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

 描述(申请人提供)：有效管理患者的抗逆转录病毒疗法(ART)对于改善临床结果和预防艾滋病毒传播至关重要，但监测1300多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)。随着项目继续专注于识别艾滋病毒感染者并以较高的CD4阈值开始抗逆转录病毒治疗，艾滋病毒提供者负担过重，这导致了较低的保留率。此外，自从世界卫生组织建议放弃常规的CD4计数监测以来，实验室一直在努力实施艾滋病毒病毒载量(VL)检测[世卫组织，艾滋病毒指南2013]。随着抗逆转录病毒治疗覆盖范围扩大到覆盖数百万人，艾滋病毒临床医生和实验室将面临额外的压力，以管理长期接受抗逆转录病毒治疗的稳定患者。实施护理现场艾滋病毒VL检测，使慢性艾滋病毒护理的任务转移到护士身上，可能有助于减轻这些负担。然而，需要证据表明，在医护人员中结合实施护理点HIV VL检测和任务转移，作为管理LMIC中慢性艾滋病毒护理的一种新的和有效的策略。该项目的科学目标是测试实施慢性艾滋病毒护理模式的临床等价性和降低成本，该模式使用护理点式艾滋病毒VL检测，以使南非一家城市诊所的医护人员能够转移任务。中心假设是，由护士实施的艾滋病毒VL快速检测是管理大多数患者慢性艾滋病毒感染的有效和具有成本效益的策略，从而使更多的资源用于需要更多关注的少数患者。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)测试使用护理点式艾滋病毒VL检测的慢性艾滋病毒护理实施模式的临床等价性，以便在南非城市诊所实现任务转移，(2)评估在Aim#1中实施拟议模型所产生的和避免的成本，以及经病毒抑制的抗逆转录病毒疗法和保留在护理中的艾滋病毒阳性者的每名成本。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，该模式结合了一种新的诊断性护理点测试与医护人员之间的任务转移，与资源有限的慢性艾滋病毒护理的护理标准相比。然后，这项随机试验将形成一个更大的多国提案的基础 论证在LMICs中实施HIV VL检测和慢性HIV护理任务转移综合护理点模式的临床等效性和成本效益。如果护士使用基于诊所的HIV VL检测在ART患者中实现病毒抑制和保留护理是具有成本效益的，那么我们的慢性HIV护理模式的实施将缓解LMICs中现有艾滋病毒提供者和实验室的压力。

 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.