Piloting at-birth point of care HIV testing strategies in Kenya

描述(由申请人提供)：早期婴儿诊断(EID)的主要目标是在临床疾病发展之前识别HIV+婴儿，以促进早期开始抗逆转录病毒治疗，提高婴儿存活率。在肯尼亚，每年有近20%的艾滋病毒阳性母亲所生的婴儿受到感染(约2万人)。如果没有早期诊断和抗逆转录病毒治疗，这些艾滋病毒阳性婴儿中有一半以上将在两岁前死亡；然而，早期抗逆转录病毒治疗(ART)开始(12周前)可以将死亡风险降低76%。2008年，肯尼亚修订了国家政策，包括对所有经聚合酶链式反应检测艾滋病毒阳性的婴儿迅速启动儿科抗逆转录病毒治疗。然而，目前的EID系统受到重大结构性障碍的阻碍，这些障碍导致对感染艾滋病毒的婴儿进行延迟和零星的检测，实验室的检测结果丢失或延迟，以及缺乏可靠的系统来通知母亲检测结果或需要返回医院。因此，只有大约三分之一的感染艾滋病毒的婴儿在18个月大之前一直留在宰牲节护理中心。拟议的研究将评估艾滋病毒婴儿跟踪系统(HITSystem(C))的影响和成本效益，该系统是一种在线干预措施，带有自动警报，旨在克服目前的开斋节障碍，方法是前瞻性地跟踪感染艾滋病毒的婴儿，改善实验室向诊所和母亲传达PCR结果的情况，并支持现有的网络，以促进高质量的艾滋病毒儿科护理。这一强大的干预措施允许临床医生、实验室技术人员和项目经理通过在线条目“实时”跟踪EID和ART计划的时间敏感干预措施，当特定婴儿的时间敏感干预措施过期时，这些条目会触发行动“警报”。当检测结果准备好或需要随访时，内置短信系统会向母亲的手机发送自动短信。HITSystem的最终目标是增加在EID服务中保留的感染艾滋病毒的婴儿的数量(直到18个月)，并促进对被诊断为HIV+的婴儿进行早期抗逆转录病毒治疗。肯尼亚两家低资源医院HIT系统干预前(n=330)和后(n=460)的试验数据显示，实施该系统的可接受性和可行性，极大地改善了EID滞留(前为31%，后为97%)和被诊断为HIV阳性的婴儿的ART启动率(前为44%，后为95%)。

DESCRIPTION (provided by applicant): The primary goal of early infant diagnosis (EID) is to identify HIV+ infants prior to the development of clinical disease to facilitate early initiation o ART and improve infant survival. Nearly 20% of Kenyan infants born to HIV+ mothers each year become infected (roughly 20,000). Without early diagnosis and ART over half of these HIV+ infants will die by the age of two years; however, early antiretroviral therapy (ART) initiation (before 12 weeks) can reduce the risk of mortality by 76%. In 2008 Kenyan National Policy was revised to include rapid initiation of pediatric ART to all infants confirmed HIV+ with PCR testing The current EID system, however, is hampered by significant structural barriers that contribute to late and sporadic testing of HIV exposed infants, lost or delayed test results from the laboratory, and the absence of a reliable system to notify mothers of test results or the need to return to the hospital. Consequently, only about one-third of HIV-exposed infants are retained in EID care until 18 months of age. The proposed study will evaluate the impact and cost-effectiveness of the HIV Infant Tracking System (HITSystem(c)), an online, intervention with automated alerts designed to overcome current EID barriers by prospectively tracking HIV-exposed infants, improving the communication of PCR results from laboratories to both clinics and mothers, and supporting existing networks to facilitate quality HIV pediatric care. This robust intervention allows clinicians, lab technicians, and program managers to track the time sensitive interventions of EID and ART programs in "real-time" through online entries which trigger action 'alerts' when time sensitive interventions are overdue for specific infants. A builtin text messaging system sends automated text messages to mothers' cell phones when test results are ready or follow up visits are needed. The ultimate goals of the HITSystem are to increase the number of HIV-exposed infants retained in EID services (until 18 months), and facilitate early ART initiation for infants diagnosed HIV+. Promising pilot data comparing pre (n=330) and post (n=460) HITSystem intervention data at two low resource hospitals in Kenya demonstrate acceptability and feasibility of implementing the system which led to highly significant improvements in EID retention (31% pre vs. 97% post), and ART initiation rates for infants diagnosed HIV+ (44% pre vs. 95% post).