SIngle-saMPLE tuberculosis evaluation to facilitate linkage to care: The SIMPLE TB trial

单样本结核病评估以促进与护理的联系：SIMPLE TB 试验

• 批准号: 9205264
• 负责人: Adithya Cattamanchi
• 金额: $ 64.15万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-01-15 至 2020-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9205264
• 关键词: Address; Adopted; Adoption; Adult; Affect; Caring; Clinical Trials; Cluster randomized trial; Community Health Centers; Country; Data; Diagnosis; Diagnostic; Diagnostic Services; Diagnostic tests; Dimensions; Early Diagnosis; Early treatment; Economics; Effectiveness; Ensure; Epidemic; Epidemiology; Evaluation; Feedback; Fluorescence Microscopy; Future; Goals; Health; Health system; Hour; Hybrids; Incidence; Intervention; Lead; Low income; Lung; Maintenance; Methods; Microscopic; Microscopy; Modeling; Molecular; Outcome; Patients; Peripheral; Policy Maker; Population; Process; Provider; Pulmonary Tuberculosis; Qualitative Methods; Randomized; Reporting; Research; Research Infrastructure; Resources; Sampling; Services; Site; Specimen; Sputum; Target Populations; Technology; Test Result; Testing; Time; Tuberculosis; Uganda; Visit; base; comparative effectiveness; contextual factors; cost; cost effectiveness; design; falls; fight against; follow-up; improved; low income country; mortality; novel; novel diagnostics; patient oriented; point of care; programs; public health relevance; scale up; standard of care; theories; transmission process; treatment duration; uptake

 DESCRIPTION (provided by applicant): In high burden countries, many patients with tuberculosis (TB) who present to community health centers are lost to follow-up before TB can be diagnosed or treated, leading to ongoing transmission. A primary reason is that the standard approach of collecting sputum specimens over multiple days for microscopic examination is not only insensitive but also inconvenient and costly for patients. Xpert MTB/RIF (Xpert) is a semi-automated molecular test that identifies 90% of TB cases within 2 hours. Xpert is now recommended as the initial diagnostic test for pulmonary TB but cannot be deployed at community health centers because of cost and infrastructure requirements. To achieve access, utilization and impact on health outcomes, strategies for successful referrals from community health centers to facilities in which Xpert is being deployed are essential. Our overall objective s to assess the effectiveness, implementation and impact of a streamlined, single- sample (SIMPLE) TB diagnostic evaluation strategy. The SIMPLE TB strategy was developed after a theory-informed assessment of provider- and patient-level barriers to TB diagnostic evaluation and through a process of stakeholder engagement. Its components include: 1) Single-sample LED fluorescence microscopy (analysis and reporting of smear results from the initial specimen within two hours); 2) Daily transport of smear-negative sputum samples to Xpert testing sites; 3) SMS-based reporting of Xpert test results to patients and health centers; and 4) Routine feedback of TB evaluation metrics to health center staff. Our central hypothesis is that the SIMPLE TB strategy will increase the number of patients with active TB for whom treatment is initiated. To test this hypothesis, we will conduct a cluster-randomized trial at 20 community health centers in Uganda to determine whether the SIMPLE TB strategy improves TB diagnosis and treatment initiation rates relative to the prevailing standard-of-care (Aim 1). Routine data collected on adults undergoing TB diagnostic evaluation at intervention and control health centers will be used to assess trial outcomes. Concurrently with the clinical trial, we will employ a mixed methods approach to evaluate in detail the process of implementation (Aim 2), focusing on factors that influence the adoption and maintenance of intervention components and faithfulness to our conceptual model. Last, we will perform economic and epidemic modeling to estimate the cost-effectiveness and epidemiological impact (i.e., future TB incidence) of the SIMPLE TB strategy (Aim 3). Relying solely on novel diagnostic technologies without also supporting health system interventions to facilitate their uptake and use is unlikely to result in sustained and meaningful progress in the ongoing fight against TB. The comprehensive research plan will generate the high-quality evidence needed to guide TB policy makers in deciding whether to adopt the SIMPLE TB strategy, and on how best to implement it at other health centers. This research will also lead to a better understanding of the factors and types of interventions associated with successful implementation of novel TB diagnostics in low- income, high TB burden countries.

 描述(申请人提供)：在高负担国家，许多到社区卫生中心就诊的结核病患者在诊断或治疗结核病之前失去了随访机会，导致了持续的传播。一个主要原因是，标准的方法，即在多天内收集痰标本进行显微镜检查，不仅不敏感，而且对患者来说也不方便和昂贵。Xpert MTB/RIF(Xpert)是一种半自动分子检测，可在2小时内确定90%的结核病病例。Xpert现在被推荐作为肺结核的初始诊断测试，但由于成本和基础设施要求，不能在社区卫生中心部署。为了实现获取、利用和对健康结果的影响，成功地从社区卫生中心转诊到部署了Xpert的设施的战略至关重要。我们的总体目标是评估简化的单样本(简单)结核病诊断评估战略的有效性、实施情况和影响。在对结核病诊断评估的提供者和患者层面的障碍进行了理论知情的评估之后，并通过利益攸关方参与的过程，制定了简单的结核病战略。它的组成部分包括：1)单样本LED荧光显微镜(在两小时内分析和报告初始样本的涂片结果)；2)每天将涂片阴性的痰样本运送到Xpert检测点；3)基于短信向患者和医疗中心报告Xpert检测结果；以及4)向医疗中心工作人员定期反馈结核病评估指标。我们的中心假设是，简单的结核病策略将增加开始治疗的活动性结核病患者的数量。为了验证这一假设，我们将在乌干达的20个社区卫生中心进行一项整群随机试验，以确定相对于普遍的护理标准(目标1)，简单结核病战略是否提高了结核病诊断和治疗启动率。在干预和控制卫生中心接受结核病诊断评估的成年人的常规数据将用于评估试验结果。在临床试验的同时，我们将采用 采用混合方法详细评估实施过程(目标2)，重点关注影响采用和维护干预组件以及对我们的概念模型的忠实性的因素。最后，我们将进行经济和流行病模拟，以估计简单结核病战略(目标3)的成本效益和流行病学影响(即未来的结核病发病率)。仅依靠新的诊断技术，而不支持卫生系统的干预措施，以促进对这些技术的吸收和使用，不太可能在目前的结核病防治工作中取得持续和有意义的进展。这项全面的研究计划将产生所需的高质量证据，以指导结核病政策制定者决定是否采用简单结核病战略，以及如何最好地在其他卫生中心实施该战略。这项研究还将有助于更好地了解与在低收入、高结核病负担国家成功实施新的结核病诊断方法相关的因素和干预措施类型。