Pulmonary Outcomes and Sequelae after Treatment-TB (POST-TB) (R01 Clinical Trial Optional)

The National Institutes of Health (NIH), through the National Institute of Allergy and Infectious Diseases (NIAID), has issued a Notice of Funding Opportunity (NOFO) titled “Pulmonary Outcomes and Sequelae after Treatment-TB (POST-TB) (R01 Clinical Trial Optional).” This initiative supports epidemiologic and observational research on the long-term cardiopulmonary effects of tuberculosis (TB) treatment, with an emphasis on those co-infected with HIV. The overarching goal is to better understand the morbidity associated with post-TB lung disease (PTLD), which can persist despite successful bacterial clearance and can contribute to both physical and socioeconomic challenges. The POST-TB initiative invites applications to conduct research within existing cohorts of TB patients, either adults or children, from platforms such as the International Epidemiology Databases to Evaluate AIDS (IeDEA), TB-RePORT, and other ongoing or completed clinical trials. Researchers are encouraged to investigate lung dysfunction, immune response biomarkers, and the role of HIV in influencing disease severity. The program does not cover routine TB treatment costs, expecting participants to receive care through public health programs. Projects should aim to determine PTLD prevalence, identify immune and environmental risk factors, and examine strategies to mitigate disease progression. Eligible applicants include U.S. and foreign entities, such as higher education institutions, nonprofits, for-profit organizations, government agencies, tribal governments, school districts, and housing authorities. All applicants must complete specific registrations (SAM, NCAGE, UEI, eRA Commons, and Grants.gov) before submission. The application must follow the SF424 (R&R) Application Guide, with detailed content requirements, including participant eligibility, data availability, study timelines, and data management plans. Applications must be submitted electronically through ASSIST, institutional S2S systems, or Grants.gov Workspace. NIH standard AIDS application due dates apply, with the next deadline on May 7, 2025. The final application submission deadline is May 24, 2025. The project duration can extend up to five years, and budgets must reflect actual project needs. Applications must align with NIH and NIAID guidelines, particularly regarding data sharing, human subject protections, and foreign collaborations. Evaluation of proposals will be based on significance, investigator capability, innovation, methodological approach, and research environment. Additional considerations include data and safety monitoring, study timeline feasibility, and resource sharing plans. Contact information for inquiries includes Dr. Robin E. Huebner (scientific/research) at rhuebner@niaid.nih.gov and Ann Devine (grants management) at adevine@niaid.nih.gov.