Opportunity Information: Apply for RFA AI 13 038
Apply for RFA AI 13 038
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovative Assays to Quantify the Latent HIV Reservoir (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Jul 1, 2013 and posted on Jul 1, 2013.
- Applicants must submit their applications by Nov 13, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,125,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: Public and State controlled institutions of higher education County governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Independent school districts Private institutions of higher education City or township governments State governments Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH grant opportunity "Innovative Assays to Quantify the Latent HIV Reservoir (R21)" (Funding Opportunity Number RFA-AI-13-038) was designed to push forward better ways to measure the latent HIV reservoir in people living with HIV who are successfully suppressed on antiretroviral therapy. The central problem the FOA is trying to solve is that HIV can persist in a small population of long-lived, latently infected cells even when standard therapy drives viral load in blood to undetectable levels. Because cure strategies aim to eliminate or permanently silence this hidden reservoir, researchers need assays that can reliably quantify how many latently infected cells remain and whether an intervention truly reduces the pool of cells capable of reigniting infection.
This FOA focuses on developing either entirely new assays or meaningful improvements to existing ones that can quantify latently infected cells more accurately, efficiently, or practically than the current benchmark approach. The commonly cited "gold standard" for measuring the replication-competent reservoir is a limiting dilution viral outgrowth assay, which attempts to induce virus production from resting CD4+ T cells and then detects outgrowth. While it is biologically relevant, the FOA emphasizes its drawbacks: it is slow, labor-intensive, expensive, and relatively imprecise, and it can underestimate the true size of the replication-competent reservoir because not all intact proviruses are induced in a single stimulation cycle. NIH is essentially signaling that the field needs something better suited for repeated measurement in clinical studies, especially early-stage proof-of-concept cure trials where decisions depend on detecting changes that may be modest but meaningful.
The announcement highlights two broad directions that would be especially valuable. One is a molecular assay capable of accurately detecting replication-competent provirus, meaning it would distinguish intact, potentially infectious proviruses from the much larger number of defective proviral fragments present in most treated individuals. Traditional PCR-based measurements of total HIV DNA can be misleading because they count defective genomes that cannot produce infectious virus. An assay that better correlates with true replication competence, while still being faster and more scalable than outgrowth methods, would significantly improve the ability to evaluate whether an intervention is shrinking the reservoir. The second direction is improving viral outgrowth assays themselves, for example by increasing induction efficiency, reducing time and sample requirements, improving throughput, or tightening precision so that fewer cells and fewer replicate cultures are needed to get a confident estimate.
Administratively, this opportunity was issued by the National Institutes of Health under the R21 mechanism, which is typically used for exploratory and developmental research where innovative concepts are being tested and early validation data are being generated. The activity categories tied to this FOA fall under health research, specifically CFDA 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The funding instrument type is a grant, and there is no cost sharing or matching requirement, which means applicants were not required to contribute non-federal funds as a condition of the award.
In terms of budget, the FOA listed an estimated total funding amount of $1,125,000 and an award ceiling of $200,000. While the FOA summary data does not spell out the exact number of anticipated awards, the combination of a total program amount and a per-award cap suggests NIH expected to make multiple awards to seed several different assay-development approaches, rather than betting on a single solution. The dates included show it was posted July 1, 2013, with an application closing date of November 13, 2013, and it was archived December 14, 2013, meaning it was a time-limited call rather than an open-ended standing program announcement.
Eligibility for this R21 was broad and intentionally inclusive, covering public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), small businesses, for-profit organizations (including those other than small businesses), and a wide range of government entities (state, county, city/township, special district). The FOA also explicitly allowed participation from Native American tribal governments and tribal organizations, public housing authorities/Indian housing authorities, independent school districts, and various mission-focused institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and Alaska Native and Native Hawaiian-serving institutions, among others. Importantly for an assay-development topic where specialized expertise may be distributed globally, non-U.S. entities and foreign institutions were eligible to apply, non-U.S. components of U.S. organizations could participate, and foreign components (as defined by NIH policy) were allowed. That international openness aligns with the scientific reality that HIV reservoir measurement is a global research priority and that key technology and clinical cohorts may exist outside the United States.
Overall, the FOA can be read as NIH making a strategic investment in measurement science for HIV cure research. The practical output NIH is looking for is not just another descriptive study of latency, but concrete assay advances that make reservoir quantification more accurate, less burdensome, and more informative about replication competence. If successful, the kinds of tools encouraged by this opportunity would make it easier to run and interpret cure-directed clinical studies by providing faster turnaround, better precision, and measurements that more directly reflect the biological endpoint that matters most: the number of cells capable of producing infectious HIV if therapy is stopped.
The full announcement was hosted on the NIH grants site (link provided in the source data), and NIH’s Office of Extramural Research webmaster contact was listed for access or linking issues, indicating the FOA followed standard NIH electronic posting and support procedures.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this NIH grant?
The opportunity is titled "Innovative Assays to Quantify the Latent HIV Reservoir (R21)" and the Funding Opportunity Number is RFA-AI-13-038.
What is the main goal of this funding opportunity?
The goal is to develop new assays, or meaningfully improve existing assays, that can quantify the latent HIV reservoir in people living with HIV who are successfully suppressed on antiretroviral therapy (ART). The emphasis is on measuring how many latently infected cells remain and whether an intervention truly reduces the pool of cells capable of reigniting infection.
Why is measuring the latent HIV reservoir important?
Even when ART reduces HIV in the blood to undetectable levels, HIV can persist in a small population of long-lived, latently infected cells. Cure strategies aim to eliminate or permanently silence this hidden reservoir, so reliable measurement tools are needed to determine whether a candidate cure intervention is working.
Who is the target population for the assays supported by this FOA?
The assays are intended for use in people living with HIV who are successfully suppressed on antiretroviral therapy, where the reservoir persists despite undetectable viral load in blood.
What benchmark method does the FOA reference as the current "gold standard"?
The FOA cites a limiting dilution viral outgrowth assay as the commonly referenced "gold standard" for measuring the replication-competent HIV reservoir.
What problems does NIH highlight with the viral outgrowth assay approach?
The FOA notes that viral outgrowth assays are slow, labor-intensive, expensive, and relatively imprecise. It also emphasizes that they can underestimate the true size of the replication-competent reservoir because not all intact proviruses are induced in a single stimulation cycle.
What types of assay advances are especially encouraged?
The FOA highlights two broad directions: (1) molecular assays that can accurately detect replication-competent provirus by distinguishing intact, potentially infectious proviruses from defective proviral fragments; and (2) improvements to viral outgrowth assays to address limitations such as induction efficiency, time, sample requirements, throughput, and precision.
Why are traditional PCR-based measurements of total HIV DNA considered potentially misleading?
Traditional PCR-based approaches that quantify total HIV DNA may count many defective proviral fragments that cannot produce infectious virus. Because of that, total HIV DNA measurements may not reflect the replication-competent reservoir that matters most for assessing cure strategies.
What does the FOA mean by an assay that detects "replication-competent provirus"?
In this FOA, replication-competent provirus refers to intact proviruses that are potentially infectious and capable of producing infectious virus, as opposed to defective proviral fragments that cannot produce infectious virus.
What practical improvements is NIH looking for in reservoir assays?
NIH is looking for tools that make reservoir quantification more accurate, less burdensome, and more informative about replication competence. Examples described in the FOA include faster turnaround, better scalability, reduced cost and labor, reduced sample needs, improved throughput, improved induction efficiency (for outgrowth assays), and tighter precision so fewer cells and replicate cultures are required for a confident estimate.
What kinds of studies is this FOA trying to support (conceptually)?
This FOA is geared toward measurement science that enables repeated measurement in clinical studies, including early-stage proof-of-concept cure trials where decisions may depend on detecting changes in the reservoir that could be modest but meaningful.
What NIH funding mechanism is used for this opportunity?
This opportunity uses the NIH R21 mechanism, which is typically intended for exploratory and developmental research focused on testing innovative concepts and generating early validation data.
What is the funding instrument type?
The funding instrument type is a grant.
Which activity categories and CFDAs are associated with this FOA?
The FOA falls under health research. The associated CFDA numbers are 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
Is cost sharing or matching required?
No. The FOA specifies that there is no cost sharing or matching requirement, meaning applicants were not required to contribute non-federal funds as a condition of an award.
What is the estimated total amount of funding available under this FOA?
The FOA lists an estimated total funding amount of $1,125,000.
What is the award ceiling?
The FOA lists an award ceiling of $200,000.
Does the FOA specify how many awards NIH planned to make?
The FOA summary information does not state the exact number of anticipated awards. However, the presence of both a total program amount and a per-award cap suggests NIH expected to make multiple awards to support several different assay-development approaches.
When was this funding opportunity posted, and what were the key dates?
It was posted on July 1, 2013. The application closing date was November 13, 2013. The opportunity was archived on December 14, 2013.
Is this FOA still open for applications?
No. The FOA was archived on December 14, 2013, and it had a defined application closing date of November 13, 2013, indicating it was time-limited rather than an ongoing open solicitation.
What types of organizations were eligible to apply?
Eligibility was broad and included public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); small businesses; for-profit organizations (including those other than small businesses); and many government entities such as state, county, city/township, and special district governments.
Were tribal governments and tribal organizations eligible?
Yes. The FOA explicitly included Native American tribal governments and tribal organizations as eligible applicants.
Were public housing authorities and independent school districts eligible?
Yes. The FOA explicitly allowed public housing authorities/Indian housing authorities and independent school districts to apply.
Were mission-focused institution types (for example HBCUs and Hispanic-serving institutions) included in the eligibility list?
Yes. The FOA explicitly referenced a range of mission-focused institutions, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and Alaska Native and Native Hawaiian-serving institutions, among others.
Were non-U.S. entities and foreign institutions eligible to apply?
Yes. The FOA states that non-U.S. entities and foreign institutions were eligible to apply. It also allows non-U.S. components of U.S. organizations to participate, and foreign components (as defined by NIH policy) were allowed.
Why does the FOA allow international participation?
The FOA frames reservoir measurement as a global research priority and notes that specialized expertise, technologies, and clinical cohorts relevant to HIV reservoir studies may exist outside the United States.
What kind of output does NIH want from projects funded under this FOA?
The FOA emphasizes concrete assay advances rather than purely descriptive studies of latency. The desired outputs are tools that improve the accuracy, efficiency, practicality, and biological relevance of reservoir quantification, particularly with respect to replication competence.
How does this FOA connect to HIV cure-directed research?
The FOA positions improved reservoir measurement as foundational for interpreting cure-directed clinical studies, because it can provide faster turnaround, better precision, and measurements more directly tied to the key biological endpoint: the number of cells capable of producing infectious HIV if therapy is stopped.
Where was the full announcement hosted, and who was listed for technical access issues?
The full announcement was hosted on the NIH grants website (link referenced in the source information). NIH’s Office of Extramural Research webmaster contact was listed for access or linking issues.
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