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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202110870407786 Date of Approval: 05/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mobile Phone Text Messaging Plus Motivational Interviewing: Effects on Breastfeeding, Child Health Outcomes (MTM-MI)
Official scientific title Mobile Phone Text Messaging Plus Motivational Interviewing: Effects on Breastfeeding, Child Health and Survival Outcomes, a Group Sequential Randomised Standard of Care Controlled Trial
Brief summary describing the background and objectives of the trial Background Lack of breastfeeding, at a minimum, doubles the risk of infant death in the first six months of life. Many infants in low resourced settings at high risk of infectious disease morbidity and death are deprived of the immunological and nutritional benefits of breast milk, through an attenuated duration of breast milk exposure. South Africa has one of the lowest exclusive breastfeeding rates in Africa, 8% in infants under 6 months of age. Mobile phone text messaging as a simple, low-cost intervention improves medication adherence among patients with HIV, diabetes and tuberculosis. Motivational interviewing has been beneficial across many health problems, including HIV viral load suppression, body weight loss, and alcohol and tobacco use. Combining a number of intervention approaches is more likely to influence behaviour change than an individual approach. Investigators assume that continued breastfeeding is sustained among women living with HIV receiving weekly text messages combined with motivational interviewing and that this contributes to improved infant health outcomes. Objectives: 1. To determine the effects of mobile phone text messaging combined with motivational interviewing versus standard of care on: (a) Continued exclusive breastfeeding to six month of child age, (b) Continued any form of breastfeeding to 6 month of child age. 2. To determine the contribution of the combined intervention on improved infant health outcomes: (a) Infant morbidity (all –cause hospitalization) and death (all –causes, (b) Infant growth. Methods Investigators propose a group sequential clinical trial to determine whether text messaging combined with motivational interviewing will prolong breastfeeding and the contribution of the combined intervention on improved infant health outcomes. The study will recruit 275 women living with HIV and HIV exposed infants at birth and randomly assign study interventions for 6 months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MTMMI
Disease(s) or condition(s) being studied Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 01/10/2021
Actual trial start date 22/07/2022
Anticipated date of last follow up 30/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 275
Actual target sample size (number of participants) 276
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
TMA2020CDF3169 ClinicalTrials.gov ID: NCT05063240
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard infant feeding counselling Standard infant feeding counselling as part of routine primary Not applicable From birth to 6 months of child age Participants randomized to the usual standard of care group will be counselled by primary healthcare nurses and trained lay counsellors to exclusively breastfeed for the first six months. Participants will be free to call the clinic staff at any time 138 Active-Treatment of Control Group
Experimental Group Mobile phone text messaging plus prospective motivational interviewing Note applicable From birth to 6 months of child age Text messaging-motivational interviewing. Every Monday morning, a text message (SMS) will be sent to participants in the intervention group encouraging participants to continue breastfeeding, and inquire if participants have any problems breastfeeding the infants. Participants will be asked to respond within 48 hours, indicating no problem or a problem with breastfeeding that requires help. In addition to text messaging, participants will have motivational interviews post-delivery at weeks 2, 6, and 10. Motivational interviews will explore and support the participant's commitment to continue breastfeeding. 138
Control Group Standard infant feeding counselling Standard infant feeding counselling as part of routine primary Not applicable From birth to 6 months of child age Participants randomized to the usual standard of care group will be counselled by primary healthcare nurses and trained lay counsellors to exclusively breastfeed for the first six months. Participants will be free to call the clinic staff at any time 138 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women living with HIV and HIV exposed infants Initiating breastfeeding soon after delivery 18 years and older Ownership of a mobile phone Infant judged to be in good health who are discharged soon after delivery Initiating formula feeding soon after delivery Multiple birth deliveries Birthweight <2500 Gestational age <36 week Adult: 19 Year-44 Year 18 Year(s) 45 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 22/06/2021 Stellenbosch University Human Research Ethics Committee HREC1
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl drive, Parow, Cape Town, Stellenbosch University Cape Town 8000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of participants who are exclusively breastfeeding - Number of participants who report giving only breast milk and no other liquid or solid based foods to infants as assessed by the infant feeding questionnaire From birth to 6 month of child age
Primary Outcome Number of participants who are practicing any form of breastfeeding - Number of participants who report giving breast milk and other liquid or solid based foods to infants as assessed by the infant feeding questionnaire From birth to 6 months of child age
Secondary Outcome All –cause hospitalization and all –cause death From birth to 6 months of child age
Secondary Outcome Infant weight in kilograms From birth to 6 months of child age
Secondary Outcome Infant length in centimetres From birth to 6 months of child age
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Khayelitsha District hospital Cnr Walter Sisulu and Steve Biko Road Khayelitsha Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP2 supported by European Union and Fondation Botnar Anna van Saksenlaan 51, 2593 HW The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Stellenbosch Francie van Zijl drive, Parow, Cape Town Cape Town 8000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof Taryn Young Francie van Zijl Drive Cape Town 8000 South Africa
Prof Mark F. Cotton Francie van Zijl Drive Cape Town 8000 South Africa
Prof Lehana Thabane McMaster University, Canada Hamilton Canada
Prof Louise Kuhn 622 West 168th Street, Columbia University New York 10032 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moleen Dzikiti moleenz@sun.ac.za +27219389512 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Moleen Dzikiti moleenz@sun.ac.za +27219389512 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Moleen Dzikiti moleenz@sun.ac.za +27219389512 Francie van Zijl
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Senior Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data will be available on SUNScholarData, an institutional research data repository that is managed by Stellenbosch University library. Participant's anonymized and de-identified data will added to the public data repository Clinical Study Report,Statistical Analysis Plan,Study Protocol Data will become available within 6 months of completing study follow up. Data will be available for 15 years Researchers working on similar maternal-child health related studies with appropriate institutional review board approvals for any additional pooled analyses
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 19/03/2025 20/01/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/03/2025
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 20/02/2023 Updating actual trial start date 22 Jul 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 04/12/2023 We recruited 276 to have balanced groups 276
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 20/02/2023 The trial started recruitment. Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 04/12/2023 Study achieved the required sample size and recruitment has been completed. Recruiting Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 13/04/2025 The trial completed follow up. Closed to recruitment,follow-up continuing Completed
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 13/04/2025 We recruited more for this arm Control Group, Standard infant feeding counselling Standard infant feeding counselling as part of routine primary, Not applicable, From birth to 6 months of child age, Participants randomized to the usual standard of care group will be counselled by primary healthcare nurses and trained lay counsellors to exclusively breastfeed for the first six months. Participants will be free to call the clinic staff at any time, 137, Active-Treatment of Control Group Control Group, Standard infant feeding counselling Standard infant feeding counselling as part of routine primary, Not applicable, From birth to 6 months of child age, Participants randomized to the usual standard of care group will be counselled by primary healthcare nurses and trained lay counsellors to exclusively breastfeed for the first six months. Participants will be free to call the clinic staff at any time, 138, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 19/03/2025 Manuscript publication date added. 20 Jan 2025
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 19/03/2025 Trial completed. No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 19/03/2025 Trial completed 17165_12221_1045.pdf