A multi-site intervention study comparing health outcomes of MAMA South Africa users versus standard of care
| ISRCTN | ISRCTN41772986 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41772986 |
| Secondary identifying numbers | MAMA |
- Submission date
- 13/02/2019
- Registration date
- 20/02/2019
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
Contact information
Scientific
Wits RHI HQ
Hillbrow Health Precinct
22 Esselen Street
Hillbrow
Johannesburg
2001
South Africa
 ORCID ID |
0000-0002-3601-7854 |
|---|---|
| Phone | +17783022837 |
| denots@gmail.com |
Study information
| Study design | Multi-centre intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Prevention |
| Scientific title | Evaluating the effectiveness of the MAMA South Africa mHealth intervention from health care utilisation, cost-effectiveness and user perspectives |
| Study 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(s) | 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 |
| 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 |
| 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 study start date | 02/07/2012 |
| Overall study end date | 31/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 504 in control and 504 in intervention group |
| Total final enrolment | 821 |
| 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 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
- Sweden
Study participating centres
Johannesburg
2001
South Africa
Stockholm
17176
Sweden
Sponsor information
University/education
Wits RHI HQ
Hillbrow Health Precinct
22 Esselen Street
Hillbrow
Johannesburg
2001
South Africa
| Phone | +27 (11) 358 5500 |
|---|---|
| hicomms@wrhi.ac.za | |
| Website | http://www.wrhi.ac.za/ |
Funders
Funder type
Industry
No information available
No information available
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Johnson & Johnson, johnson & Johnson Services, Inc., Johnson&Johnson, 强生公司, Johnson & Johnson Private Limited, ジョンソン・エンド・ジョンソント, J&J, JNJ
- Location
- United States of America
No information available
Results and Publications
| Intention to publish date | 01/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jesse Coleman (denots@gmail.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/10/2020 | 23/10/2020 | Yes | No |
Editorial Notes
23/10/2020: Publication reference added.
19/02/2019: Trial's existence confirmed by the Human Research Ethics Committee (Medical) at the University of the Witwatersrand in Johannesburg.
