Tuberculosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • 18 years of age or older at time of TB screening • Undergoing smear or Xpert sputum investigation for pulmonary TB • Undergoing Xpert or smear investigation for suspected pulmonary TB • Participant able and willing to sign informed consent and are willing to undergo study procedures and visits at the study site
Exclusion criteria
Exclusion criteria: • Younger than 18 years of age • Current diagnosis of PTB at baseline • Receiving TB treatment at baseline • Proxy individual submitting sputum on behalf of patient • Participant anticipates transferring to another facility to receive TB treatment should a diagnosis of PTB be confirmed • Participant anticipates relocating to another Province during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes were successful patient outcome (SPO) or unsuccessful patient outcome (USPO). SPO was given to patients who were TB cured or TB completed as per National TB Control guidelines for South Africa. A TB case who experienced one or more of the following was defined as having experienced a failure (USPO) event: •Failure to initiate TB treatment with 14 days of the collection date of the participant’s first TB positive rifampicin-susceptible baseline sample •Death (any cause) within 14 days of collection of Xpert positive TB sample and prior to commencing TB treatment •Death (any cause) whilst receiving TB treatment •Development of RR-TB whilst on treatment •TB treatment failure, defined as smear or culture positive at 5 months or later after commencing TB treatment •Loss to follow up during TB treatment, defined as more than 56 days late for a scheduled appointment | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome was the time to event (time to initiation of treatment and time to loss to follow up). | — |
Countries
South Africa
Contacts
Wits University