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生之前识别HIV阳性婴儿，以促进早期开始ART并提高婴儿存活率。肯尼亚每年有近20%的艾滋病毒阳性母亲所生婴儿受到感染（约20，000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时死亡;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PCR检测确诊为艾滋病毒阳性的婴儿快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，这些障碍导致对艾滋病毒暴露婴儿的检测延迟和零星，实验室检测结果丢失或延迟，没有可靠的系统通知母亲检查结果或需要返回医院。因此，只有大约三分之一的艾滋病毒感染婴儿在18个月大之前继续接受EID护理。这项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，这是一种在线干预措施，具有自动警报功能，旨在通过前瞻性地跟踪艾滋病毒暴露的婴儿，改善PCR结果从实验室到诊所和母亲的沟通，并支持现有网络，以促进高质量的艾滋病毒儿科护理，从而克服当前的EID障碍。这种强大的干预允许临床医生、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项目的时间敏感干预，当特定婴儿的时间敏感干预过期时，这些条目会触发行动“警报”。一个内置的短信系统发送自动短信到母亲的手机时，测试结果准备好或后续访问是必要的。艾滋病毒/艾滋病综合治疗系统的最终目标是增加接受早期免疫服务的艾滋病毒感染婴儿的人数（直到18个月），并促进被诊断为艾滋病毒阳性的婴儿尽早开始抗逆转录病毒治疗。在肯尼亚的两个低资源医院，有希望的试点数据比较前（n=330）和后（n=460）HIT系统干预数据，证明了实施该系统的可接受性和可行性，这导致了非常显着的改善，在EID保留（31%前对97%后），和抗逆转录病毒治疗的婴儿诊断为艾滋病毒阳性（44%前对95%后）。

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).