NCT02949713

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
2.5 years until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2020

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

October 26, 2016

Last Update Submit

September 21, 2023

Conditions

HIV InfectionsBreast Feeding

Keywords

HIVinfant feedingmHealthbehavioural intervention

Outcome Measures

Primary Outcomes (2)

  • Number of participants invited to the study who consented to participate.

    Number of participants invited to the study who consented to participate.

    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.

    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).

    6 month

  • Number of participants who are exclusively breastfeeding

    6 month post randomization

  • Number of participants who are breastfeeding

    6 month post randomization

Study Arms (2)

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.

Behavioral: Text messaging-motivational interviewing

Usual standard of care

NO INTERVENTION

Usual standard of care

Interventions

Text messaging-motivational interviewingBEHAVIORAL

Interactive weekly mobile phone text messaging plus prospective motivational interviews

Also known as: mobile phone text messaging, motivational interviewing
Text messaging-motivational interviewing

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women living with HIV
  • initiated breastfeeding within 24 hours of giving normal birth
  • on ART
  • years or older
  • ownership of a mobile phone
  • infants judged to be in good health who are discharged soon after delivery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moleen Zunza

Cape Town, Western Cape, 8000, South Africa

Location

Related Publications (2)

  • 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.

    PMID: 37816561DERIVED

  • 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.

    PMID: 28716146DERIVED

MeSH Terms

Conditions

HIV InfectionsBreast Feeding

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Moleen Zunza

    University of Stellenbosch

    PRINCIPAL INVESTIGATOR

  • Taryn Young

    University of Stellenbosch

    STUDY CHAIR

  • Mark F Cotton

    University of Stellenbosch

    STUDY CHAIR

  • Lehana Thabane

    McMaster University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 31, 2016

Study Start

May 2, 2019

Primary Completion

August 13, 2020

Study Completion

August 13, 2020

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

The IPD will be available from the corresponding author on reasonable request

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available until year 2035.
Access Criteria
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, from the corresponding author on reasonable request.

Locations

ZA(1)