Development and Testing of Novel Interventions to Improve HIV Prevention, Treatment, and Program Implementation for People Who Use Substances (R34 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Oct 18, 2026
Can you apply?
This grant is for researchers and institutions developing and testing novel interventions for HIV prevention and treatment in people who use substances. Eligible applicants include research institutions, universities, nonprofits, and government agencies with research capacity. The project must include a clinical trial component as specified in the R34 mechanism. Both U.S. and international organizations can apply, though NIH citizenship requirements may apply to key personnel. Applicants must have institutional review board capabilities or access to them for human subjects research.
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Program description
This notice of funding opportunity (NOFO) encourages formative research, intervention development, and pilot-testing of interventions. Primary scientific areas of focus include the feasibility, tolerability, acceptability and safety of novel or adapted interventions that target HIV prevention, treatment or services research for people who use drugs. For the purposes of this NOFO, “intervention” may include behavioral, social, or structural approaches, as well as combination biomedical and behavioral approaches that prevent the acquisition and transmission of HIV infection, or improve clinical outcomes for persons living with HIV.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
How to apply
Application links
Required documents
- NIH SF-424 (R&R) form
- Project Narrative (research plan)
- Budget and budget justification
- Biographical sketches of key personnel
- Institutional review board approval or assurance documentation
- Letters of support from collaborating sites (if applicable)
- Facilities and resources documentation
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.279 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$976,983,003
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$204,359,786
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$128,377,094
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$126,585,435
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$99,478,296
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$79,333,238
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$78,245,057
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$74,806,844
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$71,588,047
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$61,572,673
Top States by Funding
- NC 2 awards $1,006.2M
- NY 4 awards $261.1M
- WA 1 awards $204.4M
- CT 2 awards $155.8M
- CA 4 awards $141.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.279). How funding has trended year over year.
| 2024 | $1,245,503,136 | |
| 2025 | $1,343,517,098 | |
| 2026 est. | $20,194,375 |
FAQ
What types of organizations can apply for this R34 grant?
Research institutions, universities, nonprofits with research capacity, and government agencies are eligible. You must have infrastructure for conducting clinical research.
Is a clinical trial required?
Yes. The R34 mechanism requires planning and piloting of a clinical trial. This is a mandatory component of the award.
What activities does this grant support?
Development of novel interventions, feasibility testing, pilot clinical trial activities, and preliminary implementation research are supported. The focus is on HIV prevention and treatment for people who use substances.
What is the typical funding level for R34 grants?
R34 awards typically range from $150,000–$400,000 per year. Exact amounts depend on your specific research plan and institutional rates.
When is the next deadline?
The deadline is March 16, 2027, with applications opening January 8, 2025. Check NIH Grants.gov for any rolling deadline information.
💡 Tips for applicants
- Clearly articulate the evidence gap your intervention addresses in HIV treatment or prevention for substance users. Use published literature to justify the innovation.
- Design a feasible pilot clinical trial within the R34 budget and timeline. Phase 1 awards focus on testing, not full efficacy trials.
- Build a strong team including HIV and addiction medicine experts, biostatisticians, and community partners with relevant populations. Collaboration strengthens competitiveness.
- Address implementation science from the start. Show how your intervention could be scaled or integrated into existing programs serving substance users.
- Detail your plan for IRB approval, informed consent procedures, and participant safety monitoring. NIH prioritizes ethical rigor in addiction research.
⚠️ Common mistakes
Proposing an intervention without adequate preliminary data or justification. R34 reviewers expect clear rationale based on existing evidence.
Underestimating the complexity of conducting clinical trials with substance-using populations. Budget and timeline must realistically account for recruitment, retention, and safety protocols.
Ignoring implementation context. NIH wants to see how findings will translate to real-world HIV and addiction treatment settings, not just laboratory results.
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- OPEN Accelerating the Pace of Substance Use Research Using Existing Data (R21 Clinical Trial Not Allowed) — National Institutes of Health
- OPEN Pilot Health Services and Economic Research on the Treatment of Drug, Alcohol, and Tobacco Use Disorders (R34 Clinical Trial Optional) — National Institutes of Health
- OPEN Implementation Science to Advance HIV Prevention, Treatment, and Care (R61/R33 Clinical Trial Optional) — National Institutes of Health