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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections, Breast Feeding

Intervention / Treatment
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* Behavioral: Text messaging-motivational interviewing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text messaging-motivational interviewing<br>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<br>* Interactive weekly mobile phone text messaging plus prospective motivational interviews<br>* Other names: motivational interviewing;|
| No Intervention: Usual standard of care<br>Usual standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants invited to the study who consented to participate. | 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 | 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). | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, infant feeding, mHealth, behavioural intervention