Opportunities for HIV Cure Strategies at the Time of ART Initiation (R21 Clinical Trial Not Allowed) | PAR 23 296

Frequently Asked Questions (FAQs)

What is the NIH funding opportunity called?

The opportunity is titled "Opportunities for HIV Cure Strategies at the Time of ART Initiation (R21 Clinical Trial Not Allowed)" and is identified as PAR 23 296.

What is the main goal of this grant opportunity?

The main goal is to support early-stage, exploratory research that identifies and develops HIV cure strategies that are practical and biologically compelling to use at the time a person starts combination antiretroviral therapy (cART), and/or when cART is restarted after an analytical treatment interruption (ATI). The long-term endpoint NIH is aiming toward is sustained, treatment-free remission (durable control of HIV without continuous antiretroviral medication).

What does NIH mean by "sustained, treatment-free remission" in this context?

In this NOFO, sustained, treatment-free remission refers to durable control of HIV without needing ongoing antiretroviral therapy. The program is oriented toward cure strategy development that could eventually enable long-lasting remission after therapy is stopped.

Why does this NOFO emphasize the timing of ART initiation or re-initiation?

A key feature is the focus on interventions that can be deployed at the ART starting line (or re-start line). NIH is prioritizing this timing because viral dynamics, immune responses, and reservoir formation or re-expansion may be more modifiable at ART initiation or restart than later in infection or after long periods on suppressive therapy.

What types of research does this NOFO aim to stimulate?

It is intended to stimulate work on cure-oriented approaches that fit into real clinical workflows at ART initiation or re-initiation, rather than approaches that only make sense after years of stable suppression. The NOFO is described as supporting concept development, preclinical-to-translational studies, and other early-phase investigations that help determine whether an approach is feasible, safe in principle, and scientifically justified to pursue further.

What funding mechanism is used for this opportunity?

This opportunity uses the NIH R21 mechanism, which generally supports innovative, higher-risk/high-reward projects designed to generate strong preliminary data or proof-of-concept.

What does "R21" imply about the stage and intent of the research?

Based on the description provided, the R21 is positioned as a stepping-stone mechanism for early-stage, exploratory work. The intent is to help teams generate evidence and rationale needed to justify later, more definitive development and eventual clinical testing through mechanisms that do allow clinical trials.

Are clinical trials allowed under this funding opportunity?

No. The NOFO title explicitly states "Clinical Trial Not Allowed," and applications cannot propose independent clinical trials under this award.

If clinical trials are not allowed, what kinds of activities can applicants propose?

The description indicates applicants can propose mechanistic studies, model-based work, and other preparatory research. The work should advance a cure strategy toward readiness for later clinical evaluation without crossing into a clinical trial design NIH would classify as prohibited under this specific NOFO.

What is the practical focus of the interventions encouraged by this NOFO?

The NOFO prioritizes cure strategy concepts that can be integrated into real-world clinical workflows at the moment ART begins or resumes, rather than strategies requiring years of stable suppression before they can be applied.

What is the maximum award amount (award ceiling) for this opportunity?

The award ceiling is listed as $275,000.

Which activity category does this opportunity fall under?

It falls under the Health, Income Security and Social Services activity category.

Which CFDA numbers are associated with this opportunity?

The opportunity lists CFDA numbers 93.242, 93.855, and 93.865.

When was this opportunity created?

The opportunity was created on September 20, 2023.

What is the original closing date for the opportunity?

The original closing date is September 7, 2026.

Does the long closing window mean applicants can ignore due dates until 2026?

No. While the closing date provides a long runway, the description notes that applicants should verify which specific receipt dates apply for their chosen submission cycle and confirm all current NIH policy requirements at the time of submission.

Who is eligible to apply for this grant?

Eligibility is broad and includes many NIH applicant types across government, academia, nonprofit, and industry, as described in the NOFO summary provided.

Which U.S. government entities are eligible applicants?

Eligible government applicants include state governments; county governments; city or township governments; and special district governments.

Are educational institutions eligible?

Yes. Eligible applicants include independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; and several highlighted institution types (such as HBCUs and other serving institutions listed in the NOFO summary).

Are tribal governments and tribal organizations eligible?

Yes. Eligible applicants include federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized tribal governments.

Are housing authorities eligible to apply?

Yes. Public housing authorities and Indian housing authorities are listed as eligible applicants.

Can nonprofits apply, including those without 501(c)(3) status?

Yes. The eligible applicant list includes nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (excluding institutions of higher education in those categories as specified in the NOFO summary).

Can for-profit organizations apply?

Yes. For-profit organizations other than small businesses are eligible, and small businesses are also explicitly listed as eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. The NOFO explicitly highlights faith-based or community-based organizations among additional eligible applicant categories.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are explicitly highlighted as an additional eligible applicant category.

Are U.S. territories or possessions eligible to apply?

Yes. U.S. territories or possessions are listed among the additional eligible applicant categories.

Are non-U.S. (non-domestic) entities eligible to apply?

Yes. The NOFO highlights that non-domestic (non-U.S.) entities and regional organizations are eligible.

Does NIH indicate why it wants such broad eligibility, including international entities?

The description suggests the breadth signals NIH interest in drawing ideas from a wide range of scientific and community contexts, including international settings where ART initiation and interruption/restart scenarios may be studied under different epidemiologic and health system conditions.

What patient-care moments are specifically in scope for this NOFO?

The NOFO centers on HIV cure strategies intended for use right when a person starts cART and/or when cART is restarted after an analytical treatment interruption (ATI).

Is this opportunity intended to fund late-stage development or definitive clinical testing?

No. It is described as an early-stage, exploratory, stepping-stone opportunity intended to generate preliminary evidence and rationale to support later-stage programs and eventual clinical testing through other mechanisms that allow clinical trials.

How should applicants frame their work given the "Clinical Trial Not Allowed" restriction?

Applications should be framed to move a cure strategy toward readiness for later clinical evaluation (for example, feasibility, safety-in-principle, mechanistic rationale, or translational preparation) without proposing an independent clinical trial as the main activity under this award.