TB-CAPT CORE Trial
TB-CAPT CORE Trial
A cluster randomized controlled trial to evaluate the effect of placing GeneXpert Omni
 platforms at primary health care clinics combined with rapid communication of results on time
 to treatment initiation of microbiologically confirmed TB.
A cluster randomized controlled trial to evaluate the effect of placing GeneXpert Omni
 platforms 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 GeneXpert
 OMNI/Ultra® (and MTB/XDR cartridges).

 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 Omni/Ultra 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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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 tohospital