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首页> 外文期刊>Controlled clinical trials >Issues in the design of a clinical trial with a behavioral intervention-the Zambia exclusive breast-feeding study.
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Issues in the design of a clinical trial with a behavioral intervention-the Zambia exclusive breast-feeding study.

机译：行为干预临床试验设计的问题-赞比亚独家母乳喂养研究。

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Purpose: We present the rationale and design of the Zambian Exclusive Breast-feeding Study (ZEBS), a randomized trial evaluating the efficacy of short-duration exclusive breast-feeding (EBF) as a strategy to reduce postnatal human immunodeficiency virus (HIV) transmission while preserving the other health benefits of this important mode of infant feeding. Methods: One thousand two hundred HIV-positive pregnant women were recruited in Lusaka, Zambia, and followed with their infants for 24 months. In addition to Nevirapine (NVP), all women received intensive and frequent clinic- and home-based counseling to support exclusive breast-feeding. When the infant was 1 week of age, half of the women were randomly assigned to a group encouraged to abruptly (<24 h) cease all breast-feeding at 4 months. The primary outcome of the experimental (randomized) comparison is HIV-free survival at 24 months. The design is also observational and will compare HIV transmission rates between those who do and do not adhere to the counseling intervention promoting exclusive breast-feeding. Conclusion: Our study aims to quantify the benefit-risk ratio of early cessation of exclusive breast-feeding to interrupt mother-to-child transmission of HIV with an intensive behavioral intervention and has both observational and experimental analytic approaches. Our study design assesses efficacy and also has a prominent applied component that if the intervention is effective, it will permit rapid and sustainable adoption within low-resource communities.
机译：目的：我们介绍了赞比亚独家母乳喂养研究（ZEBS）的原理和设计，这是一项随机试验，评估短期母乳喂养（EBF）作为减少产后人类免疫缺陷病毒（HIV）传播策略的功效同时保留这种重要的婴儿喂养方式对健康的其他好处。方法：在赞比亚的卢萨卡招募了120例HIV阳性孕妇，并对其婴儿进行了24个月的随访。除奈韦拉平（NVP）外，所有妇女均接受频繁且频繁的诊所和家庭咨询，以支持纯母乳喂养。当婴儿为1周大时，一半的妇女被随机分入一个鼓励突然（<24小时）在4个月内停止所有母乳喂养的小组。实验（随机）比较的主要结果是24个月无HIV生存率。该设计还具有观察性，将比较那些坚持和不坚持促进纯母乳喂养的咨询干预措施的人之间的艾滋病毒传播率。结论：我们的研究旨在通过强化的行为干预来量化早期停止纯母乳喂养以中断HIV母婴传播的受益风险比，并具有观察性和实验性分析方法。我们的研究设计评估了疗效，并且还具有突出的应用组成部分，即如果干预措施有效，它将可以在资源贫乏的社区中迅速且可持续地采用。

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