Exploiting in Vivo or in Situ Imaging Approaches to Understand HIV-relevant Processes In The Context of Substance Use Disorders (R61/R33 Clinical Trials Optional) | RFA DA 23 001

Frequently Asked Questions (FAQs)

What is the title of this grant opportunity?

The opportunity is titled "Exploiting in Vivo or in Situ Imaging Approaches to Understand HIV-relevant Processes In The Context of Substance Use Disorders (R61/R33 Clinical Trials Optional)."

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is RFA-DA-23-001.

Which federal agency is offering this grant?

This is a National Institutes of Health (NIH) discretionary grant program.

What is the main purpose of this program?

The central goal is to support imaging-driven research at the intersection of HIV and substance use disorders (SUD). Projects are expected to further develop, refine, or actively apply modern in vivo (within a living organism) or in situ (within the original tissue context) imaging methods and related technologies to answer important biological and clinical questions about HIV and SIV.

What types of imaging approaches are emphasized?

The program emphasizes in vivo imaging (within a living organism) and in situ imaging (within intact tissue context/architecture), along with related technologies that can localize infection, characterize tissue-level events, and capture biological changes not easily observed via blood tests alone.

Which diseases or pathogens are in scope for this opportunity?

The scope includes HIV and SIV, with a focus on HIV/SIV-relevant processes, infection dynamics, and persistence.

What scientific questions is the program trying to address?

The opportunity is focused on understanding how HIV/SIV infection behaves in the body, where the virus persists (including latent reservoirs), how it causes damage over time, and how HIV/SIV treatments or SUD treatments may change these processes.

What are "latent reservoirs" and why are they highlighted?

Latent reservoirs are hard-to-eradicate pockets of virus that can remain even when standard antiretroviral therapy suppresses detectable virus in the blood. The program highlights them because imaging may help identify where reservoirs persist and what is happening within tissues that cannot be understood from blood-based measurements alone.

How does substance use disorders (SUD) fit into this program?

The program specifically targets HIV/SIV biology and clinical outcomes in the context of substance use disorders. It encourages studying how substance use, addiction biology, or SUD treatment may alter infection dynamics, persistence, inflammation, immune activation, tissue damage, and neurological impacts.

What kinds of outcomes or processes may be studied?

Examples described include inflammation, immune activation, tissue damage, neurological impacts, and other pathogenic consequences of infection, especially as they relate to substance use and/or SUD therapies.

What is meant by enabling researchers to "see" HIV/SIV processes?

The program aims to accelerate the ability to observe HIV/SIV-relevant processes in real time or within intact tissue architecture, rather than relying only on indirect measures such as blood tests.

Are studies in humans allowed, or is this limited to animal models?

Applicants are allowed to propose studies in nonhuman primates or in humans. The opportunity reflects interest in both mechanistic research and clinically relevant work.

Which tissues or body compartments are explicitly emphasized?

The opportunity explicitly calls out blood, lymphoid tissues, and brain tissues as compartments of interest, reflecting gaps in understanding virus-host interactions across the body, including sites that can be difficult to sample repeatedly or interpret without advanced imaging.

Why are lymphoid tissues and the brain specifically mentioned?

Lymphoid tissues are highlighted as key sites for viral persistence and immune activity. Brain tissues are highlighted due to relevance to neuroHIV, neuroinflammation, and neurological consequences of both HIV and substance use.

What is the funding mechanism for this opportunity?

The mechanism is an R61/R33 phased award structure.

What does the R61/R33 structure generally mean?

It generally indicates a phased innovation-to-development approach: an initial, milestone-driven stage supporting early development or feasibility work (R61), followed by a second stage to expand, validate, or apply the approach once initial goals are met (R33).

Are clinical trials required?

No. Clinical trials are optional, meaning an applicant may propose clinical trial components if appropriate, but they are not required.

What kinds of projects does the "clinical trials optional" feature allow?

It leaves room for a wide range of projects, including technology or method development and validation, as well as translational studies that apply imaging approaches to evaluate interventions, disease processes, or therapy effects in real-world settings.

Who is eligible to apply?

Eligibility is broad. Eligible applicants include state, county, and local 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 (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations (other than small businesses); and small businesses.

Are minority-serving institutions and community organizations eligible?

Yes. The opportunity explicitly lists Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); and faith-based or community-based organizations as eligible applicants.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are explicitly included in the eligibility list.

Can organizations outside the United States apply?

Yes. The opportunity explicitly includes non-domestic (non-U.S.) entities, meaning foreign organizations can apply.

What topic areas or categories is this opportunity associated with?

The opportunity is categorized under Education and Health.

What is the CFDA number associated with this opportunity?

The associated CFDA number is 93.279.

What are the key dates included in the provided information?

The funding opportunity record shows a creation date of 2021-07-08, and the original closing date listed is 2022-08-11.

Does the provided information include the award ceiling, expected number of awards, or detailed budget information?

No. The excerpt provided does not include an award ceiling, expected number of awards, or other budget specifics.

What is the overall takeaway for applicants considering this opportunity?

This program is aimed at enabling imaging-centered research that clarifies where and how HIV/SIV persists and causes harm, particularly in the context of substance use disorders and related therapies, using nonhuman primate and/or human studies with attention to blood, lymphoid, and brain compartments.