<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/NCT04421586</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100032</org_study_id>
    <nct_id>NCT04421586</nct_id>
  </id_info>
  <brief_title>VISTA: Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy</brief_title>
  <official_title>VISTA: Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      The purpose of this study is to understand why parents do or do not vaccinate their children&#xD;
      and explore what information parents need to vaccinate their children. The study will test&#xD;
      whether information about vaccinations provided during pregnancy by a health provider (VISTA&#xD;
      intervention) may improve the possibility that a child is vaccinated on time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be implemented in 10 health facility catchment areas in Mtwara region,&#xD;
      Tanzania. The study sites will be non-randomly assigned to receive VISTA or usual care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2020</start_date>
  <completion_date type="Actual">May 24, 2021</completion_date>
  <primary_completion_date type="Actual">May 24, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>Percentage of women with reduced number of concerns immediately post-counseling in the intervention arm</measure>
    <time_frame>Post-counseling (Baseline visit)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of women with reduced number of concerns in intervention versus control arms at follow up.</measure>
    <time_frame>Follow-up (up 6-months post-birth)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of children by vaccine who received the vaccine within 4-week window of due date in intervention versus control arm</measure>
    <time_frame>Follow-up (up 6-months post-birth)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of days children remain unvaccinated for each vaccine in intervention versus control arm</measure>
    <time_frame>Follow-up (up 6-months post-birth)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median number of days children remain unvaccinated for each vaccine in intervention versus control arm</measure>
    <time_frame>Follow-up (up 6-months post-birth)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of checklist items completed during counseling in intervention arm.</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of minutes spent delivering counseling per woman in intervention arm</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of women in the intervention arm who say that the information provided by the community health worker (CHW) is helpful</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of women in the intervention arm who say that the information provided by the community health worker (CHW) reduced their concerns about vaccinations</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of women in the intervention arm who say that the community health worker (CHW) helped them understand why children needed vaccines</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of women in the intervention arm who say that the community health worker (CHW) answered most of their questions</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of women in the intervention arm who say that the community health worker (CHW) was respectful</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of women in the intervention arm who say that the community health worker (CHW) explained things in terms they could understand</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of women in the intervention arm who were satisfied with their conversation with the community health worker (CHW)</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of women in the intervention arm who say they are comfortable vaccinating their child</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of women in the intervention arm who say they will speak with the CHW again</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of women in the intervention arm who say they would refer the CHW to their friends and family</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Vaccination Uptake</condition>
  <arm_group>
    <arm_group_label>Pregnant women receiving VISTA counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregnant women receiving usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Up to 30 pregnant women receiving usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VISTA</intervention_name>
    <description>VISTA will be an educational intervention.</description>
    <arm_group_label>Pregnant women receiving VISTA counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Study outcomes will be measured for health providers implementing the intervention and&#xD;
        pregnant women receiving the intervention. Up to 10 health workers (including community&#xD;
        health workers (CHW) from each of the intervention sites will participate in the study.&#xD;
&#xD;
        To participate in the study,&#xD;
&#xD;
        Health workers must be:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Work in one of the study intervention sites&#xD;
&#xD;
        Women must be:&#xD;
&#xD;
          -  In the third trimester of pregnancy&#xD;
&#xD;
          -  Residing in a study site (intervention or control)&#xD;
&#xD;
          -  At least 15 years of age&#xD;
&#xD;
          -  Planning to reside in the study site for the duration of their participation in the&#xD;
             study (until approximately 6 months after delivery to enable follow up).&#xD;
&#xD;
          -  Have at least 1 concern about childhood vaccines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        There are no exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lavanya Vasudevan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute for Medical Research (NIMR)</name>
      <address>
        <city>Mtwara</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vaccine hesitancy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 23, 2022</submitted>
    <returned>February 23, 2023</returned>
    <submitted>March 20, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04421586
org study id: Pro00100032
nct id: NCT04421586
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to understand why parents do or do not vaccinate their children
      and explore what information parents need to vaccinate their children. The study will test
      whether information about vaccinations provided during pregnancy by a health provider (VISTA
      intervention) may improve the possibility that a child is vaccinated on time.
The study will be implemented in 10 health facility catchment areas in Mtwara region,
      Tanzania. The study sites will be non-randomly assigned to receive VISTA or usual care.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Percentage of women with reduced number of concerns immediately post-counseling in the intervention arm
time frame: Post-counseling (Baseline visit)
measure: Percentage of women with reduced number of concerns in intervention versus control arms at follow up.
time frame: Follow-up (up 6-months post-birth)
measure: Percentage of children by vaccine who received the vaccine within 4-week window of due date in intervention versus control arm
time frame: Follow-up (up 6-months post-birth)
measure: Mean number of days children remain unvaccinated for each vaccine in intervention versus control arm
time frame: Follow-up (up 6-months post-birth)
measure: Median number of days children remain unvaccinated for each vaccine in intervention versus control arm
time frame: Follow-up (up 6-months post-birth)
measure: Percentage of checklist items completed during counseling in intervention arm.
time frame: Baseline
measure: Mean number of minutes spent delivering counseling per woman in intervention arm
time frame: Baseline
measure: Percentage of women in the intervention arm who say that the information provided by the community health worker (CHW) is helpful
time frame: Baseline
measure: Percentage of women in the intervention arm who say that the information provided by the community health worker (CHW) reduced their concerns about vaccinations
time frame: Baseline
measure: Percentage of women in the intervention arm who say that the community health worker (CHW) helped them understand why children needed vaccines
time frame: Baseline
measure: Percentage of women in the intervention arm who say that the community health worker (CHW) answered most of their questions
time frame: Baseline
measure: Percentage of women in the intervention arm who say that the community health worker (CHW) was respectful
time frame: Baseline
measure: Percentage of women in the intervention arm who say that the community health worker (CHW) explained things in terms they could understand
time frame: Baseline
measure: Percentage of women in the intervention arm who were satisfied with their conversation with the community health worker (CHW)
time frame: Baseline
measure: Percentage of women in the intervention arm who say they are comfortable vaccinating their child
time frame: Baseline
measure: Percentage of women in the intervention arm who say they will speak with the CHW again
time frame: Baseline
measure: Percentage of women in the intervention arm who say they would refer the CHW to their friends and family
time frame: Baseline
arm group label: Pregnant women receiving VISTA counseling
arm group type: Experimental
description: Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA
arm group label: Pregnant women receiving usual care
arm group type: No Intervention
description: Up to 30 pregnant women receiving usual care
intervention type: Behavioral
intervention name: VISTA
description: VISTA will be an educational intervention.
arm group label: Pregnant women receiving VISTA counseling
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lavanya Vasudevan, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: Tanzania
responsible party type: Sponsor
sharing ipd: No
submitted: May 23, 2022
returned: February 23, 2023
submitted: March 20, 2023