Procedures
tuberculosis
EVENT, TUBERCULOSIS
In all clusters, the tuberculosis doctors and relevant staff from the county-level CDC received a 3-day training on enrolment of patients, data collection, and the medication event reminder monitor. In both groups, patients were given a daily tuberculosis treatment regimen of 2 months of isoniazid, rifampicin, pyrazinamide, and ethambutol, followed by 4 months of isoniazid and rifampicin, and a medication event reminder monitor to store medication. The medication event reminder monitor recorded the dates and times that it was opened for more than 2 s for patients to take their medication, and recorded a daily output to indicate that it was working. Further training was conducted after the start of the study on quality control of data and follow-up of participants after the end of treatment.In clusters in the intervention group, the tuberculosis doctors at the county level received a 1·5-day training on delivering the intervention and doctors at the township and village level received a half-day training on the intervention. The medication event reminder monitor was set up to give an audio and visual reminder to take medication (daily, three times within 5 min) and attend monthly clinic visits. The default time for the daily dosing reminder was 0800 h but could be changed to an alternative time in the morning according to patient preferences. At clinic visits, the doctor could display monitor openings in the previous month on their computer, to discuss adherence with the patient. Intensive management was initiated at the first instance of non-adherence of 20–50% of treatment days when monitor was not opened as a proxy for doses missed in the previous month; township doctors would be asked to visit patients every 2 weeks and village doctors every week. At the second instance of non-adherence of 20–50% or the first instance of non-adherence of greater than 50% in the previous month, patients were switched to directly observed therapy, with medical staff observing therapy administration. Every month, staff from China CDC or the county-level CDC visited each intervention cluster to check the intervention was being implemented as planned.Patients in control clusters had the reminder functions on the medication event reminder monitor disabled. Managing doctors could not review monitor openings at clinic visits, but data were collected for the trial. In consultation with the doctor, patients chose whether to take medication under direct observation by a health-care worker, family member, or through self-administration.Patients attended monthly routine clinic visits for the 6 months of treatment. Patients had routine sputum collection for smear microscopy at 2 months, 5 months, and end of treatment. At end of treatment, an additional sputum sample was collected for solid culture (using routine laboratories) and a chest radiograph was done to help define treatment failure. Patients were telephoned at 9 and 15 months after the start of treatment and self-reported retreatment for tuberculosis. At 12 and 18 months after the start of treatment, patients attended the clinic to provide sputum for culture, have a chest radiograph, and self-report tuberculosis retreatment.Missed doses were measured by days with no opening recorded on the medication event reminder monitor, excluding days when patients reported not using the monitor because of travel or hospitalisation or when there was no medication event reminder monitor daily output to show it was working.