Propose a Partnership for Tuberculosis Research in Brazil

Through a new funding opportunity announcement (FOA) Brazil Regional Prospective Observational Research in Tuberculosis (RePORT) (U01, Clinical Trial Not Allowed), NIAID will establish a network to leverage and build upon Brazilian cohorts currently following adult and pediatric populations with active tuberculosis (TB) disease and their contacts or other high TB-risk individuals. Apply if you are an investigator able to assemble a multidisciplinary research team that includes collaborations to the existing cohorts and infrastructure, with at least one principal investigator from Brazil and one from the United States.

For this FOA, NIAID is most interested in research topics involving TB/HIV in the areas of molecular epidemiology, diagnostics, biomarkers, and vaccine development, as well as the impact of co-morbidities such as HIV and diabetes. Project outcomes should also aim to develop tools with potential to impact public health or influence decision-making in TB public health by informing stakeholders on best practices for early prevention, diagnosis, and clinical management of TB and TB/HIV.

For TB and TB/HIV research, projects could include:

• Characterizing the risk factors for and molecular epidemiology of drug-resistant TB (DR-TB) in Brazil
• Elucidating strategies to impact the transmission, incidence, and prevalence of TB in Brazil, including implementation research, or factors that may inform such strategies
• Developing or validating new diagnostics and biomarkers that predict progression to active TB and treatment outcomes of active TB
• Studying mechanisms and markers of protection from progression of infection to disease
• Studying impact and interactive pathogenesis of TB co-morbidities, such as HIV or diabetes

Projects might also include:

• Studying molecular epidemiology of DR-TB in Brazil
• Developing new diagnostic tests for prognostic biomarkers and/or active and latent TB in conjunction with laboratories and clinical centers in Brazil
• Understanding the two-way pathogenesis, impact on clinical outcomes, and associated biomarkers of TB and co-morbidities, such as HIV and diabetes
• Discovering or confirming host and microbial factors and mechanisms that affect the risk, dynamics, pathophysiology, and transmission of latent and active TB in children and adults
• Research toward the continued development of TB vaccines
• Observational and implementation studies that bridge the knowledge-practice gap in TB diagnosis, treatment, and prevention

Although the FOA centers on HIV/TB observational research and leveraging available samples and data from existing cohorts, applicants may propose to collect additional samples and clinical data as needed for the research project. If selected for funding, the awardee must implement a research protocol that meets RePORT International standards based on the framework of the RePORT International Common Protocol.

Program Nuances

Upon award, the grantee will establish an executive committee (EC) consisting of the principal investigators, key personnel, an NIAID project scientist, and at least one Brazilian Ministry of Health staff member to coordinate and facilitate research activities. Meeting at least once annually, the EC will ensure compliance with the data- and other resource-sharing policies to meet international guidelines and standards and promote research efficiency.

As a member of the RePORT network, the grantee should establish and maintain collaborations with the Caribbean, Central, and South America Network for HIV Epidemiology, the National TB Programme from the Ministry of Health of Brazil, the previous Regional Prospective Observational Cohort in Brazil, the Notifiable Diseases Information System, the TB Special Treatments Information System, and the TB-RePORT International Coordinating Center.

Applications must include go/no-go criteria to be met by the end of the third year of an award. At the end of the third year, NIH and Brazilian Ministry of Health staff will evaluate progress; if the awardee fails to meet the proposed go/no-go criteria, the project will continue under a reduced budget.

The initiative will not support research projects collecting only epidemiological data, establishing a de novo cohort, or conducting a clinical trial.

Application Details

The maximum project period is five years. Do not exceed $700,000 annual direct costs in your application’s budget request.

Applications are due on December 8, 2021.

Reach out to Dr. Sudha Srinivasan, NIAID’s scientific/research contact, if you have questions about the initiative or Dr. Cynthia de la Fuente for concerns specific to the peer review process, both of whom are listed in Section VII. Agency Contacts of the FOA.