Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201611001855404 Date of Approval: 08/11/2016
Trial Status:
TRIAL DESCRIPTION
Public title Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding among women living with HIV
Official scientific title Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding among women living with HIV
Brief summary describing the background and objectives of the trial Breastfeeding reduces the risks of dying from infections and is currently recommended as the most beneficial feeding option for infants born to women living with HIV 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 women living with HIV. 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 will be 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 women living with HIV, giving birth at a primary healthcare clinic in Cape Town, South Africa. Primary objectives: The study will determine the feasibility of conducting a larger trial evaluating the effects of interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding by HIV-infected women. We will assess the feasibility of the trial with regard to participant recruitment, proportion of eligible subjects consenting for participation and proportion with complete outcome assessment. Secondary objectives: To determine if interactive weekly mobile phone text messaging plus motivational interviewing administered at 4 study follow-up visits, compared with usual care, improve self-reported adherence to exclusive or any breastfeeding 24 weeks post-delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 01/06/2017
Actual trial start date 02/05/2019
Anticipated date of last follow up 28/02/2018
Actual Last follow-up date 31/08/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 52
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NCT02949713 ClinicalTrials.gov
N16/09/11 University of Stellenbosch Human Research Ethics Committe
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group mobile text messaging plus motivational interviewing weekly text messaging plus motivational interviews at 3 study visits 6 months from date of randomization 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. Motivational interviews will be done post randomization at weeks 2,6, and 10. 27
Control Group Standard of care Determined by primary healthcare provider 6 months from date of randomization Women are counselled to exclusively breastfeed during the first 6 months 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women living with HIV. initiating 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. 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 Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/10/2016 University of Stellenbosch Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Drive Cape Town 8000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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. 6 months
Secondary Outcome The number of participants who exclusively breastfed at 24 weeks postpartum (exit visit). 6 months
Secondary Outcome Number of participants remaining in the group they were assigned until end of study or lost to follow-up (protocol adherence). 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Worcester midwife obstetric unit Worcester Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Janssen-CTN Postdoctoral International Fellowship Award of the CIHR Canadian HIV Trials Network 588-1081 Burrard Street Vancouver BC V6B 3E6 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Moleen Zunza Francie van Zijl Drive Cape Town 8000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Taryn Young Francie van Zijl Drive Cape Town 8000 South Africa
Mark F. Cotton Francie van Zijl Drive Cape Town 8000 South Africa
Lehana Thabane 50 Charlton Avenue East Hamilton L8N 4A6 Canada
Lawrence Mbuagbaw 50 Charlton Avenue East Hamilton L8N 4A6 Canada
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moleen Zunza moleenz@sun.ac.za 00279389512 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Moleen Zunza moleenz@sun.ac.za 00279389512 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Tyergeberg 8000 South Africa Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Moleen Zunza moleenz@sun.ac.za 00279389512 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Stellenbsoch 8000 South Africa Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Investigators conducting maternal-child health studies with appropriate institutional review board approvals for any additional pooled analyses, will have access to the anonymized and de-identified individual participant data, statistical analysis code, and data dictionary from the corresponding author on reasonable request. Study Protocol Data will be available until year 2035. Investigators conducting maternal-child health studies with appropriate institutional review board approvals for any additional pooled analyses, will have access to the anonymized and de-identified individual participant data, statistical analysis code, and data dictionary from the corresponding author on reasonable request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information