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

• ClinicalTrials.gov Identifier: NCT05997511
• Recruitment Status: Active, not recruiting
• First Posted: August 18, 2023
• Last Update Posted: August 18, 2023
• Sponsor: Harvard Medical School (HMS and HSDM)
• Collaborator: Partners in Health
• Information provided by (Responsible Party): Bethany Hedt-Gauthier, Harvard Medical School (HMS and HSDM)

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
Mental Health; COVID-19; Misinformation	Behavioral: Card-Sorting Activity (Pre-intervention design); Behavioral: SMS Crafting (Pre-intervention design); Behavioral: SMS Messaging	Not Applicable

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 (Clinical Trial)
• Estimated 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.
• 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: August 1, 2023
• Estimated Primary Completion Date: August 31, 2024
• Estimated Study Completion Date: November 30, 2024

Arms and Interventions

Arm	Intervention/treatment
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 Name: text messaging
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 Name: text messaging

Outcome Measures

Primary Outcome Measures :

1. Number of COVID-19 Vaccines that are Available Monthly at Health Facilities [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Before the intervention and after 12 months of the intervention ]
   a repeated cross-sectional survey of community members

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Haiti

Zanmi Lasante

Cange, Haiti

Malawi

Partners in Health- Malawi

Neno, Malawi

Rwanda

Partners in Health- Rwanda

Kigali, Rwanda

Sponsors and Collaborators

Harvard Medical School (HMS and HSDM)

Partners in Health

More Information

• 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: August 18, 2023
• Last Update Posted: August 18, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• 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, Harvard Medical School (HMS and HSDM):

COVID-19; Mental Health; Misconception; Community Health Workers (CHWs)

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases