Background and rationale
TB, death
MULTI-DRUG-RESISTANT TUBERCULOSIS, EVENTS
Multi-drug-resistant tuberculosis (MDR-TB), which is resistance to both isoniazid and rifampicin, poses a challenge to TB control programmes globally because of the risk of worse treatment outcomes including death compared to drug-sensitive TB [In an effort to counter the effects of non-adherence, including poor treatment outcomes and transmission of resistance strains, directly observed therapy (DOT) was adopted as a strategy, where patients are observed as they take their daily dose by either a community health care worker, family member or health care worker. The observation may occur at a health facility when the patient reports for their daily dose or may entail the health provider visiting the patient at their home premise. Uganda implements a health facility-based DOT approach where all patients diagnosed with MDR-TB report to the nearest private or public health facility for DOT. Although treatment success rates on patients treated using the DOT strategy in Uganda have gradually improved from 70.6% in 2018 to 77.9% in 2020, these rates are still below the 90% target set by the WHO. Factors that contribute to low treatment success rates with DOT include lack of financial resources to make daily clinic visits, poor road infrastructure, long distances to nearest health facility, insufficient and overworked health care workers, and overburdened facilities [The Medication Events Monitoring System (MEMS) (AARDEX®) is a portable smart medication device designed to monitor treatment adherence by transmitting electronic information on the number of times the medicine cap is opened, specifying dates and times. This information is taken to correlate with actual times that patients ingest their medication and can be used to validate the accuracy of self-reported adherence. The device is operated by a long-lasting battery and is able to transmit software information in real time and store information for many months following battery outage. The information on patient non-adherence as captured by MEMS technology has been shown to accurately correlate with treatment outcomes among people living with HIV [We plan to conduct an open-label randomized non-inferiority clinical trial among patients receiving MDR-TB treatment in Uganda to compare adherence rates among those using self-administered therapy with MEMS technology vs DOT, which is the current standard of care in Uganda for MDR-TB. We will correlate adherence information with serum drug concentrations and compare determined treatment outcomes between the two groups.