Background Directly observed treatment (DOT) has been the standard of care for tuberculosis since the early 1990s, but delivery entails substantial inconvenience to patients and service providers. Remote video observed therapy (VOT) has recently been conditionally recommended by the WHO as an alternative to DOT. We tested whether levels of treatment observation were improved with VOT. Methods We conducted a randomised controlled trial of VOT (daily remote observation using a smartphone app) compared to DOT (three or five-weekly observation in home, community or clinic settings). Tuberculosis patients eligible for DOT at 22 clinics in England were allocated to trial arms by the SealedEnvelopeTM service using randomisation by minimisation. The primary outcome was completion of 80% or more scheduled treatment observations over the first two months following enrolment. Intention-to-treat and restricted (including only patients with at least one week of observation on allocated arm) analyses were conducted. The trial is registered with the ISRCTN, number ISRCTN26184967. Findings Between September 1, 2014 and October 1, 2016, we enrolled 226 patients; 112 randomised to VOT and 114 to DOT. Overall, 58% (131 of 226) had a history of homelessness, imprisonment, drug use, alcohol problems or mental health problems. Seventy percent of patients on VOT (78 of 112) had the primary outcome compared to 31% (35 of 114) of those on DOT (adjusted odds ratio 5·48; 95% confidence interval 3·10-9·68; p<0·0001). Drop-out during the first week of observation was less for VOT (10%, 11 of 112) than DOT (51%, 58 of 114). High observation levels were sustained throughout treatment for VOT patients, but declined rapidly for DOT patients. 4 Interpretation VOT is a more effective approach to observation of tuberculosis treatment than clinic- , community- or home-based DOT
