Skip to main content

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)