xml: <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/NCT06024317</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00120675</org_study_id>
      <nct_id>NCT06024317</nct_id>
    </id_info>
    <brief_title>Chanjo Kwa Wakati - Improving Vaccination Coverage and Timeliness in Rural Settings</brief_title>
    <acronym>MINT-II</acronym>
    <official_title>&quot;Chanjo Kwa Wakati&quot; - Leveraging Community Health Workers and a Responsive Digital Health System to Improve Vaccination Coverage and Timeliness in Rural Settings</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Emory University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of North 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>University of South Carolina</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>
        Background and Objective:&#xD;
  &#xD;
        Tanzania is one of 20 countries where the majority of un- and under-vaccinated children&#xD;
        reside. Prior research identified substantial rural-urban disparities in rates and timeliness&#xD;
        of childhood vaccination in Tanzania, with children in rural settings being more like to&#xD;
        receive delayed or no vaccinations. This type 1 effectiveness implementation hybrid study&#xD;
        will evaluate the effect of Chanjo Kwa Wakati (&quot;Timely Vaccination&quot; in Kiswahili), a&#xD;
        community-based, integrated digital health intervention, on vaccination timeliness. The&#xD;
        intervention combines a vaccination knowledge intervention, mobile phone-based reminders, and&#xD;
        incentives with the goal to promote timely childhood vaccinations.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        The study will be conducted in two predominantly rural regions in Tanzania with high numbers&#xD;
        of un- or under-vaccinated children. Forty rural health facilities and their catchment areas&#xD;
        (&quot;clusters&quot;) will be randomized to an early or delayed onset study arm. From each cluster,&#xD;
        three cohorts of mother-child dyads, one retrospective cohort and two prospective cohorts,&#xD;
        will be enrolled into the study. For all vaccines due during the first year of life,&#xD;
        timeliness (primary outcome) and coverage (secondary outcome) will be observed for 1200&#xD;
        children (600 intervention children and 600 non-intervention children). Study logs, fidelity&#xD;
        checklists, quantitative surveys, vaccination records, and qualitative interviews with&#xD;
        mothers and key informants will be used to inform the five constructs of the Reach,&#xD;
        Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. Results will be&#xD;
        used to develop an implementation blueprint that can guide future adaptations,&#xD;
        sustainability, and scale-up of Chanjo Kwa Wakati.&#xD;
  &#xD;
        Hypothesis:&#xD;
  &#xD;
        The hypothesis is that Chanjo Kwa Wakati is effective for increasing the timeliness of&#xD;
        childhood vaccinations due by age 1 year compared to the standard of care.&#xD;
  &#xD;
        Expected impact:&#xD;
  &#xD;
        This study will address the lack of rigorous evidence on the effectiveness of an&#xD;
        community-based digital health intervention for promoting vaccination coverage and timeliness&#xD;
        among children from sub-Saharan Africa, and identify implementation strategies to facilitate&#xD;
        the deployment of integrated vaccination interventions in low- and middle-income country&#xD;
        settings.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 1, 2024</start_date>
    <completion_date type="Anticipated">June 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2027</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>This type 1 effectiveness-implementation hybrid study uses a cluster-randomized trial design to evaluate intervention effectiveness.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Penta 3 delay in days (continuous)</measure>
      <time_frame>Assessed during the endline survey, an average follow-up period of 1 year</time_frame>
      <description>The average number of days between the Penta3 vaccination due date (at age 14 weeks) and the date on which the child received the vaccination. Dates abstracted from the child's immunization card.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Penta 3 delay &gt; 28 days (binary)</measure>
      <time_frame>Assessed during the endline survey, an average follow-up period of 1 year</time_frame>
      <description>The percentage of participants with a delay &gt;28 days between the Penta 3 vaccination due date (at age 14 weeks) and the date on which the vaccination was received. Dates abstracted from the child's immunization card.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Penta 3 coverage (binary)</measure>
      <time_frame>Assessed during the endline survey, an average follow-up period of 1 year</time_frame>
      <description>The percentage of children who received the Penta 3 vaccination. Coverage abstracted from the child's immunization card.</description>
    </other_outcome>
    <other_outcome>
      <measure>Coverage of all recommended vaccines (binary)</measure>
      <time_frame>Assessed during the endline survey, an average follow-up period of 1 year</time_frame>
      <description>The percentage of children who received all vaccines recommended by age 1 year. Coverage abstracted from the child's immunization card.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1200</enrollment>
    <condition>Vaccination</condition>
    <condition>Short Message Service (SMS)</condition>
    <condition>Incentives</condition>
    <condition>Knowledge, Attitudes, Practice</condition>
    <arm_group>
      <arm_group_label>Early onset</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>20 clusters will be assigned to the early onset arm. A cross-sectional cohort and two longitudinal cohorts will be enrolled from each cluster.&#xD;
  Both longitudinal cohorts will receive all components of the Chanjo Kwa Wakati intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Delayed onset</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>20 clusters will be assigned to the delayed onset arm. A cross-sectional cohort and two longitudinal cohorts will be enrolled from each cluster.&#xD;
  The second longitudinal cohort will receive all components of the Chanjo Kwa Wakati intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Chanjo Kwa Wakati - Knowledge Intervention</intervention_name>
      <description>Counseling scripts assessing and addressing vaccination-related knowledge gaps</description>
      <arm_group_label>Delayed onset</arm_group_label>
      <arm_group_label>Early onset</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Chanjo Kwa Wakati - Reminders</intervention_name>
      <description>Reminders of upcoming vaccination due dates, sent to the mother's mobile phone</description>
      <arm_group_label>Delayed onset</arm_group_label>
      <arm_group_label>Early onset</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Chanjo Kwa Wakati - Incentives</intervention_name>
      <description>Conditional incentives for timely vaccination, tailored to each child's vaccination schedule</description>
      <arm_group_label>Delayed onset</arm_group_label>
      <arm_group_label>Early onset</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Chanjo Kwa Wakati - Service notifications</intervention_name>
      <description>Service notifications (e.g., related to stockouts or service non-availability), sent to the mother's mobile phone</description>
      <arm_group_label>Delayed onset</arm_group_label>
      <arm_group_label>Early onset</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria for the Cross-sectional sample:&#xD;
  &#xD;
            -  mothers of children ages 12-23 months&#xD;
  &#xD;
            -  residing in the sampling area&#xD;
  &#xD;
          Inclusion Criteria for the Longitudinal sample:&#xD;
  &#xD;
            -  pregnant women in their last trimester of pregnancy&#xD;
  &#xD;
            -  residing in the sampling area&#xD;
  &#xD;
            -  expected to reside in the sampling area until the child reaches age 1 year&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women who are not living in catchment areas of participating health facilities (which&#xD;
               routinely provide maternal and child health services, including antenatal care and at&#xD;
               least weekly routine childhood immunization. Facilities must be operational, must have&#xD;
               at least 2 community health workers, and must have reported at least 100 pregnancies&#xD;
               or births in the year prior to study implementation.)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jan Ostermann, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of South Carolina</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jan Ostermann, PhD</last_name>
      <phone>18037778747</phone>
      <email>jano@mailbox.sc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lavanya Vasudevan, PhD</last_name>
      <email>lavanya.vasudevan@emory.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>National Institute for Medical Research</name>
        <address>
          <city>Dar Es Salaam</city>
          <country>Tanzania</country>
        </address>
      </facility>
      <contact>
        <last_name>Esther Ngadaya, MD, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Tanzania</country>
    </location_countries>
    <reference>
      <citation>Yelverton V, Hair NL, Ghosh SH, Mfinanga SG, Ngadaya E, Baumgartner JN, Ostermann J, Vasudevan L. Beyond coverage: Rural-urban disparities in the timeliness of childhood vaccinations in Tanzania. Vaccine. 2022 Sep 2;40(37):5483-5493. doi: 10.1016/j.vaccine.2022.07.020. Epub 2022 Aug 10. Erratum In: Vaccine. 2023 Mar 31;41(14):2425.</citation>
      <PMID>35961796</PMID>
    </reference>
    <reference>
      <citation>Vasudevan L, Baumgartner JN, Moses S, Ngadaya E, Mfinanga SG, Ostermann J. Parental concerns and uptake of childhood vaccines in rural Tanzania - a mixed methods study. BMC Public Health. 2020 Oct 20;20(1):1573. doi: 10.1186/s12889-020-09598-1.</citation>
      <PMID>33081744</PMID>
    </reference>
    <reference>
      <citation>Ostermann J, Vasudevan L, Baumgartner JN, Ngadaya E, Mfinanga SG. Do mobile phone-based reminders and conditional financial transfers improve the timeliness of childhood vaccinations in Tanzania? Study protocol for a quasi-randomized controlled trial. Trials. 2019 Jul 4;20(1):397. doi: 10.1186/s13063-019-3430-4.</citation>
      <PMID>31272487</PMID>
    </reference>
    <reference>
      <citation>Ostermann J, Hair NL, Moses S, Ngadaya E, Godfrey Mfinanga S, Brown DS, Noel Baumgartner J, Vasudevan L. Is the intention to vaccinate enough? Systematic variation in the value of timely vaccinations and preferences for monetary vs non-monetary incentives among pregnant women in southern Tanzania. Vaccine X. 2023 Jan 23;13:100266. doi: 10.1016/j.jvacx.2023.100266. eCollection 2023 Apr.</citation>
      <PMID>36814594</PMID>
    </reference>
    <reference>
      <citation>Vasudevan L, Ostermann J, Moses SM, Ngadaya E, Mfinanga SG. Patterns of Mobile Phone Ownership and Use Among Pregnant Women in Southern Tanzania: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2020 Apr 8;8(4):e17122. doi: 10.2196/17122.</citation>
      <PMID>32267240</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of South Carolina</investigator_affiliation>
      <investigator_full_name>Jan Ostermann</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Childhood vaccinations</keyword>
    <keyword>Timeliness</keyword>
    <keyword>Vaccine hesitancy</keyword>
    <keyword>Digital Health</keyword>
    <keyword>Community Health Workers</keyword>
    <keyword>Tanzania</keyword>
    <keyword>Low and middle-income country</keyword>
    <keyword>SMS reminder</keyword>
    <keyword>Conditional incentive</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The data from this study will be available from the National Institute for Medical Research, Muhimbili Research Centre, Tanzania, but restrictions apply that are governed by consent forms and data transfer agreements. Data may be made available by the authors upon reasonable request and with permission of the National Medical Research Review Committee at the National Institute for Medical Research (NIMR) in Tanzania.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024317
  org study id: Pro00120675
  nct id: NCT06024317
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background and Objective:
  
        Tanzania is one of 20 countries where the majority of un- and under-vaccinated children
        reside. Prior research identified substantial rural-urban disparities in rates and timeliness
        of childhood vaccination in Tanzania, with children in rural settings being more like to
        receive delayed or no vaccinations. This type 1 effectiveness implementation hybrid study
        will evaluate the effect of Chanjo Kwa Wakati ("Timely Vaccination" in Kiswahili), a
        community-based, integrated digital health intervention, on vaccination timeliness. The
        intervention combines a vaccination knowledge intervention, mobile phone-based reminders, and
        incentives with the goal to promote timely childhood vaccinations.
  
        Methods:
  
        The study will be conducted in two predominantly rural regions in Tanzania with high numbers
        of un- or under-vaccinated children. Forty rural health facilities and their catchment areas
        ("clusters") will be randomized to an early or delayed onset study arm. From each cluster,
        three cohorts of mother-child dyads, one retrospective cohort and two prospective cohorts,
        will be enrolled into the study. For all vaccines due during the first year of life,
        timeliness (primary outcome) and coverage (secondary outcome) will be observed for 1200
        children (600 intervention children and 600 non-intervention children). Study logs, fidelity
        checklists, quantitative surveys, vaccination records, and qualitative interviews with
        mothers and key informants will be used to inform the five constructs of the Reach,
        Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. Results will be
        used to develop an implementation blueprint that can guide future adaptations,
        sustainability, and scale-up of Chanjo Kwa Wakati.
  
        Hypothesis:
  
        The hypothesis is that Chanjo Kwa Wakati is effective for increasing the timeliness of
        childhood vaccinations due by age 1 year compared to the standard of care.
  
        Expected impact:
  
        This study will address the lack of rigorous evidence on the effectiveness of an
        community-based digital health intervention for promoting vaccination coverage and timeliness
        among children from sub-Saharan Africa, and identify implementation strategies to facilitate
        the deployment of integrated vaccination interventions in low- and middle-income country
        settings.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This type 1 effectiveness-implementation hybrid study uses a cluster-randomized trial design to evaluate intervention effectiveness.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Penta 3 delay in days (continuous)
  time frame: Assessed during the endline survey, an average follow-up period of 1 year
  description: The average number of days between the Penta3 vaccination due date (at age 14 weeks) and the date on which the child received the vaccination. Dates abstracted from the child's immunization card.
  measure: Penta 3 delay > 28 days (binary)
  time frame: Assessed during the endline survey, an average follow-up period of 1 year
  description: The percentage of participants with a delay >28 days between the Penta 3 vaccination due date (at age 14 weeks) and the date on which the vaccination was received. Dates abstracted from the child's immunization card.
  measure: Penta 3 coverage (binary)
  time frame: Assessed during the endline survey, an average follow-up period of 1 year
  description: The percentage of children who received the Penta 3 vaccination. Coverage abstracted from the child's immunization card.
  measure: Coverage of all recommended vaccines (binary)
  time frame: Assessed during the endline survey, an average follow-up period of 1 year
  description: The percentage of children who received all vaccines recommended by age 1 year. Coverage abstracted from the child's immunization card.
  arm group label: Early onset
  arm group type: Experimental
  description: 20 clusters will be assigned to the early onset arm. A cross-sectional cohort and two longitudinal cohorts will be enrolled from each cluster.
  Both longitudinal cohorts will receive all components of the Chanjo Kwa Wakati intervention.
  arm group label: Delayed onset
  arm group type: Experimental
  description: 20 clusters will be assigned to the delayed onset arm. A cross-sectional cohort and two longitudinal cohorts will be enrolled from each cluster.
  The second longitudinal cohort will receive all components of the Chanjo Kwa Wakati intervention.
  intervention type: Behavioral
  intervention name: Chanjo Kwa Wakati - Knowledge Intervention
  description: Counseling scripts assessing and addressing vaccination-related knowledge gaps
  arm group label: Delayed onset
  arm group label: Early onset
  intervention type: Behavioral
  intervention name: Chanjo Kwa Wakati - Reminders
  description: Reminders of upcoming vaccination due dates, sent to the mother's mobile phone
  arm group label: Delayed onset
  arm group label: Early onset
  intervention type: Behavioral
  intervention name: Chanjo Kwa Wakati - Incentives
  description: Conditional incentives for timely vaccination, tailored to each child's vaccination schedule
  arm group label: Delayed onset
  arm group label: Early onset
  intervention type: Behavioral
  intervention name: Chanjo Kwa Wakati - Service notifications
  description: Service notifications (e.g., related to stockouts or service non-availability), sent to the mother's mobile phone
  arm group label: Delayed onset
  arm group label: Early onset
  criteria: 
  gender: Female
  minimum age: 15 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jan Ostermann, PhD
  role: Principal Investigator
  affiliation: University of South Carolina
  last name: Jan Ostermann, PhD
  phone: 18037778747
  email: jano@mailbox.sc.edu
  last name: Lavanya Vasudevan, PhD
  email: lavanya.vasudevan@emory.edu
  facility: 
  contact: 
  country: Tanzania
  citation: Yelverton V, Hair NL, Ghosh SH, Mfinanga SG, Ngadaya E, Baumgartner JN, Ostermann J, Vasudevan L. Beyond coverage: Rural-urban disparities in the timeliness of childhood vaccinations in Tanzania. Vaccine. 2022 Sep 2;40(37):5483-5493. doi: 10.1016/j.vaccine.2022.07.020. Epub 2022 Aug 10. Erratum In: Vaccine. 2023 Mar 31;41(14):2425.
  PMID: 35961796
  citation: Vasudevan L, Baumgartner JN, Moses S, Ngadaya E, Mfinanga SG, Ostermann J. Parental concerns and uptake of childhood vaccines in rural Tanzania - a mixed methods study. BMC Public Health. 2020 Oct 20;20(1):1573. doi: 10.1186/s12889-020-09598-1.
  PMID: 33081744
  citation: Ostermann J, Vasudevan L, Baumgartner JN, Ngadaya E, Mfinanga SG. Do mobile phone-based reminders and conditional financial transfers improve the timeliness of childhood vaccinations in Tanzania? Study protocol for a quasi-randomized controlled trial. Trials. 2019 Jul 4;20(1):397. doi: 10.1186/s13063-019-3430-4.
  PMID: 31272487
  citation: Ostermann J, Hair NL, Moses S, Ngadaya E, Godfrey Mfinanga S, Brown DS, Noel Baumgartner J, Vasudevan L. Is the intention to vaccinate enough? Systematic variation in the value of timely vaccinations and preferences for monetary vs non-monetary incentives among pregnant women in southern Tanzania. Vaccine X. 2023 Jan 23;13:100266. doi: 10.1016/j.jvacx.2023.100266. eCollection 2023 Apr.
  PMID: 36814594
  citation: Vasudevan L, Ostermann J, Moses SM, Ngadaya E, Mfinanga SG. Patterns of Mobile Phone Ownership and Use Among Pregnant Women in Southern Tanzania: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2020 Apr 8;8(4):e17122. doi: 10.2196/17122.
  PMID: 32267240
  responsible party type: Principal Investigator
  investigator affiliation: University of South Carolina
  investigator full name: Jan Ostermann
  investigator title: Associate Professor
  sharing ipd: No
  ipd description: The data from this study will be available from the National Institute for Medical Research, Muhimbili Research Centre, Tanzania, but restrictions apply that are governed by consent forms and data transfer agreements. Data may be made available by the authors upon reasonable request and with permission of the National Medical Research Review Committee at the National Institute for Medical Research (NIMR) in Tanzania.