Long Acting Treatments for HIV and HIV-Associated Co-Infections (R61/R33 Clinical Trial Not Allowed) | RFA AI 20 024

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This grant opportunity, titled "Long Acting Treatments for HIV and HIV-Associated Co-Infections (R61/R33 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-AI-20-024), is a National Institutes of Health (NIH) discretionary grant program focused on advancing long-acting therapeutic options for HIV and key HIV-associated co-infections, specifically tuberculosis (TB) and viral hepatitis B and C. The central aim is to stimulate new, innovative, and multidisciplinary research that can produce effective treatments designed to be administered once per month or even less frequently, addressing persistent challenges around daily dosing, adherence, and consistent drug exposure over time. The opportunity sits within the NIH health funding activity category and is associated with CFDA number 93.855.

The scientific emphasis is on long-acting therapeutics across multiple delivery platforms, including oral formulations with extended duration, long-acting injectables, implantable systems, and transdermal products. In practical terms, the program is looking for research efforts that can meaningfully extend dosing intervals while maintaining therapeutic effectiveness and safety, which often requires integration across pharmacology, drug formulation, materials science, infectious disease biology, and translational development. By explicitly highlighting HIV along with TB and hepatitis B/C, the announcement signals interest in product concepts and enabling technologies that could improve real-world treatment for people who face overlapping infections and complex care needs, including settings where frequent clinic visits or strict daily adherence are difficult.

The mechanism is an R61/R33, which is commonly used by NIH as a phased innovation pathway. While the specific milestones are not listed in the provided excerpt, this structure generally supports an early, milestone-driven stage (R61) intended to establish feasibility and generate key proof-of-concept data, followed by a second stage (R33) aimed at further development once predefined goals are met. Importantly, the notice states "Clinical Trial Not Allowed," meaning the work proposed under this funding opportunity must not include clinical trials. Applicants would generally be expected to focus on preclinical or non-clinical development activities such as formulation development, pharmacokinetics/pharmacodynamics work, drug delivery system engineering, in vitro and in vivo efficacy studies, and other translational experiments that move a candidate long-acting approach closer to eventual clinical readiness without actually conducting a clinical trial within this award.

Eligibility is broad and includes many types of domestic U.S. applicants: state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations that are not federally recognized governments; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The opportunity also explicitly calls out additional eligible applicant categories that NIH wants to encourage, including 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, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This wide eligibility suggests NIH is aiming to attract a diverse set of teams and capabilities, from academic labs and research institutes to industry and community-linked organizations, including international groups that may bring specialized expertise or relevant disease-area experience.

Key administrative details from the source data include the sponsoring agency (NIH), the original closing date (2020-07-28), and the opportunity creation date (2020-03-23). The award ceiling and expected number of awards are not specified in the provided information. Overall, the opportunity is best understood as an NIH push to accelerate next-generation long-acting treatment science for HIV and major co-infections by supporting multidisciplinary, preclinical-to-translational research that can yield dosing strategies of monthly or longer intervals using oral, injectable, implantable, or transdermal delivery approaches, while keeping the funded scope strictly outside of clinical trial execution.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Long Acting Treatments for HIV and HIV-Associated Co-Infections (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): 93.855.
• This funding opportunity was created on 2020-03-23.
• Applicants must submit their applications by 2020-07-28. (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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