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/NCT05997511</url>
    </required_header>
    <id_info>
      <org_study_id>IRB22-1339</org_study_id>
      <nct_id>NCT05997511</nct_id>
    </id_info>
    <brief_title>Leveraging Community Health Workers to Combat COVID-19 and Mental Health Misinformation in Haiti, Malawi, and Rwanda</brief_title>
    <official_title>Leveraging Community Health Workers to Combat Health Misinformation in Haiti, Malawi, and Rwanda</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Harvard Medical School (HMS and HSDM)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Partners in Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Harvard Medical School (HMS and HSDM)</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>
        Partners In Health (PIH), in collaboration with Harvard Medical School, aims to develop and&#xD;
        evaluate an SMS-based intervention for Community Health Workers (CHWs) to combat COVID-19 and&#xD;
        mental health-related misinformation in Haiti, Rwanda, and Malawi. The study involves three&#xD;
        aims: identifying locally relevant misinformation through a card-sorting exercise with CHWs,&#xD;
        developing targeted messages through cognitive interviewing, and evaluating the effectiveness&#xD;
        of SMS-based educational message dissemination via a randomized controlled trial. The&#xD;
        evaluation will assess the impact on public health practices, knowledge and attitudes among&#xD;
        CHWs, and knowledge and attitudes among community members.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The intervention will involve sending SMS messages to randomized CHWs, addressing either&#xD;
        COVID-19 or mental health misinformation. CHWs will have access to a helpline for further&#xD;
        support and can provide feedback to refine the messaging. The evaluation will use a time&#xD;
        series analysis to measure changes in COVID-19 vaccine administration, mental health service&#xD;
        utilization, CHWs' knowledge and attitudes, and community members' knowledge and attitudes.&#xD;
        The study aims to empower CHWs with accurate information, improve public health practices,&#xD;
        and ultimately contribute to better health outcomes in the communities served by PIH.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Our study will use a cluster- randomized design with two active arms - one arm targeting COVID-19-related misinformation and a second arm targeting misinformation related to mental health.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of COVID-19 Vaccines that are Available Monthly at Health Facilities</measure>
      <time_frame>24 months</time_frame>
      <description>COVID-19 Vaccine administration will be measured using routinely collected data measured monthly at the health facility level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Mental Health Visits/ Consultations Completed Monthly at Health Facilities</measure>
      <time_frame>24 months</time_frame>
      <description>Mental health service utilization will be measured using routinely collected data measured monthly at the health facility level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Patients who Sought Care from Mental Health Services Monthly at Health Facilities</measure>
      <time_frame>24 months</time_frame>
      <description>Mental health service utilization will be measured using routinely collected data measured monthly at the health facility level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of COVID-19 Vaccine Doses Administered Monthly at Health Facilities</measure>
      <time_frame>24 months</time_frame>
      <description>COVID-19 Vaccine administration will be measured using routinely collected data measured monthly at the health facility level</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Qualitative Interviews</measure>
      <time_frame>Before, after 6 months of the intervention, and after 12 months of the intervention</time_frame>
      <description>In-depth qualitative interviews will occur before, during, and after the dissemination of messages. Prior to the message dissemination we will contact between 10-15 randomly selected CHWs per country and provide them with draft messages. Although the content of all messages will be determined by the results of the card sorting exercise, the style of the messages will vary. We will use cognitive interviewing techniques to understand how CHWs interpret each message and ask them to provide their preferences on messaging style. During subsequent qualitative sessions at midline and endline, we will ask up to ten CHWs to provide feedback on the messages that they actually received during the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Longitudinal Cohort Surveys</measure>
      <time_frame>Before, after 6 months of the intervention, and after 12 months of the intervention</time_frame>
      <description>In each country, we will also select a random sample of 175 CHWs to participate in in a longitudinal cohort consisting of a quantitative questionnaire administered before, during, and after the intervention. During our survey, we will assess both COVID-19 related outcomes (CHWs' knowledge about COVID-19, vaccination status, and intention to vaccinate) and mental health-related outcomes (CHWs' knowledge about and stigmatization of mental illness). After the start of the intervention, we will also ask CHWs to self-report whether they have received our messages or used our helpline, and we will seek to verify this information by direct observation of text messages or outgoing calls on their phone.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cross-Sectional Survey</measure>
      <time_frame>Before the intervention and after 12 months of the intervention</time_frame>
      <description>a repeated cross-sectional survey of community members</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">5100</enrollment>
    <condition>Mental Health</condition>
    <condition>COVID-19</condition>
    <condition>Misinformation</condition>
    <arm_group>
      <arm_group_label>COVID-19</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Behavioral (SMS) Intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mental Health</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Behavorial (SMS) Intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Card-Sorting Activity (Pre-intervention design)</intervention_name>
      <description>Study team members within each country will free list misinformation or misconceptions that they commonly encounter in clinical practice or daily life. Each item will be used to create paired cards - one containing the misinformation and a second containing the corresponding correct information. During qualitative interviews, we will ask CHWs to participate in a series of card sorting activities, which is a participatory research method that can inform the design of health interventions.</description>
      <arm_group_label>COVID-19</arm_group_label>
      <arm_group_label>Mental Health</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SMS Crafting (Pre-intervention design)</intervention_name>
      <description>A two-person team consisting of one local communication expert and one clinician will draft clinically correct, easy-to-understand SMS messages designed to counter identified misinformation. We will draft messages that use various styles and use cognitive interviewing with CHWs to assess their understanding of and responses to each style. The final messages used in our intervention will be determined by CHW preference.</description>
      <arm_group_label>COVID-19</arm_group_label>
      <arm_group_label>Mental Health</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SMS Messaging</intervention_name>
      <description>Final messages will be sent via SMS to all CHWs working in our study area. CHWs will also be provided with contact information for a helpline staffed by a local team member who can answer follow-up questions in the local language.</description>
      <arm_group_label>COVID-19</arm_group_label>
      <arm_group_label>Mental Health</arm_group_label>
      <other_name>text messaging</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          The intervention will be assigned at the unit of the CHWs. These individuals will also be&#xD;
          eligible for the CHW longitudinal cohort.&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  CHWs affiliated with PIH Rwanda, Malawi, or Haiti&#xD;
  &#xD;
            -  18+ years of age.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Less than 18 years old.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Zanmi Lasante</name>
        <address>
          <city>Cange</city>
          <country>Haiti</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Partners in Health- Malawi</name>
        <address>
          <city>Neno</city>
          <country>Malawi</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Partners in Health- Rwanda</name>
        <address>
          <city>Kigali</city>
          <country>Rwanda</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Haiti</country>
      <country>Malawi</country>
      <country>Rwanda</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Harvard Medical School (HMS and HSDM)</investigator_affiliation>
      <investigator_full_name>Bethany Hedt-Gauthier</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>COVID-19</keyword>
    <keyword>Mental Health</keyword>
    <keyword>Misconception</keyword>
    <keyword>Community Health Workers (CHWs)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05997511
  org study id: IRB22-1339
  nct id: NCT05997511
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Partners In Health (PIH), in collaboration with Harvard Medical School, aims to develop and
        evaluate an SMS-based intervention for Community Health Workers (CHWs) to combat COVID-19 and
        mental health-related misinformation in Haiti, Rwanda, and Malawi. The study involves three
        aims: identifying locally relevant misinformation through a card-sorting exercise with CHWs,
        developing targeted messages through cognitive interviewing, and evaluating the effectiveness
        of SMS-based educational message dissemination via a randomized controlled trial. The
        evaluation will assess the impact on public health practices, knowledge and attitudes among
        CHWs, and knowledge and attitudes among community members.
  The intervention will involve sending SMS messages to randomized CHWs, addressing either
        COVID-19 or mental health misinformation. CHWs will have access to a helpline for further
        support and can provide feedback to refine the messaging. The evaluation will use a time
        series analysis to measure changes in COVID-19 vaccine administration, mental health service
        utilization, CHWs' knowledge and attitudes, and community members' knowledge and attitudes.
        The study aims to empower CHWs with accurate information, improve public health practices,
        and ultimately contribute to better health outcomes in the communities served by PIH.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Our study will use a cluster- randomized design with two active arms - one arm targeting COVID-19-related misinformation and a second arm targeting misinformation related to mental health.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Number of COVID-19 Vaccines that are Available Monthly at Health Facilities
  time frame: 24 months
  description: COVID-19 Vaccine administration will be measured using routinely collected data measured monthly at the health facility level
  measure: Number of Mental Health Visits/ Consultations Completed Monthly at Health Facilities
  time frame: 24 months
  description: Mental health service utilization will be measured using routinely collected data measured monthly at the health facility level
  measure: Number of Patients who Sought Care from Mental Health Services Monthly at Health Facilities
  time frame: 24 months
  description: Mental health service utilization will be measured using routinely collected data measured monthly at the health facility level
  measure: Number of COVID-19 Vaccine Doses Administered Monthly at Health Facilities
  time frame: 24 months
  description: COVID-19 Vaccine administration will be measured using routinely collected data measured monthly at the health facility level
  measure: Qualitative Interviews
  time frame: Before, after 6 months of the intervention, and after 12 months of the intervention
  description: In-depth qualitative interviews will occur before, during, and after the dissemination of messages. Prior to the message dissemination we will contact between 10-15 randomly selected CHWs per country and provide them with draft messages. Although the content of all messages will be determined by the results of the card sorting exercise, the style of the messages will vary. We will use cognitive interviewing techniques to understand how CHWs interpret each message and ask them to provide their preferences on messaging style. During subsequent qualitative sessions at midline and endline, we will ask up to ten CHWs to provide feedback on the messages that they actually received during the intervention.
  measure: Longitudinal Cohort Surveys
  time frame: Before, after 6 months of the intervention, and after 12 months of the intervention
  description: In each country, we will also select a random sample of 175 CHWs to participate in in a longitudinal cohort consisting of a quantitative questionnaire administered before, during, and after the intervention. During our survey, we will assess both COVID-19 related outcomes (CHWs' knowledge about COVID-19, vaccination status, and intention to vaccinate) and mental health-related outcomes (CHWs' knowledge about and stigmatization of mental illness). After the start of the intervention, we will also ask CHWs to self-report whether they have received our messages or used our helpline, and we will seek to verify this information by direct observation of text messages or outgoing calls on their phone.
  measure: Cross-Sectional Survey
  time frame: Before the intervention and after 12 months of the intervention
  description: a repeated cross-sectional survey of community members
  arm group label: COVID-19
  arm group type: Other
  description: Behavioral (SMS) Intervention
  arm group label: Mental Health
  arm group type: Other
  description: Behavorial (SMS) Intervention
  intervention type: Behavioral
  intervention name: Card-Sorting Activity (Pre-intervention design)
  description: Study team members within each country will free list misinformation or misconceptions that they commonly encounter in clinical practice or daily life. Each item will be used to create paired cards - one containing the misinformation and a second containing the corresponding correct information. During qualitative interviews, we will ask CHWs to participate in a series of card sorting activities, which is a participatory research method that can inform the design of health interventions.
  arm group label: COVID-19
  arm group label: Mental Health
  intervention type: Behavioral
  intervention name: SMS Crafting (Pre-intervention design)
  description: A two-person team consisting of one local communication expert and one clinician will draft clinically correct, easy-to-understand SMS messages designed to counter identified misinformation. We will draft messages that use various styles and use cognitive interviewing with CHWs to assess their understanding of and responses to each style. The final messages used in our intervention will be determined by CHW preference.
  arm group label: COVID-19
  arm group label: Mental Health
  intervention type: Behavioral
  intervention name: SMS Messaging
  description: Final messages will be sent via SMS to all CHWs working in our study area. CHWs will also be provided with contact information for a helpline staffed by a local team member who can answer follow-up questions in the local language.
  arm group label: COVID-19
  arm group label: Mental Health
  other name: text messaging
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  country: Haiti
  country: Malawi
  country: Rwanda
  responsible party type: Principal Investigator
  investigator affiliation: Harvard Medical School (HMS and HSDM)
  investigator full name: Bethany Hedt-Gauthier
  investigator title: Principal Investigator
  mesh term: COVID-19
  sharing ipd: No