Oral Health in People Living with HIV and Additional Non-Communicable Diseases (R01 Clinical Trial Not Allowed) | RFA DE 20 001

Opportunity Information: Apply for RFA DE 20 001

The National Institutes of Health (NIH) released this discretionary grant funding opportunity, RFA-DE-20-001, titled "Oral Health in People Living with HIV and Additional Non-Communicable Diseases (R01 Clinical Trial Not Allowed)," to push forward research that clarifies what is happening in the mouths and overall oral health of people living with HIV (PLWH), especially those who are also dealing with non-communicable diseases (NCDs). The main idea is that as HIV has increasingly become a manageable chronic condition for many people because of antiretroviral therapy (ART), a growing share of PLWH are also living longer and facing other chronic health issues like cardiovascular disease, diabetes, kidney disease, and other NCDs. This FOA is aimed at filling major knowledge gaps about how HIV infection itself, long-term ART exposure, and the presence of NCDs interact to shape oral disease risk, severity, progression, and outcomes.

A central focus of the opportunity is understanding the combined and overlapping effects of HIV, ART, and NCDs on oral health status. In practical terms, that means research that can untangle whether certain oral conditions in PLWH are driven primarily by immune changes associated with HIV, by medication effects (such as changes in saliva, inflammation, or metabolism), by comorbid chronic diseases, or by the way these factors compound each other. The FOA encourages work that goes beyond describing oral disease prevalence and instead produces clearer evidence about mechanisms, risk profiles, and clinically meaningful patterns that could influence dental care planning for PLWH who may have complex medical histories.

The announcement also emphasizes the need to identify better approaches for prevention and treatment of oral diseases in PLWH, and it supports assessment of treatment outcomes in PLWH with or without additional NCDs. This includes research that examines how well specific dental and oral health interventions work in these populations, what factors predict better or worse outcomes, and how comorbid conditions may require adapted management strategies. A key expected contribution is evidence that can support the development or refinement of oral health treatment guidelines tailored to dental patients with HIV, recognizing that standard approaches used for the general population may not fully address the clinical realities of HIV and multimorbidity.

This is an R01 mechanism, meaning it is intended for substantial, hypothesis-driven research projects, and it is explicitly labeled "Clinical Trial Not Allowed," which signals that applications should not propose a clinical trial as defined by NIH standards. In general, that steers applicants toward observational, epidemiologic, behavioral, translational, or other non-trial study designs that still produce rigorous evidence on oral health outcomes, determinants, and care considerations for PLWH, including those with NCD comorbidities.

Eligibility is broad and includes a wide range of organizational types that can contribute to this research area. Eligible applicants include state, county, city or township governments, special district governments, and independent school districts; public and state-controlled institutions of higher education and private institutions of higher education; federally recognized Native American tribal governments as well as tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses, as well as small businesses; and other organizations that meet NIH eligibility requirements. The FOA also highlights additional eligible applicants such as 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), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, non-U.S. entities (foreign organizations), regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions. This broad eligibility reflects the reality that meaningful research in this space often benefits from partnerships among academic centers, community organizations, safety-net providers, and institutions serving populations disproportionately affected by HIV and chronic diseases.

From an administrative standpoint, the opportunity is classified under the health funding activity category and is associated with CFDA number 93.121. The FOA was created on April 8, 2019, and the original closing date listed is July 29, 2019. The notice does not provide an award ceiling or an expected number of awards in the excerpt provided, which typically means applicants would need to consult the full FOA text and NIH budget guidance for details on allowable budget levels, project periods, and anticipated funding volume. Overall, the opportunity is designed to generate stronger, more practical evidence about oral health needs and management in PLWH, particularly in the increasingly common context of HIV combined with additional chronic non-communicable diseases.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Oral Health in People Living with HIV and Additional Non-Communicable Diseases (R01 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): 93.121.
• This funding opportunity was created on 2019-04-08.
• Applicants must submit their applications by 2019-07-29. (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.

Apply for RFA DE 20 001

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