The National Institutes of Health (NIH), through various participating institutes, has issued a Notice of Funding Opportunity (NOFO) titled HIV-associated Non-Communicable Diseases Research at Low- and Middle-Income Country Institutions (R21 Clinical Trial Optional) under the R21 Exploratory/Developmental Research Grant mechanism. This funding opportunity is intended to support locally relevant research in the field of HIV-associated non-communicable diseases (NCDs) at institutions in low- and middle-income countries (LMICs). The primary goal of this initiative is to enhance research capacity, foster collaborations within and across LMICs, and stimulate new research on the impact of HIV infection on the etiopathogenesis of NCDs. It aims to develop innovative approaches for diagnosis, prevention, therapeutic interventions, and integrated clinical care for people living with HIV (PLWH) with comorbid conditions.

This NOFO is reissued as PAR-23-191 and builds upon previous funding opportunities in this area. It is administered by the Fogarty International Center (FIC) in collaboration with other NIH institutes, including the National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Mental Health (NIMH), National Institute of Dental and Craniofacial Research (NIDCR), National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The program seeks to foster interdisciplinary partnerships between HIV and NCD researchers, with the expectation that these collaborations will lead to feasibility studies that can lay the groundwork for larger-scale research initiatives.

Eligible applicants include non-domestic (non-U.S.) higher education and research institutions and other non-profit organizations in LMICs as defined by the World Bank. While U.S. institutions cannot serve as primary applicants, they may be included as collaborating institutions or consultants. The program allows foreign components of U.S. organizations to participate. Eligibility requirements also mandate that all applicants complete and maintain several registrations, including System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov.

The funding opportunity has a two-year project period with a maximum direct cost of $275,000, not exceeding $150,000 in any single year. The number of awards is contingent upon NIH appropriations and the quality of submitted applications. The research should align with NIH HIV/AIDS research priorities and may involve exploratory or developmental studies, including basic science, epidemiological, behavioral, and clinical research on HIV-associated NCDs. Specific areas of interest include early onset of geriatric diseases, improved diagnostic tools, therapeutic interventions, and better patient-centered care models for PLWH. Additionally, implementation research for integrated care management of HIV and associated NCDs is encouraged.

Key dates for submission include an open date of November 8, 2023, with subsequent Letter of Intent deadlines on November 8, 2023, November 8, 2024, and November 7, 2025. Full application deadlines for AIDS-related projects are December 8, 2023, December 9, 2024, and December 8, 2025. Scientific merit reviews will occur in March of the following year, with advisory council reviews in May, and awards are expected to be issued by July. The expiration date for this NOFO is December 9, 2025.

Applications will be evaluated based on NIH's peer review process, emphasizing innovation, feasibility, significance, investigator qualifications, approach, and potential impact. Additional review considerations include ethical protections for human subjects, inclusion of diverse populations, and research environment capabilities. Applicants must submit applications electronically via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. Upon award, recipients must comply with NIH policies, including data management and sharing requirements, as well as human subject protections.

For inquiries, potential applicants may contact designated NIH officials, including Dr. Geetha P. Bansal at the Fogarty International Center, Dr. Kendall J. Bryant at NIAAA, and other listed program officials from participating NIH institutes.