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: 8887097
• 负责人: Ingrid Valerie Bassett
• 金额: $ 14.16万
• 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 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8887097
• 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; 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; 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; 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）：在许多城市地区，在资源有限的环境中，艾滋病毒和结核病的双重流行病仍然没有减弱，TB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诊断和对结核病的治疗进行了大量投资，但仅将南非的HIV感染者中的一小部分用于结核病和完整的结核病治疗。因此，在社区一级的结核病控制仍然很差。迫切需要努力来实施和评估将早期艾滋病毒和结核病诊断，结核病治疗开始和保留在护理中的策略，并在医疗保健资源受限的背景下考虑此类策略。 XPERT MTB/RIF是一种新颖，快速，自动化的分子诊断工具，目前部署在南非集中式省级医院中，在目前尚未获得基于医院服务的人们的社区层面上有很大的潜力。该提案建立在成功的移动艾滋病毒筛查单元，该筛查部门前往南非德班乡镇等社区场所，例如出租车摊位和购物中心。我们将利用这个独特的程序正式评估在移动单元上使用XPERT的价值，并通过实施和评估“测试和治疗结核病”（T＆T TB）干预措施来促进与TB Care中的链接和保留率来建立该策略。 T＆T结核 移动单元； ii）在移动单元中使用“入门包”加快了结核病治疗启动； iii）每月短信（短信）预约提醒。在3臂设计中，我们将比较：1）T＆T TB； 2）快速测试（通过基于诊所的随访在移动单元上进行XPERT筛查）或3）通常的护理（转介给诊所进行结核病筛查）。我们提出了概念验证随机试验，以实现两个具体目标。第一个目的是建立“测试和治疗结核病”策略对南非移动艾滋病毒筛查部门的可行性，产量和浮雕影响。第二个目的是评估这种综合的HIV/TB筛查策略的成本和成本效益，以最大程度地联系到结核病护理和治疗完成。我们假设T＆T结核病策略将提高结核病治疗的完成率，并且非常有效。成本效益分析具有灵活性，可以在患有不同艾滋病毒和结核病患病率的情况下检查XPERT的可行性和负担能力。该提案是由2013年跨性别卫生HIV研究计划激发的，旨在调查艾滋病毒/结核病整合的新方法，这些方法促进了早期发现和有效参与护理，并评估这些干预措施对生存，护理质量和成本效益的影响。这种小说，移动，快速艾滋病毒和结核病筛查干预措施将使XPERT MTB/RIF技术在社区层面上进入“护理点”，并将使用创新技术来提高结核病治疗的速度。这项工作将为医生，政府和政策制定者提供有关如何通过及时且综合的移动艾滋病毒/结核病诊断和与Care的联系来最大化社区筛查的好处。