Advancing HIV/AIDS Research at the Intersection of Oral and Mental Health (R01 Clinical Trial Not Allowed) | RFA DE 23 002

Opportunity Information: Apply for RFA DE 23 002

Advancing HIV/AIDS Research at the Intersection of Oral and Mental Health (R01 Clinical Trial Not Allowed) is an NIH discretionary grant opportunity (Funding Opportunity Number RFA-DE-23-002; CFDA 93.121) designed to fund interdisciplinary research that explains how oral health and mental health interact for people living with HIV. The central goal is to move beyond studying these issues in isolation by supporting projects that examine the combined, mutually reinforcing drivers of oral health problems, mental health conditions, and related co-occurring disorders in HIV-affected populations. In practice, the FOA is looking for research that can clarify why these conditions cluster together, how they influence one another over time, and which leverage points could ultimately inform better prevention and care approaches across both dental and behavioral health settings.

A key emphasis is on understanding mechanisms and interplay across multiple levels of influence. The announcement explicitly calls out biological factors (for example, immunologic or inflammatory pathways relevant to HIV and oral disease), psychosocial factors (such as stress, stigma, trauma exposure, and social support), behavioral factors (including oral hygiene behaviors, substance use, medication adherence, diet, care-seeking patterns, and other health behaviors), and social structural factors (like poverty, housing instability, structural racism, barriers to dental and mental health services, criminal-legal involvement, and geographic access issues). The intention is to encourage research teams to integrate these levels rather than treating them as separate silos, with the expectation that stronger explanations of combined risk and resilience will emerge when oral health, mental health, and HIV-related outcomes are studied together.

The mechanism is an R01, which generally supports substantial, multi-year research projects, and the FOA states "Clinical Trial Not Allowed." That means applicants should not propose studies that meet the NIH definition of a clinical trial (for example, prospective assignment to an intervention to evaluate effects on health-related outcomes). The opportunity is instead oriented toward non-trial research designs, which may include observational studies, mechanistic and translational studies, epidemiologic analyses, secondary data analyses, cohort studies, mixed-methods investigations, implementation-related research that does not constitute a clinical trial, and other approaches that can illuminate causal pathways and multilevel interactions without prospectively assigning interventions. The core expectation is rigorous, hypothesis-driven or well-justified exploratory science that advances understanding of how oral and mental health intersect in the context of HIV.

Eligibility is broad and includes many types of domestic organizations and governments. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); public housing authorities/Indian housing authorities; federally recognized tribal governments; tribal organizations other than federally recognized tribal governments; for-profit organizations other than small businesses; small businesses; and other entities. The FOA also explicitly highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. This wide eligibility reflects the FOA's interdisciplinary intent and encourages participation from institutions that may be closely connected to the communities most impacted by HIV and by disparities in oral and mental health.

At the same time, there are important limits related to foreign involvement. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, the FOA allows "foreign components" as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may include certain foreign collaborations or activities when justified and when they meet NIH requirements for foreign components. This setup typically supports U.S.-led projects that may need international expertise, populations, or resources, without making the foreign organization the primary awardee.

The opportunity was posted by the National Institutes of Health, with a creation date of March 4, 2022, and an original closing date of July 25, 2022, indicating it was a time-limited solicitation. While the provided source data does not specify an award ceiling or the number of expected awards, the FOA is clearly positioned to fund meaningful, collaborative research that bridges dentistry, mental health, HIV medicine, behavioral science, and social science. Overall, the announcement targets projects that can explain the real-world clustering of oral disease and mental health challenges among people living with HIV, especially in the presence of social and structural inequities, and that can generate knowledge with clear relevance for future integrated care models and health equity-focused strategies.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing HIV/AIDS Research at the Intersection of Oral and Mental Health (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 2022-03-04.
• Applicants must submit their applications by 2022-07-25. (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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