Implementation strategies for a new point-of-care test for early infant diagnosis

 描述（由申请人提供）：撒哈拉以南非洲因人类免疫缺陷病毒（HIV）而造成的疾病负担最高，约有2500万HIV感染者，其中包括290万儿童。2013年，有130多万感染艾滋病毒的妇女分娩，估计有210 000名儿童新感染艾滋病毒。预防母婴传播的战略有效地减轻了儿科艾滋病毒的负担，并导致2011年批准了一项全球计划，以消除母婴艾滋病毒传播，并将感染艾滋病毒的妇女和儿童中与艾滋病毒有关的死亡率降低90%。减少儿童艾滋病毒相关发病率和死亡率将需要卫生系统有能力诊断艾滋病毒感染婴儿，并及时有效地给予抗逆转录病毒治疗。在撒哈拉以南非洲，特别是在农村地区，由于缺乏负担得起和可获得的实验室检测，婴儿早期诊断仍然具有挑战性。一种用于婴儿早期诊断的即时检测， 有效、低成本和易于管理的方法将大大改善获得检测的机会、与护理和保留的联系以及早期治疗的开始。西北全球卫生基金会开发了一种即时检测方法，最近从国际药品采购机制获得了一笔市场准入赠款，用于扩大生产。该提案将评估该检测在赞比亚南部农村地区的使用情况，赞比亚是消除儿童艾滋病毒全球计划的优先国家，也是该检测将在 最广泛使用。这项建议的目标涉及艾滋病研究办公室为国际环境下的研究概述的优先领域，包括： 在6周龄和6个月大时实施床旁p24抗原检测; 2）评估出生时新型床旁检测的性能;以及3）评估不同实施策略的结果和成本，以确定如何最好地将新检测整合到当前检测算法中。研究结果将提供关键信息，说明这种新开发的用于撒哈拉以南非洲农村地区婴儿早期诊断的护理点检测的可行性和有效性，以及这种检测以及其他类似的护理点检测应如何纳入国家艾滋病毒检测和治疗指南。拥有有效和负担得起的护理点检测将改变撒哈拉以南非洲婴儿早期诊断的状况，并大大改善艾滋病毒感染婴儿获得早期治疗的机会。

 DESCRIPTION (provided by applicant): Sub-Saharan Africa has the highest burden of disease due to human immunodeficiency virus (HIV) with approximately 25 million HIV-infected persons, including 2.9 million children. Over 1.3 million HIV-infected women gave birth in 2013 and an estimated 210,000 children were newly infected with HIV. Strategies to prevent mother-to-child transmission have been effective in reducing the burden of pediatric HIV and led to endorsement of a global plan in 2011 to eliminate mother-to-child HIV transmission and reduce HIV-related mortality among HIV- infected women and children by 90%. Reducing pediatric HIV-related morbidity and mortality will require health systems with the capacity to diagnose HIV infection infants and promptly and effectively administer antiretroviral therapy. Early infant diagnosis remains challenging in sub- Saharan Africa, particularly in rural areas, due to the lack of affordable and accessible laboratory tests. A point-of-care test for early infant diagnosis that is valid, low-cost, and easily administered would greatly improve access to testing, linkage to care and retention, and earlier treatment initiation. The Northwestern Global Health Foundation has developed a point-of-care test and recently received a market-entry grant from UNITAID to scale-up production. This proposal will evaluate use of this test in rural southern Zambia, a priority country in the global plan to eliminate pediatric HIV and a setting where the test will be most widely used. The objectives of this proposal address priority areas outlined by the Office of AIDS Research for research in international settings, and include: 1) evaluating the feasibility of implementing the point-of-care p24 antigen test at 6 weeks and 6 months of age; 2) evaluating the performance of a novel point-of-care test at birth; and 3) evaluating outcomes and costs of different implementation strategies to determine how best to integrate new tests into current testing algorithms. Study outcomes will provide critical information on the feasibility and validit of this newly developed point-of-care test for early infant diagnosis in rural sub-Saharan Africa and how this test, as well as other similar point-of-care tests, should be incorporated into national HIV testing and treatment guidelines. Having a valid and affordable point-of-care test would change the landscape of early infant diagnosis in sub-Saharan Africa and significantly improve access to early treatment for HIV-infected infants.