Cohort Studies of HIV/AIDS and Substance Use (U01 Clinical Trial Not Allowed) | RFA DA 25 003

Opportunity Information: Apply for RFA DA 25 003

The grant opportunity titled "Cohort Studies of HIV/AIDS and Substance Use (U01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-DA-25-003) is a National Institutes of Health (NIH) funding announcement intended to continue and strengthen the National Institute on Drug Abuse (NIDA) HIV Cohorts Program. The central goal is to support cohort-based research that examines the intersection of HIV/AIDS and substance use, with an emphasis on multidisciplinary work that responds to new, emerging, or high-priority research needs. Projects are expected to align with broader NIH HIV research priorities and to generate evidence that can realistically inform policy decisions, clinical practice, prevention strategies, or service delivery for communities affected by both HIV and substance use.

This NOFO uses the cooperative agreement mechanism (U01), which generally means the funded research will involve a more active partnership with NIH staff than a standard research project grant. In practice, applicants should be prepared for substantial coordination, shared expectations around program goals, and participation in program-wide activities typical of an organized cohorts program (for example, harmonization approaches, common measures, data sharing expectations, or cross-site collaboration), depending on the specific program requirements described in the full announcement. The funding activity category is listed under Education and Health, and the CFDA number associated with the opportunity is 93.279.

The scientific focus is specifically on cohort studies related to HIV/AIDS and substance use. The announcement encourages both existing cohort sites and new sites, signaling that NIDA is interested in maintaining successful ongoing cohort infrastructures while also bringing in new populations, settings, or methodological strengths where there are gaps. The "Clinical Trial Not Allowed" designation indicates that applications should not propose clinical trials as defined by NIH, so the proposed work should stay within observational cohort designs and related analyses rather than interventional testing. The intent is to leverage cohorts to answer timely questions about how substance use and HIV interact across prevention, transmission risk, engagement in care, treatment outcomes, comorbidities, and other real-world issues that are best addressed through longitudinal or cohort-based approaches.

Eligibility is broad and spans many types of U.S.-based organizations and governments. Eligible applicants include state, county, and local 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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education when applying under those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other eligible entities. The announcement also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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, and U.S. territories or possessions. This broad eligibility profile is consistent with the program goal of supporting cohort research that is deeply connected to diverse communities and service systems impacted by HIV and substance use.

There are important restrictions related to foreign involvement. Non-domestic (non-U.S.) entities and non-U.S. foreign institutions are not eligible to apply as the applicant organization. Non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" are allowed as defined in the NIH Grants Policy Statement, which typically means a U.S. applicant may include certain foreign elements in the project when scientifically justified and appropriately structured, even though a foreign institution cannot serve as the primary applicant.

Key administrative details include the original closing date of August 16, 2024, and the opportunity being categorized as discretionary funding. The source record lists an award ceiling and expected awards fields without values, which usually means applicants should rely on the full NOFO text for budget guidance, anticipated number of awards, and any limits or expectations around project period and costs. The opportunity record indicates it was created on September 11, 2023, and it is administered by NIH, with NIDA as the programmatic home given the focus on substance use in the context of HIV.

Overall, this funding opportunity is designed for organizations that can conduct or support rigorous longitudinal cohort research at the intersection of HIV/AIDS and substance use, contribute to a larger coordinated cohorts effort, and produce findings that are directly useful for improving public health responses, healthcare delivery, and policy for populations experiencing overlapping HIV and substance use risks.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Cohort Studies of HIV/AIDS and Substance Use (U01 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): 93.279.
• This funding opportunity was created on 2023-09-11.
• Applicants must submit their applications by 2024-08-16. (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 DA 25 003

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