Text Messaging Plus Motivational Interviewing in Promotion of Breastfeeding Among HIV-infected Women

September 21, 2023 updated by: Moleen Zunza, University of Stellenbosch

Feasibility and Effects of Mobile Phone Text Messaging Plus Motivational Interviewing Versus Usual Care in Promotion of Breastfeeding Among HIV-infected Women in South Africa: A Randomized, Parallel Group, Controlled Pilot Trial

The primary aim of this study is to find out whether it is feasible to conduct a larger study looking at the effect of mobile phone text messaging added to motivational interviewing on number of participants invited to the study who consented to participate and the number with complete evaluation of infant feeding practices at all study visits.

Secondary aim: In HIV-infected women initiating breastfeeding after giving birth, does interactive weekly mobile phone text messaging plus motivational interviewing versus usual care, improve self-reported adherence to exclusive or any breastfeeding 6 months post-delivery and to determine the number of women remaining in the group they were assigned until end of study or lost to follow-up (protocol adherence).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breastfeeding reduces the risks of dying from infections and is currently recommended as the most beneficial feeding option for infants born to HIV-infected women in low-resourced settings. This recommendation contradicts previous recommendations to avoid breastfeeding to prevent mother-to-child transmission of HIV. South Africa, a high HIV prevalent country, recently phased out access to free formula milk in the public sector in support of breastfeeding for HIV-infected women. The investigators previously found that few HIV-infected South African women choose breastfeeding and among those who did, many stop breastfeeding early. This study involves text messaging breastfeeding advice encouraging women to exclusively breastfeed, and inquire if they have any breastfeeding related problems, and motivational interviews exploring and supporting woman's commitment to continue breastfeeding.Participants meeting inclusion criteria who consent participation will be enrolled by a research nurse and immediately randomly assigned to text messaging plus motivational interviewing group or usual standard of care group.

The investigators propose a randomized, parallel group, standard of care-controlled pilot trial which will be conducted among HIV-infected women of low socio-economic background, giving birth at a primary healthcare clinic in Cape Town, South Africa. The pilot trial will assess the feasibility of conducting a larger trial on communication and support approaches that may improve HIV-infected woman's adherence to exclusive and continued breastfeeding.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 8000
        • Moleen Zunza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women living with HIV
  • initiated breastfeeding within 24 hours of giving normal birth
  • on ART
  • 18 years or older
  • ownership of a mobile phone
  • infants judged to be in good health who are discharged soon after delivery

Exclusion Criteria:

  • initiating both breastfeeding and formula feeding or formula feeding within 24 hours of giving birth.
  • gave birth to more than one infant
  • birth weight < 2500
  • gestational age < 36 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual standard of care
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 their infants. Participants will be asked to respond within 48 hours, indicating that they either do not have a problem or they have a problem and require 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: Text messaging-motivational interviewing
Interactive weekly mobile phone text messaging plus prospective motivational interviews
Other Names:
  • motivational interviewing
  • mobile phone text messaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants invited to the study who consented to participate.
Time Frame: 6 month post randomization
Number of participants invited to the study who consented to participate.
6 month post randomization
Number of participants with complete evaluation of infant feeding practices at all study visits
Time Frame: 6 month post randomization
Number of participants with complete evaluation of infant feeding practices at all study visits as assessed by infant feeding questionnaire.
6 month post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants remaining in the group they were assigned until end of study or lost to follow-up (protocol adherence).
Time Frame: 6 month
Number of participants remaining in the group they were assigned until end of study or lost to follow-up (protocol adherence).
6 month
Number of participants who are exclusively breastfeeding
Time Frame: 6 month post randomization
Number of participants who report giving only breast milk and no other liquids or solid based foods to their infants as assessed by the infant feeding questionnaire
6 month post randomization
Number of participants who are breastfeeding
Time Frame: 6 month post randomization
Number of participants who report giving breast milk and other liquids or solid based foods to their infants as assessed by the infant feeding questionnaire.
6 month post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Stellenbosch

Collaborators

University of British Columbia
McMaster University

Investigators

  • Principal Investigator: Moleen Zunza, University of Stellenbosch
  • Study Chair: Mark F Cotton, University of Stellenbosch
  • Study Chair: Taryn Young, University of Stellenbosch
  • Study Chair: Lehana Thabane, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2019

Primary Completion (Actual)

August 13, 2020

Study Completion (Actual)

August 13, 2020

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimated)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N16/09/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD will be available from the corresponding author on reasonable request

IPD Sharing Time Frame

Data will be available until year 2035.

IPD Sharing Access Criteria

Investigators conducting maternal-child health studies with appropriate institutional review board approvals for any additional pooled analyses, will have access to the anonymized and de-identified individual participant data, from the corresponding author on reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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