Integrated, Home-based Treatment for MDR TB and HIV in Rural South Africa

描述（由申请人提供）：南非是全球艾滋病毒负担最高的国家，耐多药结核病流行迅速增长，威胁到结核病和艾滋病毒护理和治疗的最新成果。直到最近，耐多药结核病在中心结核病转诊医院接受治疗，患者住院接受为期6个月的强化治疗。然而，随着耐多药结核病患者数量的增加和医疗基础设施的有限，集中的耐多药结核病计划不再是提供治疗的可持续方法。我们的研究小组最近在南非夸祖鲁-纳塔尔省的一个农村地区设计并实施了一项针对耐多药结核病和艾滋病毒的综合家庭治疗计划。患者在家中接受耐多药结核病和艾滋病毒的联合治疗，由一名出诊护士提供每日注射，并观察口服结核病和抗逆转录病毒药物的给药情况。强化不良事件监测、患者治疗知识教育和依从性支持是必不可少的组成部分。虽然这一方案最近已经实施，但尚未得到正式评估。在本申请中，我们提出了一项前瞻性观察性队列研究，以检查耐多药结核病和艾滋病毒的综合家庭治疗计划的可行性，有效性和安全性。我们将招募100名耐多药结核病和艾滋病病毒合并感染的患者接受该计划的治疗。我们的研究涉及：（1）可行性的定量评估（包括完成家访、注射、不良事件监测和实验室检测），（2）与住院治疗患者的死亡率和治疗结果比较，（3）不良事件的特征，（4）生存预测因子的识别。候选人是阿尔伯特·爱因斯坦医学院和蒙蒂菲奥里医学中心的医学助理教授，其长期目标是成为一名独立的研究人员，在国际资源有限的环境中研究耐药结核病和艾滋病毒。他的短期目标是扩大他在国际临床研究方面的专业知识，提高他在流行病学和生物统计学研究方法方面的熟练程度，并进一步了解临床结核病管理和诊断。他在南非开展艾滋病毒和结核病临床研究方面拥有丰富的经验。该项目将在南非Tugela Ferry的苏格兰教会医院进行，得到国际公认的艾滋病毒/结核病研究人员Gerald Friedland博士以及来自美国和南非的经验丰富的共同导师和合作者团队的支持。 相关性作为在世界艾滋病毒高流行地区对耐多药结核病和艾滋病毒的综合家庭治疗的第一次前瞻性评价，我们的研究有可能为其他资源有限的环境提供新的治疗模式的证据。

DESCRIPTION (provided by applicant): South Africa has the highest burden of HIV worldwide and has a rapidly growing MDR TB epidemic which threatens recent gains in TB and HIV care and treatment. Until recently, MDR TB was treated at centralized TB referral hospitals, with patients admitted for the full 6-month intensive phase. However, with growing numbers of MDR TB patients and limited healthcare infrastructure, the centralized MDR TB program is no longer a sustainable approach for providing treatment. Our research group recently designed and implemented an integrated home-based treatment program for MDR TB and HIV in a rural area of KwaZulu-Natal province, South Africa. Patients receive concomitant treatment for MDR TB and HIV at home by a visiting nurse who provides daily injections and observes administration of oral TB and antiretroviral medications. Intensive adverse event monitoring, patient treatment literacy education and adherence support are essential components. Although this program has recently been implemented, it has not been formally evaluated. In this application, we propose a prospective observational cohort study to examine the feasibility, effectiveness, and safety of the integrated home-based treatment program for MDR TB and HIV. We will enroll 100 MDR TB and HIV co-infected patients receiving care in the program. Our study involves: (1) a quantitative assessment of feasibility (including completion of home-visits, injections, adverse event monitoring, and laboratory testing), (2) comparison of mortality and treatment outcomes to patients treated in an inpatient program, (3) characterization of adverse events, and (4) identification of predictors of survival. The candidate is an Assistant Professor of Medicine at Albert Einstein College of Medicine and Montefiore Medical Center, whose long-term goal is to become an independent investigator studying drug- resistant TB and HIV in international, resource-limited settings. His short-term goals are to broaden his expertise in international clinical research, expand his proficiency in epidemiologic and biostatistical research methods, and further his understanding of clinical TB management and diagnostics. He has substantial experience in conducting clinical research in HIV and TB in South Africa. This project will take place at the Church of Scotland Hospital in Tugela Ferry, South Africa, with the support of Dr. Gerald Friedland, an internationally recognized HIV/TB investigator, and a team of highly experienced co-mentors and collaborators from both the US and South Africa. RELEVANCE As the first prospective evaluation of integrated, home-based treatment for MDR TB and HIV in a high-HIV prevalence area of the world, our study has the potential to provide evidence for a new model of treatment for other resource-limited settings.