UMOYA: a prospective longitudinal cohort study to evaluate novel diagnostic tools and to assess long-term impact on lung health in South African children with presumptive pulmonary TB—a study protocol

Table 2 Schedule of Events (SOE)—Diagnostics study phase

	Baseline	Week 2	Week 8	Week 16	Week 24	Unscheduled visit
History and clinical review	X	X	X	X	X	X
Mantoux	X^a		X^b			(X)
Chest radiography	X^a				X^a	(X)
Chest US^c	X^d		X^d
TB smear, liquid culture (MGIT) and Xpert MTB/RIF Ultra^e	X^e	X^e	X^e	X^e	X^e	(X)
Serum for TB biomarkers^f,g	X	X^d	X^d	X^d	X	(X)
Whole blood (PAXgene RNA tube) for TB biomarkers^f,g	X					(X)
Urine for TB biomarkers^f	X	X^d	X^d		X^d	(X)
Stool sample^f	X					(X)
Saliva sample^f	X				X^d	(X)
NPA sample for viral detection and storage^f	X	X	X		X	(X)

RNA: Ribonucleic acid; MGIT: Mycobacteria Growth Indicator Tube; NPA: Nasopharyngeal aspirate; (X) If applicable
^aHealthy control once and thereafter if clinically indicated
^bIf baseline Mantoux negative
^cChest ultrasound (US) in a specific subgroup
^dTuberculosis (TB) cases and symptomatic controls;
^eTwo respiratory samples—only in TB cases and symptomatic controls; smear and culture (not Xpert MTB/RIF Ultra) only if positive culture at week 2 until the culture is negative
^fStorage in biorepository
^gMaximum blood volumes per age are respected as per internationally accepted and National Institutes of Health (NIH) research guidelines

ISSN: 1471-2466