<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/NCT03772431</url>
  </required_header>
  <id_info>
    <org_study_id>00007318-3</org_study_id>
    <nct_id>NCT03772431</nct_id>
  </id_info>
  <brief_title>Use of Narrative Voice and Introduction Content to Improve Interactive Voice Response Surveys in Bangladesh and Uganda</brief_title>
  <official_title>A Randomized Controlled Trial of Narrative Voice and Introduction Content to Improve Interactive Voice Response (IVR) Survey Performance in Bangladesh and Uganda</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Bloomberg Family Foundation, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Epidemiology, Disease Control and Research</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 evaluates the effect of two different narrative voices (one male and one female)&#xD;
      and two different introductions (one with informational content and the other with additional&#xD;
      motivational content) on interactive voice response (IVR) survey cooperation, response,&#xD;
      refusal, and contact rates, as compared to a control group (male, informational), in&#xD;
      Bangladesh and Uganda.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using random digit dialing (RDD) sampling techniques, participants were randomized to one of&#xD;
      four arms: 1) male narrator and informational survey introduction, 2) male narrator and&#xD;
      motivational survey introduction, 3) female narrator and informational survey introduction,&#xD;
      and 4) female narrator and motivational survey introduction,male motivational, female&#xD;
      informational, female motivational) which were then followed by a noncommunicable disease&#xD;
      risk factor survey. This mobile phone survey was sent as an interactive voice response (IVR).&#xD;
      In IVR surveys, participants use their touch tone key pad to answer pre-recorded questions.&#xD;
      (i.e. If you are male, press 1; if you are female, press 2). This study was conducted in both&#xD;
      Bangladesh and Uganda.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2017</start_date>
  <completion_date type="Actual">July 17, 2017</completion_date>
  <primary_completion_date type="Actual">July 17, 2017</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 were randomized to one of four narrator/introduction combinations: 1) male voice, informational content; 2) male voice, motivational content; 3) female voice, informational content; 4) female voice, motivational content.</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 complete interviews, P is partial interviews, and R is 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 complete interviews, P is partial interviews, R is 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 refusals and breakoffs, I is complete interviews, P is 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 complete interviews, P is partial interviews, R is refusals and breakoffs, and eU is the estimated eligible proportion of unknowns</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">5580</enrollment>
  <condition>Surveys and Questionnaires</condition>
  <condition>Noncommunicable Diseases</condition>
  <arm_group>
    <arm_group_label>Male Informational</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Male voice, informational introduction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Male Motivational</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Male voice, motivational introduction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Female Informational</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Female voice, informational introduction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Female Motivational</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Female voice, motivational introduction</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Female Voice</intervention_name>
    <description>The survey was narrated by a female voice</description>
    <arm_group_label>Female Informational</arm_group_label>
    <arm_group_label>Female Motivational</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Motivational Introduction</intervention_name>
    <description>The survey introduction was worded to include motivational content</description>
    <arm_group_label>Female Motivational</arm_group_label>
    <arm_group_label>Male Motivational</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Male Voice</intervention_name>
    <description>The survey was narrated by a male voice</description>
    <arm_group_label>Male Informational</arm_group_label>
    <arm_group_label>Male Motivational</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Informational Introduction</intervention_name>
    <description>The survey introduction was worded to include informational content</description>
    <arm_group_label>Female Informational</arm_group_label>
    <arm_group_label>Male Informational</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;
          -  In Bangladesh, conversant in either English or Bangla language. In Uganda, conversant&#xD;
             in either Luo, Luganda, Runyakitara or English languages.&#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>Adnan A Hyder, PhD, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University Bloomberg School of Public Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>George W. Pariyo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Epidemiology Disease Control and Research</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Makerere University School of Public Health</name>
      <address>
        <city>Kampala</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
    <country>Uganda</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>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</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>narration</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/NCT03772431
org study id: 00007318-3
nct id: NCT03772431
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of two different narrative voices (one male and one female)
      and two different introductions (one with informational content and the other with additional
      motivational content) on interactive voice response (IVR) survey cooperation, response,
      refusal, and contact rates, as compared to a control group (male, informational), in
      Bangladesh and Uganda.
Using random digit dialing (RDD) sampling techniques, participants were randomized to one of
      four arms: 1) male narrator and informational survey introduction, 2) male narrator and
      motivational survey introduction, 3) female narrator and informational survey introduction,
      and 4) female narrator and motivational survey introduction,male motivational, female
      informational, female motivational) which were then followed by a noncommunicable disease
      risk factor survey. This mobile phone survey was sent as an interactive voice response (IVR).
      In IVR surveys, participants use their touch tone key pad to answer pre-recorded questions.
      (i.e. If you are male, press 1; if you are female, press 2). This study was conducted in both
      Bangladesh and Uganda.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomized to one of four narrator/introduction combinations: 1) male voice, informational content; 2) male voice, motivational content; 3) female voice, informational content; 4) female voice, motivational content.
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 complete interviews, P is partial interviews, and R is 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 complete interviews, P is partial interviews, R is 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 refusals and breakoffs, I is complete interviews, P is 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 complete interviews, P is partial interviews, R is refusals and breakoffs, and eU is the estimated eligible proportion of unknowns
arm group label: Male Informational
arm group type: Experimental
description: Male voice, informational introduction
arm group label: Male Motivational
arm group type: Experimental
description: Male voice, motivational introduction
arm group label: Female Informational
arm group type: Experimental
description: Female voice, informational introduction
arm group label: Female Motivational
arm group type: Experimental
description: Female voice, motivational introduction
intervention type: Other
intervention name: Female Voice
description: The survey was narrated by a female voice
arm group label: Female Informational
arm group label: Female Motivational
intervention type: Other
intervention name: Motivational Introduction
description: The survey introduction was worded to include motivational content
arm group label: Female Motivational
arm group label: Male Motivational
intervention type: Other
intervention name: Male Voice
description: The survey was narrated by a male voice
arm group label: Male Informational
arm group label: Male Motivational
intervention type: Other
intervention name: Informational Introduction
description: The survey introduction was worded to include informational content
arm group label: Female Informational
arm group label: Male Informational
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Adnan A Hyder, PhD, MBBS
role: Principal Investigator
affiliation: Johns Hopkins University Bloomberg School of Public Health
last name: George W. Pariyo, PhD
role: Principal Investigator
affiliation: Johns Hopkins University Bloomberg School of Public Health
facility: 
facility: 
country: Bangladesh
country: Uganda
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