Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pilot Roll Out of the Xpert MTB/Rif for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil: a Stepped Wedge Trial
Brief Summary: Diagnosis of tuberculosis (TB) is a challenge because sputum smear, the most rapid and inexpensive test, often fails to detect the disease, in around 20 to 30% of cases. Culture of sputum yields a correct diagnosis in up to 90% of cases, but results are only available in 4 to 8 weeks, depending on the method. A new test (Xpert MTB/Rif) based on a rapid technique, named polymerase chain reaction (PCR), detects TB in less than 2 hours over 95% of cases, in addition to identification of cases resistant to certain drugs used to treat TB. The test is expensive, but several studies have demonstrated its accuracy, and since most steps are automatized, savings can be expected from human resources work. The aims of our study are (1) to evaluate this tool as a substitute test for sputum smears in routine conditions; (2) evaluate if it is cost-effective, meaning that effectiveness of the test may outweigh the extra cost, and (3) evaluate the acceptability of the test among patients and health care workers.


Options:
A: Arm Label: Urgent ART; Type: EXPERIMENTAL; Interventions: Other: Urgent ART | Arm Label: Early ART; Type: ACTIVE_COMPARATOR; Interventions: Other: Early ART | Intervention Type: OTHER; Name: Urgent ART; Assigned to Arm(s): Urgent ART | Intervention Type: OTHER; Name: Early ART; Assigned to Arm(s): Early ART
B: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Interventional; Type: EXPERIMENTAL; Interventions: Diagnostic Test: Xpert MTB/RIF Ultra (Ultra) | Intervention Type: DIAGNOSTIC_TEST; Name: Xpert MTB/RIF Ultra (Ultra); Assigned to Arm(s): Interventional
C: Arm Label: Xpert MTB/RIF®, Determine TB LAM, Chest X-ray; Type: EXPERIMENTAL; Interventions: Device: Xpert MTB/RIF®, Determine TB LAM, Chest X-ray, Drug: ART (Atripla, Truvada, Efavirenz, Combivir), Drug: Rifampin, isoniazid, pyrazinamide, ethambutol | Arm Label: Rifampin, isoniazid, pyrazinamide, ethambutol; Type: EXPERIMENTAL; Interventions: Drug: ART (Atripla, Truvada, Efavirenz, Combivir), Drug: Rifampin, isoniazid, pyrazinamide, ethambutol | Intervention Type: DEVICE; Name: Xpert MTB/RIF®, Determine TB LAM, Chest X-ray; Assigned to Arm(s): Xpert MTB/RIF®, Determine TB LAM, Chest X-ray | Intervention Type: DRUG; Name: ART (Atripla, Truvada, Efavirenz, Combivir); Assigned to Arm(s): Rifampin, isoniazid, pyrazinamide, ethambutol, Xpert MTB/RIF®, Determine TB LAM, Chest X-ray | Intervention Type: DRUG; Name: Rifampin, isoniazid, pyrazinamide, ethambutol; Assigned to Arm(s): Rifampin, isoniazid, pyrazinamide, ethambutol, Xpert MTB/RIF®, Determine TB LAM, Chest X-ray
D: Arm Label: Xpert MTB/Rif; Type: EXPERIMENTAL; Interventions: Other: Xpert MTB/Rif | Arm Label: Sputum smear; Type: ACTIVE_COMPARATOR; Interventions: Other: Smear microscopy | Intervention Type: OTHER; Name: Xpert MTB/Rif; Assigned to Arm(s): Xpert MTB/Rif | Intervention Type: OTHER; Name: Smear microscopy; Assigned to Arm(s): Sputum smear

Answer: D