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: 10665728
• 负责人: Paul K Drain
• 金额: $ 34.8万
• 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 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10665728
• 关键词: Adherence; Behavior Therapy; Biological Assay; Caring; Chronic; Clinic; Clinical; Clinical Trials; Collaborations; Complement; Complication; Data; Development; Diagnostic; Effectiveness; Eligibility Determination; Ensure; Evaluation; Focus Groups; Goals; HIV; HIV diagnosis; Health; Health Personnel; Intervention; Laboratories; Methods; Modeling; Monitor; Outcome; Participant; Patient Self-Report; Patient-Focused Outcomes; Patients; Persons; Pilot Projects; Policies; Principal Investigator; Provider; Qualifying; 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; clinical efficacy; clinical research site; cost; cost effective; cost effectiveness; cost estimate; disability-adjusted life years; 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.

抽象的 对于数百万接受抗逆转录病毒治疗 (ART) 的艾滋病毒感染者 (PLHIV) 来说，充分的 ART 依从性 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 (LMIC) 启动和管理终身抗逆转录病毒治疗对双方来说都充满挑战 感染者和提供者的部分原因是依赖于自我报告的依从性和基于实验室的 VL 测试的延迟， 这是日常护理的一部分。博士。 Drain 和 Garrett（联合首席研究员）最近完成了一项试点 南非的一项研究表明，对接受依非韦伦治疗的 PLHIV 进行即时护理 (POC) VL 监测 与相比，ART 在 12 个月内将 VL 抑制和护理保留率提高了 14% (95% CI 6-21%) 标准实验室测试。然而，这些发现在更新、更强大的背景下的适用性 包括南非在内的多个中低收入国家引入基于多替拉韦的 ART 治疗方案尚不清楚。到 作为POC VL监测的补充，我们最近完成了一种新型的开发和初步评估 与 Abbott Diagnostics 合作进行 POC 尿液替诺福韦检测，可监测临床中 ART 的依从性 基于实时设置。基于我们的试点研究结果，我们在此应用中的目标是确定 使用 POC 替诺福韦实施综合 HIV 护理模式的临床疗效和成本效益 依从性测试和 POC VL 监测在 PLHIV 接受者中维持持久 VL 抑制 南非基于替诺福韦的 ART。我们的中心假设是 POC 替诺福韦依从性测试和 POC VL 监测将提高 VL 抑制率和护理保留率，同时是可行的、可接受的和 ART 管理的成本效益策略。我们将用三个具体的方法来客观地检验我们的中心假设 目的：(1) 确定是否可以使用 POC 替诺福韦依从性测定和 POC VL 测试将改善 VL 抑制和护理保留； (2) 监督实施情况并评估患者 南非实时 POC 替诺福韦依从性测试和 POC VL 监测的提供商观点； (3) 估计使用 POC 实施 POC 替诺福韦依从性测试的成本和成本效益 VL 监测，与无客观依从性测试和基于实验室的 VL 监测相比。为了完成这些 目标，我们将在 ART 开始时随机将 534 名参与者 (1:1) 纳入常规 POC 替诺福韦依从性测试 POC VL 监测（第 1 组）或标准护理，无客观替诺福韦依从性测试和基于实验室的 VL 监控（第 2 臂）。参与者将被跟踪比较 VL 抑制的主要综合结果 ART 开始后 18 个月时研究组之间的护理保留情况。这个随机对照 实施试验将提供有关临床疗效、可接受性和成本效益的重要数据 POC 依从性和 VL 测试的综合模型，为改善中低收入国家艾滋病毒护理的全球政策提供信息。