Immunization CoverageMQRNCT05505760
Testing Content Delivery Models for MomConnect
A study testing Quality-Based Digital Messaging in people with Immunization Coverage and Breastfeeding, run by IDinsight at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Immunization Coverage, Breastfeeding, Hematological Diseases
- What is being tested?
- Quality-Based Digital Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,867 participants
- Where
- 1 siteSouth Africa
- Study dates
- 30 May 2023to 29 Feb 2024
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women above the age of 18 signing up for MomConnect when being between 16-30 weeks pregnant
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
Crystal H Huang, PhD contact
South Africa1 site, 1 recruiting
- Recruiting
Reach Digital Health (formerly Praekelt.org)
Cape Town
Jane Passmore, +27114829775, jane@reachdigitalhealth.org
About this study
Official title: 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.
- Conditions
- Immunization Coverage, Breastfeeding, Hematological Diseases
- Being tested
- Quality-Based Digital Messaging
- Medical subject headings
- Breast Feeding, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-Based Digital MessagingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Appointment Reminder Model | Experimental | 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. Receives: Behavioral: Quality-Based Digital Messaging |
| Relevant Content Model (WhatsApp) | Experimental | 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. Receives: Behavioral: Quality-Based Digital Messaging |
| Relevant Content Model (SMS) | Experimental | 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. Receives: Behavioral: Quality-Based Digital Messaging |
| Relevant Content + Browsable Content Model | Experimental | 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. Receives: Behavioral: Quality-Based Digital Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANC visits
Binary indicator measuring whether women attended at least 8 ANC visits during pregnancy as recommended by the WHO
Measured: Based on phone survey conducted 7 weeks after expected delivery
Immunisation coverage
Binary indicator measuring whether the newborn child received all 6 vaccinations recommended at birth and 6 weeks after birth
Measured: Based on phone survey conducted 7 weeks after expected delivery
Secondary outcomes (3)
Knowledge/Attitude Index
Includes knowledge of/attitudes towards diet, breastfeeding, and anemia
Measured: Based on phone survey conducted 7 weeks after expected delivery
Behaviour Index
Includes behaviour related to ante-natal care visits, diet, pregnancy preparedness, breastfeeding, anemia, and child vaccinations
Measured: Based on phone survey conducted 7 weeks after expected delivery
User Experience
Includes WhatsApp back-end data and survey data on how users interacted with MomConnect platform
Measured: Backend data is collected throughout users' usage of the platform; survey data based on phone survey conducted 7 weeks after expected delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start30 May 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunization CoverageStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8,867 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDinsight
- Sponsor type
- University, hospital or other
- Collaborators
- Reach Digital Health (formerly Praekelt.org)
- Responsible party
- Principal investigator, Haijing Huang, IDinsight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505760
- Sponsor's protocol ID
- 008
- Acronym
- MQR
- Status last verified
- Oct 2023
- First submitted
- 16 Aug 2022
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of Quality-Based WhatsApp Messaging on Vaccine Hesitancy and Childhood Immunization in a National Maternal Messaging Program
- ClinicalTrials.gov ID
- NCT05505760
- Acronym / sponsor ID
- MQR / 008
- Conditions
- Immunization Coverage, Breastfeeding, Hematological Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8,867 participants (estimated)
- Lead sponsor
- IDinsightUniversity, hospital or other
- Collaborators
- Reach Digital Health (formerly Praekelt.org)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 18 Aug 2022 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Appointment Reminder Model | Experimental | Behavioral: Quality-Based Digital MessagingThis 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. |
| Relevant Content Model (WhatsApp) | Experimental | Behavioral: Quality-Based Digital MessagingMothers 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. |
| Relevant Content Model (SMS) | Experimental | Behavioral: Quality-Based Digital MessagingMothers 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. |
| Relevant Content + Browsable Content Model | Experimental | Behavioral: Quality-Based Digital MessagingThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women above the age of 18 signing up for MomConnect when being between 16-30 weeks pregnant
Key exclusion criteria (1 listed)
- All others
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 |
|---|---|---|
| Quality-Based Digital MessagingThe 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. | Behavioural | Appointment Reminder Model, Relevant Content + Browsable Content Model, Relevant Content Model (SMS), Relevant Content Model (WhatsApp) |
Primary outcome
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
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
3 secondary outcomes
Knowledge/Attitude Index
Time frame: Based on phone survey conducted 7 weeks after expected delivery
Behaviour Index
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Recruiting
OPTIMIZING ROUTINE DELIVERY OF ESSENTIAL CHILD HEALTH AND NUTRITION PACKAGE THROUGH PRIMARY HEALTH CARE CONTACTS
Coverage of Vitamin A Supplementation, Coverage of Immunization
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.
Crystal H Huang, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality-Based Digital Messaging in people with Immunization Coverage and Breastfeeding, run by IDinsight at 1 site in South Africa.
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 1 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 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
Contact Philipp M Kastrau, PhD (+254746649552, philipp.kastrau@idinsight.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ANC visits (time frame: Based on phone survey conducted 7 weeks after expected delivery). The study lists 2 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 27 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.