Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Sep 4, 2026
Can you apply?
This grant is for researchers planning and implementing behavioral and social intervention clinical trials focused on dental, oral, or craniofacial conditions. Eligible applicants include universities (HBCUs, HSIs, TCCUs), federal agencies, faith-based or community-based organizations, tribal governments, and regional organizations. The grant supports a two-phase approach: UG3 planning phase (up to 2 years) followed by optional UH3 implementation phase (up to 5 years). Non-U.S. organizations and foreign components of U.S. organizations are not eligible.
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Program description
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage UG3/UH3 phased cooperative agreement research applications to plan and implement behavioral and social intervention clinical trials. Studies appropriate for this announcement include clinical trials to develop and test behavior change interventions related to dental, oral, or craniofacial conditions. Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to a clinical trial implementation phase (UH3) of up to five years. Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase will permit both scientific and operational planning activities. Scientific planning activities include small-scale data collection to assess the feasibility and/or acceptability of a planned behavioral or social intervention and associated study procedures (e.g., acceptability of study content or mode of delivery; feasibility of proposed data collection procedures; preliminary testing of intervention training and fidelity monitoring procedures). Operational planning activities include, at a minimum, development of: the final clinical protocol; the intervention manual or equivalent; the data management system and other tools for data and quality management, safety and operational oversight plans; recruitment and retention strategies; and other essential documents. The UH3 phase will support the conduct of investigator-initiated intervention research at all stages, from early mechanistic research and intervention development (e.g., Stages 0/ I) through implementation and cost-effectiveness research (Stages IV/V).
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Faith-based Organization
- HBCU
- HSI (Hispanic Serving Institution)
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Researcher (independent)
- Small Business (SBA-defined)
- Special District
- State Government
- TCU (Tribal Colleges)
- Tribal Nation
- Tribal Organization
Demographic focus
How to apply
Application links
Key dates & requirements
Required documents
- R01 Application Form (SF-424)
- Project Narrative/Research Plan (describing both UG3 and UH3 phases)
- Budget Narrative and Budget (phased budget for UG3 and projected UH3)
- Biographical Sketches (key personnel)
- Letters of Support (institutional and partner commitments)
- Data Management and Quality Assurance Plan
- Recruitment and Retention Strategy
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.121 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$443,702,768
-
$32,310,944
-
$31,252,186
-
$29,535,192
-
$23,987,187
-
$23,513,241
-
$18,362,716
-
$16,829,492
-
$16,115,056
-
$15,991,067
Top States by Funding
- WA 2 awards $451.6M
- CA 14 awards $145.7M
- MI 4 awards $76.3M
- PA 4 awards $68.3M
- MA 5 awards $47.8M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.121). How funding has trended year over year.
| 2024 | $319,987,302 | |
| 2025 | $332,151,837 | |
| 2026 est. | $337,316,521 |
FAQ
What types of studies does this grant support?
It supports clinical trials for behavior change interventions related to dental, oral, or craniofacial conditions. Both mechanistic research and implementation studies are eligible.
What is the UG3/UH3 structure?
The UG3 phase provides up to 2 years for planning and feasibility testing. Successful UG3 projects may transition to the UH3 phase for up to 5 years of implementation.
What activities are covered in the planning phase?
Scientific planning includes feasibility assessments and pilot data collection. Operational planning includes protocol development, intervention manuals, data management systems, and recruitment strategies.
Who can apply?
Universities, federal agencies, faith-based organizations, tribal institutions, and regional organizations are eligible. Non-U.S. organizations cannot apply.
What is the funding level?
The announcement indicates awards up to $500,000, though exact amounts vary by project scope and phase.
💡 Tips for applicants
- Clearly present both the UG3 planning milestones and UH3 implementation objectives in a single application. Reviewers must see feasibility data even at submission.
- Develop realistic timelines and budgets for each phase. Plan recruitment and retention strategies early, as these are required operational deliverables.
- Include preliminary data demonstrating intervention acceptability or feasibility. Small-scale pilot studies strengthen the UG3 proposal significantly.
- Build a strong multidisciplinary team with behavioral science, clinical, and implementation expertise. Collaboration increases competitiveness.
- Detail the fidelity monitoring and quality assurance procedures for your intervention. Reviewers expect rigorous operational planning.
⚠️ Common mistakes
Submitting only a clinical trial protocol without sufficient planning activities or feasibility data. Proposing unclear or unrealistic UG3-to-UH3 transition milestones. Underestimating operational complexity in data management, recruitment, and safety oversight.
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