Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, Private Bag X7, Congella, Durban, 4013, South Africa.
CAPRISA-MRC TB-HIV Pathogenesis and Treatment Research Unit, Durban, South Africa.
Implement Sci. 2017 Nov 13;12(1):129. doi: 10.1186/s13012-017-0661-1.
BACKGROUND: A large and compelling clinical evidence base has shown that integrated TB and HIV services leads to reduction in human immunodeficiency virus (HIV)- and tuberculosis (TB)-associated mortality and morbidity. Despite official policies and guidelines recommending TB and HIV care integration, its poor implementation has resulted in TB and HIV remaining the commonest causes of death in several countries in sub-Saharan Africa, including South Africa. This study aims to reduce mortality due to TB-HIV co-infection through a quality improvement strategy for scaling up of TB and HIV treatment integration in rural primary healthcare clinics in South Africa. METHODS: The study is designed as an open-label cluster randomized controlled trial. Sixteen clinic supervisors who oversee 40 primary health care (PHC) clinics in two rural districts of KwaZulu-Natal, South Africa will be randomized to either the control group (provision of standard government guidance for TB-HIV integration) or the intervention group (provision of standard government guidance with active enhancement of TB-HIV care integration through a quality improvement approach). The primary outcome is all-cause mortality among TB-HIV patients. Secondary outcomes include time to antiretroviral therapy (ART) initiation among TB-HIV co-infected patients, as well as TB and HIV treatment outcomes at 12 months. In addition, factors that may affect the intervention, such as conditions in the clinic and staff availability, will be closely monitored and documented. DISCUSSION: This study has the potential to address the gap between the establishment of TB-HIV care integration policies and guidelines and their implementation in the provision of integrated care in PHC clinics. If successful, an evidence-based intervention comprising change ideas, tools, and approaches for quality improvement could inform the future rapid scale up, implementation, and sustainability of improved TB-HIV integration across sub-Sahara Africa and other resource-constrained settings. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02654613 . Registered 01 June 2015.
背景：大量有力的临床证据表明，结核病和艾滋病综合服务可降低艾滋病毒（HIV）和结核病（TB）相关的死亡率和发病率。尽管官方政策和指南建议结核病和艾滋病防治工作相整合，但实施情况不佳，导致结核病和艾滋病仍然是撒哈拉以南非洲包括南非在内的几个国家最常见的死因。本研究旨在通过提高结核病和艾滋病治疗整合质量改进策略，降低南非农村初级保健诊所中因结核病和艾滋病合并感染导致的死亡率。
方法：本研究设计为开放标签的整群随机对照试验。将负责监督南非夸祖鲁-纳塔尔省两个农村地区 40 个初级卫生保健（PHC）诊所的 16 名诊所主管随机分配至对照组（提供结核病和艾滋病整合的标准政府指导）或干预组（提供标准政府指导，通过质量改进方法积极加强结核病和艾滋病护理整合）。主要结局是结核病和艾滋病患者的全因死亡率。次要结局包括结核病和艾滋病合并感染患者开始抗逆转录病毒治疗（ART）的时间，以及 12 个月时的结核病和艾滋病治疗结局。此外，还将密切监测和记录可能影响干预措施的因素，如诊所条件和员工可用性。
讨论：本研究有可能解决在提供初级保健诊所的综合护理方面，结核病和艾滋病防治工作整合政策和指南的制定与实施之间的差距。如果成功，一项基于证据的干预措施，包括变革思路、工具和方法，可用于改善撒哈拉以南非洲和其他资源有限地区的结核病和艾滋病整合的快速扩大、实施和可持续性。
试验注册：Clinicaltrials.gov，NCT02654613。注册日期：2015 年 6 月 1 日。
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