All-oral shorter treatment regimens for multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB) Title: All-oral shorter treatment regimens for multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB): Evaluating their effectiveness, safety, feasibility, cost-effectiveness and impact on the quality of life of patients in Pakistan Location: Twelve PMDT sites i.e. ten in Punjab, and one each in Islamabad and Muzafarabad (AJK) districts. Duration: January 2020 to December 2023 Funded by: World Health Organization Study Objectives: To determine the effectiveness, safety, feasibility, cost-effectiveness and impact on the quality of life of all-oral shorter MDR/RR-TB regimen of 9/12-month duration under programmatic conditions. Study Design: A stepped-wedge design comparing patients receiving the New all-oral shorter MDR/RR-TB regimen (i.e. Bedaquiline + Linezolid) and patients receiving the standard all-oral MDR/RR-TB short treatment regimen (i.e. Bedaquiline) at 12 PMDT sites in Pakistan. About 300 intervention and 300 comparator patients will be recruited in the trial. Evaluation criteria: Effectiveness: Primary outcome: the proportion of MDR/RR-TB patients who have a favorable treatment outcome. This is defined as “cured” or “treatment completed” without recurrence during 12 months after the end of the treatment. Safety: Primary outcome: the proportion of MDR/RR-TB patients who have a serious adverse event up to 12 months after the end of the treatment. Secondary outcomes: proportion of MDR-TB patients treated with an all-oral shorter MDR/RR-TB treatment who: died while on treatment had treatment failure had a recurrent episode of MDR-TB during the 12-month follow-up period relapsed during the 12-month follow-up period were lost to follow-up during treatment are “cured without permanent disability” (up to one year after the end of the treatment) complete at least 90% of doses (treatment adherence) experience adverse events of special interest Health related Quality of Life Feasibility Cost-effectiveness from a health care perspective; affordability and socioeconomic impact for patients