Clinical trial NCT02949713: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Breast Feeding
Keywords: HIV
infant feeding
mHealth
behavioural intervention
Lead sponsor: University of Stellenbosch
Sponsor class: OTHER
Collaborators: name: McMaster University
name: University of British Columbia
First posted: 2016-10-31
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Number of participants invited to the study who consented to participate.
timeFrame: 6 month post randomization
measure: Number of participants with complete evaluation of infant feeding practices at all study visits
timeFrame: 6 month post randomization
Secondary outcomes:
measure: Number of participants remaining in the group they were assigned until end of study or lost to follow-up (protocol adherence).
timeFrame: 6 month
measure: Number of participants who are exclusively breastfeeding
timeFrame: 6 month post randomization
measure: Number of participants who are breastfeeding
timeFrame: 6 month post randomization
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Moleen Zunza
state: Western Cape
Study officials:
affiliation: University of Stellenbosch
name: Moleen Zunza
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Stellenbosch
name: Taryn Young
role: STUDY_CHAIR
affiliation: University of Stellenbosch
name: Mark F Cotton
role: STUDY_CHAIR
affiliation: McMaster University
name: Lehana Thabane
role: STUDY_CHAIR
References:
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.