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Completed

NCT Number: NCT02949713

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

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).

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Key information

Conditions

HIV Infections Behavior Blood-Borne Infections Breast Feeding Communicable Diseases Feeding Behavior Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Moleen Zunza

Cape Town, Western Cape, 8000, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text messaging-motivational interviewing

Behavioral

Interactive weekly mobile phone text messaging plus prospective motivational interviews

Other names: mobile phone text messaging, motivational interviewing

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Stellenbosch

Other

Collaborators

  • McMaster University
  • University of British Columbia

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2016
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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