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Clinical Trials/NCT02949713
NCT02949713
Completed
Not Applicable

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

University of Stellenbosch1 site in 1 country52 target enrollmentMay 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
University of Stellenbosch
Enrollment
52
Locations
1
Primary Endpoint
Number of participants with complete evaluation of infant feeding practices at all study visits
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2019
End Date
August 13, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Moleen Zunza

Dr

University of Stellenbosch

Eligibility Criteria

Inclusion Criteria

  • Women living with HIV
  • initiated breastfeeding within 24 hours of giving normal birth
  • 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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Number of participants who are exclusively breastfeeding(6 month post randomization)
  • 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 breastfeeding(6 month post randomization)

Study Sites (1)

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