A randomised controlled trial of lay health workers as direct observers for treatment of tuberculosis

SETTING: Study conducted in a suburb of Cape Town, South Africa. OBJECTIVE: Comparison of successful tuberculosis treatment outcome rates be tween self supervision, supervision by lay health worker (LHW), and supervi sion by clinic nurse. METHODS: Open, randomised, controlled trial with intention-re-treat analysi s. RESULTS: All groups (n = 156) achieved similar outcomes (LHW vs. clinic nur se: risk difference 17.2%, 95% confidence interval ICI] -0.1-34.5; LHW vs. self supervision 15%, 95% CI -3.7-33.6). New patients benefit from LHW supe rvision (LHW vs clinic nurse: risk difference 24.2%, 95% CI 6-42.5, LHW vs. self supervision 39.1%, 95% CI 17.8-60.3) as do female patients (LHW vs. c linic nurse 48.3%, 95% CI 22.8-73.8, LHW vs. self supervision 32.6%, 95% CI 6.4-58.7). CONCLUSIONS: LHW supervision approaches statistically significant superiori ty, but fails to reach it most likely due to the study's limitation, the sm all sample size. It is possible that subgroups (new and female patients) do well under LHW supervision. LHW supervision could be offered as one of sev eral supervision options within TB control programmes.