Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Sexual and Gender Minority Research Office (SGMRO)

Funding Opportunity Title
Elucidating Mechanisms Associated with HIV Related Co-Morbidities in Populations Experiencing Health Disparities (R01 - Clinical Trials Not Allowed)
Activity Code

R01 Research Project Grant

Announcement Type
New
Related Notices
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
RFA-MD-24-005
Companion Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.307, 93.847
Funding Opportunity Purpose

The purpose of this initiative is to support research to determine the underlying mechanisms that contribute to health disparities in HIV and aging and how multiple comorbidities influence overall health outcomes and quality of life among people with HIV from populations that experience health disparities.

Key Dates

Posted Date
March 01, 2024
Open Date (Earliest Submission Date)
March 22, 2024
Letter of Intent Due Date(s)

30 days prior to the application due date.

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable Not Applicable May 07, 2024 * July 2024 August 2024 December 2024
Not Applicable Not Applicable January 07, 2025 * March 2025 May 2025 July 2025
Not Applicable Not Applicable January 07, 2026 * March 2026 May 2026 July 2026

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date
January 08, 2026
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

For this RFA, the following definition is listed below:

Populations experiencing health disparities and NIMHD research priorities: Racial and ethnic minority groups (Blacks or African American, Hispanic or Latino, American Indian and Alaska Native, Asian American, Native Hawaiian and Pacific Islander populations), and/or people with less privileged socioeconomic status (SES), and intersectionality with underserved rural residents and sexual and gender minority populations and/or disability condition (https://www.nimhd.nih.gov/resources/understanding-health-disparities/minority-health-and-health-disparities-definitions.html).

NIMHD’s mission is to lead scientific research to improve minority health and reduce health disparities and envisions an America in which all populations will have an equal opportunity to live long, healthy, and productive lives. NIMHD aims to lead scientific research to improve minority health and reduce health disparities in populations that experience health disparities. NIMHD research priorities are focused on racial and ethnic minority populations and socioeconomically disadvantaged populations and specifically interested in the intersectionality of these factors among rural populations, SGM groups, and people with disabilities. See https://www.nimhd.nih.gov/news-events/news-releases/2023/pillars-of-health-disparities-science.html for more information. NIMHD encourages projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities (see the NIMHD Research Framework).

Background:

Human immunodeficiency virus (HIV) infection disproportionately impacts racial and ethnic, low SES, and sexual and gender minority (SGM) populations, with new infections disproportionately occurring in young men who have sex with men (MSM) from racial and ethnic minority populations, in particular African American/Blacks and Hispanic/Latinos. Life expectancy has increased in People with HIV (PWH) due to newly improved highly active anti-retroviral therapy (HAART) with control of viral load to undetectable levels. Despite control of the virus with successful anti-retroviral therapy, early onset of HIV-associated non-AIDS comorbidities such as diabetes, hypertension cardiovascular, liver, bone and chronic kidney disease, cognitive impairment, psychiatric disorders, and cancers are increasingly reported in PWH that appear to mimic premature or accelerated/accentuated aging.   The combined adverse effects of living with HIV and multiple comorbidities adversely effects health related quality of life, well-being, mental and physical health with more severe consequences for PWH from populations that experience health disparities.

As PWH age, they are at higher risk of multiple comorbidities as compared to non-HIV infected individuals, which can worsen the progression of the HIV disease, manifesting as organ and functional impairment, onset of frailty and increased risk of hospitalization and death. This increased risk and excess morbidity, and mortality are exacerbated in populations experiencing heath disparities. Social determinants of health (SDOH) may drive disparities in HIV disease outcomes and further accelerate aging in PWH from populations experiencing health disparities. Social determinants of health (e.g., Unstable housing, income, or food insecurity) can exacerbate barriers to care and treatment. PWH from populations experiencing health disparities experience elevated levels of psychosocial stress, isolation, depression, and post-traumatic stress that may fuel the very same pathways that lead to end-organ diseases. Furthermore, limited, or delayed access to health care, preventive services, treatment, and testing, are all factors that could negatively impact health related quality of life, well-being, and health span in populations experiencing health disparities.

The underlying mechanisms associated with HIV-associated non-AIDS comorbidities in PWH are not well established in populations experiencing health disparities, however they are complex and multifactorial. Recent reports have indicated pathways including chronic immune activation, immune exhaustion, and inflammation, alterations in the gut microbiome and metabolome, and microbial translocation; all events that can lead to immune senescence and aging. Additionally, co-infections such as Cytomegalovirus (CMV), Hepatitis B (HBV) and Hepatitis C virus (HCV) can contribute to immune senescence and aging in PWH. PWH from minority populations have a higher burden of co-infections. Other co-existing conditions, often related to lifestyle and behavioral risk factors (such as alcohol consumption, illicit substance use, smoking, poor diet, obesity, or lack of physical activity) can also affect health outcomes, increasing the risk of premature aging resulting in poorer health-related quality of life among PWH populations experiencing health disparities.

Furthermore, HIV associated non-AIDS comorbidities can complicate clinical care for multiple comorbidities especially for PWH from populations experiencing health disparities. PWH from populations experiencing health disparities encounter additional barriers to health care due to multiple stigmas related to multiple marginalized identities (e.g., Black man identifying as bisexual and from low socio-economic status). Lack of integration and coordination of medical care with multiple comorbidities can lead to gaps in timely assessment, diagnosis, and delays in treatment of chronic conditions, including poor adherence to therapy, or adverse drug reactions from polypharmacy. Limited access to care, availability of integrated care, and appropriate preventive services, may contribute to a greater burden of comorbidities in PWH from populations experiencing health disparities which may result in poor health outcomes and health related quality of life. Populations experiencing health disparities can also experience worse health outcomes because of complex interaction between multiple risk factors (social, behavioral, structural) and comorbidities.

However, less is known regarding the mechanism and pathways that can explain how HIV associated non- AIDS comorbidities influence overall health outcomes and quality of life among PWH from populations that experience health disparities.

Research Objectives

The objective of this initiative is to support research to determine the underlying mechanisms that contribute to health disparities in HIV and aging and how multiple comorbidities influence overall health outcomes and quality of life among people with HIV from populations that experience health disparities.

Studies for this initiative may include multi-disciplinary clinical, translational, behavioral, epidemiology, prevention, and health services research projects that leverage understanding of the biological factors that may explain worse health outcomes (e.g., burden of comorbidities, premature or excessive mortality, poorer health-related quality of life) in PWH populations experiencing health disparities. In addition, projects can involve primary and/or secondary data collection and analysis.

Multidisciplinary projects proposing to understand the underlying mechanisms that contribute to multiple comorbidities in PWH are expected to propose human subjects research or utilize human clinical samples along with any available clinical data. Studies in the clinical setting of successfully ART- treated PWH doing well who develops (or has) multiple chronic conditions, with the focus on clinical care of their comorbidities, is of interest. Applicants are strongly encouraged to include conceptual models and/or theoretical frameworks to examine mechanisms and pathways that contribute to multiple comorbidities in PWH.

Projects must include a focus on one or more populations whom NIH designates as experiencing health disparities as defined above. Please see: https://www.nimhd.nih.gov/about/overview/ for more information. Projects among groups with multiple marginalized identities are encouraged (e.g., racial and ethnic minority groups living in rural areas, SGM persons from racial and ethnic minority groups). Studies must have a focus on PWH - with comorbidities and incorporate relevant control group.

Multidisciplinary projects examining or addressing factors at multiple level (i.e., individual, interpersonal, community, societal) and multiple domain (i.e., behavioral, physical/built environment, health care system) are encouraged (see the NIMHD Research Framework:  https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html). Studies should consider, measure, and address if possible relevant SDOH including housing stability, income, or food security among other factors. Please see the SDOH collection of the PhenX Toolkit for more information (www.phenxtoolkit.org). Multidisciplinary teams with expertise that includes but is not limited to HIV research, familiarity with the needs of populations experiencing health disparities as defined above are strongly encouraged.

Applicants are strongly encouraged to collaborate and partner with community stakeholders and leverage community resources including people with HI V. Projects are strongly encouraged to involve collaborations, where appropriate, among relevant stakeholders, such as researchers, community organizations, clinicians, health systems, public health organizations, consumer advocacy groups, and faith-based organizations. As appropriate for the research questions posed, inclusion of key community members in the conceptualization, planning and implementation of the research are encouraged (but not required) to generate better-informed hypotheses and enhance the translation of the research results into clinical care and practice.

NIMHD Areas of Research Interest

Specific Areas of Research Interest may include but are not limited to:

  • Studies examining the effects of race and ethnicity and low SES on aging pathways in PWH.
  • Studies examining the effects of race and ethnicity, SES, neighborhood factors and multiple comorbidities on frailty, decline in physical function and end organ disease outcomes in PWH.
  • Studies examining the influence of SDOH on immune responses -innate and adaptive, and inflammation and interactions with various social stressors on aging and HIV disease outcomes.
  • Cohort studies to conduct population-based HIV health disparities research addressing the relevant SDOH to outline mechanisms that lead to disparities in HIV disease pathogenesis and clinical outcomes.
  • The interplay of multiple factors including social factors with microbiome, epigenomics, and proteomics to identify risk patterns for HIV related comorbidities.
  • Studies examining how behavioral factors (such as alcohol consumption, substance use and smoking) and comorbidity burden contribute to disparities in HIV and aging in PWH from populations that experience health disparities.
  • Studies on HIV and co-infections (e.g., CMV, HCV, HBV) and how they collectively affect HIV related comorbidities and health related quality of life in PWH from populations that experience health disparities.
  • Studies that address access to care and integrated models of care for PWH with multiple comorbidities to optimize care delivery in diverse care settings, especially rural settings.
  • Patient, clinician, and system/policy-level factors that predict receipt of appropriate treatments for co-occurring multiple comorbidities in PWH from populations that experience health disparities.
  • HIV and women studies in minority populations with comorbidities including but not limited to addressing access to care, stigma, discrimination, gender-based violence and intimate partner violence in cis and transgender women.
  • Studies focused on using community based participatory research methods while addressing clinical and patient-centered outcomes in PWH with multiple comorbidities from populations that experience health disparities.
  • Studies examining interplay of multilevel factors (i.e., individual, interpersonal, community, societal) and how they affect multiple comorbidities in PWH with intersecting identities.
  • Studies that address social and structural barriers to HIV testing, treatment-ART access and adherence, and prevention such as housing instability, food insecurity, poverty, transportation, stigma in PWH from populations that experience health disparities.
  • Studies examining resiliency factors to reduce comorbidity risks and improve health outcomes in PWH from populations that experience health disparities.

 Specific Areas of Research Interest for Participating Organizations:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People with NIDDK-relevant diseases and conditions often have other chronic health conditions.  Therefore, NIDDK is interested in projects focused on multiple HIV associated non-AIDS comorbidities and co-infections where at least one of them is within its mission (diabetes and other endocrine and metabolic diseases; digestive diseases, noncommunicable liver diseases, viral hepatitis, nutritional disorders, and obesity; and kidney, urologic and hematologic diseases). Examples include, but are not limited to, co-occurring obesity and metabolic dysfunction-associated steatohepatitis, co-occurring diabetes and kidney disease, co-occurring kidney disease and cardiovascular disease, and co-occurring viral hepatitis and cognitive dysfunction.

NIDDK encourages applications that demonstrate consideration of the Tips for Pursuing Competent Health Equity Research (see Appendix G of Pathways to Health for All). This includes applications with interdisciplinary research teams comprised of individuals with a breadth of lived experiences and biomedical scientific expertise deemed necessary to positively inform the study design, research conduct, and applicability of research findings for the populations of interest. 

Applications that are NOT responsive to this RFA include the following:

  • Studies without human subject s research or utilizing human clinical samples.
  • Studies that are focused on only animal studies.
  • Studies that do not have primary focus on HIV-related multiple comorbidities.
  • Studies whose sole purpose is to assess prevalence of comorbidities in specific populations.
  • Studies that do not focus on PWH U.S. Populations that experience health disparities.
  • Clinical trials.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission

The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

Based on availability of funds, NIMHD intends to commit ~ $3 Million for 4 awards in fiscal year 2024.
Based on availability of funds, NIDDK intends to commit ~ $1.5 Million for 2 awards in fiscal year 2024.

Award Budget

Application budgets are limited up to $500,000 in direct costs/year

Award Project Period

5 years. 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-402-1366
Email: liuyujin@mail.nih.gov

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply - Application Guide must be followed.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Describe how the project will advance our understanding of the underlying mechanisms that explain the health disparities in HIV and Aging and how multiple comorbidities influence overall health related quality of life in PWH from populations that experience health disparities.

Describe how the project uses a multidisciplinary approach, including integration of the disciplines and expertise of the research team, to understand the complex interaction of factors that underlie comorbidities in PWH from populations that experience health disparities.

If applicable describe how the community partners will participate in the conceptualization, planning and implementation of the research to inform hypotheses and facilitate translation of the research into clinical care and practice.

The projects are expected to include multi-level or multi-domain approaches to address HIV related health disparities (for more information see the NIMHD Research Framework: https://www.nimhd.nih.gov/about/overview/research-framework.html).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIMHD Referral Office by email to Dr. Maryline Laude-Sharp at maryline.laude@nih.gov when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

 

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this NOFO: How likely is the project to advance our understanding of the underlying mechanisms that explain the health disparities in HIV and Aging and how multiple comorbidities influence overall health related quality of life in PWH from populations who experience health disparities?.

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific to this NOFO:Does the composition of the multidisciplinary research team have appropriate breadth, relevance and inclusiveness of expertise and disciplines (such as HIV research, public health, behavioral, clinical, translational, epidemiology, prevention, and health services research, health disparities and aging and infectious or chronic disease's expertise)? 

 

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this NOFO: Does the project propose innovative approaches to unravel mechanisms that outline the effect of multiple comorbidities on worse HIV disease outcomes among PWH from populations that experience health disparities?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO: To what extent does the project integrate relevant strategies and approaches from various disciplines to examine the interplay of multiple factors in a meaningful way for HIV research on minority health and/or health disparities? Does the application document potential pathways or mechanisms that contribute to comorbidities in the PWH populations? Is there a consideration of understanding the pathways influenced by co-morbidities in PWH from populations that experience health disparities? Does the application propose multilevel or multi-domain approaches to address health disparities?

 

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

 
 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

 

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

 

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

 

Not Applicable

 

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

 

Not Applicable 

 

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

 

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIMHD, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Minority Health and Health Disparities. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review
  • Availability of funds
  • Relevance of the proposed project to program priorities
  • Geographic distribution of awardees

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Utibe R. Bickham-Wright, Ph.D., PMP
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-1349
Email: utibe.bickham-wright@nih.gov

Peter J Perrin, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK )
Phone: 301 451-3759
E-mail: peter.perrin@nih.hhs.gov

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov


Peer Review Contact(s)

Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: liuyujin@mail.nih.gov

Financial/Grants Management Contact(s)

Priscilla Grant, J.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov

Sunshine Wilson
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 827-4670
E-mail: sunshine.wilson@nih.gov


Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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