Text Messaging Plus Motivational Interviewing in Promotion of Breastfeeding Among HIV-infected Women

NCT ID: NCT02949713

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-02
• Study Completion Date: 2020-08-13

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.

Conditions

HIV Infections; Breast Feeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Text messaging-motivational interviewing

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.

Group Type: EXPERIMENTAL

Text messaging-motivational interviewing

Intervention Type: BEHAVIORAL

Interactive weekly mobile phone text messaging plus prospective motivational interviews

Usual standard of care

Usual standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Text messaging-motivational interviewing

Interactive weekly mobile phone text messaging plus prospective motivational interviews

Intervention Type: BEHAVIORAL

Other Intervention Names

mobile phone text messaging; motivational interviewing

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

University of Stellenbosch

OTHER

Sponsor Role: lead

Responsible Party

Moleen Zunza

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moleen Zunza

Role: PRINCIPAL_INVESTIGATOR

University of Stellenbosch

Taryn Young

Role: STUDY_CHAIR

University of Stellenbosch

Mark F Cotton

Role: STUDY_CHAIR

University of Stellenbosch

Lehana Thabane

Role: STUDY_CHAIR

McMaster University

Locations

Moleen Zunza

Cape Town, Western Cape, South Africa

Countries

South Africa

References

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.

Reference Type: DERIVED

PMID: 37816561 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28716146 (View on PubMed)

Other Identifiers

N16/09/11

Identifier Type: -

Identifier Source: org_study_id