Table 1 Primary and secondary outcomes for the CHIP-TB trial

Primary outcome

Outcome description

TPT initiation among child contacts

The cluster-level ratio of the number of household child contacts less than 15 years of age in Ethiopia and less than 5 years of age in South Africa initiated on TPT per index patient, comparing the intervention to the control arm

Secondary outcome

Outcome description

Child contact identification

The cluster-level ratio of the number of household child contacts less than 15 years of age in Ethiopia and less than 5 years of age in South Africa identified per index patient

Continuum of care

The cluster-level proportions of estimated child contacts who progress through each stage of the pediatric TB prevention continuum of care (identification, screening, initiation, and completion) overall and by age, by TPT regimen, and by country.

*estimated child contacts will be calculated using DHS data

Treatment completion (as defined by WHO TPT Handbook)

• Proportion of children initiated on TPT who successfully completed TPT

• Proportion of children initiated on TPT who were lost to follow-up

• Proportion of children initiated on TPT with incident TB (treatment failure)

• Proportion of children initiated on TPT who died

• Proportion of children initiated on TPT who discontinued TPT due to: toxicity, drug-drug interaction, severe illness (e.g., malaria), pregnancy, or family preference

*Treatment completion was defined as 11 doses in 16 weeks for 3HP and 68 doses in 4 months for 3RH [19].

Implementation outcome

Quantitative assessment

Qualitative assessment

Acceptability of home-based contact management to all stakeholders (CG, HEW, TBF, PM)

• Proportion of identified households who agree to a home visit

• Proportion declining

HIV testing (South Africa only)

• Proportion of children HIV tested by the community health team

• Proportion of newly diagnosed HIV-positive children who are referred to the clinic for ART initiation

• Individual in-depth interviews (CG, HEW, TBF, PM)

Fidelity to the home-based contact management strategy

• Proportion of children initiated on the correct TPT regimen

• Proportion of children initiated on the correct TPT dose

• Individual in-depth interviews (CG, HEW, TBF, PM)

Feasibility of home visits for CGs and community-based health teams

• Average number household visit attempts per household

• Mean and median duration of each household visit

• Proportion of index patients who refuse to provide an address or who provide an invalid/incorrect address

• Individual in-depth interviews (CG, HEW, TBF, PM)

Cost and cost effectiveness

• Mean difference in total patient and health system costs between the intervention and control arms

• Incremental cost-effectiveness ratio (ICER) where effectiveness is modeled as the number of disability adjusted life years (DLYs) averted by the intervention in comparison with the standard of care.

• Structured interviews to assess implementation costs

• Time and Motion observations of TB preventive care