Division of Epidemiology & Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Francie Van Zyl Drive, PO Box 241, Cape Town, 8000, South Africa.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
Trials. 2023 Oct 5;24(1):639. doi: 10.1186/s13063-023-07647-9.
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.
(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.
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.
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.
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.
ClinicalTrials.gov NCT05063240. Pan African Clinical Trial Registry PACTR202110870407786. Oct. 1, 2021.
在资源匮乏的环境中，许多面临高传染病发病率和死亡率风险的婴儿由于母乳喂养时间缩短，无法获得母乳喂养带来的免疫和营养益处。南非是非洲 6 个月以下婴儿纯母乳喂养率最低的国家之一，仅有 8%的婴儿采用纯母乳喂养。我们假设，接受每周短信提醒和动机访谈的 HIV 阳性女性会延长母乳喂养时间，这有助于改善婴儿的健康结局。
（1）评估手机短信和动机访谈相结合的干预措施在促进（a）纯母乳喂养和（b）6 个月以下儿童任何形式的母乳喂养方面的效果，与常规护理相比，HIV 阳性母亲。（2）评估联合干预对（a）降低全因住院率和死亡率和（b）改善 HIV 暴露婴儿 0-6 个月线性生长的效果，与常规护理相比。
我们正在开展一项临床试验，以确定短信提醒加动机访谈是否能延长母乳喂养时间并改善婴儿健康结局。我们招募了 275 名 HIV 阳性母亲及其出生时的 HIV 暴露婴儿，并将研究干预措施随机分配 6 个月。
使用标准比例检验和二项回归比较研究组的母乳喂养率。使用 Kaplan-Meier 生存曲线和 Cox 比例风险回归模型比较研究组的生存终点。使用 Poisson 随机效应模型和平均累积函数分析计数终点。我们使用混合线性回归模型评估婴儿随时间的生长变化。最大似然法将用于处理缺失数据。
研究结果可能有助于决策（1）母乳喂养政策的实施是否达到预期结果，（2）维持母乳喂养所需的干预措施，以及（3）干预措施是否对儿童健康产生影响。
ClinicalTrials.gov NCT05063240. Pan African Clinical Trial Registry PACTR202110870407786. 2021 年 10 月 1 日。
