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

COVID-19 Clinical Trial

Official title:

Leveraging Community Health Workers to Combat Health Misinformation in Haiti, Malawi, and Rwanda

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05997511
• Other study ID #: IRB22-1339
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: August 2023
• Source: Harvard Medical School (HMS and HSDM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5100
• Est. completion date: November 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Mental Health
• Misinformation

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.
• 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.
• 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.

Locations

Country	Name	City	State
Haiti	Zanmi Lasante	Cange
Malawi	Partners in Health- Malawi	Neno
Rwanda	Partners in Health- Rwanda	Kigali

Sponsors (2)

Lead Sponsor	Collaborator
Harvard Medical School (HMS and HSDM)	Partners in Health

Countries where clinical trial is conducted

Haiti,  Malawi,  Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of COVID-19 Vaccines that are Available Monthly at Health Facilities	COVID-19 Vaccine administration will be measured using routinely collected data measured monthly at the health facility level	24 months
Primary	Number of Mental Health Visits/ Consultations Completed Monthly at Health Facilities	Mental health service utilization will be measured using routinely collected data measured monthly at the health facility level	24 months
Primary	Number of Patients who Sought Care from Mental Health Services Monthly at Health Facilities	Mental health service utilization will be measured using routinely collected data measured monthly at the health facility level	24 months
Primary	Number of COVID-19 Vaccine Doses Administered Monthly at Health Facilities	COVID-19 Vaccine administration will be measured using routinely collected data measured monthly at the health facility level	24 months
Secondary	Qualitative Interviews	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.	Before, after 6 months of the intervention, and after 12 months of the intervention
Secondary	Longitudinal Cohort Surveys	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.	Before, after 6 months of the intervention, and after 12 months of the intervention
Secondary	Cross-Sectional Survey	a repeated cross-sectional survey of community members	Before the intervention and after 12 months of the intervention