Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202112740311146 Date of Registration: 17/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact evaluation of the MomConnect Programme of the Department of Health
Official scientific title mHealth4momHealth clustered randomised controlled trial to evaluate the effectiveness of the National Department of Health MomConnect programme
Brief summary describing the background and objectives of the trial The study aims to evaluate the effectiveness of the MomConnect programme in relation to knowledge, self-efficacy and behavioural intentions and practices related to contraceptive use and exclusive breastfeeding and service utilisation for contraceptives among post-partum women attending primary health care services in two provinces in South Africa. Specific objectives are: 1. To assess whether there are any differencesin the uptake of family planning services 8-10 weeks post-partum in the MomConnect intervention group compared to the control 2. To assess whether there are any differenences in the knowledge and self-efficacy to seek family planning and to breastfeed post-partum in the two study arms 3. To assess there is a difference in levels of exclusive breastfeeding at six weeks post-partum in the intervention compared to an unexposed control group 4. To assess whether there are any difference in behavioural intentions between the two study arms
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 16/03/2021
Actual trial start date
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group registration with MomConnect with additional messages about postpartum family planning Set of messages related to breastfeeding and family planning sent to women via their phones weekly. From 37 weeks gestation to 8 weeks post partum Gestational age messaging promoting a healthy pregnancy delivered via the MomConnect platform to enrolled women via Whatsapp or sms depending on their phone type. The content of the messages will include all standard MomConnect messages eg on the importance of breastfeeding as well as nine additional messages on family planning added for the purposes of the evaluation. 500
Control Group Standard antenatal and post partum care As per health services guidelines 37 weeks until 8 weeks post partum Women will continue to attend antenatal care, delivery services and post-partum care as per the standard care provided by the health facility. This will include routine information and education about her pregnancy offered by nurses. Women in the control group will receive messaging after the endline data collection is completed. 500 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
18 years or older 33-38 weeks pregnant not registered with MomConnect No direct access to a cell phone for the duration of the study HIV+ Adult: 18 Year(s)-44 Year(s) 18 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/12/2020 Wits Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
29 Princess of Wales Terrace, Parktown Johannesburg Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Initiated family planning services post partum intervention 8-10 weeks post partum
Primary Outcome Maintained exclusive breastfeeding post partum 8-10 weeks post partum
Secondary Outcome Intention to initiate family planning within the next six weeks 8-10 weeks post partum
Secondary Outcome Intention to exclusively breastfeed to six months 8-10 weeks
Secondary Outcome Knowledge about family planning 8-10 weeks
Secondary Outcome Knowledge about breasfeeding 8-10 weeks
Secondary Outcome Self-efficacy to seek family planning services 8-10 weeks
Secondary Outcome Self-efficacy to breastfeed 8-10 weeks
Secondary Outcome Satisfaction with MomConnect services 8-10 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
clinics in West Rand and Sedibeng in Gauteng province and Bojanala in North West There are 40 clinics where we will recruit women Rustenburg Vereenigning Roodepoort South Africa
Ritvallei Mogale City West Rand South Africa
Thusong clinic 12572 Ainslie Street Kagiso West Rand South Africa
Eric Ndleni 898 Flamingo Road West Rand South Africa
Randgate 1032 Baily Street West Rand South Africa
M L Peasson clinic Randfontein 1759 West Rand Johannesburg South Africa
Ya Rona clinic Nietgedacht 535, 1747 West Rand Johannesburg South Africa
Mohlakeng clinic Relerata street , Mohlakeng Randfontein South Africa
Simunye clinic 3409 Kgoltelela drive West Rand. Johannesburg South Africa
Wetsonaria clinic Saturnus street, cnr Blignaut West Rand South Africa
Khutsong clinic Khutsong Township WEst Rand Johannesburg South Africa
Thusanang 1853 C Ramaphosa St, Fochville South Africa
Muldersdrift clinic Plot 78 Swartkop Road Johannesburg South Africa
Carletonville clinic 3 Agnew Road Carletonville South Africa
Krugersdorp Central clinic Cnr Commissioner and Fountain street Krugersdorp South Africa
Dr Ramitz Martinez clinic 1901 Corane Street West Rand South Africa
Johan Heyns Frikkie Meyer street Van Der Bijl Park South Africa
Retswelapele clinic 8881 Mareka street Sharpeville South Africa
Boitumelo clinic 2001 Nelson Mandela street Sebokeng South Africa
Tshepiso clinic 1986 Tshepiso Sedibeng South Africa
Dr Helga Kuhn clinic 2063 Chestnut street Evaton South Africa
Empilisweni clinic 7724 Johanna Van Der Merwe Road Sebokeng South Africa
Evaton clinic Cnr Togo and Adams road Evaton South Africa
Johan Deo clinic 1098 Polokong Sebokeng South Africa
Levai Mbatha CHC 814 Hamilton Road Evaton South Africa
Market Avenue clinic 22 Market Avenue Vereeniging South Africa
Midvaal Community health centre 28 Mitchell Street Meyerton South Africa
Ruster Vaal clinic 1 Kiepersol Road Vereeniging South Africa
Mpumelelo clinic 13985 Nkosi street Evaton South Africa
Thlokomelong clinic 43-6 Modise street Ennerdale South Africa
Anna Leagole clinic Haartebeesfontein-A Haartebeespoort South Africa
Bafokeng clinic Luka Road Rustenburg South Africa
Boitekong CHC 234 Monareng street Boitekong South Africa
Chaneng clinic 459 Chaneng Village North West Province South Africa
Freedom Park clinic RDP phase 1 Bakwena complex Rustenburg South Africa
Kana clinic Stand no. 15975 ext 13 Rustenburg South Africa
Karlien Park clinic Sackville Street Rustenburg South Africa
Marikana clinic Municipality building Rustenburg South Africa
Sunrise Park clinic Sunrise Park Rustenburg South Africa
Thlabane CHC 3560 Monareng street Rustenburg South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Praekelt 44 Stanley Avenue Johannesburg 2092 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Praekelt 44 Stanley Avenue Johannesburg 2092 South Africa non profit
COLLABORATORS
Name Street address City Postal code Country
Professor Nicola Christofides School of Pubic Health York Road Johannesburg 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Renay Weiner renay@rthd.org 027832884375 37 Bath Avenue Rosebank
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Director RTHD and Visiting Senior Lecturer Wits School of Public Health
Role Name Email Phone Street address
Public Enquiries Renay Weiner renay@rthd.org 27832884375 9 Bath Avenue Rosebank
City Postal code Country Position/Affiliation
Johannesburg 2092 South Africa Director RTHD and Visiting Senior Lecturer Wits School of Public Health
Role Name Email Phone Street address
Scientific Enquiries Nicola Christofides nicola.christofides@wits.ac.za 27827748547 7 York Road PArktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Associate Professor School of Public Health University of the Witwatersrand
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes After data are analysed and published, anonymized data can be made available on request after de-identification and in consultation with the Ethics Committee regarding POPIA requirements Informed Consent Form,Study Protocol 6 months to three years after publication Controlled access based on a proposal directed to the Principal Investigator to be reviewed by all collaborating institutions
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information