Opportunity Information: Apply for RFA AI 16 064

The Understanding HIV Persistence in Infants (R01) opportunity (RFA-AI-16-064) is a National Institutes of Health (NIH) research grant aimed at advancing scientific understanding of why HIV can persist in infants infected around the time of birth. The central focus is on the pathogenesis of perinatal HIV-1 infection, with particular emphasis on how HIV-specific immune responses operate within an infant's developing immune system and how the virus establishes and maintains latent reservoirs early in life. The program is designed to support studies that clarify the biological and immunological mechanisms that allow HIV to remain in the body despite treatment, especially in the context of infancy when immune function is rapidly changing.

A key theme of the announcement is the infant immune system as a moving target: immune defenses in early life are not simply smaller versions of adult immunity, and the FOA is oriented toward research that accounts for these developmental dynamics. Projects are expected to examine HIV-1 immune responses under these evolving conditions, including how early immune responses may shape long-term outcomes, influence viral control, or unintentionally contribute to persistence. Another core component is investigating the establishment and maintenance of HIV-1 latent viral reservoirs, which are populations of infected cells where the virus can remain dormant and hidden from both immune clearance and standard antiretroviral therapy. Understanding how these reservoirs are seeded and sustained in infants is positioned as a crucial step toward future interventions.

The overall goal is not an immediate clinical cure, but foundational knowledge that can be used later to design strategies intended to induce HIV remission. In practical terms, remission-focused research aims to achieve durable control of HIV without continuous antiretroviral therapy, and this FOA frames infant reservoir biology and early immune interactions as critical inputs into that longer-term objective. By funding mechanistic studies in this area, NIH is seeking to build the evidence base needed to inform future therapeutic, immunologic, or combination approaches that might limit reservoir formation, reduce reservoir size, or enable sustained viral suppression after treatment interruption.

Administratively, this is a discretionary grant using the NIH R01 mechanism, categorized under Health, Income Security and Social Services. The CFDA numbers listed for the opportunity are 93.242, 93.855, 93.856, and 93.865. The opportunity was created on August 5, 2016, and the original application closing date was December 7, 2016. An award ceiling and expected number of awards were not specified in the provided source data, which typically means applicants needed to consult NIH budget guidance and the specific FOA text for constraints and expectations.

Eligibility is broad and includes many types of domestic U.S. organizations and certain non-U.S. entities. Eligible applicants include state, county, city or township 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 Native American tribal organizations that are not federally recognized tribal governments. The FOA also allows nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education in those categories), for-profit organizations other than small businesses, and small businesses. Public housing authorities and Indian housing authorities are also eligible, as well as other applicants categorized as "Others."

The announcement explicitly highlights additional eligible applicant categories that NIH wants to encourage, reflecting an interest in broad participation and inclusive institutional representation. These include Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); and Tribally Controlled Colleges and Universities (TCCUs). It also includes eligible federal agencies, faith-based or community-based organizations, Indian/Native American tribal governments other than federally recognized entities, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities such as foreign organizations. This broad eligibility suggests NIH anticipated that progress in understanding infant HIV persistence could benefit from diverse settings, international collaborations, and research capacity that spans academic, clinical, community, and governmental environments.

Taken together, the grant opportunity is best understood as a targeted call for rigorous, hypothesis-driven research that explains how HIV persists in infants from the earliest stages of infection and treatment, with the explicit intention of enabling future remission strategies. The emphasis on immune development and latent reservoirs signals that competitive applications would likely center on mechanisms, measurable immune and virologic outcomes, and studies that can meaningfully inform the design of next-generation interventions for children infected perinatally.

  • The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Understanding HIV Persistence in Infants (R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.855, 93.856, 93.865.
  • This funding opportunity was created on 2016-08-05.
  • Applicants must submit their applications by 2016-12-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs): Understanding HIV Persistence in Infants (R01) (RFA-AI-16-064)

What is this funding opportunity?

This opportunity is the NIH research grant announcement titled Understanding HIV Persistence in Infants (R01), funding research focused on why HIV can persist in infants infected around the time of birth.

What is the FOA number and mechanism?

The FOA is RFA-AI-16-064 and it uses the NIH R01 research project grant mechanism.

What is the main scientific focus of the program?

The central focus is the pathogenesis of perinatal HIV-1 infection, with emphasis on (1) how HIV-specific immune responses function within an infant's developing immune system, and (2) how HIV establishes and maintains latent reservoirs early in life.

Why does the announcement emphasize the infant immune system as a "moving target"?

The FOA highlights that infant immune defenses are not just scaled-down versions of adult immunity. Because immune function changes rapidly in early life, the program prioritizes research that accounts for these developmental dynamics when studying HIV-1 immune responses and outcomes.

What types of immune questions are applicants expected to study?

Projects are expected to examine HIV-1 immune responses under evolving early-life immune conditions, including how early immune responses may shape long-term outcomes, influence viral control, or potentially contribute to viral persistence.

What are HIV-1 latent reservoirs in the context of this FOA?

Latent reservoirs are populations of infected cells in which HIV can remain dormant and hidden from immune clearance and standard antiretroviral therapy. The FOA positions understanding how these reservoirs are seeded and sustained in infants as a core research need.

Is the goal of this program an immediate clinical cure for HIV?

No. The stated goal is to build foundational mechanistic knowledge that can later be used to design strategies intended to induce HIV remission.

How does this FOA relate to HIV remission research?

The FOA frames infant reservoir biology and early immune interactions as important inputs to longer-term remission goals. Remission-focused research aims for durable control of HIV without continuous antiretroviral therapy, and this program supports the mechanistic evidence base needed to inform future approaches.

What kinds of future interventions could this foundational work inform?

Based on the description provided, the mechanistic studies supported here are intended to inform future therapeutic, immunologic, or combination strategies that might limit reservoir formation, reduce reservoir size, or enable sustained viral suppression after treatment interruption.

What category is this grant listed under?

The opportunity is categorized under Health, Income Security and Social Services.

What CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.242, 93.855, 93.856, and 93.865.

When was the opportunity created and when did it close?

The opportunity was created on August 5, 2016, and the original application closing date was December 7, 2016.

Was an award ceiling listed?

No. The provided source data did not specify an award ceiling.

Was the expected number of awards listed?

No. The provided source data did not specify the expected number of awards.

What does it mean that award ceiling and number of awards were not specified?

In the information provided, these details were not included. The description notes that applicants typically would need to consult NIH budget guidance and the full FOA text for constraints and expectations.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic U.S. organizations and certain non-U.S. entities, including governments, higher education institutions, nonprofits, for-profits (other than small businesses), small businesses, housing authorities, and other applicants categorized as "Others."

Are state and local governments eligible?

Yes. Eligible applicants include state, county, city or township governments, and special district governments.

Are educational institutions eligible?

Yes. Eligibility includes independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education.

Are tribal entities eligible?

Yes. Eligibility includes federally recognized Native American tribal governments and Native American tribal organizations that are not federally recognized tribal governments. The announcement also lists Indian/Native American tribal governments other than federally recognized entities among encouraged eligible categories.

Are nonprofits eligible?

Yes. The FOA allows nonprofit organizations, including 501(c)(3) nonprofits and non-501(c)(3) nonprofits (excluding institutions of higher education in those categories, as described in the provided information).

Are for-profit organizations eligible?

Yes. Eligibility includes for-profit organizations other than small businesses, and it separately lists small businesses as eligible.

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are included among eligible applicants.

Does NIH encourage applications from certain institution types?

Yes. The announcement explicitly highlights and encourages participation from several institution categories, including HBCUs, Hispanic-serving Institutions, TCCUs, AANAPISIs, and Alaska Native and Native Hawaiian Serving Institutions.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are listed among eligible applicant categories.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included among eligible applicant categories.

Are foreign (non-U.S.) organizations eligible?

Yes. The FOA includes non-domestic (non-U.S.) entities, such as foreign organizations, among eligible applicant categories.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are explicitly listed as eligible applicants.

What kind of research approach does this FOA appear to prioritize?

Based on the description provided, it is a targeted call for rigorous, hypothesis-driven, mechanistic research addressing how HIV persists in infants from the earliest stages of infection and treatment.

What topics seem most central for a competitive application, based on the description?

The announcement emphasizes (1) immune development in infancy and HIV-specific immune responses under changing conditions, and (2) the establishment and maintenance of latent reservoirs early in life, with measurable immunologic and virologic outcomes that inform future remission-oriented intervention design.

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