Funding News Edition: April 19, 2023 See more articles in this edition
NIAID’s new notice of funding opportunity (NOFO) Pulmonary Outcomes and Sequelae after Treatment-TB (POST-TB) (R01, Clinical Trial Optional) invites epidemiological and observational research projects on the long-term cardiopulmonary sequelae following treatment for tuberculosis (TB) in persons living with and without HIV infection. A better understanding of post-TB lung disease (PLTD) should yield better targets for interventions to reduce the burden of long-term cardiopulmonary disease sequelae following treatment for TB.
For this NOFO, investigators should evaluate the epidemiology and clinical manifestation of post-TB lung dysfunction, risk factors for dysfunction, predictors of severity, correlates of immune system responses (cellular as well as humoral), biomarkers of lung damage, and the impact of HIV infection and its treatment on PTLD. We also encourage investigators to explore mechanisms of pathology and the risk of recurrent TB or other disease.
We expect researchers will include participants during, after, or long after TB treatment. Studies could add clinical and immunologic evaluations during treatment, and at treatment completion, as well as include persons long after a well-documented TB treatment episode where data and samples enable in-depth research.
You might also employ case-control study designs to compare persons with a history of TB to suitable controls. It should be noted that the emphasis is on understanding PTLD in persons with and without HIV who have uncomplicated TB disease and who are cured by therapy. Enrolled participants should meet or be likely to meet the current WHO definitions for treatment cure or completion and not have been considered "lost to follow-up" at any time during their treatment.
The NOFO provides a nonexclusive list of example research topics:
- In-depth assessments of lung dysfunction prevalence and severity in persons cured of TB infection.
- Measures of immune system responses (cellular as well as humoral) and their impact on lung function over time.
- The impact of HIV infection on the severity or type of dysfunction after TB cure.
- Predictors and correlates of dysfunction and severity of damage.
- Identification of biomarkers predictive of PLTD occurrence and severity.
- Individual vulnerabilities and resilience to PLTD occurrence and severity.
- Structural vulnerabilities and resilience to PLTD occurrence and severity.
- Risk of recurrent TB and other lung or respiratory infections.
- Risk of cardiovascular disease or chronic organizing pneumonia and chronic obstructive pulmonary disease in persons with PLTD.
- Quantification of the burden of PLTD on patients and their families.
You could also evaluate the incidence of cardiopulmonary disease in HIV-infected and uninfected persons, immunologic factors and biomarkers indicative of lung damage, and the impact of other potential risk factors such as alcohol or tobacco use, nutritional status, and environmental exposures. Further, you may consider preventative care such as pneumococcal and influenza vaccination, including antibiotic use in respiratory infections.
Conversely, NIAID will deem nonresponsive and not review applications that propose:
- Studies focused only on the pharmacologic or clinical impact of individual TB drugs, short-, or long-course treatment regimens.
- Studies of persons with multidrug-resistant or extensively drug-resistant TB, or those with poor adherence to TB therapy.
Clinical trials are optional but, for the sake of completing application forms properly, you need to be clear on whether or not your proposed research meets NIH’s Definition of a Clinical Trial.
The NOFO does not set a budget cap, although your budget needs to reflect the actual needs of the proposed project. For a budget request with direct costs exceeding $500,000 in any 1 year, you must receive NIAID’s approval before submitting. The scope of the proposed project should determine your project period, although the project period cannot exceed 5 years.
Foreign organizations are eligible to apply. Foreign components are allowed.
The NOFO uses NIH’s standard due dates for AIDS and AIDS-Related Applications. The first submission deadline is September 7, 2023.
If you have any questions about the NOFO, direct them to NIAID’s scientific/research contact Dr. Robin Huebner at firstname.lastname@example.org or 240-627-3216