Social protection to reduce financial burden of tuberculosis in Timor-Leste (TB-PROTECT): a cluster randomized trial
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Background To evaluate whether a tuberculosis (TB)-specific cash transfer reduces the proportion of households facing catastrophic costs and to assess its effects on treatment success and financial burden in Timor-Leste. Methods We conducted a cluster-randomized controlled trial (December 2022–September 2023) across 32 community health centers. Patients aged ≥17 years initiating standard treatment were enrolled. Intervention clusters provided monthly cash transfers (US$ 30) for six months; control clusters provided standard care. The primary outcome was the proportion of households incurring catastrophic costs (≥20% of annual income). Data were collected using modified WHO Patient Cost Surveys. Analyses followed intention-to-treat principles using multivariate regression accounting for clustering. Results Among 329 patients enrolled (161 intervention, 168 control), the proportion facing catastrophic costs was significantly lower in the intervention group (58·4%) than in the control group (85·1%; p<0·001; adjusted odds ratio 4.48, 95% CI 1.88-10.68). Indirect costs were reduced by US$237·92 (95% CI 117·68–358·17). No significant differences were observed in non-medical costs or treatment success. No intervention-related adverse events were reported. Conclusions Unconditional cash transfers significantly reduced catastrophic costs and indirect financial burden among tuberculosis patients but had no effect on treatment success. To achieve the goal of zero catastrophic costs, multidimensional social protection strategies addressing non-medical costs—including food and transport support—are essential alongside financial assistance. Trial registration Clinical Research Information Service of Republic Korea: KCT0009506 (Registered June 5th, 2024).