NCT05997511

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,109

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
3 countries

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 27, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

July 22, 2023

Last Update Submit

June 20, 2024

Conditions

Keywords

COVID-19Mental HealthMisconceptionCommunity Health Workers (CHWs)

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

    24 months

Secondary Outcomes (3)

  • Qualitative Interviews

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

  • Longitudinal Cohort Surveys

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

  • Cross-Sectional Survey

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

Study Arms (2)

COVID-19

OTHER

Behavioral (SMS) Intervention

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

Mental Health

OTHER

Behavorial (SMS) Intervention

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

Interventions

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.

COVID-19Mental Health

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.

COVID-19Mental Health
SMS MessagingBEHAVIORAL

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
COVID-19Mental Health

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- Less than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Zanmi Lasante

Cangé, Haiti

Location

Partners in Health- Malawi

Neno, Malawi

Location

Partners in Health- Rwanda

Kigali, Rwanda

Location

MeSH Terms

Conditions

Psychological Well-BeingCOVID-19Communication

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2023

First Posted

August 18, 2023

Study Start

November 27, 2023

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations