TB-CAPT CORE Truenat Trial
- Conditions
- TuberculosisDiagnoses Disease
- Interventions
- Diagnostic Test: Truenat TB platform/TB assays
- Registration Number
- NCT04568954
- Lead Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3987
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TB testing using the Truenat platform/TB assays Truenat TB platform/TB assays 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
- Primary Outcome Measures
Name Time Method Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants 7 days Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants
- Secondary Outcome Measures
Name Time Method Proportion of patients treated for TB up to 60 days from enrolment 60 days Proportion of patients treated for TB up to 60 days from enrolment
Time to bacteriological confirmation of TB 60 days Time to bacteriological confirmation of TB (up to 180 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 60 days Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment
Cost and productivity related endpoints 60 days 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
Trial Locations
- Locations (4)
Instituto Nacional de Saúde (INS)
🇲🇿Maputo, Mozambique
National Institute of Medical Research (NIMR)
🇹🇿Mbeya, Tanzania
Centro de Investigação em Saúde de Manhiça-Fundação
🇲🇿Manhiça, Vila Da Manhiça, Mozambique
Ifakara Health Institute
🇹🇿Dar es Salaam, Tanzania