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Table 1 Secondary endpoints of the CONTACT study

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

General secondary endpoints

Detailed secondary endpoints

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)