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

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity is an NIH discretionary grant announcement titled "Advancing HIV/AIDS Research at the Intersection of Oral and Mental Health (R01 Clinical Trial Not Allowed)." It is intended to support interdisciplinary research that explains how oral health and mental health interact among people living with HIV, with an emphasis on studying these issues together rather than in isolation.

What is the official funding opportunity number and CFDA number?

The Funding Opportunity Number (FOA/FON) is RFA-DE-23-002, and the CFDA number is 93.121.

What is the main goal of the FOA?

The central goal is to move beyond separate studies of oral health and mental health by supporting research that examines how these conditions cluster together in HIV-affected populations, how they influence each other over time, and which leverage points could inform better prevention and care across both dental and behavioral health settings.

Who is the research focused on?

The focus is on people living with HIV and, more broadly, HIV-affected populations, especially where oral health problems and mental health conditions co-occur alongside related disorders and social/structural inequities.

What kinds of questions or outcomes is NIH trying to understand through this FOA?

The FOA emphasizes research that clarifies why oral health problems and mental health conditions cluster together in the context of HIV, how they mutually reinforce one another, and how combined risk and resilience develop across time and context.

What does "intersection of oral and mental health" mean in this FOA?

In this context, it means studying oral health and mental health as linked, interacting systems in the lives of people living with HIV, including how biological, behavioral, psychosocial, and social structural factors jointly shape outcomes rather than treating each area as a separate silo.

What mechanism is used for this award?

The mechanism is an NIH R01, which generally supports substantial, multi-year research projects.

Are clinical trials allowed under this FOA?

No. The FOA explicitly states "Clinical Trial Not Allowed," meaning applicants should not propose studies that meet the NIH definition of a clinical trial, such as prospectively assigning participants to an intervention in order to evaluate effects on health-related outcomes.

What types of study designs are appropriate if clinical trials are not allowed?

Based on the FOA description, appropriate non-trial designs may include observational studies, mechanistic and translational studies, epidemiologic analyses, secondary data analyses, cohort studies, mixed-methods investigations, and implementation-related research that does not constitute a clinical trial. The overarching expectation is rigorous, hypothesis-driven or well-justified exploratory research that advances understanding of multilevel interactions.

What levels of influence does the FOA encourage researchers to integrate?

The FOA calls for integration across multiple levels, including biological factors (such as immunologic or inflammatory pathways), psychosocial factors (stress, stigma, trauma exposure, social support), behavioral factors (oral hygiene, substance use, medication adherence, diet, care-seeking patterns, other health behaviors), and social structural factors (poverty, housing instability, structural racism, barriers to services, criminal-legal involvement, geographic access issues).

Does the FOA encourage interdisciplinary research teams?

Yes. The FOA is designed to fund interdisciplinary research and is positioned to bridge dentistry, mental health, HIV medicine, behavioral science, and social science in order to explain the real-world clustering of conditions and drivers.

Is the FOA focused on health equity and disparities?

Yes. The FOA explicitly highlights social and structural factors such as poverty, housing instability, structural racism, and barriers to dental and mental health services, and it emphasizes understanding clustering of conditions in the presence of inequities. It also encourages participation from institutions closely connected to communities most impacted by HIV and related disparities.

What organizations are eligible to apply?

Eligibility is broad and includes many domestic organizations and governments, including: 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.

Are minority-serving institutions and community-based organizations included as eligible applicants?

Yes. The FOA 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, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations.

Are U.S. territories eligible to apply?

Yes. The FOA includes U.S. territories or possessions among the explicitly highlighted eligible applicant categories.

Can a non-U.S. (foreign) organization apply as the main applicant?

No. 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.

Are foreign collaborations allowed at all?

Yes. While foreign organizations cannot be the primary applicant, the FOA allows "foreign components" as defined in the NIH Grants Policy Statement. This means a U.S. applicant may include certain foreign collaborations or activities when justified and consistent with NIH requirements for foreign components.

What is meant by examining "combined, mutually reinforcing drivers"?

It refers to studying how drivers of oral health problems, mental health conditions, and related co-occurring disorders can interact and amplify each other in HIV-affected populations, rather than assuming each condition has separate causes and separate solutions.

Does the FOA require research to be hypothesis-driven?

The FOA indicates an expectation for rigorous, hypothesis-driven research or well-justified exploratory science that advances understanding of the oral health and mental health intersection in the context of HIV.

Does the provided FOA information list an award ceiling or the number of expected awards?

No. The provided information states that the source data does not specify an award ceiling or the number of expected awards.

When was the opportunity posted, and what was the closing date?

The opportunity was posted by NIH with a creation date of March 4, 2022, and an original closing date of July 25, 2022, indicating it was a time-limited solicitation.

What practical impact is NIH hoping this research will have?

The FOA aims to generate knowledge that can inform better prevention and care approaches across both dental and behavioral health settings, with clear relevance for future integrated care models and health equity-focused strategies.