SMS Maama Project COVID-19

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Complications; Birth Injuries
• Intervention / Treatment: Behavioral: mHealth Platform

Detailed Description

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;

1. To provide knowledge of COVID-19 symptoms, transmission, diagnosis, and treatment, in a time of social distancing and learning.
2. To improve access and linkages to maternal health services and information as well as provide appropriate referrals for pregnant females.
3. Inform the adoption of mHealth into future health delivery plans.

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Makerere University
• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants in this arm will receive the study intervention.	Behavioral: mHealth Platform; 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.
No Intervention: Routine Antenatal Care; Participants in this arm will receive no intervention.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Makerere University
• Investigators: Principal Investigator: Betty Nakabuye, MBChB, MMed, Lubaga Hospital and School of Public Health, Makerere University; Principal Investigator: Jolly Beyeza, Mulago Specialised Women's Hospital and School of Medicine, Makerere University; Principal Investigator: Katelyn Pastick, University of Minnesota; Principal Investigator: Cheryl Robertson, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): October 21, 2021
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Infant, Newborn, Diseases; Pregnancy Complications; Birth Injuries
• Other Study ID Numbers: STUDY00010582

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No