Objectives and endpoints
TB, illness, toxicity, malaria, household•, disability
MALARIA, SECONDARY
The primary objective of this study is to determine the effectiveness of home-based contact management, including TPT initiation and follow-up, using community-based healthcare workers to increase TPT initiation as compared to facility-based contact management. The primary endpoint is 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 (3HP, 3RH, or 6H) per index patient, comparing the intervention to the control arm (Table Primary and secondary outcomes for the CHIP-TB trialThe 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• 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 [• Proportion of identified households who agree to a home visit• Proportion decliningHIV 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• Proportion of children initiated on the correct TPT regimen• Proportion of children initiated on the correct TPT dose• 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• 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 careStakeholders: The secondary objectives of the study are to evaluate: (1) the TPT continuum of care by country, TPT regimen (3RH and 3HP), and age (< 5 and 5–14 years); (2) acceptability, feasibility, and fidelity of home-based contact management and HIV preventive services in each setting; (3) TPT treatment outcomes, including tolerability and reported adherence; and (4) the cost-effectiveness of home-based versus facility-based child contact management (Table Data will be collected on staffing changes within the TB clinic and community health teams and stockouts of TPT medications, pyridoxine, and other supplies needed for pediatric contact management (specimen collection, file and registers, etc.), to understand trends in the data.