Advancing Sustained/Extended Release for HIV Prevention (A-SER) (R01 Clinical Trial Not Allowed) | RFA AI 19 063

Opportunity Information: Apply for RFA AI 19 063

Advancing Sustained/Extended Release for HIV Prevention (A-SER) is an NIH R01 grant opportunity (RFA-AI-19-063) designed to push HIV prevention beyond daily pills and toward long-acting protection that lasts for months to years. The program is aimed at stimulating new and innovative sustained/extended release (SER) drug delivery systems (DDS) for HIV prevention in people who are at risk of acquiring HIV. A central idea behind the announcement is that adherence is one of the biggest real-world barriers to effective prevention, so NIH is prioritizing technologies that can keep drug levels protective over long periods with minimal user burden.

The science focus is specifically on a set of delivery platforms that NIH views as high-priority for making long-duration prevention practical and scalable. These include low-volume, self-injectable depots (formulations that could be injected in small amounts, ideally in a way that does not require a clinic visit), erosible/biodegradable implants (including in situ forming implants that create an implant-like depot after administration), intrauterine delivery systems (platforms designed for placement in the uterus to provide long-acting release), and transdermal delivery systems (such as patches or other skin-based delivery approaches). In general, the expectation is that the proposed DDS should be capable of delivering an HIV prevention agent in a controlled manner for extended timeframes, with attention to feasibility, safety, and acceptability for intended users.

A notable requirement is that applications must include an industry partner. This reflects NIHs intent to support projects that are positioned to translate into real products, not just proof-of-concept academic work. The announcement also addresses intellectual property realities: if the application uses a drug that is already approved or under development for HIV prevention or HIV treatment, and that drug is controlled by an intellectual property or patent or license holder, then those parties must be involved in a meaningful and significant way. Applicants are expected to show evidence of substantial commitment, typically through letters of support and other documentation that demonstrates the rights holders participation and willingness to enable development.

The funding mechanism is an R01 research project grant and the opportunity is explicitly labeled Clinical Trial Not Allowed, meaning the supported work should not include a clinical trial as defined by NIH. Projects would therefore be expected to focus on preclinical development, formulation and device engineering, in vitro and animal testing, product optimization, manufacturability considerations, and other translational studies that advance a platform toward readiness, without crossing into clinical trial activity under the NIH definition.

From an administrative standpoint, the opportunity is categorized as discretionary grant funding in the health area and is associated with CFDA numbers 93.242 and 93.855. The listed award ceiling is $600,000. The original closing date shown is December 4, 2019, and the opportunity was created on September 11, 2019. While the closing date indicates this particular announcement was time-bound, the description is still useful for understanding NIH priorities and the types of partnerships and deliverables NIH expects in long-acting HIV prevention technology development.

Eligibility is broad and includes many common applicant types across government, academia, nonprofit, and industry. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public housing authorities; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities. The announcement also explicitly highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, non-U.S. entities (foreign organizations), regional organizations, tribal governments other than federally recognized ones, and U.S. territories or possessions. This wide eligibility signals an interest in bringing in diverse institutional capabilities and reaching communities and regions that are often central to prevention implementation.

Overall, A-SER is essentially a product-oriented biomedical engineering and translational science push: build or significantly advance long-acting delivery technologies that can sustain HIV preventive drug exposure for extended periods, do so in platforms that could realistically be used at scale, and structure the work with the industry and IP relationships needed to move toward eventual real-world deployment.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing Sustained/Extended Release for HIV Prevention (A-SER) (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): 93.242, 93.855.
• This funding opportunity was created on 2019-09-11.
• Applicants must submit their applications by 2019-12-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $600,000.00 in funding.
• 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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