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疗法（ART）的艾滋病毒（PLHIV）的人，足够的艺术依从性 和常规的HIV病毒负荷（VL）监测对于确保病毒抑制和良好的健康结果至关重要。 低收入和中等收入国家（LMIC）的终身艺术的启动和管理对这两者都具有挑战性 PLHIV和提供商部分是由于依靠自我报告的依从性以及基于实验室的VL测试的延迟， 这是通常护理的一部分。博士。 Drain and Garrett（联合主要调查员）最近完成了一名飞行员 在南非的研究证明了接受基于efavirenz的PLHIV的即时护理（POC）VL监测 在12个月内，ART在12个月内增加了VL的抑制和保留率，增加了14％（95％CI 6-21％） 进行标准实验室测试。但是，这些发现的适用性在更新，更强大的背景下 在包括南非在内的几种LMIC中引入了基于Dolutegravir的艺术方案，尚不清楚。到 补充POC VL监控，我们最近完成了新颖的开发和初步评估 POC尿液Tenofovir测定法与Abbott Diagnostics合作，可以监测诊所中的艺术依从性 实时设置。在我们的试点研究结果的基础上，我们的目标是确定 使用POC Tenofovir实施综合HIV护理模型的临床功效和成本效益 依从性测试和POC VL监测，以维持PLHIV接收的耐用VL抑制 南非的基于Tenofovir的艺术。我们的中心假设是POC Tenofovir依从性测试和POC VL监控将提高VL抑制率和保留率，同时是可行的，可接受的，并且 成本效益的艺术管理策略。我们将客观地用三个特定的特定假设对我们的中心假设进行测试 目的：（1）确定使用POC Tenofovir依从性测定法和A的集成模型是否用于HIV监测和A POC VL测试将改善VL抑制和保留率； （2）监视实施并评估患者 以及南非实时POC Tenofovir依从性测试和POC VL监测的提供者的观点； （3）估计使用POC实施POC Tenofovir依从性测试的成本和成本效益 与没有客观依从性测试和基于实验室的VL监视相比，VL监视。完成这些 目的，我们将在ART启动时随机将534名参与者（1：1）与常规的POC Tenofovir依从性测试一起使用 POC VL监控（ARM 1）或护理标准，没有客观的Tenofovir依从性测试和基于实验室的VL 监视（ARM 2）。将遵循参与者比较VL抑制的主要综合结果 在研究启动后的18个月后，研究臂之间的护理保留。这个随机控制 实施试验将提供有关临床功效，可接受性和成本效益的关键数据 POC依从性和VL测试的综合模型，以告知全球有关改善LMIC的艾滋病毒护理的政策。