Cost of attending direct observed treatment (DOTs) (CostDots) | Through patient CRFs (transport and food costs data) | For each cost type category, data will be aggregated for each site and arm, to estimate the mean direct cost per visit |
Costs of attending injection DOTs (CostDots) | Through patient CRFs (transport and food costs data) |
Patient cost for attending scheduled patient assessment visits (CostSVisits) | Through patient CRFs (transport and food costs data) |
Patient costs for attending unscheduled patient assessment visits (CostUVisits) | Through patient CRFs (transport and food costs data) |
Food supplements (CostSupp) | Through patient CRFs | Mean spend for each time point to be calculated and presented as the cumulative difference in food purchases between arms |
Income loss during and after treatment | Reported by patients if willing to reveal their income at each time point; if not, working hours reported to be used as a proxy | If patients are unwilling to reveal their income, average salary values from the specific areas in each country will be used. The total lost hours will be multiplied with the hourly average wage. Total income loss during treatment and follow-up will be calculated |