SMS Maama Project COVID-19

NCT04739462 | Completed

• 1 other identifier: STUDY00010582
• Study Type: interventional
• Target: 248
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Pregnancy Complications; Birth Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Knowledge on COVID-19

  up to 18 weeks

• Rate of COVID Testing

  up to 18 weeks

• Change in Pregnancy Risk Knowledge

  up to 18 weeks

• Change in Breastfeeding Knowledge

  up to 18 weeks

• Antenatal Care Rate

  up to 18 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in this arm will receive the study intervention.

Behavioral: mHealth Platform

Routine Antenatal Care

NO INTERVENTION

Participants in this arm will receive no intervention.

Interventions

mHealth Platform BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Females who plan to travel out of Uganda during the study period

Sponsors & Collaborators

• University of Minnesota: lead
• Makerere University: collaborator

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Makerere University

Kampala, Uganda

Location

MeSH Terms

Conditions

Pregnancy Complications; Birth Injuries

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: September 28, 2021
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

US (1); UG (1)