RANDOMIZED CONTROLLED TRIAL OF SELF-SUPERVISED AND DIRECTLY OBSERVED TREATMENT OF TUBERCULOSIS

Background Tuberculosis is a major public-health problem in South Afri ca, made worse by poor adherence to and frequent interruption of treat ment. Direct observation (DO) of tuberculosis patients taking their dr ugs is supposed to improve treatment completion and outcome. We compar ed DO with self-supervision, in which patients on the same drug regime n are not observed taking their pills, to assess the effect of Each on the success of tuberculosis treatment. Methods We undertook an unblin ded randomised controlled trial in two communities with large tubercul osis caseloads. The trial included 216 adults who started pulmonary tu berculosis treatment for the first time, or who had a second course of treatment (retreatment patients). No changes to existing treatment de livery were made other than randomisation. Analysis was by intention t o treat. Individual patient data from the two communities were combine d. Findings Treatment for tuberculosis was more successful among self- supervised patients (60% of patients) than among those on DO (54% of p atients, difference between groups 6% [90% CI -5.1 to 17.0]). Retreatm ent patients had significantly more successful treatment outcomes if s elf supervised (74% of patients) than an DO (42% of patients, differen ce between groups 32% [11%-52%]). Interpretation At high rates of trea tment interruption, self-supervision achieved equivalent outcomes to c linic DO at lower cost. Self-supervision achieved better outcomes far retreatment patients. Supportive patient-carer relations, rather than the authoritarian surveillance implicit in DO, may improve treatment o utcomes and help to control tuberculosis.