Table 2.
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