)/(I+P+R+eU) where I is the number of participants with complete interviews, P is the number of participants with partial interviews, R is the number of participants with refusals and breakoffs, and eU is the estimated eligible proportion of unknowns
arm group label: IVR survey
arm group type: Experimental
description: Participants will receive an IVR survey
arm group label: SMS survey
arm group type: Experimental
description: Participants will receive an SMS survey
intervention type: Other
intervention name: IVR survey
description: Participants will receive an IVR survey
arm group label: IVR survey
intervention type: Other
intervention name: SMS survey
description: Participants will receive a SMS survey
arm group label: SMS survey
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dustin Gibson, PhD
role: Principal Investigator
affiliation: Johns Hopkins University Bloomberg School of Public Health
last name: Honorati Masanja, PhD
role: Principal Investigator
affiliation: Ifakara Health Institute
facility: 
country: Tanzania
citation: Gibson DG, Pariyo GW, Wosu AC, Greenleaf AR, Ali J, Ahmed S, Labrique AB, Islam K, Masanja H, Rutebemberwa E, Hyder AA. Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol. JMIR Res Protoc. 2017 May 5;6(5):e81. doi: 10.2196/resprot.7534.
PMID: 28476729
citation: Gibson DG, Pereira A, Farrenkopf BA, Labrique AB, Pariyo GW, Hyder AA. Mobile Phone Surveys for Collecting Population-Level Estimates in Low- and Middle-Income Countries: A Literature Review. J Med Internet Res. 2017 May 5;19(5):e139. doi: 10.2196/jmir.7428.
PMID: 28476725
citation: Gibson DG, Farrenkopf BA, Pereira A, Labrique AB, Pariyo GW. The Development of an Interactive Voice Response Survey for Noncommunicable Disease Risk Factor Estimation: Technical Assessment and Cognitive Testing. J Med Internet Res. 2017 May 5;19(5):e112. doi: 10.2196/jmir.7340.
PMID: 28476724
citation: Hyder AA, Wosu AC, Gibson DG, Labrique AB, Ali J, Pariyo GW. Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda. J Med Internet Res. 2017 May 5;19(5):e133. doi: 10.2196/jmir.7246.
PMID: 28476722
responsible party type: Sponsor
mesh term: Noncommunicable Diseases
sharing ipd: No