Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomised 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 breastfeeding rates in Africa, 8% in 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, (b) any form of breastfeeding, until six 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 prolong breastfeeding and improve 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 study groups using standard proportion test and binomial regression. Survival endpoints are presented using Kaplan-Meier survival curves and compared between study groups using Cox proportional-hazards regression model. Count endpoint is analysed using Poisson random-effects model and mean cumulative function.We use Mixed linear regression models to assess the evolution of infant growth over time. Maximum likelihood method will be used to handle missing data. Discussion 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: The protocol of the trial was registered before the start of the trial at clinicaltrials.gov (NCT05063240) and Pan African Clinical Trial Registry (PACTR202110870407786).