Mobile Phone Text Messaging Plus Motivational Interviewing: Effects on Breastfeeding, Child Health Outcomes (MTM-MI)

Mobile Phone Text Messaging Plus Motivational Interviewing: Effects on Breastfeeding, Child Health and Survival Outcomes, a Group Sequential Randomised Standard of Care Controlled 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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections; Breastfeeding, Exclusive
• Intervention / Treatment: Behavioral: Mobile phone text messaging plus prospective motivational interviewing; Behavioral: Standard infant feeding counselling

Detailed Description

Background

In 2010, following changes to global HIV and infant feeding guidelines, the South African vertical transmission prevention program stopped provision of formula milk and adopted breastfeeding as the recommended infant feeding modality. However, in reality, there are short-falls in attaining optimal infant feeding practices, which are contributing to failure to achieving the Sustainable Development under-five child health targets in South Africa. It is essential for the well-being of women living with HIV and their infants to establish models for supporting optimal infant feeding practices to achieve the desired child health outcomes.

Despite several proven interventions to improve breastfeeding practices, in practice there is lack of progress in implementing these interventions to achieve optimal breastfeeding practices. Telephonic support and motivational interviewing have been beneficial across many health problems, including medication adherence among people living with HIV and to reduce alcohol and tobacco use. Investigators propose to combine telephonic support with motivational interviewing to support infant feeding among women living with HIV. Combining these two interventions has great potential; it is likely to be cost-effective, simple to implement and easily integrated within the established infant feeding counselling conventional models.

Objectives

1. To determine the effects of mobile phone text messaging plus 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 all -cause death, (b) Infant growth.

Methods

Study design: Participants will be randomized in a 1:1 ratio using a permuted block method to receive study interventions versus standard of care for 24 weeks. Electronic sequence generation and random allocation will be done centrally. Participants meeting inclusion criteria who consent to participate will be enrolled and immediately assigned to a study arm sequentially.

Study interventions: All women and their infants, irrespective of study assignments, will receive health services and treatment according to the respective provincial guidelines applicable in the sector during the study. Participants will be evaluated soon after giving birth and post-delivery until cessation of breastfeeding or until end of the study.

Mobile phone text messaging: Every Monday morning, a research nurse will send text message to women in the intervention group encouraging mothers to exclusively breastfeed and inquire if mothers have any problems breastfeeding infants. Participants will be asked to respond by text within 48 hours, indicating no problem or a problem with breastfeeding and require help. The research nurse will review all the responses and then follow-up any participants who indicate a breastfeeding problem or call participants who fail to respond within 48 hours.

Motivational interviewing: In addition to text messaging, women will have individual motivational interviews post-delivery at weeks 2, 6, and 10. During the interviews, the research nurse will have to understand participant's frame of reference, reinforce participant's own self-motivational statements, monitor the readiness to change, and affirm the participant's freedom of choice. Advice will be given with participant's permission, and when given, the participant will make her own choice.

Usual standard of care: 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.

Sampling plan, recruitment, study assessment and follow-up: Pregnant women living with HIV and giving birth at a healthcare facility in Cape Town, South Africa, between October 2021 and September 2023 will be informed about the study and mothers who indicate interest in participating will be consented for the study. Informed consent will be requested to conduct an enrolment maternal interview, four in-person follow-up visits, child hospitalization medical record review, and child height and weight measurements.

Participants will have in-person follow-up at weeks 2, 6, 10, and 24 of child age. Research nurses or counselors will administer a baseline questionnaire and follow up study questionnaires.

• Study Type: Interventional
• Enrollment (Estimated): 275
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa
      • Khayelitsha District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• initiating formula feeding soon after delivery
• multiple birth deliveries
• birthweight <2500
• gestational age <36 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile phone text messaging plus prospective motivational interviewing; Experimental: 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.	Behavioral: Mobile phone text messaging plus prospective motivational interviewing; Interactive weekly mobile phone text messaging plus prospective motivational interviewing at study follow up visits; Behavioral: Standard infant feeding counselling; Standard infant feeding counselling as part of routine practice at primary healthcare facility
Active Comparator: Standard infant feeding counselling; Standard infant feeding counselling as part of routine primary healthcare practice	Behavioral: Standard infant feeding counselling; Standard infant feeding counselling as part of routine practice at primary healthcare facility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Measures

Outcome Measure	Measure Description	Time Frame
Infant morbidity	All -cause hospitalization and all -cause death	from birth to 6 months of child age
Infant weight in kilograms	Infant weight measurements	from birth to 6 months of child age
Infant length in centimetres	Infant length measurements	from birth to 6 months of child age

Collaborators and Investigators

• Sponsor: University of Stellenbosch
• Collaborators: Columbia University; McMaster University
• Investigators: Principal Investigator: Moleen Dzikiti, University of Stellenbosch; Study Chair: Mark Cotton, University of Stellenbosch; Study Chair: Louise Kuhn, Columbia University; Study Chair: Taryn Young, University of Stellenbosch; Study Chair: Lehana Thabane, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HIV; mHealth; motivational interviewing; Infant feeding; behavioural intervention
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: M21/03/010; TMA2020CDF-3169 (Other Grant/Funding Number: EDCTP2 supported by European Union and Fondation Botnar)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available within 6 months of completing study follow up. Data will be available for 15 years.
• IPD Sharing Access Criteria: Researchers working on similar maternal-child health related studies with appropriate institutional review board approvals for any additional pooled analyses
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No