REDUCE POSTNATAL TRANSMISSION OF HIV THROUGH BREASTMILK

众所周知，由感染艾滋病毒的母亲母乳喂养的婴儿有通过母乳感染艾滋病毒的风险。然而，在艾滋病毒流行占主导地位的低资源环境中，母乳喂养不能简单地用母乳替代品来取代，因为母乳替代品无法获得、负担不起而且不安全。 通过这项应用，我们的目标是测试短期纯母乳喂养的安全性和有效性，以最大限度地减少艾滋病毒传播的风险，而不增加非艾滋病毒婴儿死亡的风险。 我们建议在赞比亚卢萨卡的两个城市初级卫生保健诊所对艾滋病毒阳性母亲及其子女进行为期5年的研究。 所有艾滋病毒阳性的妇女及其婴儿将获得两剂奈韦拉平干预，并将获得有关婴儿喂养选择的风险和益处的咨询。 决定母乳喂养的女性将有资格入组本研究。 将制定一个文化上适当的、负担得起的和可持续的母乳喂养教育和支持方案，以鼓励纯母乳喂养，并鼓励所有选择母乳喂养的妇女纯母乳喂养至4个月。 一半的妇女将被随机分配到一个咨询项目，该项目将鼓励在4个月时突然断奶到完全替代喂养，另一半将被随机分配到一个项目，该项目鼓励在4个月后继续母乳喂养，并通常引入断奶食品。 儿童将被随访两年，定期病史，体检和临床采样。 这项研究的主要目的是根据随机分配，比较在4个月大时突然断奶的儿童与根据当地做法断奶的儿童的艾滋病毒传播率和2岁以下死亡率。 第二个主要目标是在观察比较的基础上，比较母亲坚持纯母乳喂养建议的婴儿与不坚持纯母乳喂养建议的婴儿之间的艾滋病毒传播情况。 次要目的是描述突然断奶对儿童发病率的急性和慢性影响。 该研究建议测试一种廉价且可能可持续的公共卫生干预措施，以减少通过母乳喂养传播艾滋病毒，同时在资源非常低的情况下保留母乳喂养对儿童健康其他方面的好处。

It is well established that infants breast fed by their HIV-infected mothers are at risk of acquiring HIV infection through breast milk. However, in low resource settings where the HIV epidemic now predominates, breast feeding cannot simply be replace by breast milk substitutes since alternatives to breast milk are unavailable, unaffordable and unsafe. With this application we aim to test the safety and efficacy of short duration exclusive breast feeding to minimize risks of HIV transmission without increasing risks of non-HIV infant mortality. We propose a 5-year study of HIV-positive mothers and their children to be conducted in two urban primary health care clinics in Lusaka, Zambia. All HIV-positive women and their infants will be offered the two-dose nevirapine intervention and will be counseled about the risks and benefits of infants feeding options. Women who indicate their decision to breast feed will be eligible for enrollment into the study. A culturally appropriate, affordable and sustainable breast feeding education and support program to encourage exclusive breast feeding will be developed, and all women who elect to breast feed will be encouraged to exclusively breast feed to 4 months. Half of the women will be randomized to a counseling program which will encourage abrupt weaning to full replacement feeding at 4 months, and half will be randomized to a program to encourage continued breast feeding after 4 months with the usual introduction of weaning foods. Children will be followed for two years with regular medical histories, physical exams and clinical sampling. The primary objective of the study, based on the random assignment, is to compare HIV transmission rates and under-2 year mortality rates in children who abruptly wean at four months of age versus children who are weaned according to local practice. The second primary objective, based on observational comparisons, is to compare HIV transmission among infants whose mothers adhere to recommendations to exclusively breast feed with those who do not. Secondary objectives are to describe acute and chronic effects of abrupt weaning on child morbidity. The study proposes to test an inexpensive and potentially sustainable public health intervention to reduce HIV transmission through breast feeding while preserving benefits of breast feeding for other aspects of child health in a very low resource settings.