Molbio Truenat TB Platform Combined With the Truenat TB Assays for Detection of Tuberculosis and Rifampicin Resistance in Adults With Presumptive Pulmonary Tuberculosis at Primary-level Diagnostic Centres in Tanzania and Mozambique: a Pragmatic, Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,987
- 试验地点
- 8
- 主要终点
- Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants
研究概览
简要总结
A cluster randomized controlled trial to evaluate the effect of placing Truenat platform/TB assays at primary health care clinics combined with rapid communication of results on time to treatment initiation of microbiologically confirmed TB.
详细描述
A cluster randomized controlled trial to evaluate the effect of placing Truenat platform/TB assays at primary health care clinics combined with rapid communication of results on time to treatment initiation of microbiologically confirmed TB.
In a setup period (survey of study centers) before randomization, the healthcare facilities (=clinics) of 4 sites will be asked to provide information about the number of TB notifications per quarter covering the period 1/2018-6/2020. From this information the foreseeable number of examined patients ("size of a clinic") will be derived, which will be used as a strata variable in randomization process.
Facilities will be randomly allocated to the standard of care (control), or Truenat platform/TB assays (intervention).
A cluster refers to a clinic. The clusters will be assigned to intervention or control arm to one of two diagnostic procedures (SOC [smear microscopy and/or Xpert MTB/RIF Ultra off-site] vs Truenat platform/TB assays on-site) following a restricted randomization strategy, whereby 6 to 8 strata of clusters will be established using the stratification variables site (clinics belong to a site) and size and apply balance criteria for them. The number of strata per site depends on heterogeneity of the sizes of the clinics as established in setup period and may be increased, typically 1 or 2 strata per site will be established.
The primary endpoint will be compared in an individual level analysis with strata and intervention as fixed effects and cluster as random effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The objective of the trial is to assess Truenat platform/TB assays in clinical care. The use of Truenat platform/TB assays does not allow blinding of clinicians and participants in this trial. The trial-related procedures will be embedded into the routine practice at the primary-level facility. Data analysts will be blinded to intervention allocation.
Randomisation takes place on a cluster level rather than for the individual patients to avoid contamination between the arms within a health facility. Since clinics will be relatively far apart, contamination is unlikely.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with presumptive pulmonary TB, as defined by the national TB treatment guidelines in each country: patients with cough more than 1-2 weeks and/or fever, night sweats, blood-stained sputum (haemoptysis) significant weight loss, abnormalities on chest radiograph
- •Adults 18 years old and above who are able and willing to consent
排除标准
- •Circumstances that raise doubt on free, informed consent (e.g. in a mentally impaired person or a prisoner)
- •Already diagnosed with TB
- •Currently receiving anti-TB therapy
- •Patients with symptoms which are only attributable to extra-pulmonary TB
- •Patients who are seriously ill and need to be admitted to hospital
结局指标
主要结局
Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants
时间窗: 7 days
Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants
次要结局
- Proportion of patients treated for TB up to 60 days from enrolment(60 days)
- Time to bacteriological confirmation of TB(60 days)
- Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment(60 days)
- Cost and productivity related endpoints(60 days)