Simplifying HIV Treatment and Monitoring (STREAM2): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa

简化艾滋病毒治疗和监测 (STREAM2)：护理点尿液替诺福韦依从性和病毒载量检测，以改善南非的艾滋病毒治疗结果

• 批准号: 10448268
• 负责人: Paul K Drain
• 金额: $ 68.92万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-23 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10448268
• 关键词: Adherence; Biological Assay; Caring; Chronic; Clinic; Clinical; Clinical Trials; Collaborations; Complement; Complication; Data; Development; Diagnostic; Ensure; Evaluation; Focus Groups; Goals; HIV; HIV diagnosis; HIV therapy; Health; Health Personnel; Intervention; Laboratories; Life; Methods; Modeling; Monitor; Network-based; Outcome; Participant; Patient Self-Report; Patient-Focused Outcomes; Patients; Persons; Pilot Projects; Policies; Principal Investigator; Provider; Questionnaires; Randomized; Regimen; Research; Services; Social Behavior; South Africa; South African; Structure; Tenofovir; Testing; Time; Training; Treatment outcome; Urine; Validation; Viral; Viral Load result; Viremia; antiretroviral therapy; arm; base; clinical efficacy; clinical research site; cost; cost effective; cost effectiveness; cost estimate; economic impact; efavirenz; experience; implementation science; implementation trial; improved; intervention cost; low and middle-income countries; microcosting; novel; point of care; point of care testing; prevent; process evaluation; standard of care; therapy adherence; transmission process; treatment as usual

ABSTRACT For millions of people living with HIV (PLHIV) receiving antiretroviral therapy (ART), adequate ART adherence and routine HIV viral load (VL) monitoring are critical to ensure viral suppression and good health outcomes. Initiation and management of life-long ART in low- and middle-income countries (LMICs) is challenging for both PLHIV and providers in part due to the reliance on self-reported adherence and delays with lab-based VL testing, which are part of the usual care. Drs. Drain and Garrett (co-principal investigators) recently completed a pilot study in South Africa demonstrating that point-of-care (POC) VL monitoring for PLHIV receiving efavirenz-based ART increased VL suppression and retention in care by 14% (95% CI 6-21%) over a 12-month period compared to standard lab testing. However, the applicability of these findings to the context of newer, more robust dolutegravir-based ART regimens being introduced in several LMICs, including South Africa, is not known. To complement POC VL monitoring, we have recently completed the development and initial evaluation of a novel POC urine tenofovir assay, in collaboration with Abbott Diagnostics, which can monitor ART adherence in clinic- based settings in real-time. Building on our pilot study results, our objective in this application is to determine the clinical efficacy and cost effectiveness of implementing an integrated HIV care model using POC tenofovir adherence testing and POC VL monitoring in maintaining durable VL suppression among PLHIV receiving tenofovir-based ART in South Africa. Our central hypotheses are that POC tenofovir adherence testing and POC VL monitoring will improve VL suppression rates and retention in care, while being a feasible, acceptable, and cost-effective strategy for ART management. We will objectively test our central hypotheses with three specific aims: (1) to determine if an integrated model for HIV monitoring using a POC tenofovir adherence assay and a POC VL test will improve VL suppression and retention in care; (2) to monitor implementation and assess patient and provider perspectives of real-time POC tenofovir adherence testing and POC VL monitoring in South Africa; and (3) to estimate the costs and cost-effectiveness of implementing POC tenofovir adherence testing with POC VL monitoring, compared to no objective adherence testing and lab-based VL monitoring. To complete these aims, we will randomize 534 participants (1:1) at ART initiation into regular POC tenofovir adherence testing with POC VL monitoring (Arm 1) or standard-of-care with no objective tenofovir adherence testing and lab-based VL monitoring (Arm 2). Participants will be followed to compare a primary composite outcome of VL suppression and retention in care between the study arms at 18 months after ART initiation. This randomized controlled implementation trial will provide crucial data on the clinical efficacy, acceptability, and cost-effectiveness of an integrated model of POC adherence and VL testing to inform global policy on improving HIV care in LMICs.

摘要 对于数百万接受抗逆转录病毒治疗的艾滋病毒感染者， 和常规HIV病毒载量（VL）监测对于确保病毒抑制和良好的健康结果至关重要。 在低收入和中等收入国家（LMICs）启动和管理终身抗逆转录病毒治疗对双方都具有挑战性。 艾滋病毒感染者和提供者的部分原因是依赖自我报告的依从性和基于实验室的VL检测的延迟， 这是常规护理的一部分。Drs. Drain和加勒特（共同主要研究者）最近完成了一个试点项目 南非的一项研究表明，接受基于依法韦仑的艾滋病毒感染者的床旁（POC）VL监测 ART在12个月期间使VL抑制和护理保留增加了14%（95% CI 6-21%）， 进行标准实验室测试然而，这些发现的适用性，以较新的背景下，更强大的 包括南非在内的几个中低收入国家正在采用以度鲁特韦为基础的抗逆转录病毒疗法，目前尚不清楚。到 补充POC VL监测，我们最近完成了一种新的开发和初步评估 POC尿液替诺福韦检测，与雅培诊断公司合作，可以监测临床上的ART依从性- 基于实时设置。基于我们的试点研究结果，我们在本申请中的目标是确定 使用POC替诺福韦实施艾滋病综合护理模式的临床疗效和成本效益 坚持检测和POC VL监测在维持持久的VL抑制中的PLHIV接受者 在南非的替诺福韦抗逆转录病毒疗法。我们的中心假设是，POC替诺福韦坚持测试和POC VL监测将提高VL抑制率和护理保留率，同时是一种可行的，可接受的， 具有成本效益的ART管理策略。我们将客观地测试我们的中心假设与三个具体的 目的：（1）确定使用POC替诺福韦粘附试验和 POC VL测试将改善VL抑制和保持护理;（2）监测实施和评估患者 和供应商对南非实时POC替诺福韦依从性检测和POC VL监测的看法; 以及（3）估计用POC实施POC替诺福韦依从性测试的成本和成本效益 与无客观依从性测试和基于实验室的VL监测相比，VL监测。完成这些 目的，我们将在ART启动时随机分配534名参与者（1：1）进行常规POC替诺福韦依从性测试， POC VL监测（第1组）或标准治疗，无客观替诺福韦依从性检测和实验室VL 监测（组2）。将对参与者进行随访，比较VL抑制的主要复合结局 在ART开始后18个月，研究组之间的护理保持率。该随机对照 实施试验将提供关于临床疗效、可接受性和成本效益的关键数据， 这是一个POC依从性和VL检测的综合模式，为改善中低收入国家艾滋病毒护理的全球政策提供信息。