Test and Treat TB: A Proof of Concept Trial in South Africa

测试和治疗结核病：南非的概念验证试验

• 批准号: 8739080
• 负责人: Ingrid Valerie Bassett
• 金额: $ 27.27万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-04 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8739080
• 关键词: Africa South of the Sahara; African; Appointment; Biometry; Caring; Cause of Death; Cessation of life; Child; Clinic; Clinical; Collaborations; Communities; Cost Effectiveness Analysis; Country; Diagnosis; Diagnostic; Diagnostic tests; Disease; Early Diagnosis; Effectiveness; Enrollment; Epidemic; Evaluation; Foundations; Government; HIV; Health care facility; Healthcare; Hospitals; Human immunodeficiency virus test; Individual; Intervention; Investments; Laboratories; Microscopy; Molecular; Nurses; Outcome; Patients; Physicians; Policy Maker; Population; Prevalence; Quality of Care; Reliance; Research; Research Infrastructure; Resources; Risk; School-Age Population; Services; South Africa; Symptoms; System; Techniques; Technology; Test Result; Testing; Text; Time; Travel; Tuberculosis; United States National Institutes of Health; Work; World Health; antiretroviral therapy; arm; base; case finding; clinical epidemiology; cost; cost effective; cost effectiveness; design; flexibility; follow-up; high risk; implementation science; improved; innovation; intervention effect; novel; novel strategies; point of care; programs; public health relevance; randomized trial; screening; stem; tool; treatment as usual; tuberculosis treatment; urban area; user-friendly

DESCRIPTION (provided by applicant): The dual epidemics of HIV and TB continue unabated in many urban areas in resource-limited settings, with TB the leading cause of death among patients enrolled in antiretroviral therapy programs in South Africa. Despite substantial investment in healthcare facility-based diagnosis and treatment of TB, only a fraction of HIV-infected people in South Africa are screened for TB and complete TB treatment; therefore TB control at the community level remains poor. Efforts are urgently needed to implement and evaluate strategies that integrate early HIV and TB diagnosis, TB treatment initiation and retention in care, and to consider such strategies in the context of constrained healthcare resources. Xpert MTB/RIF, a novel, rapid, automated molecular diagnostic tool, currently deployed within centralized provincial hospitals in South Africa, has great potential for intensifid case finding at the community level among people who are not currently accessing hospital-based services. This proposal builds upon a successful mobile HIV screening unit that travels to community venues such as taxi stands and malls in the townships of Durban, South Africa. We will leverage this unique program to formally evaluate the value of using Xpert on the mobile unit, and build upon that strategy by implementing and evaluating a "Test & Treat TB" (T&T TB) intervention for promoting linkage to and retention in TB care. T&T TB is a package of interventions that includes: i) Xpert screening with rapid receipt of Xpert MTB/RIF test results at the mobile unit; ii) expedited TB treatment initiation with a "starter pack" at the mobile unit; an iii) monthly SMS (text message) appointment reminders. In a 3-arm design, we will compare: 1) T&T TB; 2) Expedited testing (Xpert screening on the mobile unit with clinic-based follow-up) or 3) Usual care (referral to clinic for TB screening). We propose a proof-of-concept randomized trial to accomplish two specific aims. The first aim is to establish the feasibility, yield, and clnical impact of a "Test & Treat TB" strategy on a mobile HIV screening unit in South Africa. The second aim is to assess the cost and cost-effectiveness of this integrated HIV/TB screening strategy for maximizing linkage to TB care and treatment completion. We hypothesize that the T&T TB strategy will improve rates of TB treatment completion and will be very cost-effective. The cost-effectiveness analysis offers the flexibility to examine the feasibility and affordabilityof Xpert in settings with different HIV and TB prevalences. This proposal is motivated by the 2013 Trans-NIH HIV research plan to investigate new approaches to HIV/TB integration that promote early detection and effective engagement in care, and to assess the effects of these interventions on survival, quality of care, and cost-effectiveness. This novel, mobile, rapid HIV and TB screening intervention will bring Xpert MTB/RIF technology to the "point of care", at the community level, and will use innovative techniques to improve rates of TB treatment completion. This work will inform physicians, governments, and policy makers on how to maximize the benefits of community screening through timely and integrated mobile HIV/TB diagnosis and linkage to care.

描述（由申请人提供）：艾滋病毒和结核病的双重流行在资源有限的许多城市地区继续有增无减，结核病是南非参加抗逆转录病毒治疗计划的患者的主要死亡原因。尽管对基于医疗机构的结核病诊断和治疗进行了大量投资，但南非只有一小部分艾滋病毒感染者接受了结核病筛查和完整的结核病治疗;因此，社区一级的结核病控制仍然很差。迫切需要努力实施和评估将艾滋病毒和结核病早期诊断、结核病治疗启动和继续护理相结合的战略，并在卫生保健资源有限的情况下考虑这些战略。Xpert MTB/RIF是一种新型、快速、自动化的分子诊断工具，目前部署在南非的省级集中医院，在社区一级目前没有获得医院服务的人群中发现重症病例具有很大的潜力。这项建议是以一个成功的移动的艾滋病毒检查单位为基础的，该单位前往南非德班乡镇的出租车站和购物中心等社区场所。我们将利用这一独特的计划，正式评估在移动的设备上使用Xpert的价值，并通过实施和评估“检测和治疗结核病”（T&T TB）干预措施来促进结核病护理的联系和保留，从而建立该战略。T&T TB是一套干预措施，包括：i）Xpert筛查，快速接收Xpert MTB/RIF检测结果， 所述移动的单元; ii）在移动的单位使用“启动包”加速TB治疗启动; iii）每月SMS（文本消息）预约提醒。在3组设计中，我们将比较：1）T&T TB; 2）加速检测（在移动的单元上进行Xpert筛查，并进行基于诊所的随访）或3）家庭护理（转诊到诊所进行TB筛查）。我们提出了一个概念验证的随机试验，以实现两个特定的目标。第一个目标是在南非建立一个移动的艾滋病毒筛查单位，以确定“检测和治疗结核病”战略的可行性、产量和临床影响。第二个目标是评估这一艾滋病毒/结核病综合筛查战略的成本和成本效益，以最大限度地加强与结核病护理和治疗完成的联系。我们假设T&T结核病战略将提高结核病治疗完成率，并且将非常具有成本效益。成本效益分析提供了灵活性，以检查Xpert在不同HIV和TB流行率环境中的可行性和可负担性。该提案是由2013年跨NIH艾滋病毒研究计划推动的，该计划旨在研究促进早期发现和有效参与护理的艾滋病毒/结核病整合的新方法，并评估这些干预措施对生存，护理质量和成本效益的影响。这种新颖的、移动的、快速的艾滋病毒和结核病筛查干预措施将把Xpert MTB/RIF技术带到社区层面的“护理点”，并将使用创新技术提高结核病治疗完成率。这项工作将告知医生、政府和政策制定者如何通过及时和综合的移动的艾滋病毒/结核病诊断和与护理的联系，最大限度地发挥社区筛查的效益。