Opportunity Information: Apply for RFA HD 20 008
The National Institutes of Health (NIH) released this discretionary grant opportunity, RFA-HD-20-008, titled "Innovative Epidemiologic Approaches for Understanding Long-term Health Outcomes of HIV-exposed Uninfected (HEU) Populations (R61/R33 Clinical Trial Not Allowed)." It is designed to build stronger evidence about the long-term health impacts experienced by people who were exposed to HIV and/or antiretroviral therapy (ART) in utero but who are not themselves infected with HIV. The overall goal is to generate the kind of foundational, real-world data that can ultimately support the development of interventions aimed at reducing or preventing any long-term adverse outcomes associated with this early-life exposure.
A defining feature of the program is its phased, milestone-driven structure using the R61/R33 mechanism. In the first phase (R61), applicants are expected to show that they can successfully establish or leverage recruitment pathways and demonstrate the practical capacity to enroll adequate numbers of HEU participants. The target populations include HEU infants, children, adolescents, and/or young adults, and recruitment can take place in the United States and/or in international settings with a high HIV burden. This initial phase is essentially about feasibility and cohort build-out: proving that enrollment targets are realistic, that follow-up plans are workable, and that the research team can access the populations needed to answer the scientific questions in a credible way.
If the R61 phase milestones are met, the project transitions to the second phase (R33). In this phase, the established cohort is used to carry out the main research agenda using innovative epidemiologic approaches. While the announcement emphasizes innovation, it is grounded in cohort-based observational research rather than interventional clinical trials, and the FOA explicitly states "Clinical Trial Not Allowed." In practice, this points investigators toward advanced observational designs and analytic strategies that can strengthen causal inference, improve measurement of exposures and outcomes, and address confounding and bias that commonly affect long-term studies. The expectation is that these approaches will clarify how in utero exposure to HIV and/or ART may relate to later health trajectories, which could include a wide range of outcomes across development.
The opportunity is broad in who can apply, reflecting NIH's intent to support multidisciplinary and multi-sector teams capable of recruiting and following HEU populations. Eligible applicants include many types of U.S. governmental entities (state, county, city/township governments; special district governments; and independent school districts), higher education institutions (public/state-controlled and private), and housing authorities. It also includes federally recognized Native American tribal governments as well as Native American tribal organizations and other tribal governments that are not federally recognized. Nonprofits are eligible whether or not they hold 501(c)(3) status, and for-profit organizations are eligible as well (other than small businesses, which are also listed separately as eligible). In addition, the FOA explicitly highlights a wide set of "other eligible applicants," including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities and regional organizations. This breadth signals that NIH is open to applications led by institutions embedded in communities most affected by HIV, as well as international partners in high-burden settings where HEU cohorts may be larger and long-term follow-up can yield high-impact insights.
From an administrative standpoint, the funding instrument is a grant, and the activity category is listed under Health, Income Security and Social Services. The CFDA numbers associated with the opportunity are 93.242 and 93.865. The opportunity was created on 2019-09-17, and the original closing date was 2019-12-02. The source data provided does not specify an award ceiling or the expected number of awards, so applicants would normally look to the full FOA text and NIH budget guidance for details on allowable costs, project period structure across R61 and R33, and milestone requirements for transition between phases.
In plain terms, NIH used this FOA to push the field toward stronger, better-designed long-term observational research on HEU populations by first funding teams to prove they can recruit and maintain sufficient cohorts, and then funding those same teams to apply modern epidemiologic methods to understand downstream health outcomes tied to prenatal HIV and ART exposure. The end point is not an intervention trial within this program, but rather the evidence base needed to design effective interventions and policies in the future.Apply for RFA HD 20 008
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Innovative Epidemiologic Approaches for Understanding Long-term Health Outcomes of HIV-exposed Uninfected (HEU) Populations (R61/R33 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.865.
- This funding opportunity was created on 2019-09-17.
- Applicants must submit their applications by 2019-12-02. (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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