Implementing Point of Care CD4 Analysis to Decentralize HIV Care in Rural Africa

描述（由申请人提供）：估计南非有超过560万人感染艾滋病毒，这是世界上最大的流行病。其中很大一部分（45%）被认为有资格开始抗逆转录病毒治疗（ART），但尽管政府作出了重大努力，许多人并不了解自己的艾滋病毒状况，只有55%的符合条件的患者正在接受挽救生命的治疗。以社区为基础的自愿艾滋病毒咨询和检测是提高艾滋病毒检测率的一项新战略，可在病程早期对患者进行诊断，并有可能将患者与抗逆转录病毒疗法的护理和治疗联系起来，并降低艾滋病毒发病率和死亡率。撒哈拉以南非洲新诊断的艾滋病毒患者开始抗逆转录病毒治疗的一个主要障碍是确定治疗资格的CD4细胞计数分期。在南非，CD4细胞检测是在集中实验室进行的，需要复杂和昂贵的实验室基础设施，目前需要高级护士抽血。难以接触到生活在贫困农村地区的个人，他们获得CD4细胞检测设施和获得血液进行分析所需的专业护士的机会有限。快速CD4细胞护理点（POC）诊断有可能大大减少与CD4计数分期相关的延迟，并促进与护理的联系。PIMA诊断分析仪可以在20分钟内提供准确的CD4细胞计数，并可以利用手指棒获得的样本。此外，PIMA便携、简单且相对便宜。在社区环境中进行POC CD4检测可确保在艾滋病毒诊断后立即获得CD4结果。此外，使用毛细血管血液进行PIMA分析将允许将任务从专业护士转移到艾滋病毒咨询师，从而降低成本，促进艾滋病毒服务的分散化，并使护士能够开展抗逆转录病毒治疗和其他关键的、更专业的服务。我们建议在南非一个艾滋病患病率和死亡率极高的贫困农村地区，将PIMA POC测试嵌入到一个现有的成功的基于社区的艾滋病/结核病综合病例发现平台中，进行一项运筹学研究。将利用目前在社区集会场所进行艾滋病毒检测的流动小组。研究的实施措施包括1)静脉血流式细胞术与指尖穿刺毛细血管血PIMA分析的比较2)护士和HIV咨询师进行PIMA指尖穿刺毛细血管血检测的比较3)PIMA指尖穿刺检测在偏远农村地区的可行性和可接受性4)估计使用PIMA进行ART治疗节省的时间。这项研究将由一个美国和南非的团队进行，他们已经在艾滋病研究方面成功合作了十年。它有可能提供证据，支持稀缺人力资源的任务转移，增加艾滋病毒病例发现，获得护理和在服务不足的农村地区提供抗逆转录病毒治疗。该项目将为全球艾滋病毒高流行资源有限环境下的公共卫生政策和做法提供信息。

DESCRIPTION (provided by applicant): More than 5.6 million people are estimated to be living with HIV in South Africa, the largest epidemic in the world. A substantial proportion (45%) of these are believed to be eligible for initiation of antiretroviral therapy (ART), but despite a major government effort, many are not aware of their HIV status and only 55% of eligible patients are receiving life saving treatment. Community-based voluntary counseling and testing for HIV is a new strategy for improving HIV testing rates, diagnosing patients earlier in the course of disease with the potential to link patients to care and treatment with ART and to reduce HIV morbidity and mortality. A major obstacle to ART initiation among newly diagnosed HIV patients in sub-Saharan Africa is CD4 cell count staging to determine eligibility for treatment. In South Africa, CD4 cell testing is performed in centralized laboratories, requiring sophisticated and expensive laboratory infrastructure and currently, senior level nurses to draw blood. Hard to reach individuals living in impoverished rural areas have limited access to both CD4 cell testing facilities and to the professional nurses required to obtain the blood for analysis. Rapid CD4 cell point of care (POC) diagnostics has the potential to substantially reduce delays associated with CD4 count staging and to facilitate linkage to care. The PIMA diagnostic analyzer can provide an accurate CD4 cell count in 20 minutes and can utilize finger stick obtained samples. In addition, PIMA is portable, simple and relatively inexpensive. POC CD4 testing in a community setting can ensure CD4 results are available immediately after HIV diagnosis. Furthermore, the use of capillary blood for PIMA analysis would allow for task shifting from professional nurses to HIV counselors thereby reducing costs, promoting decentralization of HIV services and freeing nurses to initiate ART and other critical and more expert services. We propose to perform an operational research study of the implementation of the PIMA POC test nested into an existing successful integrated HIV/TB community based case finding platform in an impoverished rural South African region with extremely high HIV prevalence and mortality. Mobile teams which currently perform HIV testing at community congregate settings will be utilized. The implementation measures to be studied include 1) comparison of flow cytometry on venous blood to PIMA analysis of fingerstick capillary blood 2) comparison of nurses and HIV counselors performing PIMA fingerstick capillary blood testing and 3) feasibility and acceptance of the PIMA fingerstick testing in a remote rural area and 4) estimation of the time saved to ART initiation with use of PIMA. The study will be performed by a US and South African team that has successfully collaborated on HIV studies for a decade. It has the potential for providing the evidence to support task shifting of scarce human resources, increase HIV case finding, access to care, and ART provision in an underserved rural area. This project will inform public health policy and practice in high HIV prevalence resource limited settings globally. PUBLIC HEALTH RELEVANCE: PAR-10-040 Rapid point of care CD4 diagnostics can reduce the delays associated with CD4 staging for antiretroviral therapy initiation among newly diagnosed HIV patients in sub-Saharan Africa. This proposal will demonstrate that use of fingerstick obtained capillary blood for rapid point of care CD4 testing by a new technology can be performed by HIV counselors instead of highly trained nurses and can facilitate task shifting and decentralization of HIV services. This project has the potential to inform public health policy and practice in high HIV prevalence resource limited settings and to expand antiretroviral access and treatment in sub Saharan Africa and globally.