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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02949713
Enrollment
52
Registered
2016-10-31
Start date
2019-05-02
Completion date
2020-08-13
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding, HIV Infections

Keywords

HIV, infant feeding, mHealth, behavioural intervention

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.

Interventions

BEHAVIORALText messaging-motivational interviewing

Interactive weekly mobile phone text messaging plus prospective motivational interviews

Sponsors

McMaster University
CollaboratorOTHER
University of British Columbia
CollaboratorOTHER
University of Stellenbosch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants invited to the study who consented to participate.6 month post randomizationNumber of participants invited to the study who consented to participate.
Number of participants with complete evaluation of infant feeding practices at all study visits6 month post randomizationNumber of participants with complete evaluation of infant feeding practices at all study visits as assessed by infant feeding questionnaire.

Secondary

MeasureTime frameDescription
Number of participants remaining in the group they were assigned until end of study or lost to follow-up (protocol adherence).6 monthNumber 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 breastfeeding6 month post randomizationNumber 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 breastfeeding6 month post randomizationNumber of participants who report giving breast milk and other liquids or solid based foods to their infants as assessed by the infant feeding questionnaire.

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026