Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial

Table 2 SPIRIT study schedule

	Baseline phase		Intervention phase								Evaluation phase
	Allocation*	Site assessment**	Enrolment of index cases	Enrolment of contact cases	Follow-up					End of study
Timepoint			-2 W	0	W1	W2	W4	W8	W12***	*W24*
Enrolment
Eligibility screen			X	X
Informed consent			X	X
Allocation	X
Interventions
Facility-based arm			X	X			X	X	X	X
Community-based arm			X	X	X	X	X	X	X	X
Qualitative assessment		X									X
CEA					X
Assessments
Identification of contact children			X
Children started on TPT				X
Children completed TPT									X	X
Acceptability of the intervention		X									X
TPT cost					X

Abbreviations: W week, CEA cost-effectiveness analysis, TPT TB preventive therapy
*Allocation takes place before the intervention begins as the clusters are randomized and not the individuals
**The baseline phase takes place 3 months before the intervention phase
***Children started on 6 months of isoniazid have 2 additional follow-up visits at week 16 and week 20

ISSN: 1745-6215