Grants8 logo Grants8
Login Create account

Grant Details

https://www.grants.gov/search-results-detail/358093

Grant Analysis

Purpose & Target

This grant aims to support formative research, intervention development, and pilot-testing of novel or adapted interventions for people who use substances. - The core objective is to improve HIV prevention, treatment, and program implementation, focusing on feasibility, acceptability, and safety of these interventions. - Target recipients are primarily research institutions, non-profits, for-profit organizations, and various governmental entities capable of conducting clinical trials. - SECTOR-SPECIFIC: This grant is specifically focused on public health, particularly HIV/AIDS and substance use disorders. - Geographic scope is global; domestic and overseas studies are considered, with eligibility for non-U.S. entities. - Key filtering criteria include the necessity of a clinical trial, focus on substance use in relation to HIV, and engagement of 'end users'. - This is a recurring grant opportunity with multiple application cycles through May 2027, reissuing a previous program announcement.

Financial Structure

  • Max funding: Applicants may request direct costs of up to $450,000 for a maximum project period of 3 years.
  • Annual limit: In no case may any single year's direct costs exceed $225,000.
  • Project period: The maximum project period is 3 years.
  • Cost sharing: This funding opportunity does not require cost sharing.
  • Eligible costs: Direct costs are explicitly mentioned as fundable. Pre-award costs are allowable as described in NIH Grants Policy Statement.
  • Financial reporting: Recipients are required to submit Research Performance Progress Reports (RPPR) annually and financial statements. A final RPPR, invention statement, and expenditure data are required for closeout.

Eligibility Requirements

Eligible Organization Types
  • Higher Education Institutions:
    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education
  • Nonprofits:
    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • For-Profit Organizations:
    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)
  • Local Governments:
    • State Governments, County Governments, City or Township Governments, Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Federal Government:
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession
  • Other:
    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    • Non-domestic (non-U.S.) Entities (Foreign Organizations)
Geographic Requirements
  • Domestic (U.S.) and non-domestic (non-U.S.) entities are eligible.
  • Non-domestic (non-U.S.) components of U.S. Organizations are eligible.
Technical/Experience Requirements
  • Projects must include a clinical trial component (R34 Clinical Trial Required).
  • Applicants are encouraged to provide strong evidence of capability, documented resources, trained/experienced investigator team, and/or conduct of related studies.
  • Proposed projects must engage relevant 'end users' (policymakers, practitioners, community members, etc.) in study conceptualization, design, execution, and interpretation.
Exclusion Criteria
  • Applications proposing only to develop manuals, protocols, or standardization of protocols are not responsive.
  • Applications focusing only on alcohol use without inclusion of other substances are not responsive.
  • Applications that do not describe methods for engaging relevant end users of data in project development are not responsive.

Application Process

Application Process Steps
  • Registration: Applicants must complete and maintain active registrations in the following systems prior to submission (can take 6+ weeks):
    • System for Award Management (SAM) with a Unique Entity Identifier (UEI). Foreign organizations need an NCAGE code.
    • eRA Commons for the organization (identifying at least one Signing Official and one Program Director/Principal Investigator).
    • Grants.gov (requires active SAM registration).
  • Application Package Access: Obtain application forms through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
  • Submission: Applications must be submitted electronically via Grants.gov.
  • Tracking: Track application status in eRA Commons.
  • Error Correction: Applicants are encouraged to submit early to allow time to correct errors found during submission. Corrections must be submitted by the due date.
Required Documentation and Materials
  • Standard Forms: Follow instructions in the Research (R) Instructions in the 'How to Apply - Application Guide' for SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, Budget) and PHS 398 forms (Cover Page Supplement, Research Plan, Human Subjects and Clinical Trials Information, Assignment Request Form).
  • Research Strategy: Describe significance in context of future efficacy/effectiveness/implementation trial.
  • Partnerships and Collaborations: Document meaningful engagement of 'end users' and/or community experts in the Research Strategy section.
  • Approach: Include a well-defined theory of change, logic model, or cultural source and associated hypotheses. Provide specific justification for proposed activities. Evidence of feasibility. Description of intervention for development/adaptation/testing. Justification of comparison condition (if used) and sample sizes. Plans for sustainability, fidelity assessment, manualization/standardization.
  • Resource Sharing Plan: Required.
  • Data Management and Sharing Plan: Required for all applications generating scientific data.
  • Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys).
  • PD/PI Information: All PD(s)/PI(s) must include their eRA Commons ID.
Support and Assistance
  • Technical/System Issues: eRA Service Desk (web ticket, phone: 301-402-7469 or 866-504-9552 toll-free).
  • Application Instructions/Processes: NIH General Grants Information (email: [email protected], phone: 301-480-7075).
  • Grants.gov Registration/Workspace: Grants.gov Customer Support (phone: 800-518-4726, email: [email protected]).
  • Scientific/Research Questions: Contact Richard A. Jenkins, Ph.D., Candace Webb, MPH, MCHES, or Raul N. Mandler, M.D. (NIDA) via phone or email.
  • Financial/Grants Management Questions: Chief Grants Management Officer (NIDA) via email.
Project Implementation & Reporting
  • Annual Reporting: Research Performance Progress Report (RPPR) and financial statements are required annually.
  • Closeout: Final RPPR, invention statement, and expenditure data required for award closeout.
  • ClinicalTrials.gov: If applicable, the 'responsible party' must register and submit results for clinical trials. NIH expects registration and reporting of all trials.

Evaluation Criteria

Overall Impact
  • Reviewers will assess the likelihood of the project to exert a sustained, powerful influence on the research field(s).
Factor 1: Importance of the Research
  • Significance:
    • Addresses an important knowledge gap, solves a critical problem, or creates a valuable conceptual/technical advance.
    • Strong rationale for the study, rigorous scientific background (prior literature, data) justifying the proposed work.
  • Innovation:
    • Applies novel concepts, methods, or technologies, or uses existing ones in novel ways to enhance project impact.
    • Note: A project not applying novel concepts can still be of critical importance.
Factor 2: Rigor and Feasibility (Approach)
  • Rigor:
    • Potential to produce unbiased, reproducible, robust data.
    • Rigor of experimental design and appropriate controls.
    • Sufficient and well-justified sample size.
    • Quality of plans for analysis, interpretation, and reporting.
    • Adequate plans to address relevant biological variables (e.g., sex, age).
    • For human subjects/clinical trials: rigor of intervention, justified outcome variables, generalizability/relevance to subgroup, appropriate/diverse sample, adequate inclusion plans.
  • Feasibility:
    • Proposed approach is sound and achievable within timeframes.
    • Uncertainty in feasibility is balanced by potential for major advances.
    • For human subjects/clinical trials: adequacy and feasibility of recruitment/retention plan, likelihood of achieving enrollment based on age, race, ethnicity, and sex.
    • For clinical trials: feasible study timeline and milestones.
  • Specific to this NOFO:
    • Meaningful engagement of 'end users' and/or community experts in the research.
    • Appropriateness of the proposed conceptual model.
    • Justification for theoretical and empirical evidence informing the intervention.
    • Appropriateness of the methodology for the proposed NIH-defined clinical trial, including comparison conditions.
Factor 3: Expertise and Resources
  • Investigator(s):
    • Demonstrated background, training, and expertise appropriate for career stage.
    • For multiple PIs: Quality of leadership plan to facilitate coordination and collaboration.
  • Environment:
    • Institutional resources are appropriate for successful execution of work.
Additional Review Considerations (not scored but considered)
  • Protections for Human Subjects: Justification for involvement, protection against risks, potential benefits, importance of knowledge, data and safety monitoring.
  • Vertebrate Animals: Description of procedures, justification for use, interventions to minimize discomfort, justification for euthanasia.
  • Biohazards: Evaluation of hazardous materials/procedures and proposed protection.
  • Budget and Period of Support: Justification and reasonableness of budget and requested period relative to proposed research.
  • Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.

Compliance & Special Requirements

Regulatory Compliance
  • Federal Regulations: Adherence to 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
  • NIH Grants Policy Statement: Compliance with the NIH Grants Policy Statement terms and conditions.
  • Nondiscrimination: Compliance with all applicable nondiscrimination laws, including submission of an Assurance of Compliance (HHS-690).
  • Clinical Trials:
    • If applicable, registration and results submission on ClinicalTrials.gov is required.
    • Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval of all protocols.
    • Data and safety monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies.
    • Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements from FDA for investigational products.
  • Health IT: If award involves health IT, use standards from 45 CFR part 170, Subpart B, and ONC Health IT Certification Program (if applicable).
Data Protection and Security
  • Data Management and Sharing Plan: Required for all projects generating scientific data. Must be implemented as described.
  • PII/PHI Protection: Recipients with access to HHS systems or PII/PHI must develop plans and procedures modeled after the NIST Cybersecurity framework.
Ethical Standards
  • Human Subjects: Robust protections are required, including assessment of risks, benefits, and data safety monitoring.
  • Vertebrate Animals: Specific guidelines for care and use must be followed.
  • Biohazards: Adequate protection must be proposed for hazardous materials/procedures.
Intellectual Property Policies
  • An 'invention statement' is required for closeout of an award.
Special Considerations
  • This NOFO specifically funds clinical trial planning projects (R34 mechanism).
  • Meaningful engagement of 'end users' and/or community experts is a critical requirement.
  • Research topics must integrate substance use with HIV prevention or care continua.
  • Applications should lead to larger efficacy/effectiveness trials (e.g., R01 mechanism).
  • Not responsive if only developing protocols/manuals, or focusing solely on alcohol without other substances, or not engaging end users.

Grant Details

hiv prevention hiv treatment substance use drug use intervention development clinical trials pilot studies health research public health nida nih infectious disease behavioral health social interventions structural interventions biomedical interventions harm reduction addiction epidemiology underserved populations health disparities implementation science feasibility studies acceptability studies safety studies prEP viral suppression treatment adherence telehealth non-pharmacological therapies community engagement stigma reduction policy interventions health services research federal funding us government grants
Development and Testing of Novel Interventions to Improve HIV Prevention, Treatment, and Program Implementation for People Who Use Substances (R34 Clinical Trial Required)
PAR-24-329
National Institutes of Health (NIH)
UNIVERSITY NONPROFIT OTHER_FOR_PROFIT SME PUBLIC OTHER
US AF AL DZ AS AD AO AI AQ AG AR AU AT BY BE BA BR BG CA CN HR CY CZ DK EG EE FI FR GE DE GI GR HU IS IN IE IL IT JP LV LI LT LU MK MY MT MX MD ME NL NZ NO PL PT QA RO SA RS SC SG SK SI KR ES SE CH TW TR UA AE UK VA VG VI
HEALTHCARE SOCIAL TECHNOLOGY
DEVELOPMENT PILOT_PROJECTS
OTHER
SDG3 SDG10 SDG16
FUNDING RESEARCH_DEVELOPMENT CAPACITY_BUILDING PILOT_PROJECTS
450000.00
None
450000.00
USD
None
May 7, 2027, 5 p.m.
July 2027 - October 2027