Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI)
Abstract Background Many infants in low-resourced settings at high risk of infectious disease morbidity and death are deprived of the immunological and nutritional benefits of breast milk, through an attenuated duration of breast milk exposure. South Africa has one of the lowest exclusive breastfeed...
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07647-9 |
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| author | Moleen Zunza Lehana Thabane Louise Kuhn Christine Els Mark F. Cotton Taryn Young |
| author_facet | Moleen Zunza Lehana Thabane Louise Kuhn Christine Els Mark F. Cotton Taryn Young |
| author_sort | Moleen Zunza |
| collection | DOAJ |
| description | Abstract Background Many infants in low-resourced settings at high risk of infectious disease morbidity and death are deprived of the immunological and nutritional benefits of breast milk, through an attenuated duration of breast milk exposure. South Africa has one of the lowest exclusive breastfeeding rates in Africa, with 8% of infants under 6 months of age. We assume that breastfeeding is sustained among women living with HIV receiving weekly text messages and motivational interviewing and that this contributes to improved infant health outcomes. Objectives (1) To evaluate the effectiveness of a combined intervention of mobile phone text messaging and motivational interviewing in promoting (a) exclusive breastfeeding and (b) any form of breastfeeding, until 6 months of child age, compared to usual care, among mothers living with HIV. (2) To evaluate the effectiveness of a combined intervention on (a) reduction in all-cause hospitalization and mortality rates and (b) improvements in infant linear growth, compared to usual care, among HIV-exposed infants aged 0–6 months. Methods We are conducting a clinical trial to determine whether text messaging plus motivational interviewing prolongs breastfeeding and improves infant health outcomes. We are recruiting 275 women living with HIV and their HIV-exposed infants at birth and randomly assign study interventions for 6 months. Statistical methods Breastfeeding rates are compared between the study groups using a standard proportion test and binomial regression. Survival endpoints are presented using Kaplan–Meier survival curves and compared between the study groups using the Cox proportional-hazards regression model. The count endpoint is analysed using the Poisson random-effects model and mean cumulative function. We use mixed linear regression models to assess the evolution of infant growth over time. The maximum likelihood method will be used to handle missing data. Discussion The study findings may facilitate decision-making on (1) whether implementation of the breastfeeding policy achieved the desired outcomes, (2) interventions needed to sustain breastfeeding, and (3) whether the interventions do have an impact on child health. Trial registration ClinicalTrials.gov NCT05063240. Pan African Clinical Trial Registry PACTR202110870407786. Oct. 1, 2021. |
| first_indexed | 2024-03-10T17:06:06Z |
| format | Article |
| id | doaj.art-a3d424de7fbf4aceaad6d2febaf945f6 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-10T17:06:06Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-a3d424de7fbf4aceaad6d2febaf945f62023-11-20T10:48:35ZengBMCTrials1745-62152023-10-0124111110.1186/s13063-023-07647-9Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI)Moleen Zunza0Lehana Thabane1Louise Kuhn2Christine Els3Mark F. Cotton4Taryn Young5Division of Epidemiology & Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch UniversityDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityGertude H. Sergievsky Center, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical CenterWestern Cape Department of Health, Khayelitsha District HospitalDepartment of Paediatrics and Child Health, Family Center for Research With Ubuntu, Faculty of Medicine and Health Sciences, Stellenbosch UniversityDivision of Epidemiology & Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch UniversityAbstract Background Many infants in low-resourced settings at high risk of infectious disease morbidity and death are deprived of the immunological and nutritional benefits of breast milk, through an attenuated duration of breast milk exposure. South Africa has one of the lowest exclusive breastfeeding rates in Africa, with 8% of infants under 6 months of age. We assume that breastfeeding is sustained among women living with HIV receiving weekly text messages and motivational interviewing and that this contributes to improved infant health outcomes. Objectives (1) To evaluate the effectiveness of a combined intervention of mobile phone text messaging and motivational interviewing in promoting (a) exclusive breastfeeding and (b) any form of breastfeeding, until 6 months of child age, compared to usual care, among mothers living with HIV. (2) To evaluate the effectiveness of a combined intervention on (a) reduction in all-cause hospitalization and mortality rates and (b) improvements in infant linear growth, compared to usual care, among HIV-exposed infants aged 0–6 months. Methods We are conducting a clinical trial to determine whether text messaging plus motivational interviewing prolongs breastfeeding and improves infant health outcomes. We are recruiting 275 women living with HIV and their HIV-exposed infants at birth and randomly assign study interventions for 6 months. Statistical methods Breastfeeding rates are compared between the study groups using a standard proportion test and binomial regression. Survival endpoints are presented using Kaplan–Meier survival curves and compared between the study groups using the Cox proportional-hazards regression model. The count endpoint is analysed using the Poisson random-effects model and mean cumulative function. We use mixed linear regression models to assess the evolution of infant growth over time. The maximum likelihood method will be used to handle missing data. Discussion The study findings may facilitate decision-making on (1) whether implementation of the breastfeeding policy achieved the desired outcomes, (2) interventions needed to sustain breastfeeding, and (3) whether the interventions do have an impact on child health. Trial registration ClinicalTrials.gov NCT05063240. Pan African Clinical Trial Registry PACTR202110870407786. Oct. 1, 2021.https://doi.org/10.1186/s13063-023-07647-9BreastfeedingHIV/AIDSMobile phone text messagingMotivational interviewing |
| spellingShingle | Moleen Zunza Lehana Thabane Louise Kuhn Christine Els Mark F. Cotton Taryn Young Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI) Trials Breastfeeding HIV/AIDS Mobile phone text messaging Motivational interviewing |
| title | Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI) |
| title_full | Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI) |
| title_fullStr | Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI) |
| title_full_unstemmed | Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI) |
| title_short | Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI) |
| title_sort | mobile phone text messaging plus motivational interviewing versus usual care study protocol for a randomized controlled trial to evaluate effects on breastfeeding child health and survival outcomes among women living with hiv mti mi |
| topic | Breastfeeding HIV/AIDS Mobile phone text messaging Motivational interviewing |
| url | https://doi.org/10.1186/s13063-023-07647-9 |
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