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

The program is a Phase 3 randomized controlled trial that began implementation in January 2024. The trial will compare the standard of care, defined by World Health Organization guidelines, which recommends 6 months of BPaLM, to an intervention strategy that includes BPaLM given at different durations based on a participant's baseline risk of poor TB outcome. Protocol development for the trial was a key achievement in the second year of the program. Protocol version 1.0 was finalized and locked on March 14, 2024, after receiving comments and feedback from the protocol team. The team also received email confirmation from Janssen that bedaquiline will be donated, and an agreement is pending. Additionally, SMART4TB clinical operations placed the initial order for study drugs for the first 3 months of the trial from GDF. Site preparation and activation were also significant accomplishments in the second year. The PRISM-TB team initiated the budgeting and contracting process with study sites in February 2024, and the budgeting and contracting process for Mongolia is currently ongoing for Phase 1. The team has received site PI signature for v1.0 protocol, and invited PIs and study team continue to attend biweekly study team meetings. The program has not encountered any major challenges in Mongolia as of the reporting period. However, the team is preparing to support sites to initiate participant enrollment, which is planned to start in Year 3. Study data quality and assurance activities are also underway, with UCSF hiring a project coordinator in the second quarter of the year and randomize.net being chosen to randomize trial participants. In the upcoming quarter, the program plans to initiate monthly site meetings and finalize Phase 1 contract and begin budgeting for Phases 2 and 3. The program also collaborates with key partners, including UCSF, the National Tuberculosis Program, and the National Center for Communicable Diseases, Ulaanbaatar, Mongolia.