Opportunity Information: Apply for RFA AI 23 057
The National Institutes of Health (NIH) is soliciting applications for a cooperative agreement under Funding Opportunity Number RFA-AI-23-057, titled "Multidisciplinary Research to Accelerate Hepatitis B Cure in Persons Living with HIV and HBV (U19 Clinical Trial Not Allowed)." This is a discretionary health research funding opportunity (CFDA 93.855) designed to bring together multidisciplinary teams to tackle key scientific barriers to curing hepatitis B virus (HBV) infection specifically in people living with HIV (PLWH) who also have HBV. The central idea is that HIV/HBV coinfection is not a one-size-fits-all condition; differences in the host (human biology, immune function, comorbidities, treatment histories) and in the virus (HBV genotypes, variants, replication dynamics) can change how disease progresses, how long the virus persists, and how the immune system contributes to both control and damage. The NOFO prioritizes research that clarifies these sources of heterogeneity and uses that knowledge to guide realistic, evidence-based HBV cure strategies tailored to PLWH.
A defining feature of this opportunity is the requirement to build an observational cohort rather than run interventional clinical trials. The NOFO explicitly states "Clinical Trial Not Allowed," which means applicants should not propose studies where participants are prospectively assigned to receive a specific intervention to test an outcome. Instead, the cohort is meant to accelerate discovery through careful, structured observation of participants over time, coupled with deep clinical characterization and integrated laboratory science. In practical terms, NIH is looking for programs that can collect and harmonize clinical data, biospecimens, and immunologic/virologic measurements in a way that enables robust translational research. The goal is to connect what is seen at the bedside (clinical phenotypes and outcomes) with what is measured in the lab (viral markers, immune signatures, mechanisms of persistence and immunopathology), so the field can identify which cure approaches are most promising for which subgroups of coinfected individuals.
Because this is a U19 cooperative agreement, the expectation is not a single-project, single-lab effort, but a coordinated program made up of multiple, linked research components. Multidisciplinary teams are expected to span clinical expertise (such as infectious diseases, hepatology, HIV medicine, cohort management, and clinical phenotyping) and basic/translational science (such as virology, immunology, systems biology, biomarker discovery, and pathogenesis research). The cooperative agreement mechanism also signals substantial NIH involvement beyond standard grant administration, typically through collaborative oversight, milestone-driven progress, and program-level coordination to maximize shared value and comparability across studies. The emphasis on accelerating discovery and increasing clinical impact suggests that the cohort and associated research infrastructure should be designed for broad utility, enabling the team to generate insights that can directly inform future cure-directed trials or interventions even if such trials are not part of this award.
The scientific scope centers on understanding how host and viral heterogeneity shape three interrelated areas: (1) pathogenesis of disease, meaning how liver disease develops and progresses in the setting of HIV/HBV coinfection; (2) viral persistence, meaning the mechanisms that allow HBV to remain in the body despite immune pressure and antiviral therapy, including reservoirs and molecular forms of viral nucleic acids that are difficult to eradicate; and (3) immunopathology, meaning how immune responses may contribute both to control of HBV and to liver inflammation or injury. By mapping these factors in PLWH, the funded research is intended to reveal mechanistic targets and practical biomarkers that can guide cure strategies, including identifying who may benefit from particular approaches and how to measure meaningful movement toward cure.
Eligibility for this funding opportunity is broad and includes a wide range of domestic organizations and governmental entities: state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education institutions); for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities. NIH also explicitly highlights additional eligible applicant categories aimed at broadening participation and representation, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, non-U.S. (foreign) entities, regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions. This breadth aligns with the cohort-based nature of the work, where partnerships with community, public health, and diverse clinical settings can be essential to enrolling and retaining participants and ensuring findings generalize across populations.
Key administrative details include the sponsoring agency (National Institutes of Health), the funding instrument (cooperative agreement), and the original closing date of March 13, 2024. While the source data lists an award ceiling and expected awards fields without values, the structure and complexity implied by a U19 cooperative agreement typically point to larger, programmatic awards that support multiple integrated projects and shared cores or resources. Overall, the opportunity is best understood as an NIH effort to build coordinated, high-impact research programs that can generate a clearer, more actionable picture of HBV persistence and disease mechanisms in PLWH, using a well-designed observational cohort as the engine for discovery and for translating mechanistic findings into credible cure-focused strategies.Apply for RFA AI 23 057
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Multidisciplinary Research to Accelerate Hepatitis B Cure in Persons Living with HIV and HBV (U19 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
- This funding opportunity was created on 2023-10-10.
- Applicants must submit their applications by 2024-03-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the funding opportunity?
This opportunity is a National Institutes of Health (NIH) cooperative agreement under Funding Opportunity Number (FON) RFA-AI-23-057, titled "Multidisciplinary Research to Accelerate Hepatitis B Cure in Persons Living with HIV and HBV (U19 Clinical Trial Not Allowed)."
What is the main goal of this NIH program?
The goal is to accelerate progress toward curing hepatitis B virus (HBV) infection in people living with HIV (PLWH) who are also infected with HBV. The program focuses on overcoming key scientific barriers by bringing together multidisciplinary teams and using an observational cohort to generate clinically meaningful, evidence-based insights that can guide future cure strategies.
What type of award mechanism is this?
This is a U19 cooperative agreement. That means NIH expects a coordinated, program-level effort with multiple linked research components rather than a single standalone project, and NIH will have substantial involvement beyond standard grant administration (for example, collaborative oversight and milestone-driven coordination).
Are clinical trials allowed under this opportunity?
No. The Notice of Funding Opportunity (NOFO) explicitly states "Clinical Trial Not Allowed." Applicants should not propose studies in which participants are prospectively assigned to receive a specific intervention to evaluate an outcome.
If clinical trials are not allowed, what kind of human research is expected?
The NOFO requires building an observational cohort. The expectation is structured observation of participants over time, with deep clinical characterization and integrated laboratory science. The cohort is intended to support translational discovery by linking clinical outcomes and phenotypes with virologic and immunologic measurements.
What does "observational cohort" mean in the context of this program?
In this program, an observational cohort refers to a group of PLWH who also have HBV that is followed over time without assigning participants to specific interventions. The emphasis is on systematically collecting clinical data and biospecimens and performing integrated laboratory assessments to understand disease mechanisms and variability.
Who is the target population for the research?
The target population is persons living with HIV (PLWH) who are coinfected with hepatitis B virus (HBV).
Why does the NOFO emphasize that HIV/HBV coinfection is not "one-size-fits-all"?
The NOFO emphasizes heterogeneity because differences in host factors (such as immune function, comorbidities, and treatment histories) and viral factors (such as HBV genotypes, variants, and replication dynamics) can influence disease progression, viral persistence, and immune-driven liver damage. Understanding these differences is presented as essential for developing realistic cure strategies tailored to subgroups of coinfected individuals.
What scientific areas are prioritized?
The scientific scope centers on understanding how host and viral heterogeneity shape three interrelated areas: (1) pathogenesis of disease (how liver disease develops and progresses in HIV/HBV coinfection), (2) viral persistence (mechanisms that allow HBV to remain despite immune pressure and antiviral therapy, including reservoirs and difficult-to-eradicate molecular forms of HBV nucleic acids), and (3) immunopathology (how immune responses contribute to both HBV control and liver inflammation or injury).
What kinds of data and samples are NIH expecting programs to collect?
NIH is looking for programs that can collect and harmonize clinical data, biospecimens, and immunologic/virologic measurements. The emphasis is on building an infrastructure where bedside observations (clinical phenotypes and outcomes) are meaningfully connected to laboratory findings (viral markers, immune signatures, and mechanisms of persistence and immunopathology).
How is "translation" described in this NOFO?
Translation is described as connecting clinical phenotypes and outcomes with lab-based viral and immune measurements in a way that produces actionable insights. Even though interventional trials are not part of this award, the cohort and integrated science are intended to directly inform future cure-directed trials or interventions.
What types of research teams does NIH want to see?
NIH is soliciting multidisciplinary teams spanning clinical expertise (for example, infectious diseases, hepatology, HIV medicine, cohort management, and clinical phenotyping) and basic/translational science (for example, virology, immunology, systems biology, biomarker discovery, and pathogenesis research).
Why is a multidisciplinary approach important for this program?
The NOFO frames HBV cure in PLWH as a complex problem shaped by both clinical variability and underlying mechanisms of viral persistence and immune response. Multidisciplinary teams are positioned to combine longitudinal clinical observation with deep mechanistic laboratory investigation, increasing the chance of identifying meaningful biomarkers and credible cure strategies for specific subgroups.
What is the intended value of the cohort beyond a single study?
The cohort and associated research infrastructure are expected to be designed for broad utility, enabling robust translational research and generating insights that can guide the field toward cure strategies and future interventional studies (even though those trials are not conducted under this award).
What is the CFDA number associated with this opportunity?
The opportunity is listed as a discretionary health research funding opportunity under CFDA 93.855.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the application due date listed for this opportunity?
The information provided lists an original closing date of March 13, 2024.
What types of organizations are eligible to apply?
Eligibility is broad and includes: state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education institutions); for-profit organizations (other than small businesses); and small businesses; and other eligible entities.
Are foreign (non-U.S.) organizations eligible to apply?
Yes. The eligibility language explicitly includes non-U.S. (foreign) entities.
Are faith-based or community-based organizations eligible?
Yes. The eligibility language explicitly includes faith-based or community-based organizations.
Are minority-serving institutions and tribally controlled institutions included as eligible applicants?
Yes. The NOFO highlights eligibility for multiple institution types aimed at broadening participation and representation, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are U.S. territories or possessions eligible?
Yes. Eligibility explicitly includes U.S. territories or possessions.
Are federal agencies eligible to apply?
Yes. The eligibility language includes eligible federal agencies.
Does the NOFO describe expected award size or number of awards?
The source information notes that award ceiling and expected awards fields are listed without values. However, the U19 cooperative agreement mechanism and the described program structure imply a larger, coordinated, programmatic award supporting multiple integrated projects and shared resources.
What does NIH involvement typically look like in a cooperative agreement?
The NOFO characterizes cooperative agreements as involving substantial NIH involvement beyond standard grant administration, such as collaborative oversight, milestone-driven progress, and program-level coordination to maximize shared value and comparability across studies.
What kind of outcomes is this program trying to enable?
The program is intended to enable mechanistic targets and practical biomarkers that can guide cure strategies, including clarifying which subgroups of coinfected individuals may benefit from particular approaches and how to measure meaningful progress toward cure.
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