HIV InfectionsNCT02949713
Text Messaging Plus Motivational Interviewing in Promotion of Breastfeeding Among HIV-infected Women
A study testing Text messaging-motivational interviewing in people with HIV Infections and Breast Feeding, run by University of Stellenbosch at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections, Breast Feeding
- What is being tested?
- Text messaging-motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Africa
- Study dates
- 2 May 2019to 13 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- HIV Infections, Breast Feeding
- Being tested
- Text messaging-motivational interviewing
- Keywords
- HIV, infant feeding, mHealth, behavioural intervention
- Medical subject headings
- HIV Infections, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messaging-motivational interviewingBehavioural
Also called mobile phone text messaging, motivational interviewing
Interactive weekly mobile phone text messaging plus prospective motivational interviews
| Study group | Role | What they receive |
|---|---|---|
| Text messaging-motivational interviewing | Experimental | 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. Receives: Behavioral: Text messaging-motivational interviewing |
| Usual standard of care | No intervention | Usual standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants invited to the study who consented to participate.
Number of participants invited to the study who consented to participate.
Measured: 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.
Measured: 6 month post randomization
Secondary outcomes (3)
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).
Measured: 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
Measured: 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.
Measured: 6 month post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start2 May 2019
- Primary completion13 Aug 2020
- Study completion13 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stellenbosch
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, University of British Columbia
- Responsible party
- Principal investigator, Moleen Zunza, University of Stellenbosch
- Investigators
- Moleen Zunza, Principal investigator, University of StellenboschTaryn Young, Study chair, University of StellenboschMark F Cotton, Study chair, University of StellenboschLehana Thabane, Study chair, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949713
- Sponsor's protocol ID
- N16/09/11
- Status last verified
- Sep 2023
- First submitted
- 26 Oct 2016
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available from the corresponding author on reasonable request
Publications
Zunza M, Young T, Cotton M, Slogrove A, Mbuagbaw L, Kuhn L, Thabane L. Evaluating interactive weekly mobile phone text messaging plus motivational interviewing for breastfeeding promotion among women living with HIV, giving normal birth at a primary healthcare facility in South Africa: a feasibility randomised controlled trial. BMJ Open. 2023 Oct 10;13(10):e073385. doi: 10.1136/bmjopen-2023-073385.
PubMed 37816561Zunza 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.
PubMed 28716146
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02949713
- Acronym / sponsor ID
- N16/09/11
- Conditions
- HIV Infections, Breast Feeding
- Keywords
- HIV, infant feeding, mHealth, behavioural intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of StellenboschUniversity, hospital or other
- Collaborators
- McMaster University, University of British Columbia
- Study start
- 2 May 2019 (actual)
- Primary completion
- 13 Aug 2020 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text messaging-motivational interviewing | Experimental | Behavioral: Text messaging-motivational interviewingEvery 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. |
| Usual standard of care | No intervention | –Usual standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women living with HIV
- initiated breastfeeding within 24 hours of giving normal birth
- on ART
- 18 years or older
- ownership of a mobile phone
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text messaging-motivational interviewingAlso: mobile phone text messaging, motivational interviewingInteractive weekly mobile phone text messaging plus prospective motivational interviews | Behavioural | Text messaging-motivational interviewing |
Primary outcome
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.
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.
3 secondary outcomes
Number of participants remaining in the group they were assigned until end of study or lost to follow-up (protocol adherence).
Time frame: 6 month
Number of participants who are exclusively breastfeeding
Time frame: 6 month post randomization
Number of participants who are breastfeeding
Time frame: 6 month post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 37816561Zunza M, Young T, Cotton M, Slogrove A, Mbuagbaw L, Kuhn L, Thabane L. Evaluating interactive weekly mobile phone text messaging plus motivational interviewing for breastfeeding promotion among women living with HIV, giving normal birth at a primary healthcare facility in South Africa: a feasibility randomised controlled trial. BMJ Open. 2023 Oct 10;13(10):e073385. doi: 10.1136/bmjopen-2023-073385.
- Derived from this study: PubMed 28716146Zunza 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.
- Individual participant dataSharing planned: Yes. The IPD will be available from the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moleen Zunza principal investigator
University of Stellenbosch
Taryn Young study chair
University of Stellenbosch
Mark F Cotton study chair
University of Stellenbosch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text messaging-motivational interviewing in people with HIV Infections and Breast Feeding, run by University of Stellenbosch at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants invited to the study who consented to participate. (time frame: 6 month post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02949713, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.