Single, clear statement: This grant aims to support the development and testing of interventions to reduce HIV-associated stigma, thereby improving HIV prevention, treatment, care, and the quality of life for People Living with HIV (PLWH) in Low- and Middle-Income Countries (LMICs), including addressing intersecting stigmas and enhancing stigma measurement.
Target recipient type and size: Primarily academic and research institutions, and non-profit organizations. While no specific size is mentioned, the R01 mechanism and collaboration requirements suggest established entities.
MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC (Public Health, HIV/AIDS Research).
Geographic scope and any location requirements: Primary research must be conducted in Low- and Middle-Income Countries (LMICs). U.S. institutions are eligible but are strongly encouraged to collaborate as key personnel with one or more investigators from an academic or research institution in an LMIC. Non-U.S. High-Income Country Institutions cannot be the primary partner for an LMIC institution. Hong Kong-based institutions are not eligible as primary LMIC partners.
Key filtering criteria for initial grant screening: Focus on HIV-associated stigma reduction, research and intervention development, and relevance to LMIC populations and contexts.
Grant frequency and program context: This is a recurring grant opportunity, indicated by its reissuance (reissue of PAR-21-344) and multiple application due dates extending through December 2025. The program aims to foster collaborative research and build research capacity in LMICs.
Financial Structure
Total direct costs: Max $400,000 over the entire three-year project period.
Annual direct costs: Max $200,000 in any single year.
Cost sharing: Not required.
Eligible costs: Budget request must reflect the actual needs of the proposed project. Applicants should budget funds for at least one PD/PI to attend the annual program network meeting in Bethesda, MD.
Indirect cost policies: Not explicitly detailed, subject to NIH Grants Policy Statement.
Currency: USD (implied by NIH/U.S. government funding).
Other Eligible Organizations: Non-domestic (non-U.S.) Entities (Foreign Institutions). These are restricted to higher education and/or research institutions and other non-profit organizations in LMICs as defined by The World Bank (low-, lower-middle-, or upper-middle-income economies).
Hong Kong-based institutions are not eligible as applicant or primary LMIC partner institutions. If Hong Kong is included, a second institution in mainland China must be involved as the primary collaborating LMIC institution.
Non-U.S. High-Income Country Institutions are not eligible as the primary partner for an LMIC Institution, but may be included as consultants if they offer special opportunities for the proposed research.
Collaboration Requirements
One or more investigators from an academic or research institution in the U.S. and one or more investigators from an academic or research institution in an LMIC are strongly encouraged to collaborate as key personnel on the application.
U.S. investigators must have LMIC collaborators.
Registration Requirements
Applicant organizations must complete and maintain active registrations with: System for Award Management (SAM) (requires annual renewal), Unique Entity Identifier (UEI) (assigned via SAM.gov), eRA Commons (requires at least one Signing Official and one Program Director/Principal Investigator (PD/PI) account), and Grants.gov. These registrations can take 6 weeks or more and must be completed prior to application submission.
Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) code to register in SAM.
All PD(s)/PI(s) must have an eRA Commons account and affiliate it with the applicant organization. This can take up to 2 weeks.
Cost Sharing
Cost sharing is not required.
Application Limits
Applicant organizations may submit more than one application, provided each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time.
Application Process
Application Deadlines and Timeline
Application Due Dates (for New, Renewal, Resubmission, Revision applications):
November 20, 2023
November 20, 2024
December 22, 2025
All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date: December 23, 2025.
Earliest Start Date: July 2024 (for Dec 2023 submissions), July 2025 (for Dec 2024 submissions), July 2026 (for Dec 2025 submissions).
Project period: Up to three years.
Application Submission
Submission Method: Electronic submission is required. Use NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Tracking: Applicants must track the status of their application in eRA Commons.
Early Submission: Applicants are encouraged to apply early to allow time for error correction.
Late Submissions: Applications missing the due date/time will be subject to NIH Policy on Late Application Submission.
Required Documentation and Materials
SF424 (R&R) Application Guide forms: Follow all instructions, including PHS 398 Cover Page Supplement, SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, and Budget forms.
PHS 398 Research Plan: Must include a Research Strategy that defines the stigma-associated problem, articulates research questions, justifies relevance to LMIC settings, describes intervention development, resources, and outcome measures. Integration of research capacity strengthening for LMIC institutions is required.
Letters of Support: Required from each collaborator and collaborating institution.
Resource Sharing Plan: Required, or a rationale for not sharing resources.
Data Management and Sharing Plan: Required for due dates on or after January 25, 2023.
PHS Human Subjects and Clinical Trials Information: Required if human subjects are involved. Follow instructions for Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
PHS Assignment Request Form: All instructions must be followed.
Pre-Application Requirements
Letter of Intent: Encouraged, but not required or binding. Due November 20, 2023; November 20, 2024; November 20, 2025. Should include descriptive title, PD(s)/PI(s) contact info, key personnel, participating institutions, and funding opportunity number.
Post-Award Requirements and Reporting
Annual Reporting: Recipients must submit the Research Performance Progress Report (RPPR) annually and financial statements.
Closeout: A final RPPR, invention statement, and expenditure data portion of the Federal Financial Report are required for award closeout.
Subaward Reporting: Recipients must report on all first-tier subawards over the threshold to the Federal Subaward Reporting System (FSRS).
Integrity and Performance Matters: Recipients with active federal awards totaling over $10,000,000 must report and maintain current information in SAM about civil, criminal, and administrative proceedings related to federal awards.
Clinical Trials.gov Registration: If the award involves clinical trials, the responsible party must register and submit results information on ClinicalTrials.gov.
Evaluation Criteria
Overall Impact
Reviewers will provide an overall impact score based on the likelihood for the project to exert a sustained, powerful influence on the research field(s).
Scored Review Criteria
Significance: Assesses the importance of the problem addressed, its magnitude in the LMIC context, relevance to HIV-related health outcomes, and potential to reduce stigma and increase health.
Investigators: Evaluates the expertise, experience, and complementary qualifications of the PD(s)/PI(s) and other key personnel, including their capacity to facilitate collaborations and strengthen LMIC research capabilities.
Innovation: Considers novel scientific ideas, new model systems, tools, or technologies. Emphasizes innovative stigma-reduction strategies and improved stigma measurement.
Approach: Examines the clarity of research questions, the appropriateness of the methodological approach, resource utilization, and plans for outcome measures, including formative research.
Environment: Assesses the adequacy of institutional support, facilities, equipment, and collaborative arrangements for the proposed research.
Additional Review Criteria (Not Scored)
Study Timeline: Evaluation of the feasibility and appropriateness of the proposed project timeline.
Foreign Organizations: Assessment of whether the project utilizes unique talent, resources, populations, or environmental conditions available in other countries that augment U.S. resources.
Select Agent Research: Review of plans for safe and secure handling of select agents, if applicable.
Resource Sharing Plans: Assessment of the reasonableness of resource sharing plans or the justification for not sharing.
Authentication of Key Biological and/or Chemical Resources: Review of plans for validating these resources, if applicable.
Budget and Period of Support: Evaluation of whether the budget and requested project duration are justified and reasonable for the proposed research.
Programmatic Selection Factors
Scientific and technical merit of the proposed project (as determined by peer review).
Availability of funds.
Relevance of the proposed project to program priorities.
Geographic balance of projects.
Scientific topics for programmatic balance.
Compliance & Special Requirements
Regulatory Compliance
General: All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement, as well as Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.
Non-discrimination: Recipients must complete an HHS Assurance of Compliance form (HHS 690) to ensure programs comply with federal civil rights laws prohibiting discrimination based on race, color, national origin, age, sex, and disability. This includes ensuring meaningful access for persons with limited English proficiency and effective communication with persons with disabilities.
Conscience Protection: Compliance with applicable federal religious nondiscrimination laws and conscience protection and associated anti-discrimination laws.
Research Integrity: Subject to Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.
Data Management and Protection
Data Management and Sharing Plan: Required for all applications for due dates on or after January 25, 2023. Recipients must adhere to and implement their approved plan.
Genomic Data Sharing: Implementation changes for Genomic Data Sharing Plans apply to applications due on or after January 25, 2023.
Ethical and Safety Standards
Human Subjects: Recipient institutions must ensure all protocols involving human subjects are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and Safety Monitoring: Oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) are required.
Investigational Products: Clinical research involving investigational therapeutics, vaccines, or devices must be performed under an FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE).
Special Programmatic Requirements
Scope Focus: Applications are considered non-responsive and will not be reviewed if they do not address, or are not relevant to, the development of a stigma-reduction intervention strategy explicitly linked to the measurement of a beneficial health outcome in PLWH.
Capacity Building: Proposed work is expected to contribute to building sustainable capacity for stigma research in LMICs. Applicants should explicitly address needs and plans for collaborating LMIC institutions to develop research capacity.
Multidisciplinary Teams: Applicants are encouraged to assemble teams with appropriate multidisciplinary expertise, potentially including US and LMIC collaborators.
Grant Details
hiv/aids
stigma reduction
low- and middle-income countries
lmics
public health
global health
intervention research
clinical trial optional
health outcomes
hiv prevention
hiv treatment
quality of life
adolescents
youth
key populations
caregivers
research project grant
r01
nih
fogarty international center
fic
national institutes of health
non-profit
higher education
research institution
capacity building
data sharing
sdg3
sdg10
sdg17
Interventions for Stigma Reduction to Improve HIV/AIDS Prevention, Treatment and Care in Low- and Middle- Income Countries (R01 - Clinical Trial Optional)
PAR-23-190
National Institutes of Health (NIH)
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