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Grant Analysis

Purpose & Target

This grant aims to expand the HIV/AIDS prevention toolkit by funding research into the intersection of alcohol use and HIV acquisition and transmission, including the development, testing, and implementation of new and existing interventions. - The primary target recipients are research institutions, non-profit organizations, and for-profit entities of various sizes, capable of conducting scientific research, clinical trials, and epidemiological studies. - SECTOR-SPECIFIC - Projects may target 'hot spots' in the US (e.g., US South) but also allow international (non-U.S.) organizations to apply. - Key filtering criteria include a focus on HIV prevention, a clear connection to alcohol use, research-oriented projects (R01 activity code), and a willingness to conduct clinical trials (optional). - This is a reissued recurring funding opportunity (R01 Research Project Grant) from the National Institutes of Health (NIH) and National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of ongoing efforts to address public health challenges.

Financial Structure

Application budgets are not limited but must reflect the actual needs of the proposed project.
Total funding amount for fiscal year 2025: $2,000,000.
Anticipated number of awards: 2 - 4.
Maximum project period: 5 years.
Cost sharing is not required.
Matching funds are not required.
The currency for funding is USD.
Recipients are required to submit annual financial statements (Federal Financial Report portion).
All awards are subject to the terms and conditions, cost principles, and audit requirements described in the NIH Grants Policy Statement and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).

Eligibility Requirements

Organizational Eligibility

Eligible entities include:
Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status)
For-Profit Organizations (Small Businesses, other For-Profit)
Local, State, County, City or Township, Special District, and Indian/Native American Tribal Governments (Federally Recognized or other)
Eligible Agencies of the Federal Government, U.S. Territory or Possession
Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Organizations)
Non-domestic components of U.S. Organizations are eligible to apply.

Geographic Requirements

There are no explicit geographic restrictions on the applicant's location, as foreign organizations are eligible.
Research focus is specifically encouraged for HIV/AIDS 'hot spots' in the US, such as the US South, and international settings.

Registration Requirements

All applicant organizations must complete and maintain active registrations with:
System for Award Management (SAM) – requires annual renewal.
NATO Commercial and Government Entity (NCAGE) Code for foreign organizations (in place of CAGE code).
Unique Entity Identifier (UEI) – obtained via SAM.gov, must be consistent across all registrations.
eRA Commons – for organizational accounts and for Program Directors/Principal Investigators (PD/PIs).
Grants.gov – requires active SAM registration.
PD(s)/PI(s) must also have an eRA Commons account.

Exclusion Criteria

Studies focusing only on patients in HIV care but not explicitly on 'Treatment as Prevention' are not considered responsive.
Studies that include vertebrate animals or are primarily focused on developing animal models are not considered responsive.
Basic behavioral or biological studies that do not inform translation to intervention activities are not considered responsive.

Application Process

Key Dates

Open Date (Earliest Submission Date): April 07, 2025
Letter of Intent Due Date(s): 30 days before each application due date (not required, not binding, but encouraged).
Application Due Dates:
May 07, 2025 (latest time 5:00 PM local time of applicant organization)
September 07, 2025 (latest time 5:00 PM local time of applicant organization)
January 07, 2026 (latest time 5:00 PM local time of applicant organization)
May 07, 2026 (latest time 5:00 PM local time of applicant organization)
Expiration Date: May 08, 2026.

Submission Process

Applications must be submitted electronically through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
Applicants must follow instructions in the Research (R) Instructions in the 'How to Apply - Application Guide' and any program-specific instructions in this announcement.
Early submission is encouraged to allow time for correcting any errors before the deadline.
All PD(s)/PI(s) must include their eRA Commons ID in the application.
The unique entity identifier (UEI) provided on the application must match the identifier used in the organization's eRA Commons profile and System for Award Management (SAM).
If requesting $500,000 or more in direct costs in any single year (excluding consortium F&A), applicants must contact a Scientific/Research Contact at least 6 weeks prior to submission.

Required Documentation and Materials

Standard NIH application forms (SF424(R&R) series, PHS 398 series) as specified in the 'How to Apply - Application Guide'.
Resource Sharing Plan: Required for all applications.
Data Sharing Plan: Required for all applications, especially those with human subject research, describing plans for submitting data to NIAAA-sponsored repositories.
Data Management and Sharing Plan: Required for all research generating scientific data, consistent with the 2023 NIH Policy for Data Management and Sharing.
Appendix: Only limited materials allowed (e.g., blank questionnaires or surveys); no publications or other materials unless specified.
PHS Human Subjects and Clinical Trials Information form: Required if human subjects research, clinical research, or NIH-defined clinical trials are involved.

Reporting Obligations

Recipients are required to submit the Research Performance Progress Report (RPPR) annually.
Financial statements are required annually.
A final RPPR, invention statement, and expenditure data are required for award closeout.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria

Importance of the Research (Significance and Innovation): This evaluates the significance of the research question and the innovation of the proposed concepts, methodologies, or approaches.
Rigor and Feasibility (Approach): This assesses whether the overall strategy, methodology, and analyses are well-reasoned and appropriate, and if potential problems are addressed, ensuring the project's feasibility.
Expertise and Resources (Investigator(s) and Environment): This considers the suitability of the investigators and their team's experience/expertise, and whether the research environment and resources are conducive to the project's success.

Additional Review Criteria (Considered for Overall Impact, Not Scored)

Protections for Human Subjects: Adequacy of plans to protect human research participants.
Vertebrate Animals: If applicable, evaluation of animal care and use plans.
Biohazards: Assessment of hazardous materials/procedures and proposed protections.
Resubmissions: The full application is evaluated as presented.
Renewals: Progress made in the previous funding period is evaluated.
Revisions: The appropriateness of the proposed expansion of the project's scope is evaluated.

Additional Review Considerations (Not Scored)

Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring the validity of these resources.
Budget and Period of Support: Evaluation of whether the budget and requested project duration are justified and reasonable relative to the proposed research.

Funding Decisions

Decisions are made based on: scientific and technical merit (determined by peer review), availability of funds, and relevance of the proposed project to program priorities.

Compliance & Special Requirements

Regulatory Compliance

Compliance with all terms and conditions outlined in the NIH Grants Policy Statement is required.
Adherence to 2 CFR Part 200, 'Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards', is mandatory.
Recipients must comply with all applicable nondiscrimination laws and submit an HHS-690 Assurance of Compliance.
All federal statutes and regulations relevant to federal financial assistance apply.

Research Ethics and Data Security

ClinicalTrials.gov: Clinical trials must be registered, and results submitted, on ClinicalTrials.gov (expected for all trials, legally required for some).
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: Required for all protocols involving human subjects.
Data and Safety Monitoring Requirements: Applicable to all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials).
Investigational New Drug (IND) or Investigational Device Exemption (IDE) Requirements: Necessary for clinical research involving investigational products.
Data Management and Sharing: Recipients must implement an approved Data Management and Sharing Plan consistent with the 2023 NIH Policy.
Health IT standards: If involving health IT, it must meet standards in 45 CFR part 170, Subpart B, and be certified under the ONC Health IT Certification Program where applicable.
Cybersecurity: If recipients handle HHS information/operational technology systems or Personal Identifiable Information (PII)/Personal Health Information (PHI), they must develop plans modeled after the NIST Cybersecurity framework.

Financial and Administrative

Mandatory Disclosure: Recipients must disclose any federal criminal law violations (fraud, bribery, gratuity) potentially affecting federal awards (2 CFR 200.113).

Special Research Focus and Innovation

Research is encouraged to focus on specific high-risk groups for alcohol-related HIV/AIDS acquisition/transmission (e.g., men who have sex with men, commercial sex workers, HIV-serodiscordant couples, pregnant women living with HIV, victims of trauma/violence, individuals newly-released from incarceration, residents of HIV/AIDS epicenters in low-resourced settings).
The NOFO specifically encourages research in HIV/AIDS 'hot spots' in the US, such as the US South.
Emphasis is placed on incorporating innovative, state-of-the-art measurement and analytic approaches (e.g., biomarkers for alcohol use, passive alcohol sensors, mHealth interventions, virtual reality).
Pragmatic trials and adaptive designs are strongly encouraged.
Applications should integrate a syndemic approach to address alcohol use with common comorbidities and contributory conditions (e.g., intimate partner violence, homelessness, discrimination, stigma).
The grant promotes research that creates new communication strategies and incorporates new technological approaches for recruitment and retention of high-risk groups.
The NIH/NIAAA is committed to understanding and reducing health disparities; applications promoting training of minority health researchers and fostering innovative partnerships are encouraged, including community-based participatory research.

Grant Details