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    NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

    This grant supports planning and implementing behavioral and social intervention clinical trials related to dental, oral, or craniofacial conditions, with a two-year planning phase (UG3) and potential transition to a five-year clinical trial implementation phase (UH3).

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    Funder: National Institutes of Health

    Due Dates: June 6, 2025 (New) | July 8, 2025 (Renewal/Resubmission/Revision) | September 4, 2025 (AIDS) | October 7, 2025 (New) | November 6, 2025 (Renewal/Resubmission/Revision) | January 6, 2026 (AIDS) | Additional cycles through January 8, 2028

    Funding Amounts: Up to $500,000 direct costs per year; UG3 phase: 1 year; UH3 phase: up to 5 years; budgets must reflect actual project needs

    Summary: Supports planning and implementation of behavioral and social intervention clinical trials related to dental, oral, or craniofacial health, using a milestone-driven UG3/UH3 cooperative agreement mechanism.

    Key Information: UG3/UH3 application must be submitted as a single application; only projects meeting UG3 milestones may transition to UH3; no support for FDA-regulated drug/device/biologic trials.


    Description

    This funding opportunity supports the planning and implementation of behavioral and social intervention clinical trials relevant to dental, oral, and craniofacial (DOC) health, including associated medical and mental health comorbidities. The program uses a two-phase, milestone-driven cooperative agreement (UG3/UH3):

    • UG3 Phase (Planning): Up to 1 year for scientific and operational planning, including feasibility studies, protocol development, and preparation for trial implementation.
    • UH3 Phase (Implementation): Up to 5 years for conducting the clinical trial, contingent on successful completion of UG3 milestones and administrative review.

    Projects must address behavior change interventions, and may include a wide range of populations, conditions, and intervention types, provided they are not FDA-regulated drug, device, or biologic trials. Both traditional and innovative methodologies (e.g., mobile health, telehealth, adaptive trial designs) are encouraged.


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