Grants

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HIV Treatment Adherence Research (R03)

National Institutes of Health

-Purpose. This funding opportunity announcement (FOA) issued by the National Institute of Mental Health and National Institute on Drug Abuse invites grant applications from applicant organizations to advance scientific research and intervention regarding HIV treatment adherence. -Mechanism of Support. This FOA will utilize the NIH Small Research Grant (R03) mechanism and runs in parallel with FOAs of similar scientific scope, PA-07-338, which solicits applications under the Research Project Grant (R01) mechanism; PA-07-340, which solicits applications under the Exploratory/Developmental (R21) mechanism; and PAR-07-341, which solicits applications under the Exploratory Grants for Mental Health Interventions and Services (R34) mechanism. Please note that the participating organizations vary across this set of FOAs. -The R03 grant mechanism supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology.

Education

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HIV Treatment Adherence Research (R21)

National Institutes of Health

-Purpose. This funding opportunity announcement (FOA) issued by the National Institute of Mental Health, National Institute on Drug Abuse, and National Institute of Nursing Research invites grant applications from applicant organizations to advance scientific research and intervention regarding HIV treatment adherence. -Mechanism of Support. This FOA will utilize the NIH Exploratory/Developmental (R21) grant mechanism and runs in parallel with FOAs of similar scientific scope, PA-07-338, which solicits applications under the Research Project Grant (R01) mechanism; PA-07-339, which solicits applications under the under the Small Research Grant (R03) mechanism; and PAR-07-341, which solicits applications under the Exploratory Grants for Mental Health Interventions and Services (R34) mechanism. Please note that the participating organizations vary across this set of FOAs. -The R21 grant mechanism is intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Up to $200K

Education

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HIV Treatment Adherence Research (R34)

National Institutes of Health

-Purpose. This funding opportunity announcement (FOA) issued by the National Institute of Mental Health invites applications for Exploratory Grants for Mental Health Interventions and Services (R34) from applicant organizations to advance scientific research and intervention regarding HIV treatment adherence. -Mechanism of Support. This FOA will utilize the NIMH Exploratory Grants for Mental Health Interventions and Services (R34) grant mechanism and runs in parallel with FOAs of similar scientific scope, PA-07-338, which solicits applications under the Research Project Grant (R01) mechanism; PA-07-339, which solicits applications under the under the Small Research Grant (R03) mechanism; and PA-07-340, which solicits applications under the Exploratory/Developmental (R21) mechanism. Please note that the participating organizations vary across this set of FOAs. -Funds Available and Anticipated Number of Awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Up to $225K

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HIV Vaccines Clinical Trials Network Leadership and Operations Center

NIAID - National Institute of Allergy and Infectious Diseases

This proposal outlines the scientific agenda of the Leadership and Operations Center of the HIV Vaccine Trials Network (HVTN), which has pioneered immunological approaches to HIV prevention. One of the major accomplishments of the HVTN in this grant period has been the conduct of 3 vaccine and 2 monoclonal antibody (mAb) efficacy trials that have provided proof of principle that 1) broadly neutralizing antibodies (bnAbs) can prevent HIV acquisition and 2) vaccine approaches that elicit non-neutralizing antibodies, even cross-clade non-neutralizing antibodies, are not effective. These trials provide a new roadmap for HIV prevention: induction of bnAbs is the path to an effective HIV vaccine. This proposal describes a novel fast-track Discovery Medicine phase 1 program to assess, in an iterative fashion, candidate trimers, germline and lineage-based vaccines designed to elicit bnAbs in adults and HIV-1–exposed infants. This program integrates novel candidate immunogens using sequential immunizations with B-cell sequencing to elicit mature functional bnAbs. The HVTN utilizes 13 geographically diverse core sites and another 10-14 protocol specific sites for its studies in the US. International research sites are also critical to HVTN’s scientific strategy and directly advance public health goals to end the HIV epidemic in the U.S. Conducting trials in high-incidence international settings allows the HVTN to evaluate prevention strategies more rapidly with smaller sample sizes and substantially lower cost, thereby accelerating the advancement of prevention interventions for the U.S. population. The use of international sites also enables evaluation of diverse HIV subtypes and supports the identification of immune correlates of protection in locations with sufficient endpoint accrual. The HVTN 703 study showed the remarkable benefit of mAb therapy for preventing HIV in women; it enrolled 1,700 women in sub-Saharan Africa and followed them for two years to show bnAbs could prevent HIV. This contrasts with a proposed 11,000-women study requiring 4 years of follow-up if conducted only in the U.S. We are now designing a combination passive immunization bnAb study in the U.S. to begin in 2028 rather than a 2034 start date if past foundational studies could not be conducted efficiently with high prevalence international sites. Vaccine clinical trials involve a complex interplay between clinical trial sites, HVTN laboratories, computational scientists, and our operational, training, mentoring, and fiscal management teams; these interactions are described in the application. The clinical, laboratory and statistical infrastructure we have built for immune-based prevention of HIV will also be used to assist in tuberculosis vaccine development. Our network integrates community representatives and community advisory boards into all our research process and conduct. We will also continue to develop the next generation of vaccine scientists and expand our scientific collaborations to engage the scientific community to utilize the extensive specimen and data repositories we have established. The overall goal of the HVTN in this proposal is to develop immune-based preventive interventions that will reduce HIV acquisition in adults and infants by more than 80%.

Up to $1

2027-11-30

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HIV-1 antibodies in the presence of tuberculosis and other coinfections

NIAID - National Institute of Allergy and Infectious Diseases

PROJECT SUMMARY Worldwide, tuberculosis (TB) is the most common disease in people living with HIV (PWH). Although, studies have conclusively demonstrated that HIV-1 enhances the development and progression of TB, there is limited understanding about TB effects on HIV-1 pathogenesis. We have observed that PWH and TB as compared to PWH/No TB have broader and more potent HIV-1 neutralizing antibodies (nAbs). We hypothesize that TB changes both the HIV-1 immune response and the characteristics of the viruses present in PWH. This is important because our knowledge about HIV-1 pathogenesis primarily comes from individuals that do not have concomitant TB; the ubiquitous HIV-1 TB syndemic provides an imperative to understand the effects of TB in PWH. TB influences multiple aspects of HIV-1 pathogenesis. Broad and more potent HIV-1 nAbs, observed in PWH and TB, provides selection pressure, and we will assess if TB leads to the emergence of more nAb resistant strains. Resistant viruses are a primary reason it has been difficult to prevent HIV-1 transmission through vaccination and induce virus remission with antibody-based therapies. We will also examine the impact of other diseases common in PWH, such as talaromycoses, histoplasmosis, cryptococcosis, and non- tuberculous mycobacteria. Comparing HIV-1 immune responses and virus characteristics in PWH and the various different opportunistic infections will provide insights into the pathogenesis of TB enhanced immune responses. These studies will highlight the importance of specific inflammatory programs, unique microbial antigens, and anatomic co-localization for the enhanced humoral response with TB. We hypothesize that TB and potentially other diseases increase the frequency and functionality of T follicular helper cells, which are an essential component of a broadly potent humoral response. Antibodies can also mediate effector cell function through Fc domains, such as antibody dependent cellular cytotoxicity (ADCC). We will also examine if TB selects for ADCC resistant strains because prior studies have shown that ADCC is important in preventing HIV-1 transmission and ameliorating disease outcomes after HIV-1 acquisition. Furthermore, neutralization resistant strains are often ADCC susceptible and vice-versa. We will also isolate and characterize antibodies that mediate broad and potent neutralization and ADCC. PWH and TB will harbor unique HIV-1 antibodies because they arise in the presence of highly resistant HIV-1 variants. TB mediated influence on HIV-1 immunity and the subsequent effect on the frequency of resistant strains has direct implications for future broadly potent nAb based vaccine strategies and therapies aimed at inducing virus remission in the absence of combination antiretroviral therapy. Our studies will highlight the importance of TB status for antibody based prevention and post-treatment control strategies and the type of antibodies that will work in HIV TB endemic regions of the world.

Up to $873K

2031-03-31

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HIV-1 Vpr and Mucosal Immunopathogenesis

NIAID - National Institute of Allergy and Infectious Diseases

PROJECT SUMMARY Unraveling the basic functional properties of individual HIV-1 proteins could provide important clues relevant towards novel therapies and cure strategies. The functional properties of most HIV-1 proteins had been dissected in great detail, but among the viral `accessory' proteins, HIV-1 Vpr remains enigmatic. HIV-1 Vpr has been linked to diverse phenotypes that include significant effects on apoptosis, cell-cycle arrest, innate immune regulation and latency reactivation by interacting with a multitude of host proteins. Interestingly, Vpr-associated replication phenotypes were most consistent in myeloid cells such as macrophages and dendritic cells, but not in CD4 T cells. These data are puzzling, as in persons with HIV-1 infection (PWH), macrophage-tropic viruses typically do not emerge until later clinical stages. As a highly conserved virion-associated protein, HIV-1 Vpr is expected to exert its effects very early on, when mucosal CD4+ T cells serve as critical cellular infection targets. Specifically, during acute HIV-1 infection, high levels of HIV-1 replication and CD4 T cell depletion in the gastrointestinal (GI) tract contributes to a dysregulated epithelial barrier. The subsequent translocation of bacteria and/or bacterial products from the gut lumen to the underlying lamina propria and systemic circulation leads to persistent inflammation and chronic immune activation that does not resolve with antiretroviral therapy. Recently, HIV-1 Vpr was reported to alter the transcriptome and/or proteome of CD4 T cell lines and mitogen-activated blood CD4 T cells, but without a significant effect on virus replication. We suspect that inconsistencies reported for HIV-1 Vpr function could be due to the use of infection models that may not capture fundamental attributes of early HIV-1 replication in vivo. Previously, we established the Lamina Propria Aggregate Culture (LPAC) model to study the biology of clinically relevant HIV-1 strains in primary immune cell types derived from the GI tract. Using the LPAC model, we observed that Vpr in the context of transmitted/founder HIV-1 had a consistent defect in (Aim 1) replication and (Aim 2) depletion of primary gut CD4 T cells. To begin to decipher the underlying molecular mechanisms, we propose to evaluate critical virological determinants linked to various Vpr functional attributes. Linking unbiased proteomic and transcriptomic approaches with focused strategies to track the replication block, we will pinpoint candidate pathways and molecular partners in gut CD4 T cells for subsequent in-depth analyses. Altogether, this exploratory study promises to expand our understanding of HIV-1 Vpr biology in CD4 T cells, the main cellular targets of HIV-1, and in the process, enrich our understanding of HIV-1 mucosal pathogenesis.

Up to $429K

2028-05-31

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HIV-CRISP for Same Visit Test and Switch Viral Load and Resistance Testing

NIAID - National Institute of Allergy and Infectious Diseases

Project Summary HIV drug resistance represents a growing and underappreciated threat to the U.S. HIV response. Although more than 1.2 million people are living with HIV in the U.S., only about 60% achieve durable viral suppression, and resistance is a major contributor to treatment failure and regimen switching. Current resistance testing relies on centralized, PCR and sequencing-based platforms that are expensive, slow, and available only at specialty laboratories, requiring multiple clinic visits and highly trained personnel. As a result, same- day, resistance-informed treatment decisions are rarely possible, even in major U.S. cities, and are essentially inaccessible in rural areas, mobile care units, and safety-net clinics serving areas where the epidemic is increasingly concentrated. These gaps most severely affect communities already carrying the highest burden of HIV incidence and treatment failure in the U.S. Without affordable, accessible, point-of-care (POC) resistance testing, the durability of ART and the success of the national Ending the HIV Epidemic initiative are at risk. Our project aims to develop HIV-CRISP to addresses this critical gap by developing a cost-effective, same- visit “test-and-switch” POC device that integrates CRISPR-based nucleic acid detection with a bioinspired microfluidic chip (CamoChip). This fully automated platform enables simultaneous detection of HIV viral load and drug resistance to four major ART classes (NRTIs, NNRTIs, INSTIs, and PIs) during a single clinic visit. By empowering providers to make immediate, resistance-informed treatment decisions, HIV-CRISP reduces delays in therapy initiation or modification and minimizes the risk of treatment failure. The project is structured around three specific aims: Specific Aim 1: optimize a PAMmer-assisted CRISPR system for accurate detection and profiling of HIV drug resistance mutations; Specific Aim 2: enhance CamoChip readout technology for rapid, multiplex POC testing; and Specific Aim 3: integrate these components into a user-informed POC device and validate its performance against standard methods with clinical samples. Each aim not only drives independent scientific advances but also converges on the development of a transformative POC diagnostic. HIV-CRISP represents an innovation in HIV diagnostics with broad public health significance. This platform supports wide access to high-quality HIV care in under-resourced settings across the U.S. and globally, while also providing a foundation adaptable to other infectious diseases and health conditions.

Up to $816K

2031-04-30

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HIV/AIDS Clinical Trials Network Clinical Trials Units

National Institutes of Health

The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance the National Institutes of Health (NIH) mission by supporting four Clinical Trials Networks (CTNs) each comprised of a Leadership and Operations Center, Statistical and Data Management Center, and Laboratory Center working with Clinical Trials Units (CTUs), to advance prevention and treatment research on HIV and HIV-associated diseases. CTNs will conduct randomized controlled clinical studies at CTUs testing innovative strategies and conduct implementation research targeted to end the HIV epidemic. This NOFO will solicit applications for CTUs providing scientific expertise to conduct these clinical trials and implementation research studies. Each CTU will include an administrative hub and domestic and/or international Clinical Research Sites to promote efficient utilization of resources and infrastructure. CTUs conduct multiple clinical studies, from more than one CTN, and can access, recruit, and retain relevant study participants. International studies produce crucial findings significantly benefiting Americans with or at-risk of HIV or HIV-related diseases.Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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HIV/AIDS Clinical Trials Network Clinical Trials Units

National Institutes of Health

HIV/AIDS Clinical Trials Network Clinical Trials Units

Rolling

general

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HIV/AIDS Clinical Trials Network Clinical Trials Units

National Institutes of Health

The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance the National Institutes of Health (NIH) mission by supporting four Clinical Trials Networks (CTNs) each comprised of a Leadership and Operations Center, Statistical and Data Management Center, and Laboratory Center working with Clinical Trials Units (CTUs), to advance prevention and treatment research on HIV and HIV-associated diseases. CTNs will conduct randomized controlled clinical studies at CTUs testing innovative strategies and conduct implementation research targeted to end the HIV epidemic. This NOFO will solicit applications for CTUs providing scientific expertise to conduct these clinical trials and implementation research studies. Each CTU will include an administrative hub and domestic and/or international Clinical Research Sites to promote efficient utilization of resources and infrastructure. CTUs conduct multiple clinical studies, from more than one CTN, and can access, recruit, and retain relevant study participants. International studies produce crucial findings significantly benefiting Americans with or at-risk of HIV or HIV-related diseases.Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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HIV/AIDS Clinical Trials Network Laboratory Centers

National Institutes of Health

The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance its mission by supporting four Clinical Trials Networks (CTNs) each comprised of a Leadership and Operations Center, Statistical and Data Management Center, and Laboratory Center (LC) working with Clinical Trials Units, to test prevention and treatment strategies and conduct implementation research designed to end the HIV epidemic. This NOFO will solicit applications for up to four LCs that will provide laboratory structure and technologies to one or more CTNs and conduct laboratory testing for Network trials, according to regulatory standards. The LC oversees site-affiliated clinical and specialized laboratories and ensures protocol-specified laboratory testing.  The LC will: 1) support sample integrity from collection to final testing/storage; 2) use appropriate laboratory data capturing management and tracking systems; 3) select, determine readiness, and approve laboratories; and 4) promote state-of-the-art laboratory assays. The LC will increase testing capacity to meet advances in prevention and treatment of HIV and HIV-related diseases. Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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HIV/AIDS Clinical Trials Network Laboratory Centers

National Institutes of Health

The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance its mission by supporting four Clinical Trials Networks (CTNs) each comprised of a Leadership and Operations Center, Statistical and Data Management Center, and Laboratory Center (LC) working with Clinical Trials Units, to test prevention and treatment strategies and conduct implementation research designed to end the HIV epidemic. This NOFO will solicit applications for up to four LCs that will provide laboratory structure and technologies to one or more CTNs and conduct laboratory testing for Network trials, according to regulatory standards. The LC oversees site-affiliated clinical and specialized laboratories and ensures protocol-specified laboratory testing. The LC will: 1) support sample integrity from collection to final testing/storage; 2) use appropriate laboratory data capturing management and tracking systems; 3) select, determine readiness, and approve laboratories; and 4) promote state-of-the-art laboratory assays. The LC will increase testing capacity to meet advances in prevention and treatment of HIV and HIV-related diseases.Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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HIV/AIDS Clinical Trials Network Leadership and Operations Centers

National Institutes of Health

The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance the National Institutes of Health (NIH) mission by supporting four Clinical Trials Networks (CTNs) each comprised of a Leadership and Operations Center (LOC), Statistical and Data Management Center, and Laboratory Center working with Clinical Trials Units to advance prevention, treatment, and implementation research designed to end the HIV epidemic. This NOFO will solicit applications for four LOCs to provide scientific leadership, research prioritization, and conduct studies in a CTN. A LOC develops the research agenda in one of these areas: 1) HIV therapeutics/cure, and prevention/treatment for HIV-associated comorbidities in adults; 2) HIV prevention/treatment in maternal/adolescent/pediatric populations; 3) biomedical HIV prevention strategies for adults/adolescents; and 4) immune-based prevention for HIV and HIV-associated diseases. CTNs will conduct HIV implementation research improving uptake of evidence-based prevention and treatment strategies across the lifespan. High impact LOC studies will produce crucial findings significantly benefiting Americans with or at-risk of HIV and HIV-associated diseases.Grant authorities that allow NIAID to forecast this opportunity are: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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HIV/AIDS Clinical Trials Network Leadership and Operations Centers

National Institutes of Health

The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance the National Institutes of Health (NIH) mission by supporting four Clinical Trials Networks (CTNs) each comprised of a Leadership and Operations Center (LOC), Statistical and Data Management Center, and Laboratory Center working with Clinical Trials Units to advance prevention, treatment, and implementation research designed to end the HIV epidemic. This NOFO will solicit applications for four LOCs to provide scientific leadership, research prioritization, and conduct studies in a CTN. A LOC develops the research agenda in one of these areas: 1) HIV therapeutics/cure, and prevention/treatment for HIV-associated comorbidities in adults; 2) HIV prevention/treatment in maternal/adolescent/pediatric populations; 3) biomedical HIV prevention strategies for adults/adolescents; and 4) immune-based prevention for HIV and HIV-associated diseases. CTNs will conduct HIV implementation research improving uptake of evidence-based prevention and treatment strategies across the lifespan. High impact LOC studies will produce crucial findings significantly benefiting Americans with or at-risk of HIV and HIV-associated diseases.Grant authorities that allow NIAID to forecast this opportunity are: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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HIV/AIDS Clinical Trials Network Statistical and Data Management Centers

National Institutes of Health

The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance the National Institutes of Health (NIH) mission by supporting four Clinical Trials Networks (CTNs) each comprised of a Leadership and Operations Center, Statistical and Data Management Center (SDMC), and Laboratory Center (LC) working with Clinical Trials Units (CTUs), to advance prevention, treatment, and implementation research on HIV and HIV-associated diseases. This NOFO will solicit applications for up to four SDMCs to provide leadership for developing and implementing each CTN research agenda with the goal of ending the HIV epidemic. Each SDMC will coordinate study design and execution, including data collection, monitoring, and analyses. SDMCs manage clinical and laboratory data submitted by CTUs and the LC ensuring data quality, regulatory compliance, and continual reporting of protocol and site performance. SDMCs foster innovative trial design and statistical methods, statistical and data practices harmonization, and ensure validated systems for data capture and integration, according to NIH data sharing policies.Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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HIV/AIDS Clinical Trials Network Statistical and Data Management Centers

National Institutes of Health

The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance the National Institutes of Health (NIH) mission by supporting four Clinical Trials Networks (CTNs) each comprised of a Leadership and Operations Center, Statistical and Data Management Center (SDMC), and Laboratory Center (LC) working with Clinical Trials Units (CTUs), to advance prevention, treatment, and implementation research on HIV and HIV-associated diseases. This NOFO will solicit applications for up to four SDMCs to provide leadership for developing and implementing each CTN research agenda with the goal of ending the HIV epidemic. Each SDMC will coordinate study design and execution, including data collection, monitoring, and analyses. SDMCs manage clinical and laboratory data submitted by CTUs and the LC ensuring data quality, regulatory compliance, and continual reporting of protocol and site performance. SDMCs foster innovative trial design and statistical methods, statistical and data practices harmonization, and ensure validated systems for data capture and integration, according to NIH data sharing policies.Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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HIV/AIDS, Severe Mental Illness And Homelessness (R01)

National Institutes of Health

-Purpose. This Funding Opportunity Announcement (FOA) issued by the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), and the National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), invites research grant applications focused on persons with severe mental illness (SMI), either before or after HIV infection, and the expansion of HIV-related research to include homeless persons. The FOA solicits studies on the development, implementation, evaluation, and dissemination of effective HIV-prevention interventions, and studies related to the epidemiology of HIV infection in the target populations. Multidisciplinary research teams and collaborative alliances are encouraged. -Mechanism of Support. This FOA will utilize the NIH Research Project Grant (R01) grant mechanism, Applications of related or identical scientific scope are also solicited under the NIH Small Research Grant (R03), the NIH Exploratory/Developmental Grant (R21), and the NIMH Clinical Exploratory Research Grant (R34) grant mechanisms, responding to FOAs PA-06-180, PA-06-181, and PAR-06-248, respectively. -Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.