RFA-DA-25-060
High Priority HIV and Substance Use Research (RM1 Clinical Trial Optional)
Summary
RFA-DA-25-060: High Priority HIV and Substance Use Research
Research Focus
This funding opportunity supports interdisciplinary team research at the intersection of HIV and substance use, targeting prevention, treatment, and cure strategies for people who use addictive substances (opioids, stimulants, nicotine, cannabinoids, and combinations including alcohol). The National Institute on Drug Abuse (NIDA) seeks research that addresses gaps in the HIV care continuum, comorbidities (cardiovascular, respiratory, neurological, psychiatric), and health outcomes across the lifespan. Research may span basic science, translational, epidemiologic, clinical, intervention, and implementation science approaches. Priority areas include HIV etiology and pathogenesis in substance use populations; HIV latency and neurocognitive impairment in the central nervous system (CNS); systems-science approaches to testing and prevention; whole-person care models integrating HIV, substance use disorder (SUD), and comorbidity treatment; social determinants of health; and bridging across biological scales and disciplines to understand shared mechanisms of HIV persistence and related comorbidities.
At a Glance
- Who can apply: Research teams of 3–6 PD/PIs from eligible institutions (US-based research only)
- Funding & project length: Not stated; 5-year award period specified
- Award mechanism: RM1 (Research Project with Complex Structure); clinical trials optional
- Key dates: LOI due 30 days before application deadline; application cycles with deadlines in August 2024, February 2025, August 2025, February 2026, and August 2026; expiration March 6, 2027
- Best fit for: Interdisciplinary teams combining expertise in HIV virology, neuroscience, epidemiology, behavioral/social sciences, implementation science, or health economics to tackle a single, integrated, transformative research goal requiring synergistic collaboration
Key Facts
Deadline
Fri, March 5, 2027
Posted
Wed, January 17, 2024
Award / Year (direct costs)
$500,000
Max Total
$2,500,000
Max Duration
5 years
Keywords
Research Areas
Gotchas (9)
Applications proposing only clinical epidemiological, observational, genetic, or comparative effectiveness research are non-responsive
90%
Source Text
“Applications proposing only clinical epidemiological or observational studies, genetic studies, or comparative effectiveness research.”
This NOFO is restricted to research teams of three to six PD/PIs—solo PIs or teams outside this range are ineligible, which differs sharply from typical R01 mechanisms.
95%
Source Text
“This initiative is open only to research teams of three to six PD/PIs proposing to pursue challenging research questions at the intersection of HIV and substance use.”
The research must have a single overarching goal and integrated plan that is synergistic and essential to that goal—not parallel or series efforts. Projects that are primarily expansions of existing p
95%
Source Text
“Applications responding to this NOFO are required to have a single overarching goal and an integrated research plan that incorporates multiple perspectives and disciplines to deliver transformative outcome(s) within the 5-year award period... It should also be of sufficient scope and complexity that it can only be achieved through an integrative interdisciplinary team effort and not by individual, parallel, or series of efforts. All contributions by each team member and components of the researc”
Applications proposing only clinical trials designed to answer specific questions about safety, tolerability, acceptability, or efficacy (phase I, II, III, or pivotal) will be deemed non-responsive an
95%
Source Text
“Clinical trials designed to answer only specific questions related to safety, tolerability, acceptability, or efficacy of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions (e.g., phase I, phase II, phase III, or pivotal clinical trials). PIs are strongly encouraged to discuss any planned clinical trial in consideration for this opportunity with the scientific program contact to avoid errors in interpretation.”
Applications proposing research and data collection outside the US will not be accepted, even if the team is US-based. This is a geographic restriction on the research site, not just applicant organiz
95%
Source Text
“Applications proposing research and data collection outside the US will not be accepted.”
NOFO explicitly not intended for applications that only expand existing research programs or focus only on technology/medication/infrastructure development
90%
Source Text
“This NOFO is not intended for applications proposing projects that only expand existing research programs, nor for applications that focus only on development of new technologies, medications and/or infrastructure.”
Applications focused solely on alcohol exposure are explicitly non-responsive and will be withdrawn without review, even though alcohol is mentioned elsewhere as a substance of interest in combination
90%
Source Text
“Applications focused solely on alcohol exposure.”
Applications proposing only to discover/develop a small molecule, biologic therapeutic, or device to treat SUD or HIV are non-responsive. Technology development alone is insufficient; it must be part
90%
Source Text
“Applications proposing only to discover and/or develop a small molecule, biologic therapeutic, or therapeutic device to treat SUD or HIV and HIV-associated comorbidities.”
Preliminary data is explicitly required in the application. This is a mandatory component that differs from some R01 mechanisms and must be included in the research plan.
90%
Source Text
“Applications submitted under this NOFO are required to have a detailed research plan, preliminary data, and a clear description of the nexus between HIV and substance use.”