Point-of-care virologic testing to improve outcomes of HIV-infected children

描述（由申请人提供）：尽管我们尽了最大努力推出母婴艾滋病毒预防服务，但在赞比亚等发展中国家，许多儿童仍未能逃脱感染。幸运的是，挽救生命的抗逆转录病毒治疗现在在许多情况下都可以获得，但为了使其发挥作用，必须确定受感染的新生儿并立即开始治疗。婴儿艾滋病毒感染的诊断是这一进程的一个主要障碍。与成人艾滋病毒检测不同，婴儿诊断需要特殊的实验室设备和人员，只有在先进的实验室才能获得。因此，大多数儿童要么根本无法获得艾滋病毒诊断，要么必须等待数周才能收到检测结果。在赞比亚——和该地区的许多国家一样——超过一半的新生儿在接受检测并被发现感染后从未真正开始治疗。剑桥大学开发了一种名为“SAMBA”的新型即时检测（POC），可以通过检测血液中的HIV遗传物质来诊断婴儿感染HIV。专门为发展中国家的环境设计的SAMBA结果在两个小时内就可以准备好。该测试有两种版本，一种是定性测试（用于婴儿诊断），一种是半定量测试（用于治疗监测）。本提案描述了一项SAMBA POC病毒学检测的聚类随机试验，以改善赞比亚感染艾滋病毒的儿童的预后。POC技术将放置在初级保健站点，并具有两项功能：(1)为感染艾滋病毒的母亲所生的婴儿在出生后6周提供当日早期婴儿艾滋病毒诊断，以及(2)对接受抗逆转录病毒治疗的儿童进行治疗监测。12家机构将参与试验。其中一半将被随机分配来实施POC技术，另一半将采用目前的护理标准——在现场以外进行婴儿诊断，治疗监测主要基于临床评估。试验的主要结果将是每个研究组中感染艾滋病毒的儿童在最初诊断18个月后仍然存活、接受护理、血液中没有艾滋病毒循环（治疗成功的一个指标）的比例。这项研究将由赞比亚传染病研究中心（CIDRZ）进行。CIDRZ成立于2001年，由提出这项研究的团队领导，在nih资助的研究和pepfar资助的服务实施方面都有丰富的经验。

DESCRIPTION (provided by applicant): Despite our best efforts to roll out mother-to-child HIV prevention services, many children in developing nations such as Zambia do not escape infection. Fortunately, life-saving antiretroviral therapy is now available in many settings, but i order for it to work, infected newborns must be identified and treatment started immediately. Diagnosis of infant HIV infection represents a major hurdle to this process. Unlike HIV testing in adults, infant diagnosis requires special laboratory equipment and personnel available only in sophisticated laboratories. As a result, most children either have no access to HIV diagnosis at all or must wait for weeks to receive their test result. In Zambia - as in many countries in the region - more than half of newborns who are tested and found to be infected never actually start treatment. The University of Cambridge has developed a new point-of-care (POC) test called "SAMBA" that can diagnose infant HIV infection by detecting HIV genetic material in the blood. Designed specifically for developing world settings, SAMBA results are ready in two hours. Two versions of the test are available, a qualitative test (for infant diagnosis) and a semi-quantitatie test (for treatment monitoring). This proposal describes a cluster-randomized trial of the SAMBA POC virologic test to improve outcomes of HIV-infected children in Zambia. The POC technology will be placed in primary care sites and serve two functions: (1) provision of same-day, early infant HIV diagnosis at 6 weeks of life for infants born to HIV-infected mothers, and (2) treatment monitoring of children on antiretroviral therapy. Twelve facilities will participate n the trial. Half of the sites will be randomly assigned to implement the POC technology and the other half will employ the current standard of care - where infant diagnosis is performed off site and treatment monitoring is based primarily upon clinical assessment. The trial's primary outcome will be the proportion of HIV-infected children in each study arm who remain alive, in care, and with no HIV circulating in their bloodstream (an indicator of treatment success) 18 months after their initial diagnosis. The study will be conducted by the Centre for Infectious Disease Research in Zambia (CIDRZ). Established in 2001, and led by the team proposing this study, CIDRZ has substantial experience with both NIH-sponsored research and PEPFAR-sponsored service implementation.