Martin Delaney Collaboratory for Pediatric HIV Cure Research (UM1 Clinical Trial Not Allowed) | RFA AI 20 036

Opportunity Information: Apply for RFA AI 20 036

The Martin Delaney Collaboratory for Pediatric HIV Cure Research (RFA-AI-20-036) is a National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) funding opportunity designed to push pediatric HIV cure research forward through a highly coordinated, team-based approach. The program is focused on children, adolescents, and young adults up to 24 years of age who were infected perinatally, with particular emphasis on those treated very early in life. The overarching aim is to develop realistic paths to an HIV cure in pediatric populations, where "cure" is defined in two ways: either complete eradication of HIV from the body or sustained viral remission, meaning durable viral suppression that continues even after antiretroviral therapy (ART) is stopped.

This opportunity uses a UM1 cooperative agreement mechanism, which signals that projects are expected to operate as a collaboratory rather than as isolated studies. In practical terms, awardees would be expected to run integrated research programs that connect basic science, clinical insights, and applied research tools, and to do so in a way that accelerates translation of discoveries toward clinical relevance. Although the work is meant to inform future clinical applications, the FOA is explicitly labeled "Clinical Trial Not Allowed," indicating that applications should not propose NIH-defined clinical trials under this award. Instead, the emphasis is on generating the foundational knowledge, technologies, and preclinical or translational evidence needed to enable effective pediatric cure strategies.

Scientifically, the FOA targets several core needs in the pediatric cure field. A central theme is improving understanding of HIV latency and persistence in children, including how and where viral reservoirs are established, maintained, and potentially differ from adult reservoirs due to developmental immunology, timing of infection, and early ART. Applicants are expected to pursue innovative cure concepts and approaches, which could include strategies aimed at reducing or eliminating reservoirs, preventing viral rebound, or enabling long-term immune control without continuous therapy. Just as important is the development and evaluation of assays and other measurement modalities that can accurately characterize HIV reservoirs in pediatric settings, where sample volumes, ethical considerations, and developmental factors can make measurement more difficult than in adults. The FOA also stresses translating findings into clinical settings, meaning that tools and insights should be built with real-world pediatric care and research constraints in mind.

From a funding and administrative standpoint, the opportunity was issued by the U.S. Department of Health and Human Services through NIH, with a creation date of June 15, 2020, and an original application closing date of December 7, 2020. It anticipates a single award (ExpectedAwards: 1), suggesting NIH intended to fund one major, comprehensive collaboratory rather than multiple smaller projects. The award ceiling is listed at $3,500,000, indicating the maximum annual direct cost level or total cost cap as specified in the announcement materials. The activity aligns with health-related federal assistance programs under CFDA numbers 93.242, 93.279, 93.855, and 93.865.

Eligibility is broad and includes many organization types that could realistically assemble the multidisciplinary capabilities required for a collaboratory. Eligible applicants include public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and various governmental entities such as state, county, and city governments, as well as tribal governments and tribal organizations. This breadth reflects the expectation that successful applications may involve multi-institution partnerships spanning academia, clinical networks, laboratory science, biostatistics, assay development, and potentially industry-enabled technology platforms, all coordinated under a single integrated program.

In short, this FOA supports a single, large, coordinated pediatric HIV cure research collaboratory focused on perinatally infected youth, especially those treated early, with the goal of advancing the science needed to achieve either durable ART-free remission or true eradication. It prioritizes pediatric-specific reservoir biology, development of better reservoir measurement tools, and evaluation of innovative cure strategies in ways that are tightly connected to eventual clinical translation, while stopping short of supporting clinical trials within this award mechanism.

• The Department of Health and Human Services, National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Martin Delaney Collaboratory for Pediatric 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, 93.855, 93.865.
• This funding opportunity was created on Jun 15, 2020.
• Applicants must submit their applications by Dec 07, 2020. (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.
• The number of recipients for this funding is limited to 1 candidate(s).
• 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 (see text field entitled Additional Information on Eligibility for clarification).

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