Interaction between ARVs and Hormones in HIV and Coinfections (R01 Clinical Trial Optional) | RFA AI 24 018

Opportunity Information: Apply for RFA AI 24 018

The National Institutes of Health (NIH) is offering a discretionary grant opportunity titled "Interaction between ARVs and Hormones in HIV and Coinfections (R01 Clinical Trial Optional)" under Funding Opportunity Number RFA-AI-24-018. This is an R01 research project grant, meaning it is geared toward supporting substantial, hypothesis-driven research projects that can generate rigorous, publishable findings and, when appropriate, produce actionable evidence to inform clinical care and public health practice. The scientific focus is on understanding how hormone therapy and antiretroviral drugs (ARVs) interact when ARVs are used for HIV treatment, HIV prevention, and the management of HIV-related co-infections. Because the NOFO is labeled "Clinical Trial Optional," applicants may propose studies that include a clinical trial component, but they are not required to do so; strong applications could also be preclinical, translational, pharmacologic, or mechanistic in design.

At its core, the NOFO is aimed at identifying and characterizing drug-hormone interactions. In practical terms, this means research that clarifies how hormone therapies (for example, gender-affirming hormone therapy or other clinically indicated hormonal regimens) may affect ARV pharmacokinetics and pharmacodynamics, and how ARVs may in turn alter hormone levels, hormone metabolism, therapeutic effects, or side effect profiles. The opportunity explicitly includes ARVs used both for treatment and for prevention, which commonly encompasses antiretroviral therapy for people living with HIV as well as pre-exposure prophylaxis (PrEP) or other prevention strategies. The mention of "HIV and co-infections" broadens the scope beyond HIV alone and signals interest in real-world clinical complexity, where patients may be managing additional infectious diseases and taking other medications that could compound interaction risks or alter safety and efficacy.

The NOFO’s objective implies several kinds of outcomes NIH is likely seeking from funded work. These include clearer guidance on whether hormone therapy changes ARV exposure (too low, risking reduced effectiveness; or too high, increasing toxicity), whether ARVs change hormone exposure (potentially reducing desired hormonal effects or increasing adverse effects), and which combinations pose the highest risk or require monitoring, dose adjustments, or alternative regimens. Studies may also address adherence and persistence indirectly if interaction concerns, side effects, or perceived reductions in hormone effectiveness influence whether people continue ARVs or hormone therapy as prescribed. Overall, the funding is intended to support research that improves evidence-based care for populations who use hormone therapy and also rely on ARVs for HIV treatment or prevention, including those with co-infections.

Eligibility for this opportunity is broad and includes many types of U.S.-based applicants as well as certain non-U.S. entities. Eligible applicants listed 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, and Native American tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and an "other" category that can cover additional eligible organizational forms depending on NIH policy and the NOFO’s specific terms. The NOFO further highlights additional eligible applicant types 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), eligible federal government agencies, faith-based or community-based organizations, regional organizations, tribal governments that are not federally recognized, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This breadth suggests NIH is encouraging a wide range of research institutions and community-connected organizations to participate, potentially supporting studies that are clinically relevant and grounded in the needs of diverse populations.

Key administrative details from the source information include the original application due date of 2024-07-30 and the creation date of 2024-03-28. The opportunity is categorized under the broad activity areas of education, health, income security, and social services, and it is associated with CFDA numbers 93.242, 93.279, 93.855, and 93.865, reflecting the NIH program and funding lines supporting the announcement. The listing does not provide an award ceiling or expected number of awards in the provided excerpt, which typically means applicants should consult the full NOFO text for budget guidance, project period expectations, and any institute-specific limits or preferences.

In summary, RFA-AI-24-018 is designed to generate strong evidence about how hormone therapy and ARVs influence one another in the context of HIV treatment, HIV prevention, and HIV-related co-infections, with the flexibility to include or exclude clinical trials. NIH is positioning this opportunity to support research that can directly inform safer, more effective, and more person-centered care by clarifying interaction mechanisms, clinical significance, and implications for dosing, monitoring, outcomes, and real-world use across diverse settings and populations.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Interaction between ARVs and Hormones in HIV and Coinfections (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.279, 93.855, 93.865.
• This funding opportunity was created on 2024-03-28.
• Applicants must submit their applications by 2024-07-30. (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 AI 24 018

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: