Mental HealthNCT05997511
Leveraging Community Health Workers to Combat COVID-19 and Mental Health Misinformation in Haiti, Malawi, and Rwanda
A study testing Card-Sorting Activity (Pre-intervention design), SMS Crafting (Pre-intervention design) and SMS Messaging in people with Mental Health and COVID-19, run by Harvard Medical School (HMS and HSDM) at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health, COVID-19, Misinformation
- What is being tested?
- Card-Sorting Activity (Pre-intervention design), SMS Crafting (Pre-intervention design) and SMS Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,109 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 27 Nov 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CHWs affiliated with PIH Rwanda, Malawi, or Haiti
- 18+ years of age.
Who cannot join
- Less than 18 years old.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health, COVID-19, Misinformation
- Being tested
- Card-Sorting Activity (Pre-intervention design), SMS Crafting (Pre-intervention design), SMS Messaging
- Keywords
- COVID-19, Mental Health, Misconception, Community Health Workers (CHWs)
- Medical subject headings
- Psychological Well-Being, COVID-19, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Card-Sorting Activity (Pre-intervention design)Behavioural
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)Behavioural
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 MessagingBehavioural
Also called text 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.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Other | Behavioral (SMS) Intervention Receives: Behavioral: Card-Sorting Activity (Pre-intervention design); Behavioral: SMS Crafting (Pre-intervention design); Behavioral: SMS Messaging |
| Mental Health | Other | Behavorial (SMS) Intervention Receives: Behavioral: Card-Sorting Activity (Pre-intervention design); Behavioral: SMS Crafting (Pre-intervention design); Behavioral: SMS Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
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
Measured: 24 months
Number of COVID-19 Vaccine Doses Administered Monthly at Health Facilities (if available)
COVID-19 Vaccine administration will be measured using routinely collected data measured monthly at the health facility level
Measured: 24 months
Secondary outcomes (3)
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.
Measured: Before, after 6 months of the intervention, and after 12 months of the intervention (only in Rwanda & Haiti)
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.
Measured: Before, after 6 months of the intervention, and after 12 months of the intervention (only in Rwanda & Haiti)
Cross-Sectional Survey
a repeated cross-sectional survey of community members
Measured: Before the intervention and after 12 months of the intervention (only in Rwanda & Haiti)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start27 Nov 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 5,109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- Partners in Health
- Responsible party
- Principal investigator, Bethany Hedt-Gauthier, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997511
- Sponsor's protocol ID
- IRB22-1339
- Status last verified
- Jun 2024
- First submitted
- 22 Jul 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Community Health Workers to Combat Health Misinformation in Haiti, Malawi, and Rwanda
- ClinicalTrials.gov ID
- NCT05997511
- Acronym / sponsor ID
- IRB22-1339
- Conditions
- Mental Health, COVID-19, Misinformation
- Keywords
- COVID-19, Mental Health, Misconception, Community Health Workers (CHWs)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,109 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- Partners in Health
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | Other | Behavioral: Card-Sorting Activity (Pre-intervention design), Behavioral: SMS Crafting (Pre-intervention design), Behavioral: SMS MessagingBehavioral (SMS) Intervention |
| Mental Health | Other | Behavioral: Card-Sorting Activity (Pre-intervention design), Behavioral: SMS Crafting (Pre-intervention design), Behavioral: SMS MessagingBehavorial (SMS) Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CHWs affiliated with PIH Rwanda, Malawi, or Haiti
- 18+ years of age.
Key exclusion criteria (1 listed)
- Less than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | COVID-19, Mental Health |
| 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. | Behavioural | COVID-19, Mental Health |
| SMS MessagingAlso: text messagingFinal 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. | Behavioural | COVID-19, Mental Health |
Primary outcome
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
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
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
3 secondary outcomes
Qualitative Interviews
Time frame: 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)
Cross-Sectional Survey
Time frame: Before the intervention and after 12 months of the intervention (only in Rwanda & Haiti)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Card-Sorting Activity (Pre-intervention design), SMS Crafting (Pre-intervention design) and SMS Messaging in people with Mental Health and COVID-19, run by Harvard Medical School (HMS and HSDM) at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Haiti, Malawi, Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Mental Health Visits/ Consultations Completed Monthly at Health Facilities (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.