Point-of-care viral load testing to enable task shifting for chronic HIV care

 描述（由申请人提供）：有效管理接受抗逆转录病毒治疗（ART）的患者对于改善临床结果和预防艾滋病毒传播至关重要，但监测超过1300万艾滋病毒感染者的终身ART已成为一项挑战，特别是在低收入和中等收入国家（LMIC）。由于方案继续侧重于识别艾滋病毒感染者和在较高的CD4阈值开始抗逆转录病毒治疗，艾滋病毒提供者负担过重，导致保留率很低。此外，自世界卫生组织建议放弃常规CD4计数监测以来，实验室一直在努力实施HIV病毒载量（VL）检测[WHO，HIV指南2013]。随着抗逆转录病毒治疗的覆盖范围扩大到数百万人，艾滋病毒临床医生和实验室将面临额外的压力，以管理慢性抗逆转录病毒治疗的稳定患者。实施护理点艾滋病毒VL检测，使任务转移到护士慢性艾滋病毒护理可能有助于减轻这些负担。然而，需要证据证明，在医护人员中联合实施护理点HIV VL检测和任务转移是管理中低收入国家慢性HIV护理的一种新的有效策略。该项目的科学目标是测试实施慢性HIV护理模式的临床等效性和降低成本，该模式使用即时HIV VL检测试剂盒，以实现南非城市诊所医疗保健工作者的任务转移。中心假设是，快速艾滋病毒VL检测，由护士实施，是一种有效的和具有成本效益的策略，在大多数患者的慢性艾滋病毒感染的管理，从而使更多的资源被定向在少数患者谁需要更多的关注。客观检验中心假设的计划将通过以下两个具体目标来完成：（1）使用护理点HIV VL检测来测试慢性HIV护理实施模式的临床等效性，以实现南非城市诊所的任务转移，以及（2）评估实施目标1中拟议模式所产生和避免的成本，以及每名艾滋病毒阳性者接受抗逆转录病毒治疗并继续接受治疗的成本。这项工作是创新的，因为它使用了一种实施模式的随机评估，该模式将一种新的诊断性护理点测试与医疗工作者之间的任务转移相结合，而不是在资源有限的环境中进行慢性艾滋病毒护理的护理标准。这项随机试验将成为一项更大的多国提案的基础 证明在中低收入国家实施综合护理点HIV VL检测和慢性HIV护理任务转移模式的临床等效性和成本效益。如果护士使用诊所为基础的HIV VL检测是具有成本效益的实现病毒抑制和保留在ART患者的护理，那么我们的慢性HIV护理模式的实施将减轻现有的艾滋病毒提供者和实验室在中低收入国家的压力。

 DESCRIPTION (provided by applicant): Effective management of patients on antiretroviral therapy (ART) is essential to improve clinical outcomes and prevent HIV transmission, but monitoring life-long ART for over 13 million HIV-infected people has become a challenge, particularly in low- and middle-income countries (LMICs). As programs continue to focus on identifying HIV-infected people and starting ART at higher CD4 thresholds, HIV providers have been overburdened, which has resulted in poor retention rates. In addition, laboratories have been working to implement HIV viral load (VL) testing since the World Health Organization's recommendation to move away from routine CD4 count monitoring [WHO, HIV guidelines 2013]. As ART coverage scales up to include millions more people, additional strain will be placed on HIV clinicians and laboratories to manage stable patients on chronic ART. Implementing point-of-care HIV VL testing to enable task shifting to nurses for chronic HIV care may help mitigate these burdens. However, evidence for a combined implementation of point-of-care HIV VL testing and task shifting among healthcare workers as a novel and effective strategy for managing chronic HIV care in LMICs is needed. The scientific objective of this project is to test the clinical equivalence and reduced cost of implementing a model for chronic HIV care that uses a point-of-care HIV VL assay to enable task shifting among healthcare workers at an urban clinic in South Africa. The central hypothesis is that rapid HIV VL testing, implemented by nurses, is an effective and cost-efficient strategy for management of chronic HIV infection in the majority of patients, thereby allowing more resources to be directed at the minority of patients who need greater attention. The plan to objectively test the central hypothesis will be completed by the following two specific aims: (1) to test the clinical equivalence of an implementation model for chronic HIV care using point-of-care HIV VL testing to enable task shifting in an urban South African clinic, and (2) to assess the costs, both incurred and averted, of implementing the proposed model in Aim #1, and the cost per HIV-positive person virally suppressed on ART and retained in care. This work is innovative because it uses a randomized evaluation of an implementation model that combines a novel diagnostic point-of-care test with task shifting among healthcare workers compared to standard of care for chronic HIV care in a resource-limited setting. This randomized trial will then form the basis of a larger, multi-country proposal to demonstrate the clinical equivalence and cost-effectiveness of implementing an integrated point-of-care HIV VL testing and task shifting model for chronic HIV care in LMICs. If nurses using clinic-based HIV VL testing were cost-effective for achieving both viral suppression and retention in care among patients on ART, then implementation of our chronic HIV care model would alleviate the strain on existing HIV providers and laboratories in LMICs.