Condition category
Pregnancy and Childbirth
Date applied
13/02/2019
Date assigned
20/02/2019
Last edited
20/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This research was done to try to measure the impact of a project which sent pregnancy and child support information to pregnant women and new mothers in Johannesburg, South Africa. The information was sent by text message twice a week starting during pregnancy and continued until the child was one year of age.

Who can participate?
Women over the age of 18 who received ANC and PNC services at one of the participating ANC/PNC sites during the study period, and who delivered with a skilled birth attendant at one of two participating delivery sites

What does the study involve?
The study involves receiving informative text messages on a mobile phone twice a week from the week participants sign up during pregnancy and until their newborn child is 12 months old. Some participants are invited to attend an interview about the text messages.

What are the possible benefits and risks of participating?
The direct benefit of the study is receiving the information in the text messages. These are not expected to pose any risk to the participants.

Where is the study run from?
1. Wits Reproductive Health and HIV Institute (South Africa)
2. Karolinska Institutet (Sweden)

When is the study starting and how long is it expected to run for?
July 2012 to May 2015

Who is funding the study?
1. United Nations Foundation
2. Babycentre
3. Johnson and Johnson
4. mHealth Alliance

Who is the main contact?
Dr Jesse Coleman
denots@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jesse Coleman

ORCID ID

http://orcid.org/0000-0002-3601-7854

Contact details

Wits RHI HQ
Hillbrow Health Precinct
22 Esselen Street
Hillbrow
Johannesburg
2001
South Africa
+17783022837
denots@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

MAMA

Study information

Scientific title

Evaluating the effectiveness of the MAMA South Africa mHealth intervention from health care utilisation, cost-effectiveness and user perspectives

Acronym

MAMA SA

Study hypothesis

The MAMA South Africa intervention is a cost-effective way of improving attendance to antenatal and postnatal care.

Ethics approval

Human Research Ethics Committee (Medical) at the University of the Witwatersrand in Johannesburg, Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown, Johannesburg, 2193, South Africa. Research Administrator: Mr Rhulani (Mkansi Rhulani.Mkansi@wits.ac.za) or Ms Zanele Ndlovu (zanele.ndlovu@wits.ac.za), Tel: +27 (0)11 717 1252/2700/1234/2656, 31/01/2014

Study design

Multi-centre intervention study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Maternal health, newborn health, HIV

Intervention

The mHealth intervention consisted of twice-weekly informative and stage-based maternal health information text messages sent to women during pregnancy until their child was one year of age. The intervention was offered to all pregnant women receiving ANC care at the intervention sites and supplemented the clinical standard of care offered. Intervention participants could join the SMS intervention between their 5th and 39th week of pregnancy. An additional 104 messages were sent postnatally, and included reminders for each vaccination during the first year. The intervention ran from July 2012 to August 2014. The last enrolled patient was followed until May 2015.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Attendance to antenatal care, collected from clinical ANC records (number of visits during the pregnancy)

Secondary outcome measures

1. Childhood immunizations received, collected from the “road to Health” booklets that each infant receives and where immunization data are recorded, at birth, age 6 weeks, age 10 weeks, age 14 weeks, and age 9 months
2. Postnatal infant HIV testing collected from the delivery site PCR testing database at age 6 weeks
3. Birth outcomes collected from the maternal register database at the delivery site at birth
4. Cost-effectiveness calculated based on MAMA user costs, health care system costs and programmatic costs which were entered in the Lives Saved Tool (LiST), a tool used to model the impact of scaling-up health-related interventions used to reduce maternal, neonatal and child mortality costs collected retrospectively including data from planning of intervention

Overall trial start date

02/07/2012

Overall trial end date

31/05/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Over the age of 18 at recruitment
2. Received ANC and PNC services at one the participating ANC/PNC sites during the study period
3. Delivered with a skilled birth attendant at one of two participating delivery sites
4. Have had regular access to a cellular phone

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

504 in control and 504 in intervention group

Total final enrolment

821

Participant exclusion criteria

1. Younger than 18 years of age
2. Did not give consent to participate
3. Did not fulfil inclusion criteria

Recruitment start date

02/07/2012

Recruitment end date

21/08/2014

Locations

Countries of recruitment

South Africa

Trial participating centre

Wits Reproductive Health and HIV Institute
Wits RHI HQ, Hillbrow Health Precinct, 22 Esselen Street, Hillbrow
Johannesburg
2001
South Africa

Trial participating centre

Karolinska Institutet
Department of Public Health, Tomtebodavägen 18A
Stockholm
17176
Sweden

Sponsor information

Organisation

Wits Reproductive Health and HIV Institute

Sponsor details

Wits RHI HQ
Hillbrow Health Precinct
22 Esselen Street
Hillbrow
Johannesburg
2001
South Africa
+27 (11) 358 5500
hicomms@wrhi.ac.za

Sponsor type

University/education

Website

http://www.wrhi.ac.za/

Funders

Funder type

Industry

Funder name

United Nations Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Babycentre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Johnson and Johnson

Alternative name(s)

Johnson & Johnson, JNJ

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

mHealth Alliance

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This study has resulted in five sub-studies, three about uptake of ANC and PNC services, one on cost-effectiveness and one qualitative study on user perceptions. Two papers have already been published (July 2017 and July 2018 - see publication list). One paper is being submitted for consideration in March 2019, another will be submitted before June 2019.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jesse Coleman (denots@gmail.com).

Intention to publish date

01/03/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Effectiveness of an SMS-based maternal mHealth intervention to improve clinical outcomes of HIV-positive pregnant women. Coleman J, Bohlin KC, Thorson A, Black V, Mechael P, Mangxaba J, Eriksen J. AIDS Care. 2017 Jul;29(7):890-897. doi: 10.1080/09540121.2017.1280126. Epub 2017 Jan 20. PMID: 28107805

Forecasting the Value for Money of Mobile Maternal Health Information Messages on Improving Utilization of Maternal and Child Health Services in Gauteng, South Africa: Cost-Effectiveness Analysis. LeFevre A, Cabrera-Escobar MA, Mohan D, Eriksen J, Rogers D, Neo Parsons A, Barre I, Jo Y, Labrique A, Coleman J. JMIR Mhealth Uhealth. 2018 Jul 27;6(7):e153. doi: 10.2196/mhealth.8185. PMID: 30054263

Publication citations

Additional files

Editorial Notes

19/02/2019: Trial's existence confirmed by the Human Research Ethics Committee (Medical) at the University of the Witwatersrand in Johannesburg.