Multidisciplinary Studies of HIV/AIDS and Aging is offered by the National Institutes of Health (NIH) through multiple participating institutes including NHLBI, NIAMS, NIDCR, NIDDK, NIDA, NIMH, NCI, and NIAAA. The R21 program supports innovative, exploratory research at the intersection of HIV/AIDS and aging, encouraging multidisciplinary approaches that span biomedical, behavioral, and social science.

Eligible applicants include state and local governments, nonprofits, small businesses, and educational institutions. Applications are due May 7, 2026, under funding opportunity number PAR-25-355. This funding opportunity has expired but NIH may accept applications on a case-by-case basis for a short period after expiration to accommodate late or continuous submission policies.

Expired PAR-25-355: Multidisciplinary Studies of HIV/AIDS and Aging (R21 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Heart, Lung, and Blood Institute ( NHLBI ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) National Institute on Drug Abuse ( NIDA ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and National Cancer Institute ( NCI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ), June 30, 2025 - participation added as per NOT-AA-25-018 All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers. Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Multidisciplinary Studies of HIV/AIDS and Aging (R21 Clinical Trial Optional) R21 Exploratory/Developmental Research Grant January 8, 2026 Notice of Early Expiration of PAR-25-355, "Multidisciplinary Studies of HIV/AIDS and Aging (R21 Clinical Trial Optional)" .

See Notice NOT-AG-26-003 . June 30, 2027 Notice of NIAAA Participation in PAR-25-355 "Multidisciplinary Studies of HIV/AIDS and Aging (R21 Clinical Trial Optional)" . See Notice NOT-AA-25-018 .

March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) 93.

866, 93. 846, 93. 313, 93.

847, 93. 279, 93. 121, 93.

242, 93. 233, 93. 837, 93.

838, 93. 839, 93. 840, 93.

853, 93. 393, 93. 396, 93.

399, 93.

273 Funding Opportunity Purpose This NOFO invites applications at the intersection of HIV and aging by proposing research that aims to meet the following objectives: 1) Improve the understanding of biological, clinical, and socio-behavioral aspects of aging through the lens of HIV infection and its treatment; and 2) Improve approaches for testing, preventing, and treating HIV infection, and managing HIV-related comorbidities, co-infections, and complications in different populations and cultural settings by applying current aging science approaches.

Proposed research must be consistent with the HIV/AIDS Research Priorities outlined by NIH’s Office of AIDS Research (OAR) as described in NOT-OD-20-018 . Funding Opportunity Goal(s) To encourage biomedical, social, and behavioral research and research training directed toward greater understanding of the aging process and the diseases, special problems, and needs of people as they age.

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. New Date January 08, 2026 per issuance of NOT-AG-26-003 .

(Original Expiration Date: January 08, 2027) Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Currently, roughly 53%of American adults living with HIV are over the age of 50. By 2030, that number is projected to rise to over 70%. The portion of older adults with HIV is expected to rise primarily because of the successes of modern antiretroviral therapy (ART), which has allowed individuals infected at a younger age to survive into older age.

Additionally, the prevalence of HIV infection in older age is attributable to new infections in later life, with approximately 16% of new diagnoses in Americans occurring in adults age 50 and older.

In contrast to the pre-modern era of HIV treatment, where AIDS-related opportunistic infections and cancers were common, the most frequent morbidities and causes of death for individuals undergoing treatment for HIV infection are similar to those seen in older non-infected adults.

These conditions include cardiovascular disease, lung disease, infection-related and non-infection-related cancers, neurocognitive and neuropsychiatric disorders, osteopenia/osteoporosis, liver cirrhosis, and renal disease.

In addition, individuals living with HIV infection may exhibit many of the clinical and socio-behavioral characteristics commonly observed in aging, such as multiple morbidities, polypharmacy, declining physical and cognitive function, alterations in body composition, social isolation, and increasing caregiver burden.

People living with HIV (PLWH) also exhibit molecular changes associated with aging, such as epigenetic alterations, mitochondrial impairment, and telomere shortening. Thus, accumulating evidence suggests that HIV and/or its treatment may lead, at least in part, to an accelerated aging phenotype.

In addition, recent advances have led to greater adoption of pre-and post-exposure prophylaxis, but the impact of these measures on aging is unclear.

This NOFO invites applications at the intersection of HIV and aging by proposing research that aims to meet the following objectives: 1) Improve the understanding of biological, clinical, and socio-behavioral aspects of aging through the lens of HIV infection and its treatment; and 2) Improve approaches for testing, preventing, and treating HIV infection, and managing HIV-related comorbidities, co-infections, and complications in different populations and cultural settings by applying current aging science approaches.

Proposed research must be consistent with the HIV/AIDS Research Priorities outlined by NIH’s Office of AIDS Research (OAR) as described in NOT-OD-20-018 .

This NOFO encourages applications with the following characteristics: Clinical orientation: HIV in aging involves complex interactions among multiple physiologic systems and a variety of human-level factors such as functional status, quality of life, health behaviors, and psychosocial issues; therefore, studying individual factors in isolation may be counter-productive.

This NOFO encourages animal models and in vitro studies where appropriate; however, inclusion of such approaches should be integrated with human studies or demonstrate direct relevance to clinical features of HIV/AIDS. Focus on aging or the aged: Applicants are strongly encouraged to enroll individuals across the range of older ages, especially individuals at the upper end of the age range (i.e., 70 years or older).

Comparisons between younger and older HIV-infected populations or comparisons between older HIV-infected individuals and their age-matched non-HIV-infected counterparts are appropriate.

Attention to geriatric outcomes: In addition to traditional important outcomes of HIV/AIDS research (e.g., viral load, survival), studies are encouraged to also include outcomes considered important in geriatric medicine and gerontology, such as physical and cognitive function, quality of life measures, and social support.

Leveraging existing resources where possible: A variety of NIH-funded resources are available to study HIV in aging, such as longitudinal studies of HIV-infected individuals and/or their non-infected counterparts (observational or interventional), clinical networks, and research centers.

Leveraging such resources through secondary analyses of available data, ancillary studies, or utilization of existing infrastructure are cost-effective approaches to testing hypotheses or generating relevant data for further studies. Please see OAR's quick reference guide on HIV and Aging Efforts Across NIH for a detailed list of relevant resources and cohort studies.

Selection of appropriate controls : Aging individuals living with HIV have varied and complex clinical pictures. Biological and psychological co-morbidities, treatment regimens, lifestyle and behavioral factors, socioeconomic factors, and social support may all impact disease development, coping, and progression.

This complexity presents a significant challenge to identifying appropriate control populations in observational studies of aging individuals with HIV. Such studies should include adequate justification for selection of the proposed control group(s).

Characterization of phenotypes: Several biological or behavioral phenotypes of HIV in aging that have been elucidated may have markedly different disease courses, biological underpinnings, and treatment responses. Such phenotypes may be described by characteristics like frailty/disability, accelerated aging, successful aging, or other descriptors.

Investigators are encouraged to maximize the homogeneity of subgroups by defining specific phenotypes in analyses. Exploratory/Developmental nature: New directions that expand or shift existing paradigms are needed to advance the science of HIV and aging. Studies that move the science into new directions with little or no preliminary data are appropriate for this mechanism.

Interests of Specific Institutes/Centers/Offices Supporting multidisciplinary studies of HIV/AIDS and aging is consistent with the mission of multiple NIH Institutes, Centers, and Offices (ICOs) . Below are the specific research interests of the majority of ICOs participating in this NOFO. Applicants are strongly encouraged to contact the ICO’s Scientific/Research contact listed in Section VII.

Agency Contacts of this NOFO prior to submission of an application to discuss the research interest of a specific ICO. National Institute on Aging ( NIA ) NIA is interested in understanding how biological, clinical, and socio-behavioral processes affect older individuals with HIV and their caregivers, and the social, economic, and health consequences of HIV.

Example topics include the following: Interactions among aging-related genetic, molecular, cellular, and physiological changes with HIV risk, infection, and pathogenesis.

Interactions among individual-level factors and interpersonal, social, and structural factors, and their contributions to the physical, psychological, and economic well-being of individuals; and interactions among HIV/AIDS, other disease, and population aging, particularly in low-income areas such as low-income areas of sub-Saharan Africa.

Interactions among HIV infection, treatment, and development or progression of cognitive decline (HIV-associated neurocognitive decline (HAND), dementia, and other disabilities in older adults. Interactions of HIV infection and treatment with other aging-related diseases, conditions, and syndromes and geriatrics-informed approaches to assessment and management of older adults with HIV.

National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) Alcohol use disorders (AUD) are prevalent among PLWH. Consequently, PLWH and AUD are known to experience the common adverse health effects of alcohol use (organ and tissue injury and accidents such as falls) and comorbid psychological conditions (e.g., depression, anxiety, post-traumatic stress, and pain).

How these alcohol-related health problems and comorbidities, individually or in combination, progress as individuals age is complex and still poorly understood. In addition, alcohol use and viral expression and associated immunological responses, including progressive dysregulation of the immune system, may have additive or synergistic effects on the progression of aging.

Among individuals who drink, even treated HIV can be associated with accelerated aging, possibly from treatment sequelae or legacy effects, and notably from AUD comorbidity. Improved biomarker measurement may facilitate a more complete understanding of the mechanisms underlying accelerated aging in the context of alcohol-related comorbid conditions.

In general, alcohol exposure, hazardous (and harmful) patterns of use, and AUD diagnosis are associated with different types of functional impairment (e.g., frailty). Improved management of alcohol use could lead to improved fulfillment of social roles, as well as improved HIV-related health outcomes over the lifespan.

Further research is needed to take into account the important relationships between patterns of alcohol use and HIV treatment and care outcomes among PLWH as they age.

Supported studies may include, but are not limited to: Addressing the important relationships between patterns of alcohol use and HIV treatment and care outcomes among PLWH as they age, including the development and application of innovative adaptive intervention strategies and implementation research to inform efforts to bring evidence-based interventions to population scale.

National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) NIAMS encourages studies focused on the following: Observational, biopsychosocial/behavioral, translational, basic/pre-clinical/clinical research, and mechanistic clinical trials focused on how the process of aging in the presence or treatment of HIV/AIDS impacts diseases within the NIAMS core mission, which are more common among the aging population (e.g., rheumatologic disorders, bone fractures, osteoporosis, osteoarthritis).

Interdisciplinary research aimed at elucidating factors that may drive the aging population living with HIV/AIDS to develop NIAMS mission-related diseases and understanding how the interplay between aging and HIV/AIDS may promote the acceleration or worsening of these diseases. NIAMS will not support applications proposing clinical trials submitted in response to this NOFO.

Clinical trials instead should be submitted to a NIAMS clinical trial-specific funding opportunity (see NIAMS' Investigator-Initiated Clinical Research web page). Consultation with NIAMS staff is strongly recommended for investigators planning a clinical trial with a mechanistic outcome. If NIAMS determines after submission that a clinical outcome is a primary objective of the study, NIAMS will not accept the application.

National Institute of Dental and Craniofacial Research ( NIDCR ) NIDCR is interested in soliciting innovative and multi-disciplinary basic, translational, and clinical research on the intersection of HIV/AIDS and aging that is relevant to dental, oral, and craniofacial (DOC) health.

Specifically, NIDCR encourages research investigating how the process of aging impacts the presence or treatment of HIV-associated oral comorbidities, co-infections, and complications (CCCs) in the context of PLWH. NIDCR will not support applications proposing clinical trials submitted in response to this NOFO.

Supported studies may include, but are not limited to: Periodontal disease progression in the context of HIV infection and highly active antiretroviral therapy (HAART). Mechanisms of dental caries development and progression in PLWH. Effects of HIV/AIDS and HAART on salivary gland infiltrates, fibrosis, and xerostomia.

Oral mucosal pathologies and composition changes in the context of HIV/AIDS. HIV infection, HAART, and their influence on developing osteonecrosis of the jaw.

National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) NIDDK supports biomedical research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life.

NIDDK encourages projects that seek to elucidate how aging-related mechanisms and pathways contribute to comorbidities, co-infections, complications, and tissue reservoirs located in anatomical sites relevant to its mission. Topics of interest at the intersection of HIV and aging include, but are not limited to, the following: Pathophysiological processes underlying NIDDK-related comorbidities or complications.

Impact of HIV or its treatment with physiological processes within its mission, such as metabolism, normal blood development, or gastrointestinal immune homeostasis. Viral reservoir dynamics in anatomic sites relevant to NIDDK’s mission, such as the gastrointestinal mucosa, adipose tissue, liver, kidney, and male genital tract. Social determinants of health that impact co-occurring conditions with NIDDK’s mission.

Effectiveness research on programs aimed at social determinants of health impacting co-occurring conditions within NIDDK’s mission.

National Institute on Drug Abuse ( NIDA ) NIDA is interested in research to explore the impact of substance use and substance use disorders (SUD) on HIV acquisition, prevention, care and clinical course in relation to aging, including changes across the adult life span and research questions of particular application to people age 50 and older.

Substances of interest include: cannabinoids, nicotine, cocaine, stimulants, opioids, prescription drugs, or combinations of these drugs.

The research areas of interest include, but are not limited to: Leveraging existing epidemiological data (e.g., MWCCS: MACS/WIHS Combined Cohort Study) to evaluate the effects of aging on substance use patterns and their associations with viral suppression, mortality and HIV-related comorbidities among PLWH.

Examining long-term patterns of HIV and substance use on service utilization, substance use outcomes, and medical consequences among aging PLWH. Optimizing, Integrating and/or scaling up of evidence-based HIV and SUD prevention and/or care interventions for older people who use or misuse addictive substances.

Examining the intersection of social determinants of health, aging and substance use on HIV clinical and service utilization outcomes. Addressing HIV and substance use stigmas and how they affect substance use and HIV services among aging populations. Genomic, epigenomic, or single cell studies at the intersection of aging, neuroHIV, and SUD.

Impact of chronic substance use on the emergence of age-related cognitive and behavioral deficits (e.g., memory, attention, self-regulatory processes, social behavior, decision making, compulsivity, balance, mobility) in PLWH. Metabolomics of the aging brain in the context of ART, HIV and SUD and the impact of waste clearance on healthy aging in these populations.

Aging-related changes that impact drug metabolism and their impact on HIV and currently available antiretrovirals and pharmacological treatments for substance use. Of particular interest are studies examining patterns of use and effects of cannabis products in aging PLWH, including interactions with alcohol and medications commonly prescribed to people over 65 (or NIA’s threshold age).

Patterns of polysubstance use and its physiological effects in PLWH who are over age 65. Non-pharmacologic and non-invasive interventions to prevent or reduce substance use and misuse in aging adults living with HIV.

National Institute of Mental Health ( NIMH ) NIMH is keenly interested in interdisciplinary research studies that are conceptually grounded and employ basic, translational, and clinical approaches to better comprehend outcomes at the intersection of aging and HIV.

NIMH and its Division of AIDS Research (DAR) research program areas of interest in HIV and Aging include, but are not limited to: Evaluate Impact and Identify Targets : Investigate HIV's impact on cognition, motor function, and mental health in aging adults to comprehend mechanistic pathways and identify potential intervention targets.

Mechanisms and Aging-Related Traits: Study physiological and biobehavioral etiopathogenesis relevant to cognitive, motor, and mental health outcomes in aging individuals with HIV. Explore how HIV status and viral load affect accelerated aging, neurocognitive aging, and successful aging traits. Neurotherapeutic Approaches: Identify neurotherapeutic approaches addressing interactions between HIV and aging processes.

Behavioral Factors and Comorbidities : Investigate the effects of social and behavioral factors on mental health and HIV outcomes in aging populations, while also assessing the impact of neurological and psychiatric comorbidities on health outcomes to enable the development of targeted interventions.

Interventions and Continuum Optimization : Research interventions for preventing HIV acquisition in aging populations and explore adaptations to the HIV care continuum to enhance outcomes in aging individuals living with HIV.

National Institute of Neurological Disorders and Stroke ( NINDS ) NINDS supports basic, translational, and clinical research on the brain and nervous system and uses this knowledge to reduce the burden of neurological disease. In the context of HIV disease, NINDS is particularly interested in the neurological complications of HIV infection that affect the brain, spinal cord, and peripheral nervous system.

For the purposes of this NOFO, specific topics of interest might include (but would not be limited to): The long-term consequences of latent HIV in the CNS as it pertains to the modulation of chronic neuroinflammation and cognitive impairment in aging; the mechanisms by which chronic HIV exacerbates long-term blood-brain barrier damage and cerebrovascular dysfunction.

Studies of the mechanisms by which chronic HIV primes the CNS for neurodegeneration, including in the context of AD/ADRD and other age-associated neurodegenerative disorders. The long-term effect of chronic antiretroviral therapy (ART) exposure throughout the lifespan on the central and peripheral nervous systems.

Mechanisms of HIV-associated peripheral neuropathy and chronic pain in aged individuals; and studies that address the question of whether chronic HIV infection and exposure to ART cause accelerated aging of the CNS.

While NINDS will support studies focused on the effect of chronic HIV on cognitive outcomes in the setting of neurological disease, applications that are solely interested in mental health and psychiatric outcomes will not be supported by NINDS . This includes applications that solely rely upon RDoC-based constructs for neurobehavioral analyses.

Rather, NINDS strongly prefers the incorporation of additional multidimensional measures of neurological function, such as NIH Toolbox and Neuro-QOL -based assessments of cognitive, motor, and sensory function. In addition, only mechanistic clinical trials and Basic Experimental Studies with Humans (BESH) will be supported by NINDS under this funding opportunity.

Clinical trials that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions will not be supported under this NOFO Rather, such projects should be submitted to one of NINDS’ clinical trial-specific funding announcements (such as PAR-22-142 or PAR-21-237 ).

NINDS urges investigators to follow the NIH guidance for rigor and transparency in grant applications and additionally recommends the research practices described on NINDS' resource web page on preparing applications to ensure that robust experiments are designed, potential experimenter biases are minimized, results and analyses are transparently reported, and results are interpreted carefully.

These recommended research practices include, where applicable: rationale for the chosen model(s) and primary/secondary endpoints, clear descriptions of tools and parameters, blinding, randomization, ensuring adequate sample size, pre-specified inclusion/exclusion criteria, handling of missing data and outliers, appropriate controls, preplanned analyses, appropriate quantitative techniques, clear indication of exploratory vs. confirmatory components of the study, consideration of limitations, and plans for transparent reporting of all methods, analyses, and results so that other investigators can evaluate the quality of the work and potentially perform replications.

National Cancer Institute ( NCI ) Recent data indicates an increase in a variety of cancer types (e.g., anus, liver, oral cavity/pharynx, lung, and Hodgkin lymphoma), which is driven primarily by the growth and aging of PLWH who are on highly effective antiretroviral therapy. Aging is, by itself, a key factor promoting the development of many cancers, and HIV infection can itself cause certain manifestations of premature aging.

There is a lack of data on the interplay between aging, HIV, long-term exposure to antiretroviral drugs, and other factors promoting cancer development in PLWH who are aging. In addition, there is little understanding of the interplay between host factors and immune perturbations that occur in aging and how these interactions affect cancers that are mostly seen in older people (e.g., clonal hematopoiesis and biological aging).

Therefore, NCI is interested in applications proposing studies on the following: Research studies to help understand how aging in the presence of chronic HIV infection affects the risk, spectrum, and biology of cancer in PLWH. Cancer treatment outcomes and survivorship in PLWH. Office of Research on Women's Health ( ORWH ) ORWH supports research projects that address topics of relevance to aging, HIV, and women.

Intersectional approaches to women, aging, and HIV are encouraged. For this NOFO, areas of particular interest include: Projects to understand and address weathering, social isolation, stigma, and loneliness in the context of HIV and aging. Community-led interventions to improve testing, prevention, and treatment among older populations of women.

Comorbidity and multi-morbidity among older populations of women living with HIV. Understanding the influence of sex on HIV infection and pathogenesis in the context of aging. Understanding the role of HIV in violence, trauma and mental health in aging women living with HIV.

Community-centered interventions to engage older women in HIV research, including HIV cure-related research. Clinical Research Operations Management System NIA utilizes a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research.

NIA Clinical Research Operations & Management System (CROMS) is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects.

NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021 and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant and as described in NOT-AG-23-017 .

Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (GPS 4. 1. 15.

7). Details regarding the standard operating procedures for CROMS can be found on the NIA CROMS website . When applicable, all NIA grantees must ensure: 1.

The study’s Informed Consent Document (ICD) lists “The National Institutes of Health (NIH) and its authorized representatives” as one of the organizations that may look at or receive copies of information in participants’ study records. According to DHS HHS OHRP 45 CFR 46 §46. 116 , all ICDs must contain “A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.

” If using the NIA informed consent template please see Section 6: Statement of Confidentiality. 2. An assigned NIH ClinicalTrials.

gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials. gov. Non-responsiveness Criteria Applications that are not aligned with OAR's priority areas, as described in NOT-OD-20-018 , will be considered non-responsive to this NOFO.

Non-responsive applications will not be reviewed. Examples of research not aligned with OAR's priority areas include: Research on natural history and epidemiology that is entirely focused on a co-morbidity and does not have any focus on or inclusion of HIV.

Research on co-infecting pathogens, but not in the context of HIV infection; basic immunology studies of general relevance, but not specific to HIV; basic cancer-related immunology studies not in the context of HIV infection; or studies on co-morbidities of general relevance, but not in the context of HIV.

Data analysis and systems tools that are not HIV related (e.g., genomics and other omics studies with little or no relevance to HIV). Studies of behaviors (e.g., sexual activities, drug use activities) or social conditions where HIV/AIDS is only one of many outcomes without a focus on how HIV/AIDS is unique in that context.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.

The maximum project period is 2 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators