Opportunity Information: Apply for RFA AI 14 020

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovative Assays to Quantify the Latent HIV Reservoir (R01)" 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 Jun 27, 2014 and posted on Jun 27, 2014.
  • Applicants must submit their applications by Nov 7, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $1,300,000.00 to eligible and selected applicants.
  • Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) County governments Independent school districts Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) City or township governments Small businesses State governments Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses.
  • 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.
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Opportunity Summary:

The Innovative Assays to Quantify the Latent HIV Reservoir (R01) funding opportunity (RFA-AI-14-020) is a National Institutes of Health discretionary grant aimed at improving how researchers measure the hidden, long-lived pool of HIV-infected cells that persists in people living with HIV who are taking effective antiretroviral therapy. This so-called latent HIV reservoir is one of the main barriers to curing HIV, because standard therapy can suppress virus in the blood to undetectable levels but does not eliminate cells that harbor dormant, integrated HIV DNA capable of restarting infection if treatment stops. The central goal of the announcement is to support research that develops new assays or meaningfully upgrades existing assays so they can quantify latently infected cells more accurately, more efficiently, and with better practicality for use in clinical studies that test cure strategies.

A key motivation for the program is that the field has relied heavily on a limiting dilution viral outgrowth assay as the traditional benchmark for measuring replication-competent latent virus. While widely used, this approach is described as slow, labor intensive, resource heavy, and relatively imprecise. In practice, the assay requires substantial time, specialized expertise, and large numbers of cells, and it can underestimate the true reservoir because not all intact proviruses are induced to replicate under the assay conditions. Because cure-oriented interventions often aim to reduce the reservoir by modest but clinically meaningful amounts, measurement tools that are noisy, time-consuming, or systematically biased make it harder to run clear proof-of-concept trials and to compare results across studies.

Projects responsive to this FOA would therefore focus on either (1) molecular assays that can accurately detect and quantify replication-competent proviruses (not just total HIV DNA or defective genomes), or (2) improved viral outgrowth approaches that increase efficiency, sensitivity, and precision compared with the classic limiting dilution format. The overall emphasis is on developing reservoir quantification methods that better track the biologically relevant target: latent infection that is capable of producing infectious virus. Better assays would directly support in vivo HIV cure research by allowing investigators to evaluate whether an intervention truly reduces the reservoir, to estimate effect sizes with greater confidence, and to design smaller, faster, and more interpretable early-phase clinical studies.

Administratively, this opportunity was offered as an NIH R01 research grant in the health area, tied to CFDA programs 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The FOA was posted June 27, 2014, with an original and current closing date of November 7, 2014, and an archive date of December 8, 2014. The announcement listed an estimated total funding amount of $1.3 million and explicitly stated that cost sharing or matching was not required.

Eligibility was broad and included many common NIH applicant types across academia, government, nonprofit, and industry. Eligible applicants included public and private institutions of higher education, nonprofits with and without 501(c)(3) status, for-profit organizations (including small businesses), and multiple levels of government entities (state, county, city/township, special districts, and independent school districts). The eligibility list also encompassed tribal organizations and tribal governments (both federally recognized and other than federally recognized), public housing authorities/Indian housing authorities, and a range of mission- or population-focused institutions such as Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian-serving institutions, and Asian American Native American Pacific Islander-serving institutions. In addition, the FOA allowed participation by certain federal agencies, faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations), reflecting NIHs intent to draw on a wide pool of technical expertise in assay development and validation.

For reference and administrative support, the full announcement was hosted on the NIH grants website, with contact information directing technical access or linking problems to the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV).

Frequently Asked Questions (FAQs)

What is the name of this funding opportunity?

The opportunity is titled Innovative Assays to Quantify the Latent HIV Reservoir (R01).

What is the FOA number?

The FOA number is RFA-AI-14-020.

What type of grant mechanism is being used?

This is an NIH R01 research grant opportunity (a discretionary grant).

What is the overall purpose of this FOA?

The FOA aims to improve how researchers measure the latent HIV reservoir, the long-lived pool of HIV-infected cells that persists in people living with HIV who are on effective antiretroviral therapy.

What is the latent HIV reservoir, and why does it matter?

The latent HIV reservoir refers to cells that contain dormant, integrated HIV DNA that can restart infection if antiretroviral treatment stops. It is described as one of the main barriers to curing HIV because standard therapy can suppress virus in the blood to undetectable levels but does not eliminate these infected cells.

What is the central research goal supported by this announcement?

The central goal is to support research that develops new assays or meaningfully upgrades existing assays so they can quantify latently infected cells more accurately, more efficiently, and with better practicality for clinical studies that test HIV cure strategies.

Why is improved measurement of the reservoir important for HIV cure research?

Cure-oriented interventions may reduce the reservoir by modest but clinically meaningful amounts. If measurement tools are noisy, slow, or systematically biased, it becomes harder to run clear proof-of-concept trials, estimate effect sizes confidently, and compare results across studies.

What existing benchmark assay is discussed in the FOA, and what are its limitations?

The FOA notes that the field has relied heavily on a limiting dilution viral outgrowth assay as a traditional benchmark for measuring replication-competent latent virus. It is described as slow, labor intensive, resource heavy, and relatively imprecise. It also requires substantial time, specialized expertise, and large numbers of cells, and it can underestimate the reservoir because not all intact proviruses are induced to replicate under the assay conditions.

What kinds of projects are considered responsive to this FOA?

Responsive projects focus on one of two areas:

  1. Molecular assays that can accurately detect and quantify replication-competent proviruses (not just total HIV DNA or defective genomes), or
  2. Improved viral outgrowth approaches that increase efficiency, sensitivity, and precision compared with the classic limiting dilution format.

What does the FOA emphasize as the most biologically relevant measurement target?

The emphasis is on quantifying latent infection that is capable of producing infectious virus, rather than only measuring total HIV DNA or defective genomes.

How are better assays expected to help clinical studies?

Better assays are expected to support in vivo HIV cure research by helping investigators determine whether an intervention truly reduces the reservoir, estimate effect sizes with greater confidence, and design smaller, faster, and more interpretable early-phase clinical studies.

Which CFDA programs are associated with this opportunity?

The FOA is tied to CFDA programs 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).

When was the FOA posted?

The FOA was posted on June 27, 2014.

What were the closing dates for the opportunity?

The announcement lists an original and current closing date of November 7, 2014.

When was the FOA archived?

The archive date is December 8, 2014.

What was the estimated total funding amount?

The FOA listed an estimated total funding amount of $1.3 million.

Is cost sharing or matching required?

No. The announcement explicitly states that cost sharing or matching is not required.

Who is eligible to apply?

Eligibility is broad and includes many common NIH applicant types across academia, government, nonprofit, and industry. Eligible applicants include:

  • Public and private institutions of higher education
  • Nonprofits with and without 501(c)(3) status
  • For-profit organizations (including small businesses)
  • State, county, city/township, special district, and independent school district governments
  • Tribal organizations and tribal governments (federally recognized and other than federally recognized)
  • Public housing authorities/Indian housing authorities
  • Historically Black Colleges and Universities (HBCUs)
  • Hispanic-serving institutions
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian-serving institutions
  • Asian American Native American Pacific Islander-serving institutions
  • Certain federal agencies
  • Faith-based and community-based organizations
  • Regional organizations
  • U.S. territories or possessions
  • Non-U.S. entities (foreign organizations)

Are non-U.S. (foreign) organizations allowed to apply?

Yes. The eligibility list includes non-U.S. entities (foreign organizations).

Are for-profit companies eligible to apply?

Yes. The FOA includes for-profit organizations, including small businesses, as eligible applicants.

Are community-based and faith-based organizations eligible?

Yes. The eligibility list explicitly includes faith-based and community-based organizations.

Are tribal governments and tribal organizations eligible?

Yes. The FOA includes tribal organizations and tribal governments, including those that are federally recognized and those other than federally recognized.

Where was the full announcement hosted?

The full announcement was hosted on the NIH grants website.

Who should be contacted for technical access issues or linking problems?

For technical access or linking problems, the FOA directs users to contact the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.

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