Tuberculosis Infections and Infestations Respiratory tuberculosis, bacteriologically and histologically confirmed
Conditions
Interventions
The intervention is the implementation of the GeneXpert MTB/RIF Diagnostic Instrument at randomised laboratories. The intervention laboratories will receive Xpert MTB/RIF, with one Xpert MTB/RIF test
Sponsors
Bill and Melinda Gates Foundation (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The laboratories are placed in four Provinces geographically separate in serving a mix of clinics that have been allocated a GX16 Machine 2. Tuberculosis (TB) suspected participants contribute towards samples evaluated in the laboratories 3. Male and female participants 4. Aged 18 and above
Exclusion criteria
Exclusion criteria: 1. The laboratories part of other TB Xpert MTB/RIF evaluations 2. Laboratories which already have an Xpert MTB/RIF instrument 3. Laboratories which do not comply with standard of care TB diagnostics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness of Xpert MTB/RIF in reducing early mortality in TB suspects | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The primary default rate among newly diagnosed TB cases 2. The time from enrolment to start of treatment for drug susceptible TB and appropriate treatment for drug-resistant TB 3. The incremental cost per life saved and disability-adjusted life year (DALY) averted, including reductions in transmission of drug susceptible and drug resistant TB, from a provider and client perspective | — |
Countries
South Africa
Outcome results
None listed