SMS Maama Project COVID-19

Study Overview
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Brief Summary
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The study's purpose is to demonstrate the ability of an mHealth platform as a feasible way of sharing information in a time of restricted movement in order to inform future studies.

Detailed Description
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The primary objective of this trial is to assess whether an mHealth platform increases maternal health knowledge in the areas of birth preparedness, pregnancy, and birth complications as measured by the pre- and post-surveys in comparison to routine antenatal care. The secondary objectives of this trial are; To provide knowledge of COVID-19 symptoms, transmission, diagnosis, and treatment, in a time of social distancing and learning. To improve access and linkages to maternal health services and information as well as provide appropriate referrals for pregnant females. Inform the adoption of mHealth into future health delivery plans.

Official Title
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mHealth for Improvement of Access to Maternal Health Services in the Era of COVID-19 Pandemic (SMS Maama Project)

Conditions
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Pregnancy Complications, Birth Injuries

Intervention / Treatment
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* Behavioral: mHealth Platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Own a personal mobile phone Attend ANC at Kisenyi Health Centre IV, Kawempe Hospital or Rubaga Hospital Are at least 24-26 weeks estimated gestational age Literate in English or Luganda Capable of sending/receiving text messages Exclusion Criteria: - Females who plan to travel out of Uganda during the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants in this arm will receive the study intervention. | Behavioral: mHealth Platform<br>* All participants randomized to the intervention group will receive 2-4 informational texts each week and will also receive interactive health screening questions throughout enrollment. A participant will also receive appointment reminder texts. All SMS text messages will be transmitted through a local organization known as The Medical Concierge Group (TMCG) via an electronic system that allows for bulk messaging. TMCG also staffs a 24-hour call line for those using TMCG services to call in for medical related questions. This call line is staffed by doctors and nurses; SMS Maama participants randomized to the interventional group will be able to access this call line free of charge as part of their enrollment in SMS Maama.<br>|
| No Intervention: Routine Antenatal Care<br>Participants in this arm will receive no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pre- to Post-Intervention Knowledge | Outcome is reported as the percent of pregnant participants who recognize key danger signs during pregnancy, labor and childbirth, and postpartum period. Knowledge is measured pre-intervention (approximately 24-26 weeks gestation) and post-intervention (approximately 2 weeks following delivery). The timeframe is calculated to be 16-18 weeks. | up to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knowledge on COVID-19 | Outcome reported as the percent of pregnant participants who identify key symptoms, modes of transmission, and measures to prevent SARS-CoV-2 infection (COVID-19). Knowledge is measured pre-intervention (approximately 24-26 weeks gestation) and post-intervention (approximately 2 weeks following delivery). The timeframe is calculated to be 16-18 weeks. | up to 18 weeks | 
| Rate of COVID Testing | Outcome is reported as the percent of pregnant participants who were tested for SARS-CoV-2 during pregnancy. | up to 18 weeks | 
| Change in Pregnancy Risk Knowledge | Outcome is reported as the percent of pregnant participants who believe pregnant females are at increased risk for COVID-19. Knowledge is measured pre-intervention (approximately 24-26 weeks gestation) and post-intervention (approximately 2 weeks following delivery). The timeframe is calculated to be 16-18 weeks. | up to 18 weeks | 
| Change in Breastfeeding Knowledge | Outcome is reported as the percent of pregnant participants who believe it is safe to breastfeed their newborn if they have or have had COVID-19. Knowledge is measured pre-intervention (approximately 24-26 weeks gestation) and post-intervention (approximately 2 weeks following delivery). The timeframe is calculated to be 16-18 weeks. | up to 18 weeks | 
| Antenatal Care Rate | Outcome is reported as the percent of pregnant participants who attend at least 4 antenatal care visits. | up to 18 weeks | 
| Skilled Birth Attendance Rate | Outcome is reported as the percent of pregnant participants who give birth at a hospital. | up to 18 weeks | 
| Rate of Negative Pregnancy Outcomes | Outcome is reported as the percent of pregnant participants who experience a negative pregnancy outcome (e.g. maternal/neonatal complications, miscarriage, stillbirth, and/or neonatal death). | up to 18 weeks |