Division of Tuberculosis Elimination and Health Systems Strengthening, KNCV Tuberculosis Foundation, The Hague, Netherlands
Division of Tuberculosis Elimination and Health Systems Strengthening, KNCV Tuberculosis Foundation, The Hague, Netherlands.
BMJ Open. 2023 Mar 14;13(3):e068685. doi: 10.1136/bmjopen-2022-068685.
Successful treatment of tuberculosis depends to a large extent on good adherence to treatment regimens, which relies on directly observed treatment (DOT). This in turn requires frequent visits to health facilities. High costs to patients, stigma and burden to the health system challenged the DOT approach. Digital adherence technologies (DATs) have emerged as possibly more feasible alternatives to DOT but there is conflicting evidence on their effectiveness and feasibility. Our primary objective is to evaluate whether the implementation of DATs with daily monitoring and a differentiated response to patient adherence would reduce poor treatment outcomes compared with the standard of care (SOC). Our secondary objectives include: to evaluate the proportion of patients lost to follow-up; to compare effectiveness by DAT type; to evaluate the feasibility and acceptability of DATs; to describe factors affecting the longitudinal engagement of patients with the intervention and to use a simple model to estimate the epidemiological impact and cost-effectiveness of the intervention from a health system perspective.
This is a pragmatic two-arm cluster-randomised trial in the Philippines, South Africa, Tanzania and Ukraine, with health facilities as the unit of randomisation. Facilities will first be randomised to either the DAT or SOC arm, and then the DAT arm will be further randomised into medication sleeve/labels or smart pill box in a 1:1:2 ratio for the smart pill box, medication sleeve/label or the SOC respectively. We will use data from the digital adherence platform and routine health facility records for analysis. In the main analysis, we will employ an intention-to-treat approach to evaluate treatment outcomes.
The study has been approved by the WHO Research Ethics Review Committee (0003296), and by country-specific committees. The results will be shared at national and international meetings and will be published in peer-reviewed journals.
ISRCTN17706019.
结核病的成功治疗在很大程度上取决于对治疗方案的良好依从性，这依赖于直接观察治疗（DOT）。这反过来又需要频繁到医疗机构就诊。患者的高费用、耻辱感和对卫生系统的负担给 DOT 方法带来了挑战。数字依从技术（DATs）作为可能更可行的 DOT 替代方法已经出现，但它们的有效性和可行性存在相互矛盾的证据。我们的主要目标是评估使用 DAT 进行日常监测并对患者的依从性做出差异化反应是否会降低不良治疗结局的发生率，与标准治疗（SOC）相比。我们的次要目标包括：评估失访患者的比例；比较不同 DAT 类型的效果；评估 DAT 的可行性和可接受性；描述影响患者对干预措施长期参与的因素，并使用简单模型从卫生系统角度估计干预措施的流行病学影响和成本效益。
这是一项在菲律宾、南非、坦桑尼亚和乌克兰进行的实用两臂聚类随机试验，以卫生机构为随机单位。机构将首先被随机分配到 DAT 或 SOC 组，然后 DAT 组将进一步以 1:1:2 的比例随机分配到智能药盒、药物套/标签或智能药盒、药物套/标签或 SOC 中。我们将使用数字依从性平台和常规卫生机构记录的数据进行分析。在主要分析中，我们将采用意向治疗方法评估治疗结果。
该研究已获得世界卫生组织研究伦理审查委员会（0003296）和各国特定委员会的批准。结果将在国家和国际会议上分享，并将在同行评议期刊上发表。
ISRCTN85413048.
