June 2024 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, notices of special interest, or solicitations for Council’s input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements.

Note: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Fiscal Year (FY) 2025 Division of AIDS (DAIDS) Concept

FY 2026 DAIDS Concepts

Notice of Special Interest (NOSI): Epigenetic Modulation of HBV cccDNA and Integrated HBV DNA (iDNA): Implications for Epigenetic Treatment Strategies Against HBV in HIV/HBV Co-Infection

For the published notice of special interest, check the June 28, 2024 Guide notice, Notice of Special Interest (NOSI): Epigenetic Modulation of HBV cccDNA and integrated HBV DNA (iDNA): Implications for Epigenetic Treatment Strategies Against HBV in HIV/HBV Co-Infection. 

Martin Delaney Collaboratories for HIV Cure Research

Request for Applications—proposed FY 2026 initiative

Contact:
Diane Lawrence
diane.lawrence2@nih.gov

Objective: This initiative seeks to address major obstacles to the eradication (cure) of HIV infection and long-term antiretroviral therapy (ART)-free control of viral rebound (remission) in people living with HIV. The goal is to extend our understanding of the basic biology and dynamics of persistent HIV reservoirs; to develop improved assays, methodology, and animal models to expedite research progress; and to design, develop, and test therapeutic strategies for achieving long-term HIV remission or eradication. This will require innovative and highly collaborative research, rapid response to evolving science and emerging technologies, emphasis on the basic biology and dynamics of persistent HIV reservoirs in diverse global populations, and development of improved assays, methodologies, and model systems. The dynamic structure of the Martin Delaney Collaboratory (MDC) program seeks to increase the pace of research, leverage common resources, facilitate collaborations, and engage and train future HIV cure researchers.

Description: This initiative will support highly collaborative research partnerships among academic institutions, industry, government, and community-based organizations. An estimated six to eight MDCs will be supported. Foreign applications and international partnerships will be encouraged.

Martin Delaney Collaboratory for Pediatric HIV Cure Research

Request for Applications—proposed FY 2026 initiative

Contact:
Tania Lombo
tania.lombo@nih.gov

Objective: This initiative will stimulate research to address major obstacles to the eradication (cure) of HIV infection or long-term antiretroviral therapy-free control of viral rebound (remission) in infected pediatric individuals. The goal is to extend our understanding of the basic biology and dynamics of persistent HIV reservoirs; to develop improved assays, methodology, and animal models to expedite research progress; and to design, develop, and test therapeutic strategies for achieving long-term HIV remission or eradication specifically in people living with HIV under 18 years of age. The collaborative and dynamic structure of the pediatric Martin Delaney Collaboratory (MDC) program seeks to increase the pace of HIV cure research, leverage common resources, facilitate collaborations, and engage and train the next generation of pediatric HIV cure researchers.

Description: This initiative will support HIV cure research in pediatric populations through partnerships between academic institutions, industry, government, and community-based organizations. It is anticipated that one pediatric program will be supported. The award recipient will be encouraged to communicate and collaborate with the awards made under the companion Martin Delaney Collaboratory programs via annual meetings, trans-MDC working groups, and review by a Scientific Advisory Board. The pediatric MDC will work together with the Coordination Center and other MDCs to maximize collaboration and sharing of data, and resources to ensure coordination for common activities.

Martin Delaney Collaboratories for HIV Cure Research Coordination Center

Request for Applications—proposed FY 2026 initiative

Contact:
Diane Lawrence
diane.lawrence2@nih.gov

Objective: The overarching goal of the program is to enable diverse, dynamic, and highly collaborative research to enhance understanding of HIV persistence and to design, develop, and test combined therapeutic strategies for long-term HIV control and/or eradication in people living with HIV. The Coordination Center will support effective collaborations, enhancing efficiency, facilitating consultations to support Martin Delaney Collaboratory (MDC) research, engaging early-stage investigators, and organizing feedback on the overall program.

Description: This initiative will support an MDC Coordination Center that will provide administrative, scientific, technical, and management support to enhance the collaborative and cooperative interdisciplinary environment of the MDC award recipients and stakeholders (see companion adult MDC and pediatric MDC concepts above).

Limited Competition: International epidemiology Databases to Evaluate AIDS (IeDEA)

Request for Applications—proposed FY 2026 initiative

Contact:
Lori Zimand Abramson
lzimand@niaid.nih.gov

Objective: This reissue initiative seeks to continue the seven regional data center awards comprising the IeDEA program, which brings together clinical and research data within regions, and in collaboration globally, to monitor and guide the response to the HIV/AIDS epidemic. IeDEA answers key questions about the long term-term impact of HIV and its treatment, the epidemiology of common co-infections (hepatitis and tuberculosis) and respective health care utilization including medications, procedures, and vaccines. IeDEA uses cutting-edge data science techniques to validate and harmonize data within and across regions. It develops novel statistical methods to account for missing data, to understand and minimize bias, and utilizes other techniques to maximize the utility of observational data. The goal is to conduct analyses that produce comparable results across regions, combine data from multiple regions to answer compelling questions, and produce patient-level surveillance outcomes to monitor program implementation. Results will contribute to success in implementing the National HIV/AIDS Strategy, and monitoring outcomes and success of international HIV programs such as PEPFAR.

Description: This limited competition will continue funding for five U.S. institutions and two European universities to conduct research in seven global regions of the world. The regions are: North America; Caribbean; Central and South America; West, Central, Eastern, and Southern Africa; and Asia Pacific. The program supports epidemiologists, data management specialists, and statisticians to conduct research on collected clinical data and selected subcohorts of patients. Sources include cohort studies, clinical trials networks, public and private clinics and hospitals, and private care providers. The initiative will support work on the long-term impact of HIV and its treatment, the epidemiology of common co-infections (hepatitis and tuberculosis), and evaluations of the implementation of health care including medications, procedures, and vaccines; studies of comorbidities such as cancer; disruption of physiological and metabolic processes leading to end organ impairment; mental health; and alcohol and substance use. Research should include participants across the lifespan. While most data are collected through normal clinical care or other research protocols, IeDEA also supports a Sentinel Research Network, which samples participants from clinic populations in a more intensive prospective cohort.

Consortia for HIV/AIDS Vaccine Development & Immunology (CHAVDI)

Request for Applications—proposed FY 2026 initiative

Contact:
Stuart Z. Shapiro
sshapiro@niaid.nih.gov

Objective: This initiative will support a coordinated multidisciplinary effort in HIV vaccine development that cannot be accomplished with individually conducted single project grants. Examples of potential research are listed below.

Description: This initiative will support multidisciplinary teams focused on critical questions such as:

  1. Immune responses that prevent and control HIV/SIV infection.
  2. Immunogens that induce broadly cross-protective antibodies to HIV-1.
  3. Immunogens that otherwise prevent and/or control infection through, for example, enhancement of T cell-based mechanisms of early virus control.

Use of the complex cooperative agreement award will facilitate “big science” approaches, i.e., research that requires close coordination of multiple investigators or groups of investigators. Examples of projects include iterative design and testing in nonhuman primates and GMP manufacture of product for testing in clinical trials of:

  1. Multi-stage immunogens designed to induce the affinity maturation necessary to make broadly neutralizing antibodies.
  2. Immunogens designed to induce T cell responses to conserved, immune-subdominant virus epitopes.
  3. Vaccines that induce other immune responses that may synergize with neutralizing antibodies to induce protection against HIV transmission and/or control of infection.

Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-Infections (AT LASt)

For the published request for applications, check the November 22, 2024 Guide announcement, Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-infections (AT LASt) (R61/R33 Clinical Trial Not Allowed). 

NIAID Virology Quality Assurance (VQA) Program

For the published request for proposals, check the January 8, 2025 solicitation, NIAID Virology Quality Assurance.

Elucidating Immunometabolic Responses to HIV Infection that Increase TB or HBV Risk

For the published program announcements with special receipt, referral, and/or review considerations, check the December 18, 2024 Guide announcements, Elucidating Immunometabolic Responses to HIV Infection that Increase TB or HBV Risk (R01, Clinical Trial Not Allowed) and Elucidating Immunometabolic Responses to HIV Infection that Increase TB or HBV Risk (R21, Clinical Trial Not Allowed).

Next Generation Multipurpose (NGM) Prevention Technologies

Program Announcement with Special Receipt, Referral, and/or Review Considerations—proposed FY 2026 initiative

Contacts:
James Cummins
cumminsje@niaid.nih.gov

Kristen Porter
kristen.porter@nih.gov

Objective: This reissue initiative will support the continued development of multipurpose prevention technologies (MPTs) for prevention of pregnancy and sexually transmitted infections (STIs).

Description: For the purposes of DAIDS, the focus will be on licensed contraceptives combined with anti-HIV drugs (licensed or unlicensed). Applicants may propose any combination of a prevention and contraception product that uses a sustained release platform to provide the minimal windows of efficacy/protection identified below. The overarching objective will be the continued expansion of a pipeline of MPT candidates.

All proposed MPT approaches must address a minimal window of protection of 30 days or 1 menstrual cycle from either a single dose regimen (injection) or continuous dosing regimen (implant, transdermal patch, etc.). Development of longer durations of protection and durations congruent when a licensed contraceptive is incorporated into the MPT will continue to be encouraged. Co-packaging as a MPT strategy of an existing licensed hormonal contraceptive and a licensed antiviral strategy will be discouraged. Clinical trials are optional. When a clinical trial(s) is/are proposed, they are expected to concentrate on the identification of Preferred User Characteristics (PUCs) to increase potential user’s adherence. PUCs are defined as the look-and-feel properties of the sustained drug delivery system that will influence potential users’ decisions for initial, continued, and habitual use. Clinical trials posed solely for first-in-human testing and/or to determine the safety/efficacy of proposed MPTs will be actively discouraged.

Resources Access for Preclinical Integrated Drug Development (RAPIDD) Program

Program Announcement with Special Receipt, Referral, and/or Review Considerations (PAR)—proposed FY 2026 initiative

Contact:
Marina Protopopova
marina.protopopova@nih.gov

Objective: The RAPIDD Program (X01 resource access PAR) enables the use of DAIDS preclinical services to facilitate the development of promising therapeutics and prevention strategies for HIV and HIV-associated co-infections and has the following objectives:

  1. Provide access to DAIDS preclinical contract resources and services.
  2. Increase investigator awareness of DAIDS preclinical resources and services.
  3. Provide a standardized process to request services.
  4. Optimize the selection of projects for DAIDS preclinical services.

Description: The RAPIDD Program (X01 resource access PAR) allows institutions to request access to resources from the existing “DAIDS Preclinical Services for HIV Therapeutics” and “Resources to Advance Pediatrics and HIV Prevention Science (RAPPS)” base contracts. These contracts provide the extramural scientific community preclinical support to develop promising and emerging investigator-initiated research and fills critical development and resource gaps at no cost to an investigator.

The requests will vary based on investigator specific needs but will conform to the scope of the existing indefinite delivery/indefinite quantity contracts. Priority considerations will be given to those requests that target high-priority research areas of DAIDS, such as development of less toxic and longer-lasting drugs for HIV and HIV-associated co-infections, novel HIV targets and inhibitors, novel immune-based therapies, next generation HIV prevention strategies, multipurpose prevention technologies, and age-appropriate pediatric formulations.

Role of Defective Proviruses in HIV Persistence

For the published program announcement with special receipt, referral, and/or review considerations, check the December 9, 2024 Guide announcement, Role of Defective Proviruses in HIV Persistence (R01, Clinical Trial Not Allowed).

Targeting Cell Surface HIV Envelope for Cell Elimination

For the published program announcement with special receipt, referral, and/or review considerations, check the December 2, 2024 Guide announcement, Targeting Cell Surface HIV Envelope for Cell Elimination (R01, Clinical Trial Not Allowed).

Transgender People: Immunity, Prevention, and Treatment of HIV and STIs

Program Announcement with Special Receipt, Referral, and/or Review Considerations—proposed FY 2026 initiative

Contact:
James Cummins
cumminsje@niaid.nih.gov

Objective: This reissue initiative continues support for critically needed biomedical information to effectively prevent and treat HIV and other sexually transmitted infections (STIs) in transgender people.

Description: There are many medical and surgical interventions that transgender people undergo as part of gender affirmation that might impact HIV and other STIs acquisition and treatment. Few studies have addressed these issues in this population with very high HIV burden and vulnerability. Understanding the needs and tailoring programs to transgender people is critical to effectively address HIV and other STIs in this population.

Clinical trials are not allowed for this initiative. However, use of biological samples is allowed. The program is for exploratory awards (R21) in an emerging area to obtain the preliminary data for future research efforts.

Notice of Special Interest (NOSI): Investigating TB Pathogenesis and Host Immunity to Preserve Lung Health After TB

For the published notice of special interest, check the October 30, 2024 Guide notice, Notice of Special Interest (NOSI): Establishing and Utilizing Pre-Clinical Animal Models to Study Post-TB Lung Disease Development.

Notice of Special Interest (NOSI): Sustained Release of Antivirals for Treatment or Prevention (SRATP)

Notice of Special Interest (NOSI)—proposed FY 2026 initiative

Contacts:
Marina Protopopova
marina.protopopova@nih.gov

Kristen Porter
kristen.porter@nih.gov

Objective: The objectives of this NOSI are to 1) support the development of innovative sustained release (SR)/long-acting (LA) products and strategies that provide a minimum of 3 months of HIV treatment or prevention and 2) develop SR/LA strategies for a minimum of once-a-month treatment of tuberculosis and hepatitis B in people living with HIV, and a once-a-month treatment of hepatitis C with the ultimate goal to develop a one-shot cure of hepatitis C.

Description: This initiative is focused on the development of innovative technologies to enable intermittent dosing to treat and prevent HIV and HIV co-infections. Use of samples from clinical trials supported elsewhere and animal research including nonhuman primates may be supported. Clinical trials are not allowed.

There is no set-aside funding for this NOSI.

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