Mongolia Quarterly Report: Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB)

The trial aims to improve the treatment of rifampin-resistant TB by identifying the right regimen and duration based on a patient's baseline risk of treatment failure and relapse. The standard of care will be defined by WHO guidelines, which currently recommend 6 months of BPaLM. Protocol development for PRISM-TB involved receiving comments on a mature draft of the protocol and study design in the first quarter of Year 2. A risk stratification algorithm was finalized, and each SMART4TB regional CAB nominated representatives to the PRISM-TB protocol team. The protocol team met with the WHO team, who provided input to the near-final PRISM-TB design. The categorizations "easier-to-treat" and "harder-to-treat" were removed from the informed consent form (ICF) to reduce the risk of stigmatization. Agreement with product developers was also a key achievement. The PRISM-TB team received email confirmation from Janssen that bedaquiline will be donated, and an agreement is pending. Meetings were held with Otsuka regarding Dlm donation and potentially expanding the scope of the FQ-R cohort. Site preparation and activation are ongoing, with SMART4TB preparing to support sites to initiate participant enrollment. Invited PIs and study team continue to attend biweekly study team meetings, and budget-specific meetings were initiated in December 2023. Study data quality and assurance activities are also underway. Database technology has been selected, and data management systems and Case Report Forms (CRFs) are in development. REDCap has been chosen for its existing license at UCSF, and a data analyst and data manager have been hired for the project. Challenges and lessons learned indicate that PRISM-TB has not encountered any major challenges in Mongolia as of the reporting period. In-country coordination and collaboration are ongoing, with meetings with sites to coordinate trial implementation, visits, and site preparation. SMART4TB/Mongolia communication involves regular meetings with the PI and study team, including a call on 08Nov23 and a meeting at the Union conference in Paris on 17Nov23. Key partners include UCSF, the National Tuberculosis Program, and the National Center for Communicable Diseases, Ulaanbaatar, Mongolia.