<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/NCT03252288</url>
  </required_header>
  <id_info>
    <org_study_id>D0271</org_study_id>
    <secondary_id>1R21TW010262</secondary_id>
    <nct_id>NCT03252288</nct_id>
  </id_info>
  <brief_title>mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Vaccinations</brief_title>
  <acronym>MINT</acronym>
  <official_title>mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Childhood Vaccinations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fogarty International Center of the National Institute of Health</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Medical Research, Tanzania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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>
      Vaccination is a cost-effective strategy for conferring immunity against a host of&#xD;
      preventable diseases, however, rates of timely childhood vaccinations remain inadequate in&#xD;
      resource-limited settings. We propose to evaluate the feasibility and efficacy of&#xD;
      mHealth-assisted conditional cash transfers as a means of overcoming individual barriers to&#xD;
      timely vaccinations. The study will form the basis for a pragmatic randomized controlled&#xD;
      trial of the efficacy and cost-effectiveness of mHealth reminders and conditional cash&#xD;
      transfers for improving rates of timely vaccinations among young children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vaccination is one of the most cost-effective strategies for conferring immunity against a&#xD;
      host of preventable diseases. The World Health Organization estimates that over 2.5 million&#xD;
      child deaths are prevented annually worldwide due to vaccination efforts. Infants must&#xD;
      receive all recommended vaccinations in a timely manner to be fully protected from deadly&#xD;
      infectious diseases such as tuberculosis, diphtheria, pertussis and polio. A large body of&#xD;
      evidence has shown that children living in socio-economically disadvantaged backgrounds are&#xD;
      more likely to be vaccinated late, or not at all, compared to their counterparts from&#xD;
      wealthier and more educated families. While Tanzania has successfully achieved high national&#xD;
      vaccination coverage, there remain substantial regional variations. In this proposal we seek&#xD;
      to evaluate the feasibility of combining two emerging types of interventions - mHealth and&#xD;
      conditional cash transfers - to overcome individual barriers to timely vaccinations.&#xD;
      Researchers at Duke University and Tanzania's National Institute of Medical Research (NIMR)&#xD;
      will collaborate to evaluate whether mobile phone (mHealth)-based vaccination reminders,&#xD;
      combined with a financial incentive scheme for families with young children, may result in&#xD;
      improved vaccination coverage and timeliness. The specific aims of the proposal are to (1)&#xD;
      conduct formative research to identify locally relevant client-side and provider-side&#xD;
      barriers to timely vaccinations; (2) develop an mHealth system to facilitate and monitor&#xD;
      timely vaccinations and conduct surveys with late-stage pregnant women to derive&#xD;
      willingness-to-accept estimates and a feasible incentive structure; and (3) assess the&#xD;
      efficacy of a combination intervention consisting of mHealth reminders and conditional cash&#xD;
      transfers for improving the rates and timeliness of vaccinations among infants in their first&#xD;
      6 months of life. Qualitative follow-up surveys with providers and a subset of clients will&#xD;
      assess barriers to the acceptability and scalability of an mHealth supported conditional&#xD;
      cash-transfer intervention for timely vaccination. The study will be implemented with support&#xD;
      from Tanzania's Ministry of Health and Social Welfare Immunization and Vaccine Development&#xD;
      Programme. The results of the proposed study will form the basis for a pragmatic randomized&#xD;
      controlled trial of the efficacy and incremental cost-effectiveness of mHealth reminders and&#xD;
      conditional cash transfers as means of improving timely vaccinations of young children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 13, 2018</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>A random event (scheduled vaccination date for a child based on date of birth) will determine whether a women does not receive an intervention (before a certain calendar date) or receives an intervention (after a certain calendar date).</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Timely vaccination visits</measure>
    <time_frame>Up to 6 months after birth</time_frame>
    <description>Number of vaccination visits within 4 weeks of scheduled visit dates</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of vaccinations received</measure>
    <time_frame>Up to 6 months after birth</time_frame>
    <description>Number of vaccinations received</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of timely vaccinations received</measure>
    <time_frame>Up to 6 months after birth</time_frame>
    <description>Number of vaccinations received within 4 weeks of scheduled vaccination dates</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">412</enrollment>
  <condition>Immunization</condition>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reminders only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reminders are sent 1 week and 1 day before each scheduled vaccination date</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reminders + Conditional financial transfer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reminders are sent 1 week and 1 day before each scheduled vaccination date; and conditional financial transfers are made for each on-time vaccination visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reminders</intervention_name>
    <description>Text of phone-call based reminders to mobile phones</description>
    <arm_group_label>Reminders + Conditional financial transfer</arm_group_label>
    <arm_group_label>Reminders only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conditional financial transfers</intervention_name>
    <description>Full amount paid if visit occurs within 1 week of the scheduled visit; partial amount is paid if visit occurs &gt;1 week but within 4 weeks of the scheduled visit</description>
    <arm_group_label>Reminders + Conditional financial transfer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant, last trimester&#xD;
&#xD;
          -  Access to mobile phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Unwillingness to receive study-related information and reminders via mobile phone&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Institute for Medical Research</name>
      <address>
        <city>Dar es Salaam</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data from the proposed study will be stored in a data repository; this data will be de-identified so that they cannot be linked back to individuals. Investigators wishing to use study data to answer new research questions may submit data analysis concept proposals for consideration by the Principal Investigators. The Principal Investigators will review the proposal and will provide those submitting scientifically rigorous and promising proposals access to the data repository to address their research questions. This will ensure that the data resources of the proposed study will provide the greatest possible benefit to the scientific community.</ipd_description>
  </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/NCT03252288
org study id: D0271
secondary id: 1R21TW010262
nct id: NCT03252288
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vaccination is a cost-effective strategy for conferring immunity against a host of
      preventable diseases, however, rates of timely childhood vaccinations remain inadequate in
      resource-limited settings. We propose to evaluate the feasibility and efficacy of
      mHealth-assisted conditional cash transfers as a means of overcoming individual barriers to
      timely vaccinations. The study will form the basis for a pragmatic randomized controlled
      trial of the efficacy and cost-effectiveness of mHealth reminders and conditional cash
      transfers for improving rates of timely vaccinations among young children.
Vaccination is one of the most cost-effective strategies for conferring immunity against a
      host of preventable diseases. The World Health Organization estimates that over 2.5 million
      child deaths are prevented annually worldwide due to vaccination efforts. Infants must
      receive all recommended vaccinations in a timely manner to be fully protected from deadly
      infectious diseases such as tuberculosis, diphtheria, pertussis and polio. A large body of
      evidence has shown that children living in socio-economically disadvantaged backgrounds are
      more likely to be vaccinated late, or not at all, compared to their counterparts from
      wealthier and more educated families. While Tanzania has successfully achieved high national
      vaccination coverage, there remain substantial regional variations. In this proposal we seek
      to evaluate the feasibility of combining two emerging types of interventions - mHealth and
      conditional cash transfers - to overcome individual barriers to timely vaccinations.
      Researchers at Duke University and Tanzania's National Institute of Medical Research (NIMR)
      will collaborate to evaluate whether mobile phone (mHealth)-based vaccination reminders,
      combined with a financial incentive scheme for families with young children, may result in
      improved vaccination coverage and timeliness. The specific aims of the proposal are to (1)
      conduct formative research to identify locally relevant client-side and provider-side
      barriers to timely vaccinations; (2) develop an mHealth system to facilitate and monitor
      timely vaccinations and conduct surveys with late-stage pregnant women to derive
      willingness-to-accept estimates and a feasible incentive structure; and (3) assess the
      efficacy of a combination intervention consisting of mHealth reminders and conditional cash
      transfers for improving the rates and timeliness of vaccinations among infants in their first
      6 months of life. Qualitative follow-up surveys with providers and a subset of clients will
      assess barriers to the acceptability and scalability of an mHealth supported conditional
      cash-transfer intervention for timely vaccination. The study will be implemented with support
      from Tanzania's Ministry of Health and Social Welfare Immunization and Vaccine Development
      Programme. The results of the proposed study will form the basis for a pragmatic randomized
      controlled trial of the efficacy and incremental cost-effectiveness of mHealth reminders and
      conditional cash transfers as means of improving timely vaccinations of young children.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A random event (scheduled vaccination date for a child based on date of birth) will determine whether a women does not receive an intervention (before a certain calendar date) or receives an intervention (after a certain calendar date).
primary purpose: Health Services Research
masking: None (Open Label)
measure: Timely vaccination visits
time frame: Up to 6 months after birth
description: Number of vaccination visits within 4 weeks of scheduled visit dates
measure: Number of vaccinations received
time frame: Up to 6 months after birth
description: Number of vaccinations received
measure: Number of timely vaccinations received
time frame: Up to 6 months after birth
description: Number of vaccinations received within 4 weeks of scheduled vaccination dates
arm group label: No intervention
arm group type: No Intervention
description: No intervention
arm group label: Reminders only
arm group type: Experimental
description: Reminders are sent 1 week and 1 day before each scheduled vaccination date
arm group label: Reminders + Conditional financial transfer
arm group type: Experimental
description: Reminders are sent 1 week and 1 day before each scheduled vaccination date; and conditional financial transfers are made for each on-time vaccination visit
intervention type: Behavioral
intervention name: Reminders
description: Text of phone-call based reminders to mobile phones
arm group label: Reminders + Conditional financial transfer
arm group label: Reminders only
intervention type: Behavioral
intervention name: Conditional financial transfers
description: Full amount paid if visit occurs within 1 week of the scheduled visit; partial amount is paid if visit occurs >1 week but within 4 weeks of the scheduled visit
arm group label: Reminders + Conditional financial transfer
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Tanzania
responsible party type: Sponsor
sharing ipd: No
ipd description: Data from the proposed study will be stored in a data repository; this data will be de-identified so that they cannot be linked back to individuals. Investigators wishing to use study data to answer new research questions may submit data analysis concept proposals for consideration by the Principal Investigators. The Principal Investigators will review the proposal and will provide those submitting scientifically rigorous and promising proposals access to the data repository to address their research questions. This will ensure that the data resources of the proposed study will provide the greatest possible benefit to the scientific community.