TB-CAPT CORE Truenat Trial

Foundation for Innovative New Diagnostics (FIND)

Status: Active, not recruiting

Conditions: Tuberculosis; Diagnoses Disease

Treatments: Diagnostic Test: Truenat TB platform/TB assays

Study type: Interventional

Funder types: Other

Identifiers

NCT04568954

TB041-3/1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 to hospital

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,200 participants in 2 patient groups

TB testing using the Truenat platform/TB assays

Experimental group

Description:

TB testing using the Truenat platform/TB assays placed at primary health care clinics combined with rapid communication of results and same day TB treatment initiation

Treatment:

Diagnostic Test: Truenat TB platform/TB assays

Standard of care Arm

No Intervention group

Description:

Standard of care for TB testing using a combination of smear microscopy and laboratory (off-site) Xpert testing, may vary by clinic depending on availability of transport and stock of Xpert MTB/RIF or Xpert MTB/RIF Ultra cartridges (Xpert).