General secondary endpoints | Detailed secondary endpoints |
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Cascade of care for the initiation and completion of TPT of child contacts < 5 years or HIV-infected 5–14 years and reasons of dropouts at different steps of the cascade | Number of screened children and proportion of children screened among child contacts < 5 years or HIV-infected 5–14 years declared by the index case |
Proportion of children potentially eligible for TPT: TB disease excluded | |
Proportion of children eligible for TPT after exclusion of contraindication to TPT | |
Proportion of children started on TPT among those eligible for TPT | |
Proportion of children who did not complete TPT among those started on TPT and reasons of interruptions | |
Cascade of care for TB detection of child contacts | Proportion of children with symptoms suggestive of TB: presumptive TB |
Proportion of presumptive TB cases investigated for TB | |
Proportion of children diagnosed with TB | |
Proportion of children with TB diagnosis who are started on TB treatment | |
Cascade of care for TB detection of adult contacts | Number of adults screened and proportion of adults screened among household identified adult contacts |
Proportion of adults with symptoms suggestive of TB: presumptive TB cases | |
Proportion of adults presumptive TB cases diagnosed with TB | |
Safety and treatment adherence for children under TPT | Proportion of children with serious adverse events |
Proportion of children with adverse events of interest: peripheral neuropathy, clinical hepatotoxicity | |
Ratio of dose taken as indicated (ticked) on the treatment card by the parent/guardian over the total number of doses to be taken by prescription | |
Endpoints at 6 months | Treatment outcomes of children started on TB treatment |
Proportion of children diagnosed with TB after initiation of TPT: during and after TPT | |
Proportion of children diagnosed with TB among those who were not started on TPT and were not diagnosed with TB at baseline assessment | |
Before-after comparison for TB adult and pediatric cases and for TPT initiation and completion from health facility registers | Number of patients diagnosed with TB and registered |
Proportion of children among all patients diagnosed with TB and registered | |
TB treatment outcomes of patients (adults and children) diagnosed with TB and registered | |
Number of children started on TPT | |
Completion rate of children started on TPT | |
Acceptability and feasibility of the intervention | Attitudes, willingness, and motivation to have a visit in their household |
Myths, anticipated fears, stigma, and risks of having a visit in their household | |
Actual experiences with household visits | |
Perception of the disease, its risk, and the notion of prevention, including TPT | |
Description of critical events during house visits and how these were dealt with | |
Identification of main constraints | |
Fidelity of the study | Proportion of delivered activities compared to the intended activities of the model |
Cost-effectiveness of the intervention | Costs of CHW/community nurse assessment and treatment |
Costs of facility-based assessment and treatment | |
Other facility costs (overheads, diagnosis, hospitalizations) | |
Direct parent/guardian costs (related to care) | |
Indirect parent/guardian costs (unrelated to care, e.g., dissaving, travel costs) |