A stool based qPCR for the diagnosis of TB in children and people living with HIV in Uganda, Eswatini and Mozambique (Stool4TB): a protocol for a multicenter diagnostic evaluation

Table 1 Schedule of events

	Baseline	Week 2	Month 2	Months 4	Month 6
PRESUMPTIVE TB
Past medical history	X
TB exposure assessment^a	X		X
Full clinical assessment	X	X (tel adults)^b	X
CD4, HIV viral load (if HIV positive)^c	X
Chest X-Ray	X
Diagnostic Samples	X		if symptoms
SPUTUM (ultra, culture, Biorepository)
STOOL (ultra, qPCR, Bio)
URINE (LAM, bio)
Blood^d	IC (60)
TB CASE^e
Clinical assessment	X	X	X	X	X
Chest X-Ray					X
ATT response (sputum, stool)		cTB	cTB	cTB	cTB
Blood^d	cTB (200)	cTB (200)		cTB (200)	cTB (200)

IC Ill controls, cTB confirmed TB
^a TB exposure assessment will be performed via questionnaire in every participant and TST/IGRA will be performed at baseline if available on site
^bOn week 2, the clinical assessment will be performed by telephone in adults without symptoms
^cIf HIV infected and have not had VL and CD4 count in the last 3 months. Up to six months VL and CD4 counts will be accepted
^dBlood (PAXgene, QF, serum): QuantiFERON will be collected in baseline and four months for those starting treatment and at baseline in 60 ill controls (10 pressumptive TB participants that do not meet the criteria for TB disease per category and site). PAXgene and serum will be collected at baseline, week 2, month 4 and month 6 for those starting treatment, and at baseline in 60 healthy controls
^eIf a decision is made to start ATT after the baseline visit, the schedule of follow-up visits should be adapted so that the TB treatment start date will be the new “baseline” date

ISSN: 1471-2334