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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05505760
Other study ID # 008
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 30, 2023
Est. completion date February 29, 2024

Study information

Verified date October 2023
Source IDinsight
Contact Philipp M Kastrau, PhD
Phone +254746649552
Email philipp.kastrau@idinsight.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 8867
Est. completion date February 29, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Quality-Based Digital Messaging
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.

Locations

Country Name City State
South Africa Reach Digital Health (formerly Praekelt.org) Cape Town

Sponsors (2)

Lead Sponsor Collaborator
IDinsight Reach Digital Health (formerly Praekelt.org)

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary ANC visits 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
Primary Immunisation coverage 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 Knowledge/Attitude Index Includes knowledge of/attitudes towards diet, breastfeeding, and anemia Based on phone survey conducted 7 weeks after expected delivery
Secondary Behaviour Index 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
Secondary User Experience 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
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