Elucidating HIV and HIV-treatment Associated Metabolic/Endocrine Dysfunction (R01) | Apply Online

Frequently Asked Questions (FAQs)

What is the name of this funding opportunity?

The opportunity is titled "Elucidating HIV and HIV-treatment Associated Metabolic/Endocrine Dysfunction (R01)" and is identified by the funding opportunity number RFA-DK-16-014.

Which agency is offering this grant?

This is an NIH discretionary grant solicitation issued by HHS/NIH, specifically through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

What grant mechanism is being used?

The mechanism is an NIH R01 Research Project Grant, which is generally used to support hypothesis-driven research programs of substantial scope.

What is the main purpose of the FOA?

The central aim is to support human-focused research that moves beyond broad clinical observations and produces clearer mechanistic and clinically meaningful evidence about metabolic and endocrine dysfunction in people living with HIV, including why it occurs, who is most at risk (or protected), and what can be done to prevent, treat, or potentially reverse these complications.

What kinds of scientific questions are emphasized?

The FOA emphasizes elucidating pathophysiology and etiology, identifying risk factors and protective factors, and clarifying how HIV infection and HIV treatment contribute to metabolic and endocrine problems.

Does the research have to involve human subjects?

Yes. A key requirement is that proposed projects must involve human subjects with HIV infection or use human-derived materials or data from HIV-infected individuals.

What counts as "human-derived materials or data" under this FOA?

Examples described include biospecimens and datasets originating from HIV-infected populations, such as blood, tissue, imaging, or well-annotated clinical data from HIV-infected individuals.

Are studies required to be conducted directly in participants?

Not necessarily. Studies may be conducted directly in participants (for example, clinical phenotyping, longitudinal cohort work, metabolic testing, or intervention-oriented clinical studies) or may rely on biospecimens and datasets derived from HIV-infected individuals.

Is the focus on HIV virology outcomes?

No. The stated emphasis is on metabolic and endocrine dysfunction in the context of HIV and/or antiretroviral therapy, aligned with NIDDK and the Division of Diabetes, Endocrinology, and Metabolic Diseases (DEM). The focus is on diabetes-related processes, endocrine disturbances, and broader metabolic disease mechanisms rather than purely virologic outcomes.

Does the FOA include antiretroviral therapy (ART) effects as part of the scope?

Yes. The scope includes the impacts of antiretroviral therapy regimens on endocrine organs and metabolic pathways, as well as metabolic/endocrine consequences associated with HIV infection itself.

Are inflammation and immune activation within scope?

Yes. The FOA explicitly notes interest in downstream effects of chronic inflammation or immune activation as they relate to metabolic and endocrine dysfunction in HIV-infected individuals.

Can projects include investigation of risk and protective factors?

Yes. The scope includes identifying who is most at risk (or protected), which encompasses risk factors and protective factors relevant to metabolic and endocrine complications.

Are prevention or treatment strategies allowed, or is it only basic mechanism work?

The FOA highlights interest in strategies that could prevent, treat, or reverse dysfunction, leaving room for translational research such as evaluating modifiable clinical factors, testing candidate interventions, or developing evidence to inform clinical management approaches.

Can host conditions that interact with HIV or ART be considered?

Yes. The opportunity notes the influence of relevant host conditions that may interact with infection or treatment to shape metabolic and endocrine outcomes.

Which NIDDK division mission should applications align with?

Applications must align with the mission of NIDDK's Division of Diabetes, Endocrinology, and Metabolic Diseases (DEM).

Who is eligible to apply?

Eligibility is broad and includes: state, county, and city 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status, excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; and small businesses, plus an "others" category as described in the full announcement.

Is this opportunity associated with a CFDA number?

Yes. The opportunity is listed under CFDA number 93.847.

When was the FOA created and posted?

The FOA was created and posted on November 3, 2015.

What is the application closing date?

The application closing date is March 9, 2016. The original and current closing dates are the same.

What is the award ceiling?

The listed award ceiling is $500,000, indicating an upper limit specified by the announcement for award size.

Does the FOA guarantee awards up to the ceiling amount?

No. The actual award amount would depend on NIH review outcomes, the proposed scope, and NIDDK program considerations.

What kinds of research activities are suggested as examples?

Examples described include clinical phenotyping, longitudinal cohort research, metabolic testing, and intervention-oriented clinical studies, as well as studies using biospecimens or clinical datasets derived from HIV-infected individuals.

What is the intended end impact of the supported research?

The intended impact is to generate mechanistic and clinically meaningful evidence that clarifies why metabolic and hormonal dysfunction occurs in people living with HIV, identifies who is most at risk or protected, and informs approaches to prevent, treat, or potentially reverse these complications.