Point of Care HIV-1 Diagnosis to Improve Rates of ART Initiation among Infants

摘要 儿童艾滋病仍然是赞比亚的一种公共卫生紧急情况，大多数新发病例 由围产期传播引起的感染。早期婴儿诊断(EID)，及时启动 抗逆转录病毒治疗(ART)和有效的长期临床随访对于 方案的成功和拯救感染艾滋病毒的儿童的生命。在赞比亚，目前的 婴儿感染的诊断标准是艾滋病毒DNA聚合酶链式反应，在仅有的三种中的一种情况下进行 全国的参考实验室。临床量大，标本运输时间长 可能会导致诊断延迟数周，这被认为是导致大量 程序自然减员和临床结果不佳。 我们提出了一项新的护理点(POC)技术的随机对照试验，用于早期 婴儿艾滋病毒诊断，由英国剑桥大学开发。我们将介绍 在赞比亚卢萨卡的2个产后设施中进行的基于简单扩增的分析(Samba) 护理的标准是为所有出生6周的艾滋病毒感染儿童提供非现场DNA聚合酶链式反应。 符合条件的、感染艾滋病毒的婴儿将被随机分配到Samba当天进行婴儿诊断 或者是目前的护理标准。我们的主要结果将是艾滋病毒感染者的比例 每个研究组中的儿童在治疗后12周内开始抗逆转录病毒治疗 正在抽取诊断样本。我们的次要成果将包括：1)比较 每个研究组开始抗逆转录病毒治疗的时间，2)仍然感染艾滋病毒的儿童的比例 在生命6个月时接受护理(根据艾滋病毒状况分层)，以及3)Samba技术的可行性 在我们的背景下。 2.

Abstract Pediatric AIDS remains a public health emergency in Zambia, with the majority of new infections resulting from perinatal transmission. Early infant diagnosis (EID), timely initiation of antiretroviral therapy (ART), and effective long-term clinical follow-up are critical to programmatic success and to saving the lives of HIV-infected children. In Zambia, the current standard for diagnosis of infant infection is HIV DNA PCR, performed at one of only three reference laboratories in the country. High clinical volume and long specimen transport times can result in diagnostic delays of many weeks, and this is believed to contribute to substantial program attrition and poor clinical outcomes. We propose a randomized, controlled trial of a new point-of-care (POC) technology for early infant HIV diagnosis, developed at the University of Cambridge, U.K. We will introduce the Simple AMplification-Based Assay (SAMBA) in 2 postnatal facilities in Lusaka, Zambia, where the standard of care is to offer off-site DNA PCR to all HIV-exposed children at 6 weeks of life. Eligible, HIV-exposed infants will be randomly assigned to SAMBA same-day infant diagnosis or the current standard of care. Our primary outcome will be the proportion of HIV-infected children in each study arm who commence antiretroviral therapy within 12 weeks of the diagnostic specimen being drawn. Our secondary outcomes will include: 1) a comparison of time to ART initiation in each study arm, 2) the proportion of HIV-exposed children who remain in care at 6 months of life (stratified by HIV status), and 3) feasibility of the SAMBA technology in our setting. 2