Qualitative and Quantitative Data for Tuberculosis Infection Prevention and Control in KwaZulu-Natal and Western Cape, South Africa, 2018-2021

This multidisciplinary project adopted a 'whole systems' approach using methods from epidemiology, anthropology, and health systems research (Systems dynamic modelling) to understand the context, practice, and the potential for effective implementation of IPC for TB in South Africa. This project was conducted over four years (2017–2021) and had three stages:

1) observe & measure (data collection),
2) combine & design (system dynamics workshops)
3) model & cost (mathematical and economic modelling).

These three phases of the project addressed seven research question. Research question 1 described the policy and systems context by looking at how South African policies on IPC for TB have evolved and been implemented. We spoke with members of civil society, and policymakers. For Research question 2, which related to the epidemiological context, we estimated how much TB transmission happens in clinics compared to other community locations. We estimated how many adults attending clinics had active TB and/or TB symptoms. We also estimated the risk of contact between people with infectious TB and other clients within clinics, and separately estimated, among community members, the frequency of social contacts in clinics as compared to other settings where people meet.

Research questions 3 and 4 examined the effect of clinic design and working practices on transmission and looked to understand healthcare workers perceptions of risk and responsibility. We used structured and in-depth qualitative methods to document IPC practice in health clinics considering the role of clinic design, organisation of care, work practices, as well as health care worker, manager, and patient ideas about risk and responsibility in IPC. We spoke to patients, health workers, as well as specialists in primary care, IPC, and the built environment. The collected data enabled us to calculate the ventilation of waiting areas and consultation rooms; and we examined how people moved around clinics and where they spent time.

Research question 5 involved the designing of whole-systems interventions to improve TB infection prevention and control. We used system dynamics modelling (SDM) to bring our data together and design interventions. With researchers, patient and union representatives, practitioners from clinics and hospitals, and policymakers from District, Provincial, and National Departments of Health, we developed ‘models’ (diagrams) of the system and identified targets for interventions to reduce Mtb transmission. Our collaborators prioritised interventions based on how likely they were to be effective and how easily they could be implemented.

Research questions 6 and 7 involved synthesis of all these data to develop a package of health systems interventions to reduce DR-TB transmission in clinics, adapted to the constraints and opportunities of the South African health system.

We used mathematical and economic modelling to project the potential impact of interrupting clinic-based transmission on community-wide TB incidence, and the consequent economic benefits for health systems and households.<p>Drug-resistant tuberculosis (DR-TB) is a major threat to global public health, causing one in four estimated worldwide deaths attributable to antimicrobial resistance. In South Africa, DR-TB transmission within clinics, particularly to HIV-positive people, is well-documented. Most TB transmission happens before people start TB treatment, but DR-TB transmission may continue after treatment is started, raising concern as DR-TB services in South Africa are decentralised from hospitals to primary care clinics. The extent to which exposure in clinics, as compared to other community settings, drives ongoing transmission of DR-TB requires better definition, to mobilise necessary resources to address this problem. Guidelines for clinics concerning infection prevention and control (IPC) measures to reduce DR-TB transmission are widely available. There is ample evidence that recommended measures are not put into practice, but limited understanding of the reasons. A comprehensive approach to understanding barriers to implementation is required to design effective IPC interventions for DR-TB.

Failure of IPC measures for DR-TB is often attributed to health care workers (HCW) failure to adhere to guidelines. Cognisant that HCW are part of a health system with specific organizational features, we examine how the health system as a whole supports IPC measures. We investigate the biological, environmental, infrastructural, and social dynamics of DR-TB transmission in clinics in two provinces in South Africa (KwaZulu-Natal and Western Cape). Our aim is to provide evidence for effective ways to improve IPC for DR-TB, addressing not only behavioural factors, but also the ways in which clinic space, infrastructure, work and patient flows are managed, and a rights-based occupational health ethos might be cultivated.

Our innovative approach brings together a team from several scientific disciplines. Taking a 'whole systems' approach, we will use methods from epidemiology, anthropology, and health systems research to understand the context, practice, and the potential for effective implementation of IPC for DR-TB. We will examine how South African policies on IPC for TB have evolved and been implemented. The epidemiological context will be defined by estimating how much DR-TB transmission happens in clinics compared to other community locations. We will estimate the risk of contact between people with infectious DR-TB and other clients within clinics, and separately estimate, among community members, the frequency of social contacts in clinics as compared to other settings where people meet.

We will use structured and in-depth qualitative methods to document IPC practice in health clinics: the role of clinic design, organisation of care, work practices, as well as HCW, manager, and patient ideas about risk and responsibility in IPC. In collaboration with key stakeholders, we will use health systems mapping and model-building exercises to visually document the environmental and organizational barriers and enablers to implementing optimal DR-TB IPC.

Synthesis of all these data will lead to development of a package of health systems interventions to reduce DR-TB transmission in clinics, adapted to the constraints and opportunities of the South African health system. We will use mathematical and economic modelling to project the potential impact of interrupting clinic-based transmission on community-wide TB incidence, and the consequent economic benefits for health systems and households.

In addition to significant academic, policy and programme-relevant outputs, the project will create an interdisciplinary platform for future implementation and evaluation of health systems strategies to improve IPC. It will stimulate discussion between researchers working on DR-TB and other drug-resistant infections, and foster greater public awareness of the importance of systems that minimize the risk of airborne infections in health facilities.</p>

本多学科项目采用"整体系统"方法，结合流行病学、人类学及卫生系统研究（含系统动力学建模），旨在理解南非结核病（Tuberculosis，TB）感染预防与控制（Infection Prevention and Control，IPC）的背景、实践现状及有效实施潜力。项目历时四年（2017–2021年），分为三个阶段：1）观察与测量（数据收集）；2）整合与设计（系统动力学研讨会）；3）建模与成本分析（数学及经济建模）。

这三个阶段共解决了七个研究问题。研究问题1通过分析南非结核病IPC政策的演变与实施情况，描述政策与系统背景。研究团队与民间社会成员及政策制定者进行了访谈。研究问题2聚焦流行病学背景，估算诊所内结核病传播与其他社区场所的差异；评估就诊成人中活动性结核病及/或结核病症状的发生率；同时估算诊所内传染性结核病患者与其他就诊者的接触风险，并单独分析社区成员在诊所与其他社交场所的社交接触频率。

研究问题3和4探讨了诊所设计与工作实践对传播的影响，并旨在理解医护人员对风险与责任的认知。研究团队采用结构化及深度定性方法，记录卫生诊所的IPC实践，涉及诊所设计、护理组织、工作实践，以及医护人员、管理者和患者对IPC中风险与责任的认知。研究对象包括患者、医护人员，以及初级保健、IPC及建筑环境领域的专家。收集的数据用于计算候诊区及诊室的通风情况，并分析人员在诊所内的流动路径及停留区域。

研究问题5涉及设计整体系统干预措施，以改善结核病感染预防与控制。研究采用系统动力学建模（System Dynamics Modelling，SDM）整合数据并设计干预措施。联合研究人员、患者及工会代表、诊所及医院从业者，以及地区、省、国家卫生部门的政策制定者，研究团队构建了系统"模型"（图表），并确定了减少结核分枝杆菌（Mycobacterium tuberculosis，Mtb）传播的干预目标。合作者根据干预措施的有效性可能性及实施难易程度，对其进行了优先级排序。

研究问题6和7涉及综合所有数据，开发一套适应南非卫生系统约束与机遇的卫生系统干预措施包，以减少诊所内耐药结核病（Drug-Resistant Tuberculosis，DR-TB）的传播。

研究团队采用数学及经济建模，预测中断诊所传播对社区结核病发病率的潜在影响，以及对卫生系统和家庭带来的经济收益。

耐药结核病（Drug-Resistant Tuberculosis，DR-TB）是全球公共卫生的重大威胁，占全球估计因抗菌药物耐药性（Antimicrobial Resistance，AMR）导致死亡病例的四分之一。在南非，诊所内的DR-TB传播（尤其针对HIV阳性人群）已有充分记录。大多数结核病传播发生在患者开始治疗前，但DR-TB传播可能持续到治疗开始后，这一现象因南非DR-TB服务从医院下放到初级保健诊所而引发关注。诊所内暴露与其他社区场所相比对DR-TB持续传播的影响程度尚需进一步明确，以调动必要资源解决该问题。关于诊所内减少DR-TB传播的IPC措施指南已广泛存在，但推荐措施未得到实施的原因仍知之甚少。需要采用综合方法理解实施障碍，以设计有效的DR-TB IPC干预措施。

DR-TB的IPC措施失败常被归咎于医护人员（HCW）未遵守指南。考虑到HCW是具有特定组织特征的卫生系统的一部分，本研究探讨了卫生系统整体如何支持IPC措施。研究调查了南非两个省份（夸祖鲁-纳塔尔省及西开普省）诊所内DR-TB传播的生物、环境、基础设施及社会动态。研究目标是为改善DR-TB IPC提供有效方法的证据，不仅涉及行为因素，还包括诊所空间、基础设施、工作及患者流动的管理方式，以及如何培养基于权利的职业健康理念。

本研究的创新方法汇聚了多学科团队。采用"整体系统"方法，结合流行病学、人类学及卫生系统研究方法，理解DR-TB IPC的背景、实践现状及有效实施潜力。研究分析了南非结核病IPC政策的演变与实施情况；通过估算诊所内DR-TB传播与其他社区场所的差异，定义流行病学背景；评估诊所内传染性DR-TB患者与其他就诊者的接触风险，并单独分析社区成员在诊所与其他社交场所的社交接触频率。

研究采用结构化及深度定性方法记录卫生诊所的IPC实践：包括诊所设计、护理组织、工作实践的作用，以及医护人员、管理者和患者对IPC中风险与责任的认知。联合关键利益相关者，研究团队采用卫生系统映射及模型构建方法，可视化记录实施最佳DR-TB IPC的环境与组织障碍及促成因素。

综合所有数据将有助于开发一套适应南非卫生系统约束与机遇的卫生系统干预措施包，以减少诊所内DR-TB的传播。

研究团队采用数学及经济建模，预测中断诊所传播对社区结核病发病率的潜在影响，以及对卫生系统和家庭带来的经济收益。

除了重要的学术、政策及项目相关产出外，本项目还将创建跨学科平台，用于未来卫生系统策略的实施与评估，以改善IPC。项目将促进DR-TB与其他耐药性感染研究人员之间的讨论，并提高公众对卫生机构中最小化空气传播感染风险系统重要性的认识。