- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05997511
Leveraging Community Health Workers to Combat COVID-19 and Mental Health Misinformation in Haiti, Malawi, and Rwanda
June 20, 2024 updated by: Bethany Hedt-Gauthier, Harvard Medical School (HMS and HSDM)
Leveraging Community Health Workers to Combat Health Misinformation in Haiti, Malawi, and Rwanda
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.
Study Overview
Status
Active, not recruiting
Conditions
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.
Rwanda and Haiti CHWs will receive the messages for 12 months, but Malawi CHWs will receive the messages for 6 months due to a CHW transition in country.
Study Type
Interventional
Enrollment (Actual)
5109
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: COVID-19
Behavioral (SMS) Intervention
|
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.
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.
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:
|
|
Other: Mental Health
Behavorial (SMS) Intervention
|
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.
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.
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
24 months
|
|
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
|
24 months
|
|
Number of COVID-19 Vaccine Doses Administered Monthly at Health Facilities (if available)
Time Frame: 24 months
|
COVID-19 Vaccine administration will be measured using routinely collected data measured monthly at the health facility level
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative Interviews
Time Frame: Before, after 6 months of the intervention, and after 12 months of the intervention (only in Rwanda & Haiti)
|
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 (only in Rwanda & Haiti)
|
|
Longitudinal Cohort Surveys
Time Frame: Before, after 6 months of the intervention, and after 12 months of the intervention (only in Rwanda & Haiti)
|
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 (only in Rwanda & Haiti)
|
|
Cross-Sectional Survey
Time Frame: Before the intervention and after 12 months of the intervention (only in Rwanda & Haiti)
|
a repeated cross-sectional survey of community members
|
Before the intervention and after 12 months of the intervention (only in Rwanda & Haiti)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2023
Primary Completion (Estimated)
January 31, 2025
Study Completion (Estimated)
January 31, 2025
Study Registration Dates
First Submitted
July 22, 2023
First Submitted That Met QC Criteria
August 15, 2023
First Posted (Actual)
August 18, 2023
Study Record Updates
Last Update Posted (Actual)
June 24, 2024
Last Update Submitted That Met QC Criteria
June 20, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB22-1339
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
PfizerActive, not recruitingCOVID-19 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | COVID-19 Vaccines | SARS-CoV-2 Infection, COVID19 | COVID-19 Vaccination | SARS-CoV-2 Infection, COVID-19 | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionUnited States
-
Shanghai Public Health Clinical CenterNot yet recruiting
-
Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
Eggensberger OHGBavarian Health and Food Safety Authority (LGL)RecruitingPost COVID-19 Condition | Post COVID-19 | Post COVID-19 Syndrome | Long COVID-19 Syndrome | Post COVID-19 Condition (PCC)Germany
-
PfizerRecruitingRespiratory Tract Diseases | COVID-19 | Pneumonia | Lung Diseases | Coronavirus Disease 2019 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | Upper Respiratory Tract Infections | Respiratory Tract Infection | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionBelgium
-
ModeX Therapeutics, An OPKO Health CompanyRecruitingCOVID -19 | COVID-19 (Prevention)United States
-
Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaRecruitingFatigue | Post-COVID-19 Syndrome | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19 | Long-COVID | Post-COVID ConditionCanada
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
University of Missouri, Kansas CityNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruitingCOVID-19 Testing BehaviorsUnited States
Clinical Trials on Card-Sorting Activity (Pre-intervention design)
-
VID Specialized UniversityActive, not recruitingObesity and OverweightNorway
-
Alejandro LuciaHospital General Universitario Gregorio Marañon; Hospital Infantil Universitario... and other collaboratorsRecruitingHematopoietic System--CancerSpain
-
Universidade do PortoFoundation for Science and Technology, PortugalActive, not recruitingHypertension | Diabetes | Osteoarthritis | Dyslipidemia | Respiratory Disorders | Multimorbidity | Obese Patients | Sarcopenia in Elderly | High Blood Cholesterol | Depression DisordersPortugal
-
Insud PharmaKenya Medical Research Institute; Barcelona Institute for Global Health; European... and other collaboratorsRecruitingSoil-Transmitted HelminthsGhana, Kenya
-
Instituto Nacional de Cardiologia Ignacio ChavezInstituto Mexicano de Investigaciones NefrológicasCompletedQuality of Life | Kidney Failure | Renal Dialysis | Diastolic Dysfunction | Hemodiafiltration | Aerobic TrainingMexico