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）：在资源有限的许多城市地区，艾滋病毒和结核病的双重流行势头有增无减，结核病是南非参加抗逆转录病毒治疗项目的患者死亡的主要原因。尽管在基于卫生保健设施的结核病诊断和治疗方面进行了大量投资，但南非只有一小部分艾滋病毒感染者接受了结核病筛查并完成了结核病治疗；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早期艾滋病毒和结核病诊断、结核病治疗开始和保留纳入护理的战略，并在卫生保健资源有限的背景下考虑这些战略。Xpert MTB/RIF是一种新型、快速、自动化的分子诊断工具，目前已在南非的省级集中式医院部署，在目前无法获得医院服务的人群中，具有在社区一级加强病例发现的巨大潜力。这项建议建立在一个成功的移动艾滋病毒筛查单位的基础上，该单位前往南非德班城镇的出租车站和商场等社区场所。我们将利用这一独特的项目，正式评估在移动单位使用Xpert的价值，并在这一战略的基础上，实施和评估“结核病检测与治疗”（T&T TB）干预措施，以促进结核病护理的联系和保留。结核分枝杆菌结核病是一揽子干预措施，包括：i)专家筛查，快速收到专家结核分枝杆菌/RIF检测结果