<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/NCT03797950</url>
  </required_header>
  <id_info>
    <org_study_id>GHS-ERC008/07/18</org_study_id>
    <nct_id>NCT03797950</nct_id>
  </id_info>
  <brief_title>Mobile Nudges to Increase Early Vaccination Coverage in Rural Areas</brief_title>
  <acronym>GEVaP</acronym>
  <official_title>Mobile Nudges to Increase Early Vaccination Coverage in Rural Areas: A Pilot Investigation in Ghana's Northern Region</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Tropical &amp; Public Health Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Innovations for Poverty Action</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swiss Tropical &amp; Public Health Institute</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>
      Despite major progress made in vaccination coverage overall, timeliness of vaccines remains a&#xD;
      key concern in many settings. At the same time, access to mobile phones has increased&#xD;
      rapidly, offering new opportunities to track and deliver health services. This research&#xD;
      project uses these newly available mobile phone networks to simultaneously address two of the&#xD;
      biggest bottlenecks in vaccine delivery: timely documentation of births, and lack of maternal&#xD;
      effort or access to get essential vaccines. To increase documentation, investigators will&#xD;
      train volunteers in each community to report new births via mobile phone to a central&#xD;
      coordinator, and send small monetary rewards via mobile phone to volunteers for this&#xD;
      reporting. To increase vaccination coverage, investigators will send reminder messages&#xD;
      directly to mothers, and will also test small monetary rewards to volunteers and to mothers&#xD;
      as an incentive to complete recommended vaccinations. The designs to provide vaccination&#xD;
      encouragement will be tested through a small community randomized controlled trial in 15&#xD;
      selected villages in Ghana's Northern region. The primary outcome for the pilot study will be&#xD;
      the percentage of children who received both the polio birth dose (OPV0) vaccination within&#xD;
      two weeks of life (14 days) and the BCG vaccination within the first four weeks (28 days) of&#xD;
      life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite major progress made in vaccination coverage overall, timeliness of vaccines remains a&#xD;
      key concern in many settings. Early vaccination coverage is particularly low in settings&#xD;
      where a large share of women deliver at home, as it is the case in Ghana's Northern region,&#xD;
      where only a minority of women seek out facilities for delivery. In Ghana, 95% of children&#xD;
      receive BCG vaccination within the first two years of life, but only about half of these&#xD;
      children receive the vaccine within the first 30 days after delivery. Less than 50% of&#xD;
      children in Ghana's Northern region receive Bacillus Calmette-Guérin (BCG) vaccines within&#xD;
      the first three months of their life, and less than 40% get polio vaccination, exposing a&#xD;
      large number of infants to these diseases.&#xD;
&#xD;
      Recent research conducted in this region shows that the large majority of households have&#xD;
      access to mobile phones, even in the most rural areas. this project uses mobile phone&#xD;
      networks to simultaneously address two of the biggest bottlenecks in vaccine delivery: timely&#xD;
      documentation of births, and lack of maternal effort or access to essential vaccines.&#xD;
      Evidence from other low resource settings suggests that even small rewards can often result&#xD;
      in substantial increases in vaccine uptake - investigators will test this hypothesis using&#xD;
      mobile networks in rural areas of Northern Ghana.&#xD;
&#xD;
      The main objective of this study is to assess the extent to which mobile-phone based reminder&#xD;
      or reward systems can increase early vaccination coverage. Investigators will assess two&#xD;
      specific interventions through the pilot study:&#xD;
&#xD;
        1. a mobile-phone based call and text system which will be used to contact mothers to&#xD;
           highlight the importance of early vaccinations, provide reminders (nudges) to mothers&#xD;
           encouraging them to get their newborn vaccinated and providing information on where and&#xD;
           when vaccinations are available in their community.&#xD;
&#xD;
        2. a community volunteer-based system that will provide small mobile credit rewards to both&#xD;
           community volunteers and mothers for completing the early vaccinations within the first&#xD;
           month of newborn life.&#xD;
&#xD;
      Research Hypotheses (H1-3) H1: Nudging mothers through voice and text messages will increase&#xD;
      early vaccination coverage.&#xD;
&#xD;
      H2: Nudging mothers through community volunteers and small rewards will increase early&#xD;
      vaccination coverage.&#xD;
&#xD;
      Given that birth documentation remains low in many parts of Ghana, investigators will also&#xD;
      test a new community-based reporting model, under which volunteers appointed by the community&#xD;
      will receive small rewards for reporting births that occur in their communities.&#xD;
      Investigators will test the extent to which such a program results in successful reporting of&#xD;
      births:&#xD;
&#xD;
      H3: Providing small mobile-phone based incentives to volunteers selected by communities for&#xD;
      reporting births will result in accurate and timely reporting of births in rural areas.&#xD;
&#xD;
      The study is an open label cluster-randomized controlled trial with three arms: a control&#xD;
      arm, a voice reminder arm (group A), and a cash incentive arm (group B). During the&#xD;
      intervention phase community volunteers will be appointed to document all births in 10&#xD;
      randomly selected treatment communities (group A and group B), and will receive small cash&#xD;
      rewards delivered via &quot;mobile money&quot; for all documented births. In each of two active&#xD;
      treatment arms, women across five villages will be enrolled in a proactive program over a&#xD;
      period of six months. In intervention group A, participating women will receive reminders&#xD;
      about vaccinations recommended at birth delivered via mobile phones. In intervention group B,&#xD;
      participating women will receive encouragement from a community-appointed volunteer to&#xD;
      complete recommended vaccinations and community volunteers and woman will receive small cash&#xD;
      rewards delivered via &quot;mobile money&quot; for completing the recommended birth dose vaccinations&#xD;
      on time. No volunteer will be appointed to documents births in the 5 control-arm villages and&#xD;
      no women in the 5 control-arm villages will be actively enrolled nor receive a pro-active&#xD;
      program intervention during the intervention phase.&#xD;
&#xD;
      After the intervention phase is complete, an endline population-based household survey will&#xD;
      be conducted in the 15 study villages (5 control, 5 treatment group A, 5 treatment group B)&#xD;
      to evaluate the effect of the intervention programs on vaccine coverage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">July 9, 2019</completion_date>
  <primary_completion_date type="Actual">July 9, 2019</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Full on time early vaccination coverage (OPV0 and BCG)</measure>
    <time_frame>First month of life</time_frame>
    <description>Percentage of infants born during study who received both BCG and OPV0 vaccinations on time (OPV0 within first 2 weeks of life and BCG within first month of life)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>On time BCG coverage</measure>
    <time_frame>First month of life</time_frame>
    <description>Percentage of infants who received BCG vaccination on time (within first month of life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>On time OPV coverage</measure>
    <time_frame>First two weeks of life (14 days)</time_frame>
    <description>Percentage of infants born during study who received OPV0 on time (within first two weeks of life)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Birth documentation and reporting coverage</measure>
    <time_frame>First month of life</time_frame>
    <description>Percentage of live births in the community during the study which are documented and reported by community health volunteers</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Immunization Coverage</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No active intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voice Reminder (Group A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Community-appointed volunteers will document births in the community and will receive small monetary rewards via &quot;mobile money&quot; for all documented births. Enrolled women will receive reminders via mobile phone to highlight the importance of early vaccinations for newborns. Messages will recommend that women take their newborns to get the BCG and Polio0 vaccine as soon as possible after birth (within the first two weeks of life for Polio0 and within the first month for BCG). Information on where and when these vaccines will be available in the woman's community will be provided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cash Incentive (Group B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Community-appointed volunteers will document births in the community and will receive small monetary rewards via &quot;mobile money&quot; for all documented births. Volunteers will encourage enrolled women to seek early vaccination for their newborns. Messages will recommend that women take their newborns to get the BCG and Polio0 vaccine as soon as possible after birth (within the first two weeks of life for Polio0 and within the first month for BCG). Volunteers will provide information on where and when these vaccines will be available in the woman's community. Volunteers and enrolled women will receive small monetary rewards via &quot;mobile money&quot; for receiving OPV0 and BCG vaccinations on time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Voice Reminder (Group A)</intervention_name>
    <description>Woman with a recent delivery will be contacted via mobile phone by a central study staff member to encourage them to vaccinate their newborn with OPV0 and BCG, and information on where and when vaccines are available in this community will be provided. Community volunteers will receive small incentives for documenting births in the community.</description>
    <arm_group_label>Voice Reminder (Group A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cash Incentive (Group B)</intervention_name>
    <description>Mobile phone based monetary incentives will be provided to community volunteers and to women with a recent delivery who vaccinate newborns with OPV0 and BCG on time. Community volunteers will receive small incentives for documenting births in the community.</description>
    <arm_group_label>Cash Incentive (Group B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who have given birth to a live-born, surviving infant in the last two weeks (14&#xD;
             days) and reside in the community.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who do not reside in the community.&#xD;
&#xD;
          -  Women whose newborn has passed away.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Woman who have recently given birth</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guenther Fink, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swiss Institute for Tropical and Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Innovations for Poverty Action</name>
      <address>
        <city>Tamale</city>
        <state>Karaga</state>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OPV</keyword>
  <keyword>BCG</keyword>
  <keyword>vaccine delivery</keyword>
  <keyword>mhealth</keyword>
  <keyword>incentives</keyword>
  <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/NCT03797950
org study id: GHS-ERC008/07/18
nct id: NCT03797950
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite major progress made in vaccination coverage overall, timeliness of vaccines remains a
      key concern in many settings. At the same time, access to mobile phones has increased
      rapidly, offering new opportunities to track and deliver health services. This research
      project uses these newly available mobile phone networks to simultaneously address two of the
      biggest bottlenecks in vaccine delivery: timely documentation of births, and lack of maternal
      effort or access to get essential vaccines. To increase documentation, investigators will
      train volunteers in each community to report new births via mobile phone to a central
      coordinator, and send small monetary rewards via mobile phone to volunteers for this
      reporting. To increase vaccination coverage, investigators will send reminder messages
      directly to mothers, and will also test small monetary rewards to volunteers and to mothers
      as an incentive to complete recommended vaccinations. The designs to provide vaccination
      encouragement will be tested through a small community randomized controlled trial in 15
      selected villages in Ghana's Northern region. The primary outcome for the pilot study will be
      the percentage of children who received both the polio birth dose (OPV0) vaccination within
      two weeks of life (14 days) and the BCG vaccination within the first four weeks (28 days) of
      life.
Despite major progress made in vaccination coverage overall, timeliness of vaccines remains a
      key concern in many settings. Early vaccination coverage is particularly low in settings
      where a large share of women deliver at home, as it is the case in Ghana's Northern region,
      where only a minority of women seek out facilities for delivery. In Ghana, 95% of children
      receive BCG vaccination within the first two years of life, but only about half of these
      children receive the vaccine within the first 30 days after delivery. Less than 50% of
      children in Ghana's Northern region receive Bacillus Calmette-Guérin (BCG) vaccines within
      the first three months of their life, and less than 40% get polio vaccination, exposing a
      large number of infants to these diseases.

      Recent research conducted in this region shows that the large majority of households have
      access to mobile phones, even in the most rural areas. this project uses mobile phone
      networks to simultaneously address two of the biggest bottlenecks in vaccine delivery: timely
      documentation of births, and lack of maternal effort or access to essential vaccines.
      Evidence from other low resource settings suggests that even small rewards can often result
      in substantial increases in vaccine uptake - investigators will test this hypothesis using
      mobile networks in rural areas of Northern Ghana.

      The main objective of this study is to assess the extent to which mobile-phone based reminder
      or reward systems can increase early vaccination coverage. Investigators will assess two
      specific interventions through the pilot study:

        1. a mobile-phone based call and text system which will be used to contact mothers to
           highlight the importance of early vaccinations, provide reminders (nudges) to mothers
           encouraging them to get their newborn vaccinated and providing information on where and
           when vaccinations are available in their community.

        2. a community volunteer-based system that will provide small mobile credit rewards to both
           community volunteers and mothers for completing the early vaccinations within the first
           month of newborn life.

      Research Hypotheses (H1-3) H1: Nudging mothers through voice and text messages will increase
      early vaccination coverage.

      H2: Nudging mothers through community volunteers and small rewards will increase early
      vaccination coverage.

      Given that birth documentation remains low in many parts of Ghana, investigators will also
      test a new community-based reporting model, under which volunteers appointed by the community
      will receive small rewards for reporting births that occur in their communities.
      Investigators will test the extent to which such a program results in successful reporting of
      births:

      H3: Providing small mobile-phone based incentives to volunteers selected by communities for
      reporting births will result in accurate and timely reporting of births in rural areas.

      The study is an open label cluster-randomized controlled trial with three arms: a control
      arm, a voice reminder arm (group A), and a cash incentive arm (group B). During the
      intervention phase community volunteers will be appointed to document all births in 10
      randomly selected treatment communities (group A and group B), and will receive small cash
      rewards delivered via "mobile money" for all documented births. In each of two active
      treatment arms, women across five villages will be enrolled in a proactive program over a
      period of six months. In intervention group A, participating women will receive reminders
      about vaccinations recommended at birth delivered via mobile phones. In intervention group B,
      participating women will receive encouragement from a community-appointed volunteer to
      complete recommended vaccinations and community volunteers and woman will receive small cash
      rewards delivered via "mobile money" for completing the recommended birth dose vaccinations
      on time. No volunteer will be appointed to documents births in the 5 control-arm villages and
      no women in the 5 control-arm villages will be actively enrolled nor receive a pro-active
      program intervention during the intervention phase.

      After the intervention phase is complete, an endline population-based household survey will
      be conducted in the 15 study villages (5 control, 5 treatment group A, 5 treatment group B)
      to evaluate the effect of the intervention programs on vaccine coverage.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Full on time early vaccination coverage (OPV0 and BCG)
time frame: First month of life
description: Percentage of infants born during study who received both BCG and OPV0 vaccinations on time (OPV0 within first 2 weeks of life and BCG within first month of life)
measure: On time BCG coverage
time frame: First month of life
description: Percentage of infants who received BCG vaccination on time (within first month of life)
measure: On time OPV coverage
time frame: First two weeks of life (14 days)
description: Percentage of infants born during study who received OPV0 on time (within first two weeks of life)
measure: Birth documentation and reporting coverage
time frame: First month of life
description: Percentage of live births in the community during the study which are documented and reported by community health volunteers
arm group label: Control
arm group type: No Intervention
description: No active intervention
arm group label: Voice Reminder (Group A)
arm group type: Experimental
description: Community-appointed volunteers will document births in the community and will receive small monetary rewards via "mobile money" for all documented births. Enrolled women will receive reminders via mobile phone to highlight the importance of early vaccinations for newborns. Messages will recommend that women take their newborns to get the BCG and Polio0 vaccine as soon as possible after birth (within the first two weeks of life for Polio0 and within the first month for BCG). Information on where and when these vaccines will be available in the woman's community will be provided.
arm group label: Cash Incentive (Group B)
arm group type: Experimental
description: Community-appointed volunteers will document births in the community and will receive small monetary rewards via "mobile money" for all documented births. Volunteers will encourage enrolled women to seek early vaccination for their newborns. Messages will recommend that women take their newborns to get the BCG and Polio0 vaccine as soon as possible after birth (within the first two weeks of life for Polio0 and within the first month for BCG). Volunteers will provide information on where and when these vaccines will be available in the woman's community. Volunteers and enrolled women will receive small monetary rewards via "mobile money" for receiving OPV0 and BCG vaccinations on time.
intervention type: Behavioral
intervention name: Voice Reminder (Group A)
description: Woman with a recent delivery will be contacted via mobile phone by a central study staff member to encourage them to vaccinate their newborn with OPV0 and BCG, and information on where and when vaccines are available in this community will be provided. Community volunteers will receive small incentives for documenting births in the community.
arm group label: Voice Reminder (Group A)
intervention type: Behavioral
intervention name: Cash Incentive (Group B)
description: Mobile phone based monetary incentives will be provided to community volunteers and to women with a recent delivery who vaccinate newborns with OPV0 and BCG on time. Community volunteers will receive small incentives for documenting births in the community.
arm group label: Cash Incentive (Group B)
criteria: 
gender: Female
gender based: Yes
gender description: Woman who have recently given birth
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Guenther Fink, PhD
role: Principal Investigator
affiliation: Swiss Institute for Tropical and Public Health
facility: 
country: Ghana
responsible party type: Sponsor
sharing ipd: No