Clinical trial NCT04568954: TB-CAPT CORE Truenat Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Diagnoses Disease
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
name: National Institute for Medical Research, Tanzania
name: Centro de Investigação em Saúde de Manhiça
name: Instituto Nacional de Saúde, Mozambique
name: Ifakara Health Institute
First posted: 2020-09-29
Enrollment: 3987
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants
timeFrame: 7 days
Secondary outcomes:
measure: Time to bacteriological confirmation of TB
timeFrame: 60 days
measure: Proportion of patients treated for TB up to 60 days from enrolment
timeFrame: 60 days
measure: Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment
timeFrame: 60 days
measure: Cost and productivity related endpoints
timeFrame: 60 days
Other outcomes:
Locations:
city: Manhiça
country: Mozambique
facility: Centro de Investigação em Saúde de Manhiça-Fundação
state: Vila Da Manhiça
city: Maputo
country: Mozambique
facility: Instituto Nacional de Saúde (INS)
city: Dar es Salaam
country: Tanzania
facility: Ifakara Health Institute
city: Mbeya
country: Tanzania
facility: National Institute of Medical Research (NIMR)
Study officials:
affiliation: Medical Center of the University of Munich
name: Katharina Kranzer
role: PRINCIPAL_INVESTIGATOR
References: