ClinicalTrials.gg
Active, not recruitingNCT05997511Updated Jun 24, 2024

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

An interventional study of Card-Sorting Activity (Pre-intervention design) and SMS Crafting (Pre-intervention design) in Mental Health, COVID-19 and Misinformation, sponsored by Harvard Medical School (HMS and HSDM). Active, not recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-24.

Primary conditionCOVID-19Registry: Psychological Well-BeingReclassifiedWhy we changed it
Registry
Psychological Well-Being — the first condition term the registry derived for this study.
ClinicalTrials.gg
COVID-19
Why
  1. Psychological Well-Being is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name COVID-19.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Harvard Medical School (HMS and HSDM) · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
5,109
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Mental Health
  • COVID-19
  • Misinformation

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Keywords

  • COVID-19
  • Mental Health
  • Misconception
  • Community Health Workers (CHWs)
03

In context

COVID-19 Reclassified

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 5,109 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Harvard Medical School (HMS and HSDM) is the lead sponsor of 55 studies on the registry; 14 are open to participants now.

Compared within COVID-19, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychological Well-Being. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

The intervention will be assigned at the unit of the CHWs. These individuals will also be eligible for the CHW longitudinal cohort.

Inclusion criteria

Inclusion Criteria:

  • CHWs affiliated with PIH Rwanda, Malawi, or Haiti
  • 18+ years of age.

Exclusion criteria

Exclusion Criteria:

  • Less than 18 years old.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,109 participants (actual)

Study arms

  • Other
    COVID-19

    Behavioral (SMS) Intervention

    Behavioral: Card-Sorting Activity (Pre-intervention design) · Behavioral: SMS Crafting (Pre-intervention design) · Behavioral: SMS Messaging

  • Other
    Mental Health

    Behavorial (SMS) Intervention

    Behavioral: Card-Sorting Activity (Pre-intervention design) · Behavioral: SMS Crafting (Pre-intervention design) · Behavioral: SMS Messaging

Interventions

  • BehavioralCard-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.

  • BehavioralSMS 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.

  • BehavioralSMS 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.

    Also known as: text messaging

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 months

  2. 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

    Time frame: 24 months

  3. 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

    Time frame: 24 months

Secondary outcomes

  1. 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.

    Time frame: Before, after 6 months of the intervention, and after 12 months of the intervention (only in Rwanda & Haiti)

  2. 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.

    Time frame: Before, after 6 months of the intervention, and after 12 months of the intervention (only in Rwanda & Haiti)

  3. Cross-Sectional Survey

    a repeated cross-sectional survey of community members

    Time frame: Before the intervention and after 12 months of the intervention (only in Rwanda & Haiti)

07

Study locations

3 sites
  • Zanmi Lasante
    Cange, Haiti
  • Partners in Health- Malawi
    Neno, Malawi
  • Partners in Health- Rwanda
    Kigali, Rwanda
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05997511
Lead sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
Partners in Health
Responsible party
Bethany Hedt-Gauthier (Principal Investigator, Harvard Medical School (HMS and HSDM)) — Principal investigator
First posted
Aug 18, 2023
Start date
Nov 27, 2023
Primary completion
Jan 31, 2025 (estimated)
Completion
Jan 31, 2025 (estimated)
Last update
Jun 24, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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