search
Back to results

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

Primary Purpose

HIV Infections, Breast Feeding

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Text messaging-motivational interviewing
Sponsored by
University of Stellenbosch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV Infections focused on measuring HIV, infant feeding, mHealth, behavioural intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV-infected
  • initiating breastfeeding soon after giving 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:

  • formula feeding
  • pregnant with > 1 infant
  • birth weight < 2000
  • gestational age < 36 weeks

Sites / Locations

  • Moleen Zunza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Text messaging-motivational interviewing

Usual standard of care

Arm Description

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.

Usual standard of care

Outcomes

Primary Outcome Measures

Number of participants invited to the study who consented to participate.
Number of participants invited to the study who consented to participate.
Number of participants with complete evaluation of infant feeding practices at all study visits
Number of participants with complete evaluation of infant feeding practices at all study visits as assessed by infant feeding questionnaire.

Secondary Outcome Measures

Number of participants remaining in the group they were assigned until end of study or lost to follow-up (protocol adherence).
Number of participants remaining in the group they were assigned until end of study or lost to follow-up (protocol adherence).
Number of participants who are exclusively breastfeeding
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
Number of participants who are breastfeeding
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.

Full Information

First Posted
October 26, 2016
Last Updated
September 21, 2023
Sponsor
University of Stellenbosch
Collaborators
McMaster University, University of British Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT02949713
Brief Title
Text Messaging Plus Motivational Interviewing in Promotion of Breastfeeding Among HIV-infected Women
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
August 13, 2020 (Actual)
Study Completion Date
August 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Stellenbosch
Collaborators
McMaster University, University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Breast Feeding
Keywords
HIV, infant feeding, mHealth, behavioural intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text messaging-motivational interviewing
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual standard of care
Arm Type
No Intervention
Arm Description
Usual standard of care
Intervention Type
Behavioral
Intervention Name(s)
Text messaging-motivational interviewing
Other Intervention Name(s)
mobile phone text messaging, motivational interviewing
Intervention Description
Interactive weekly mobile phone text messaging plus prospective motivational interviews
Primary Outcome Measure Information:
Title
Number of participants invited to the study who consented to participate.
Description
Number of participants invited to the study who consented to participate.
Time Frame
6 month post randomization
Title
Number of participants with complete evaluation of infant feeding practices at all study visits
Description
Number of participants with complete evaluation of infant feeding practices at all study visits as assessed by infant feeding questionnaire.
Time Frame
6 month post randomization
Secondary Outcome Measure Information:
Title
Number of participants remaining in the group they were assigned until end of study or lost to follow-up (protocol adherence).
Description
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
Title
Number of participants who are exclusively breastfeeding
Description
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
Time Frame
6 month post randomization
Title
Number of participants who are breastfeeding
Description
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.
Time Frame
6 month post randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moleen Zunza
Organizational Affiliation
University of Stellenbosch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Taryn Young
Organizational Affiliation
University of Stellenbosch
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark F Cotton
Organizational Affiliation
University of Stellenbosch
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lehana Thabane
Organizational Affiliation
McMaster University
Official's Role
Study Chair
Facility Information:
Facility Name
Moleen Zunza
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
8000
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
28716146
Citation
Zunza M, Cotton MF, Mbuagbaw L, Lester R, Thabane L. Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding among women living with HIV in South Africa: study protocol for a randomized controlled trial. Trials. 2017 Jul 17;18(1):331. doi: 10.1186/s13063-017-2079-0.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs