Elucidating HIV and HIV-treatment Associated Metabolic/Endocrine Dysfunction (R01 Clinical Trial Optional) | RFA DK 17 036

Opportunity Information: Apply for RFA DK 17 036

This grant opportunity, titled "Elucidating HIV and HIV-treatment Associated Metabolic/Endocrine Dysfunction (R01 Clinical Trial Optional)" (RFA-DK-17-036), is a National Institutes of Health (NIH) discretionary funding announcement run through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), specifically aligned with the Division of Diabetes, Endocrinology, and Metabolic Diseases (DEM). The central purpose is to fund innovative research that explains how HIV infection itself, HIV-related host factors, and/or antiretroviral therapy (ART) contribute to metabolic and endocrine dysfunction. In addition to identifying causes and biological mechanisms, the FOA also encourages work that clarifies disease pathways and practical factors that increase or reduce risk, and it supports studies aimed at developing or testing strategies to prevent, treat, or potentially reverse these dysfunctions in people living with HIV.

The scientific scope is intentionally broad but clearly centered on metabolic and endocrine outcomes. Applicants are expected to propose research that advances understanding of the pathophysiology and etiology of metabolic and endocrine problems in HIV-infected individuals, including how HIV, inflammation, immune activation, co-existing conditions, or ART regimens may drive changes in glucose regulation, lipid metabolism, body composition, hormone systems, or other endocrine and metabolic processes. The FOA is open to both mechanistic projects (for example, studies designed to pinpoint biological pathways or causal mechanisms) and clinical research, including clinical trials, since the announcement is explicitly labeled "Clinical Trial Optional." That means an application may include a clinical trial when appropriate, but a trial is not required; strong non-trial mechanistic and translational approaches are also within scope as long as they fit DEM/NIDDK mission priorities.

The funding mechanism is an NIH R01 research project grant. The listing identifies an award ceiling of $500,000, indicating the maximum award amount anticipated under this opportunity. The activity category is health-related, with a focus area that includes food and nutrition and broader health concerns, and it is tied to CFDA number 93.847. The opportunity was created on November 21, 2017, and the original closing date was March 13, 2018.

Eligibility is expansive and includes many types of domestic applicants across government, education, nonprofit, and private sectors. Eligible applicants include state, county, and city or township governments; 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (as long as they are not institutions of higher education when applying under those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other applicant types that NIH permits under this FOA. The FOA also explicitly highlights categories of institutions and organizations that NIH encourages as eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Restrictions on non-U.S. participation are clearly spelled out. Non-domestic (non-U.S.) entities (foreign organizations) and non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply directly, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, the FOA allows foreign components as defined in the NIH Grants Policy Statement, meaning a U.S.-based applicant may include certain international elements or collaborations if they meet NIH definitions and policy requirements, even though foreign institutions cannot serve as the applicant organization.

Overall, the opportunity is aimed at generating high-impact evidence about why metabolic and endocrine complications occur in people living with HIV and how those problems might be mitigated. The emphasis is on innovative work that connects HIV infection and HIV treatment exposures to measurable metabolic or endocrine outcomes, identifies mechanisms and modifiable risk or protective factors, and supports the development and evaluation of interventions, including but not limited to clinical trials, as long as the project fits within NIDDK DEM priorities.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Elucidating HIV and HIV-treatment Associated Metabolic/Endocrine Dysfunction (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2017-11-21.
• Applicants must submit their applications by 2018-03-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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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