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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
3,987
Truenat TB platform/TB assays, a molecular diagnostic test developed by Molbio diagnostics, for the diagnosis of Mycobacterium tuberculosis complex (MTBC) and Truenat MTB-RIF Dx for detection of RIF resistance was endorsed in 2020 by the WHO for TB diagnosis. The system has been designed to be operated as a point-of-care- diagnostic solution in peripheral laboratories with minimal infrastructure. It takes about 25 minutes to do the DNA extraction and another 35 minutes to diagnose TB. It is portable and battery operated, have no need for a computer or laptop, and operate from 2-40 C ambient temperature. The system uses room temperature stable reagents with long shelf life.
Centro de Investigação em Saúde de Manhiça-Fundação
Manhiça, Vila Da Manhiça, Mozambique
Instituto Nacional de Saúde (INS)
Maputo, Mozambique
Ifakara Health Institute
Dar es Salaam, Tanzania
National Institute of Medical Research (NIMR)
Mbeya, Tanzania
Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants
Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants
Time frame: 7 days
Time to bacteriological confirmation of TB
Time to bacteriological confirmation of TB (up to 180 days) from enrolment
Time frame: 60 days
Proportion of patients treated for TB up to 60 days from enrolment
Proportion of patients treated for TB up to 60 days from enrolment
Time frame: 60 days
Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment
Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment
Time frame: 60 days
Cost and productivity related endpoints
Patients' costs related to care at 60 days from enrolment. * Number of lost working days over the past month at 60 days from enrolment * Monthly earning in the past month at 60 days from enrolment
Time frame: 60 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.