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

The program is a cooperative agreement between the United States Agency for International Development (USAID) and Johns Hopkins University, with a contract number of 7200AA22CA00005. The program's geographic focus is on Pakistan, and its quarterly reporting period spans from October 2023 to December 2023. The PRISM-TB activity is a Phase 3 randomized controlled trial designed 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 is defined by World Health Organization (WHO) guidelines, which recommend 6 months of BPaLM. The intervention strategy involves BPaLM given at different durations based on a participant's baseline risk of poor TB outcome. Key achievements and deliverables submitted for the PRISM-TB activity include protocol development, agreement with product developers, site preparation and activation, and participant enrollment. The protocol development involved comments from a mature draft of the protocol and study design, risk stratification algorithm finalization, and nomination of representatives from regional CABs to the PRISM-TB protocol team. Agreement with product developers included email confirmation from Janssen on bedaquiline donation and meetings with Otsuka regarding Dlm donation and expanding the scope of the FQ-R cohort. Site preparation and activation involved preparing sites to initiate participant enrollment, attending biweekly study team meetings, and budget-specific meetings initiated in December 2023. Participant enrollment is planned to start in Year 3. Study data quality and assurance activities included database technology selection, data management systems and Case Report Forms (CRFs) development, and REDCap chosen for its existing license at UCSF. Challenges and lessons learned for the PRISM-TB activity include no major challenges encountered in Pakistan as of the reporting period. Upcoming events include meetings with sites to coordinate trial implementation, visits, and site preparation. In-country coordination and collaboration involved inviting PIs from public sector sites in Sindh Province to participate in protocol team meetings and a call with Pakistan PI on 20Dec23. The ESI program has 4 phases, and candidates from Pakistan will be invited to apply for Phase 1 of this training program in Year 2. The program will send out emails to key contacts in Pakistan announcing the initiation and recruitment of the ESI program application for Phase 1 for Cohort 2. Successful completion of Phase 1 training will require a number of deliverables, including submission of a research proposal concept sheet. Key partners for the ESI program include UCSF, the National Tuberculosis Program, and Public sector sites in Sindh Province.