Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04568954
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2020-09-23
Brief Title:
TB-CAPT CORE Truenat Trial
Sponsor:
Foundation for Innovative New Diagnostics Switzerland
Organization:
Foundation for Innovative New Diagnostics Switzerland
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A cluster randomized controlled trial to evaluate the effect of placing Truenat platformTB 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 platformTB 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 12018-62020 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 platformTB 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 andor Xpert MTBRIF Ultra off-site vs Truenat platformTB 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
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 12018-62020 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 platformTB 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 andor Xpert MTBRIF Ultra off-site vs Truenat platformTB 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None