Back to resultsLeveraging Community Health Workers to Combat COVID-19 and Mental Health Misinformation in Haiti, Malawi, and Rwanda
Primary Purpose
Mental Health, COVID-19, Misinformation
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Card-Sorting Activity (Pre-intervention design)
SMS Crafting (Pre-intervention design)
SMS Messaging
Sponsored by
About this trial
This is an interventional prevention trial for Mental Health focused on measuring COVID-19, Mental Health, Misconception, Community Health Workers (CHWs)
Eligibility 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.
Sites / Locations
- Zanmi Lasante
- Partners in Health- Malawi
- Partners in Health- Rwanda
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
COVID-19
Mental Health
Arm Description
Behavioral (SMS) Intervention
Behavorial (SMS) Intervention
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
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.
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.
Cross-Sectional Survey
a repeated cross-sectional survey of community members
Full Information
NCT ID
NCT05997511
First Posted
July 22, 2023
Last Updated
August 15, 2023
Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
Partners in Health
1. Study Identification
Unique Protocol Identification Number
NCT05997511
Brief Title
Leveraging Community Health Workers to Combat COVID-19 and Mental Health Misinformation in Haiti, Malawi, and Rwanda
Official Title
Leveraging Community Health Workers to Combat Health Misinformation in Haiti, Malawi, and Rwanda
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
Partners in Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health, COVID-19, Misinformation
Keywords
COVID-19, Mental Health, Misconception, Community Health Workers (CHWs)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
5100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
COVID-19
Arm Type
Other
Arm Description
Behavioral (SMS) Intervention
Arm Title
Mental Health
Arm Type
Other
Arm Description
Behavorial (SMS) Intervention
Intervention Type
Behavioral
Intervention Name(s)
Card-Sorting Activity (Pre-intervention design)
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
SMS Crafting (Pre-intervention design)
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
SMS Messaging
Other Intervention Name(s)
text messaging
Intervention 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.
Primary Outcome Measure Information:
Title
Number of COVID-19 Vaccines that are Available Monthly at Health Facilities
Description
COVID-19 Vaccine administration will be measured using routinely collected data measured monthly at the health facility level
Time Frame
24 months
Title
Number of Mental Health Visits/ Consultations Completed Monthly at Health Facilities
Description
Mental health service utilization will be measured using routinely collected data measured monthly at the health facility level
Time Frame
24 months
Title
Number of Patients who Sought Care from Mental Health Services Monthly at Health Facilities
Description
Mental health service utilization will be measured using routinely collected data measured monthly at the health facility level
Time Frame
24 months
Title
Number of COVID-19 Vaccine Doses Administered Monthly at Health Facilities
Description
COVID-19 Vaccine administration will be measured using routinely collected data measured monthly at the health facility level
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Qualitative Interviews
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.
Time Frame
Before, after 6 months of the intervention, and after 12 months of the intervention
Title
Longitudinal Cohort Surveys
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.
Time Frame
Before, after 6 months of the intervention, and after 12 months of the intervention
Title
Cross-Sectional Survey
Description
a repeated cross-sectional survey of community members
Time Frame
Before the intervention and after 12 months of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Zanmi Lasante
City
Cange
Country
Haiti
Facility Name
Partners in Health- Malawi
City
Neno
Country
Malawi
Facility Name
Partners in Health- Rwanda
City
Kigali
Country
Rwanda
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Leveraging Community Health Workers to Combat COVID-19 and Mental Health Misinformation in Haiti, Malawi, and Rwanda
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