- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05505760
Testing Content Delivery Models for MomConnect (MQR)
October 25, 2023 updated by: Haijing Huang, IDinsight
Testing the Effectiveness of Quality-Based WhatsApp Messaging on Vaccine Hesitancy and Childhood Immunization in a National Maternal Messaging Program
The case for mobile health (mHealth) has been gaining traction as a source to improve health outcomes of individuals.
mHealth refers to the use of Information and Communication Technologies (ICT) to support health care.
The ubiquity and penetration of mobile phones presents the opportunity to deliver health care services directly to citizens, with the greatest potential gains in under-resourced health ecosystems.
Operating for 8 years and currently supporting 1.28 million mothers through their pregnancies and early childhood care, MomConnect represents one of the largest maternal health messaging platforms in the world.
Implemented at the national level, MomConnect has been credited with being the first national-scale mHealth program of its kind and has won numerous international awards.
As a WhatsApp-delivered service, MomConnect has been limited by WhatsApp's historical terms of service.
In its current form, MomConnect can only start a conversation with mothers once a week by alerting them of their upcoming antenatal care (ANC) appointment.
Recent changes to WhatsApp's terms of service have removed the restriction around push messages for certain programs, including MomConnect.
Messages have historically been restricted to weekly conversation starters and carry only generic administrative reminder-style information.
As a result, it is possible that many mothers are failing to engage with the content as much as they could.
If mothers were more engaged, it could greatly increase exposure and knowledge of reducing the total number of mothers exposed to critical maternal and infant health content.
With the updated terms of service, there is an opportunity to test different ways of engaging mothers.
This study proposes to evaluate, through a randomized controlled trial (RCT), the relative effect of three new behaviorally-informed program models on key knowledge of and adoption of healthy behaviors.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
8867
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.
Study Contact
- Name: Philipp M Kastrau, PhD
- Phone Number: +254746649552
- Email: philipp.kastrau@idinsight.org
Study Contact Backup
- Name: Crystal H Huang, PhD
- Email: crystal.huang@idinsight.org
Study Locations
-
-
-
Cape Town, South Africa
- Recruiting
- Reach Digital Health (formerly Praekelt.org)
-
Contact:
- Jane Passmore
- Phone Number: +27114829775
- Email: jane@reachdigitalhealth.org
-
-
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
Inclusion Criteria:
- Pregnant women above the age of 18 signing up for MomConnect when being between 16-30 weeks pregnant
Exclusion Criteria:
- All others
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Appointment Reminder Model
This is the current MomConnect WhatsApp model (control).
Mothers receive weekly conversation starter messages reminding them about their upcoming clinic appointments, providing more comprehensive and relevant maternal health information only after mothers respond to the appointment reminder.
|
The impact of MomConnect's models will be evaluated using a randomized controlled trial (RCT).
Randomization will be at the individual level, where an individual refers to the "unique user", which is defined by the unique phone number used at the time of registration to MomConnect at health facilities.
Randomizing control and treatment allocations ensures that the study groups will be comparable in terms of observable and unobservable characteristics in expectation.
Therefore, statistical inference can shed light on the likelihood that any differences in outcome variables at the end of the intervention were caused by the intervention as compared to chance.
We will also study the treatment effects on different outcomes between the different arms of the experiment - comparing outcomes across different treatment arms or outcomes in the control to outcomes in treatment arms will help us answer the aforementioned research questions.
|
Experimental: Relevant Content Model (WhatsApp)
Mothers receive weekly conversation starter messages on WhatsApp, which carry both clinic appointment reminders along with some maternal and infant health information relevant to their pregnancy/postpartum stage.
In addition, a list of "frequently asked questions" (FAQs) relevant to the week of pregnancy the mother is in are provided so that mothers can engage further with maternal health information topics relevant to them.
|
The impact of MomConnect's models will be evaluated using a randomized controlled trial (RCT).
Randomization will be at the individual level, where an individual refers to the "unique user", which is defined by the unique phone number used at the time of registration to MomConnect at health facilities.
Randomizing control and treatment allocations ensures that the study groups will be comparable in terms of observable and unobservable characteristics in expectation.
Therefore, statistical inference can shed light on the likelihood that any differences in outcome variables at the end of the intervention were caused by the intervention as compared to chance.
We will also study the treatment effects on different outcomes between the different arms of the experiment - comparing outcomes across different treatment arms or outcomes in the control to outcomes in treatment arms will help us answer the aforementioned research questions.
|
Experimental: Relevant Content Model (SMS)
Mothers receive twice weekly conversation starter messages of 160 characters each per SMS, which carry both clinic appointment reminders as well as maternal and infant health information, relevant to their stage of pregnancy or the age of their baby.
Mothers can access the list of frequently asked questions relevant to their week of pregnancy via USSD.
|
The impact of MomConnect's models will be evaluated using a randomized controlled trial (RCT).
Randomization will be at the individual level, where an individual refers to the "unique user", which is defined by the unique phone number used at the time of registration to MomConnect at health facilities.
Randomizing control and treatment allocations ensures that the study groups will be comparable in terms of observable and unobservable characteristics in expectation.
Therefore, statistical inference can shed light on the likelihood that any differences in outcome variables at the end of the intervention were caused by the intervention as compared to chance.
We will also study the treatment effects on different outcomes between the different arms of the experiment - comparing outcomes across different treatment arms or outcomes in the control to outcomes in treatment arms will help us answer the aforementioned research questions.
|
Experimental: Relevant Content + Browsable Content Model
This is a combination of the Relevant Content and Browsable Content Models on WhatsApp (RCM+BCM), including appointment reminders, clinical information, a browsable menu and prompts to relevant stage-based topics.
Mothers receive weekly conversation starter messages.
|
The impact of MomConnect's models will be evaluated using a randomized controlled trial (RCT).
Randomization will be at the individual level, where an individual refers to the "unique user", which is defined by the unique phone number used at the time of registration to MomConnect at health facilities.
Randomizing control and treatment allocations ensures that the study groups will be comparable in terms of observable and unobservable characteristics in expectation.
Therefore, statistical inference can shed light on the likelihood that any differences in outcome variables at the end of the intervention were caused by the intervention as compared to chance.
We will also study the treatment effects on different outcomes between the different arms of the experiment - comparing outcomes across different treatment arms or outcomes in the control to outcomes in treatment arms will help us answer the aforementioned research questions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ANC visits
Time Frame: Based on phone survey conducted 7 weeks after expected delivery
|
Binary indicator measuring whether women attended at least 8 ANC visits during pregnancy as recommended by the WHO
|
Based on phone survey conducted 7 weeks after expected delivery
|
Immunisation coverage
Time Frame: Based on phone survey conducted 7 weeks after expected delivery
|
Binary indicator measuring whether the newborn child received all 6 vaccinations recommended at birth and 6 weeks after birth
|
Based on phone survey conducted 7 weeks after expected delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge/Attitude Index
Time Frame: Based on phone survey conducted 7 weeks after expected delivery
|
Includes knowledge of/attitudes towards diet, breastfeeding, and anemia
|
Based on phone survey conducted 7 weeks after expected delivery
|
Behaviour Index
Time Frame: Based on phone survey conducted 7 weeks after expected delivery
|
Includes behaviour related to ante-natal care visits, diet, pregnancy preparedness, breastfeeding, anemia, and child vaccinations
|
Based on phone survey conducted 7 weeks after expected delivery
|
User Experience
Time Frame: Backend data is collected throughout users' usage of the platform; survey data based on phone survey conducted 7 weeks after expected delivery
|
Includes WhatsApp back-end data and survey data on how users interacted with MomConnect platform
|
Backend data is collected throughout users' usage of the platform; survey data based on phone survey conducted 7 weeks after expected delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 30, 2023
Primary Completion (Estimated)
February 29, 2024
Study Completion (Estimated)
February 29, 2024
Study Registration Dates
First Submitted
August 16, 2022
First Submitted That Met QC Criteria
August 16, 2022
First Posted (Actual)
August 18, 2022
Study Record Updates
Last Update Posted (Actual)
October 27, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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 Hematological Diseases
-
Istituto Clinico HumanitasRecruiting
-
UNC Lineberger Comprehensive Cancer CenterTerminatedHematological DisorderUnited States
-
University of ChicagoTerminated
-
Chroma TherapeuticsCompletedLymphoid Malignancies | Hematological DiseaseFrance, Belgium, Netherlands
-
Orsenix LLCCompleted
-
Charite University, Berlin, GermanyUnknownHematological DiseaseGermany
-
University Hospital HeidelbergUniversity of Cologne; University Hospital Freiburg; University Hospital DresdenTerminated
-
The First Affiliated Hospital of Soochow UniversityRecruitingHematopoietic Stem Cell Transplantation | Malignant Hematological DiseasesChina
-
Zealand University HospitalUnknownHematological CancerDenmark
-
Institute of Hematology & Blood Diseases HospitalRecruitingAllogeneic Hematopoietic Stem Cell Transplantation | Hematological DiseaseChina
Clinical Trials on Quality-Based Digital Messaging
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI)RecruitingCardiovascular Diseases | Atherosclerosis | HIV | Human Immunodeficiency VirusUnited States
-
Scripps Whittier Diabetes InstituteNot yet recruiting
-
Johns Hopkins UniversityCompleted
-
Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID)Completed
-
University of MichiganAgency for Healthcare Research and Quality (AHRQ)Completed
-
Vanderbilt University Medical CenterJohns Hopkins UniversityCompletedPulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension | Associated Pulmonary Arterial Hypertension | Heritable Pulmonary Arterial HypertensionUnited States
-
University of PittsburghUniversity of Michigan; Allegheny Singer Research Institute (also known as...Completed
-
University of California, San FranciscoNational Cancer Institute (NCI); Dana-Farber Cancer Institute; University of... and other collaboratorsRecruitingKidney Cancer | Renal Cell Carcinoma | Breast Cancer | Ovarian Cancer | Rectal Cancer | Prostate Cancer | Bladder Cancer | Endometrial Cancer | Colon CancerUnited States
-
Children's Hospital of Fudan UniversityRecruitingAttention Deficit Hyperactivity DisorderChina