Leveraging Community Health Workers to Combat COVID-19 and Mental Health Misinformation in Haiti, Malawi, and Rwanda

Sponsor
Harvard Medical School (HMS and HSDM) (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05997511
Collaborator
Partners in Health (Other)
5,100
3
2
16
1700
106.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Card-Sorting Activity (Pre-intervention design)
  • Behavioral: SMS Crafting (Pre-intervention design)
  • Behavioral: SMS Messaging
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5100 participants
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.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.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Leveraging Community Health Workers to Combat Health Misinformation in Haiti, Malawi, and Rwanda
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: COVID-19

Behavioral (SMS) Intervention

Behavioral: Card-Sorting Activity (Pre-intervention design)
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.

Behavioral: SMS Crafting (Pre-intervention design)
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.

Behavioral: SMS Messaging
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.
Other Names:
  • text messaging
  • Other: Mental Health

    Behavorial (SMS) Intervention

    Behavioral: Card-Sorting Activity (Pre-intervention design)
    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.

    Behavioral: SMS Crafting (Pre-intervention design)
    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.

    Behavioral: SMS Messaging
    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.
    Other Names:
  • text messaging
  • Outcome Measures

    Primary Outcome Measures

    1. Number of COVID-19 Vaccines that are Available Monthly at Health Facilities [24 months]

      COVID-19 Vaccine administration will be measured using routinely collected data measured monthly at the health facility level

    2. Number of Mental Health Visits/ Consultations Completed Monthly at Health Facilities [24 months]

      Mental health service utilization will be measured using routinely collected data measured monthly at the health facility level

    3. Number of Patients who Sought Care from Mental Health Services Monthly at Health Facilities [24 months]

      Mental health service utilization will be measured using routinely collected data measured monthly at the health facility level

    4. Number of COVID-19 Vaccine Doses Administered Monthly at Health Facilities [24 months]

      COVID-19 Vaccine administration will be measured using routinely collected data measured monthly at the health facility level

    Secondary Outcome Measures

    1. Qualitative Interviews [Before, after 6 months of the intervention, and after 12 months of the intervention]

      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.

    2. Longitudinal Cohort Surveys [Before, after 6 months of the intervention, and after 12 months of the intervention]

      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.

    3. Cross-Sectional Survey [Before the intervention and after 12 months of the intervention]

      a repeated cross-sectional survey of community members

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    The intervention will be assigned at the unit of the CHWs. These individuals will also be eligible for the CHW longitudinal cohort.

    Inclusion Criteria:
    • CHWs affiliated with PIH Rwanda, Malawi, or Haiti

    • 18+ years of age.

    Exclusion Criteria:
    • Less than 18 years old.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zanmi Lasante Cange Haiti
    2 Partners in Health- Malawi Neno Malawi
    3 Partners in Health- Rwanda Kigali Rwanda

    Sponsors and Collaborators

    • Harvard Medical School (HMS and HSDM)
    • Partners in Health

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bethany Hedt-Gauthier, Principal Investigator, Harvard Medical School (HMS and HSDM)
    ClinicalTrials.gov Identifier:
    NCT05997511
    Other Study ID Numbers:
    • IRB22-1339
    First Posted:
    Aug 18, 2023
    Last Update Posted:
    Aug 18, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bethany Hedt-Gauthier, Principal Investigator, Harvard Medical School (HMS and HSDM)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 18, 2023