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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201611001855404 Date of Registration: 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: 18 Year(s)-44 Year(s) 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 10/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 21/09/2023 We updated the actual trial start date. 02 May 2019
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 21/09/2023 We updated the actual trial completion date. 31 Aug 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 21/09/2023 We revised the sample size to 60 which assumed to be sufficient to assess feasibility end points. 84 60
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 21/09/2023 Enrollment stopped at the end of March 2020 due to lockdown measures for reducing COVID-19 infection transmission risk. 52
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 21/09/2023 Trial completed follow up of study participants in 2020. Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 21/09/2023 Updated the field that was not completed previously. Simple randomization using a randomization table created by a computer software program
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 21/09/2023 Updated the field that was not completed previously. Allocation was determined by the holder of the sequence who is situated off site
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 21/09/2023 We included mothers who had normal vaginal deliveries. HIV-infected women initiating breastfeeding soon after giving 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 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.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 21/09/2023 Viral load was dropped as an exclusion criterion because it was not available in the medical records for most of the participants. Birth weight was changed from <2000 to <2500, to include only infants with normal birth weight. viral load > 400 copies/ml formula feeding pregnant with > 1 infant birth weight < 2000 gestational age < 36 weeks 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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 21/09/2023 We included adult women and their new born infants. Adult: 19 Year-44 Year
Section Name Field Name Date Reason Old Value Updated Value
Ethics IsApprovedByEC 15/11/2016 edit true true
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 10/07/2018 pactr update Pregnancy and Childbirth
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/09/2023 Enrolled was stopped early because of the COVID-lockdown measures which were implemented in South Africa in March 2020. Experimental Group, mobile text messaging plus motivational interviewing, weekly text messaging plus motivational interviews at 4 study visits, 6 months from date of randomization, Participants will register their phone numbers into an automated SMS software (provided by WelTel.org). 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 2,6,14, 42, 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,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/09/2023 Enrolled was stopped early because of the COVID-lockdown measures which were implemented in South Africa in March 2020. 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, 42, Active-Treatment of Control Group 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
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/09/2023 We revised and updated the primary feasibility outcomes. Primary Outcome, Number of participants completing all study follow-up visits, 6 months 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
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/09/2023 We revised the outcomes into feasibility outcomes and secondary exploratory outcomes. The changes include the updated secondary exploratory outcomes. Secondary Outcome, Number of participants consenting study participation, 3 months Secondary Outcome, The number of participants who exclusively breastfed at 24 weeks postpartum (exit visit). , 3 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/09/2023 We revised the outcomes into feasibility outcomes and secondary exploratory outcomes. The changes include the updated secondary exploratory outcomes. Secondary Outcome, The number of participants who exclusively breastfed at 24 weeks postpartum (exit visit). , 3 months Secondary Outcome, The number of participants who exclusively breastfed at 24 weeks postpartum (exit visit). , 6 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/09/2023 We revised the outcomes into feasibility outcomes and secondary exploratory outcomes. The changes include the updated secondary exploratory outcomes. Secondary Outcome, Number of participants who are exclusively breastfeeding, 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
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 21/09/2023 The study got permission from the Western Cape Department of Health to access Worcester midwife obstetric unit as the recruitment site. Primary healthcare facility, Khayelitsha, Cape Town, 7783, South Africa Worcester midwife obstetric unit , Worcester, Cape Town, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/09/2023 ethics approval letter has been uploaded. TRUE, University of Stellenbosch Human Research Ethics Committee, Francie van Zijl Drive, Cape Town, 8000, South Africa, , 17 Oct 2016, , , TRUE, University of Stellenbosch Human Research Ethics Committee, Francie van Zijl Drive, Cape Town, 8000, South Africa, , 17 Oct 2016, 0027219389677, applyethics@sun.ac.za, 1855_1497_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 21/09/2023 The phone number changed. Principal Investigator, Moleen, Zunza, Dr., moleenz@sun.ac.za, , 00279389314, Francie van Zijl Drive, Cape Town, 8000, South Africa, Researcher Principal Investigator, Moleen, Zunza, Dr., moleenz@sun.ac.za, , 00279389512, Francie van Zijl Drive, Cape Town, 8000, South Africa, Researcher
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 21/09/2023 The phone number and position changed. Principal Investigator, Moleen, Zunza, Dr., moleenz@sun.ac.za, , 00279389512, Francie van Zijl Drive, Cape Town, 8000, South Africa, Researcher Principal Investigator, Moleen, Zunza, Dr., moleenz@sun.ac.za, , 00279389512, Francie van Zijl Drive, Cape Town, 8000, South Africa, Senior Lecturer
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 21/09/2023 The phone number changed. Public Enquiries, Moleen, Zunza, Dr., moleenz@sun.ac.za, , 00279389314, Francie van Zijl Drive, Tyergeberg, 8000, South Africa, Researcher Public Enquiries, Moleen, Zunza, Dr., moleenz@sun.ac.za, , 00279389512, Francie van Zijl Drive, Tyergeberg, 8000, South Africa, Researcher
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 21/09/2023 The phone number and position changed. Public Enquiries, Moleen, Zunza, Dr., moleenz@sun.ac.za, , 00279389512, Francie van Zijl Drive, Tyergeberg, 8000, South Africa, Researcher Public Enquiries, Moleen, Zunza, Dr., moleenz@sun.ac.za, , 00279389512, Francie van Zijl Drive, Tyergeberg, 8000, South Africa, Senior Lecturer
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 21/09/2023 The phone number and position changed. Scientific Enquiries, Moleen, Zunza, Dr., moleenz@sun.ac.za, , 00279389314, Francie van Zijl Drive, Stellenbsoch, 8000, South Africa, Researcher Scientific Enquiries, Moleen, Zunza, Dr., moleenz@sun.ac.za, , 00279389512, Francie van Zijl Drive, Stellenbsoch, 8000, South Africa, Senior Lecturer
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 21/09/2023 We updated the field. 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.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 21/09/2023 Updated the field. Data will be available until year 2035.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 21/09/2023 Updated the field. 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.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 21/09/2023 The study protocol was published in Trials DOI 10.1186/s13063-017-2079-0. Study Protocol
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 21/09/2023 Results will be shared after publication of the manuscript. No No