NCT04089800

Brief Summary

The overall goal of the MatHealth project is to improve maternal health using an enhanced mobile phone-based multimedia application among illiterate women in rural southwestern Uganda. Building on a prototype of a mobile maternal health support technology developed as part of the on-going PhD research by one of our team members, The investigators will redesign the prototype to make it suitable for illiterate populations by engaging the local communities/prospective users to incorporate multimedia components such as videos and audios. Using the enhanced prototype, the investigators will carry out a reasonably large scale field study in Uganda, where the investigators will empirically implement the prototype among the rural community and assess its preliminary impact on maternal health. The investigators hypothesize that implementing the enhanced prototype will result in increased access to high quality, relevant local and culturally acceptable maternal health information that can enable mothers and families demonstrate improved health-seeking and preventative behaviors, including early uptake and adherence to antenatal check-ups and care including HIV testing, good nutrition, birth preparedness, dealing with danger signs, among others; all of which should ultimately contribute to improved maternal and child survival. The investigators will contribute to and benefit from a culture of continuous learning by engaging with the local/user communities, policy makers, and researchers to share lessons learned and best practices.This will potentially facilitate the translation of our research findings into medical care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

September 5, 2019

Last Update Submit

June 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adherence to antenatal visits

    The investigators will use Statistical Package for Social Scientists (SPSS) to determine the mean (standard deviation), median (interquartile range), and number of missed antenatal visits by participants as determined by the hospital antenatal records.

    24 Weeks

Secondary Outcomes (1)

  • Maternal health knowledge and attitudes

    12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

For 9 months, each of the 40 women in the intervention condition will use their phones to access the multimedia-based antenatal videos and audios tailored to their pregnancy stages. Participants will use the prototype until six weeks after giving birth. The intervention implementation is estimated to take 9 months including a 6 weeks follow-up after delivery, which implies that the implementation will be completed by November/ December 2019. The investigators will install the final prototype on a phone and give each participant in the intervention group a phone with a prototype installed, and explain how it works. Women will get support in resolving technical issues that may arise with the application between March and May 2019.

Other: Mobile phone based multimedia application

Control

NO INTERVENTION

The 40 women in the control condition will receive the usual standard care of antenatal check-up and counselling but no multimedia intervention.

Interventions

The investigators shall develop a multimedia mobile health application using Java programming language, while the database that hosts multimedia messages shall be developed using SQlite. It shall be an offline (stand-alone) application following user-centered design approaches that involve incorporating input from pregnant women as prospective users. Pregnant women shall be provided with solar chargers to supplement electricity charging. The application has three major functionalities, appointment reminder function, calling function and the multimedia (Video and audio) function.

Intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly Pregnant women shall be recruited and enrolled into the study through self representation of gender identity
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Initiating antenatal care at MRRH at the earliest presentation in the first and second trimester
  • Being illiterate-not having studied beyond primary seven or elementary education
  • Being able to access electricity or any other form of power to charge a phone
  • Age \>18 years;
  • Residents of Mbarara, i.e. within 20 km of the MRRH
  • Willing and able to give informed consent.

You may not qualify if:

  • At the earliest presentation in the third trimester
  • Being Literate-having studied beyond primary seven or elementary education
  • Age \<18 years;
  • Not Residents of Mbarara, i.e. Beyond 20 km of the MRRH
  • Not Willing and unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara Site

Mbarara, Uganda

Location

Study Officials

  • Angella Musiimenta, PhD

    Mbarara University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 13, 2019

Study Start

September 20, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations