Martin Delaney Collaboratories for HIV Cure Research (UM1 Clinical Trial Not Allowed) | RFA AI 20 035

Opportunity Information: Apply for RFA AI 20 035

The Martin Delaney Collaboratories for HIV Cure Research (UM1 Clinical Trial Not Allowed), Funding Opportunity Number RFA-AI-20-035, is a National Institutes of Health (NIH) cooperative agreement designed to tackle one of the hardest barriers to an HIV cure: viral persistence in people whose HIV is otherwise controlled by suppressive antiretroviral therapy (ART). Even when ART keeps plasma virus levels undetectable, HIV can remain hidden in long-lived cellular and tissue reservoirs, creating the risk of viral rebound if treatment stops. This FOA funds coordinated, collaborative programs that combine basic, clinical, and applied research to develop credible cure strategies, where a cure is defined either as sustained viral remission without ongoing ART (sometimes described as durable post-treatment control) or as eradication of HIV infection.

A central feature of the program is its collaboratory model. Instead of supporting isolated projects, NIH is looking for integrated teams that work together across disciplines and institutions, with a clear plan for coordination, data sharing, and decision-making. The research is expected to be milestone-driven, meaning applicants should propose measurable goals and go/no-go decision points that keep the program focused on deliverables and make it easier to prioritize the most promising approaches as evidence emerges. Because this is a cooperative agreement (UM1), NIH typically has substantial scientific involvement during the award period, which generally means closer programmatic oversight, coordination expectations, and an emphasis on achieving agreed-upon milestones.

The scientific scope is tightly centered on strategies that address HIV reservoirs and viral rebound. Supported work should include innovative methods to better characterize and quantify persistent HIV-1 reservoirs, including understanding which reservoirs are truly capable of causing rebound (rebound-competent virus). The FOA also emphasizes research aimed at understanding and predicting post-treatment control, including biomarkers, mechanisms of immune control, and models that can forecast whether and when rebound will occur after ART interruption. Beyond measurement and prediction, the program encourages development and testing of therapeutic strategies intended to control viral rebound after discontinuation of ART, as well as strategies that aim to eradicate HIV or permanently inactivate the virus in cells that harbor rebound-competent HIV. In short, the program is built around three connected priorities: measure the problem more accurately, predict and understand rebound better, and test interventions that can deliver remission or elimination.

A key policy change in this iteration is the restriction on clinical trials. While some clinical research is required, clinical trials are not supported under this FOA. That means applicants can include human-focused work such as clinical cohort studies, intensive sampling protocols, laboratory analyses linked to clinical specimens, observational or translational studies, and other non-trial clinical investigations, but they should not propose interventional clinical trials. This constraint is important for applicants to reflect in their study designs, timelines, staffing, and regulatory planning, especially if they are used to cure-focused programs that include analytic treatment interruptions or experimental therapeutic administration in trial settings.

Another defining requirement is that each application must include at least one private sector entity. The purpose of this requirement is to speed translation from discovery to product development by ensuring that industry partners (for example, biotech or pharmaceutical companies, or other private sector organizations with relevant development capabilities) are embedded in the collaboratory from the start. In practice, NIH is signaling that successful teams should have a realistic pathway for moving promising findings toward therapeutic development and eventual testing, even though this particular FOA does not itself fund clinical trials. Applicants should therefore be prepared to describe how the private sector partner will contribute tangible capabilities such as platform technologies, manufacturing know-how, assay development, candidate optimization, regulatory strategy, or other translational infrastructure.

Eligibility is broad across U.S.-based organizations and includes state, county, city, township, and 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 (including those other than federally recognized tribal governments); nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses, plus an "other" category that can cover additional eligible domestic entities. The FOA also 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), faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions. At the same time, non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant can include certain defined foreign collaborations or activities if they meet NIH policy requirements and are well-justified scientifically.

From a funding and administrative standpoint, the award mechanism is a cooperative agreement (UM1) under NIH, listed within the broad health-related activity category, with CFDA numbers 93.242, 93.279, 93.847, 93.853, and 93.855 associated with NIH programs. The opportunity was created on 2020-06-15, with an original closing date of 2020-12-07. The stated award ceiling is $3,500,000, indicating the program anticipates relatively large, multi-component collaborative efforts consistent with the collaboratory structure and the milestone-based expectations. While the number of expected awards is not specified in the provided source data, the scale and structure suggest NIH intended to support a limited number of sizable, highly coordinated teams.

Overall, this FOA is aimed at building well-managed, translationally oriented collaboratories that can generate decisive progress on the core obstacles to curing HIV: identifying and measuring the reservoirs that matter, understanding and forecasting viral rebound and post-treatment control, and advancing therapeutic strategies that can either keep the virus durably suppressed without ART or eliminate/inactivate rebound-competent virus altogether, all while working in tight coordination with at least one private sector partner and staying within a non-clinical-trial clinical research framework.

• The National Institutes of Health in the education, food and nutrition, health sector is offering a public funding opportunity titled "Martin Delaney Collaboratories for HIV Cure Research (UM1 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, 93.279, 93.847, 93.853, 93.855.
• This funding opportunity was created on 2020-06-15.
• Applicants must submit their applications by 2020-12-07. (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 $3,500,000.00 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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