September 2025 DAIDS Council-Approved Concepts

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

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

Table of Contents

Fiscal Year (FY) 2027 Division of AIDS (DAIDS) Concepts

• Implementation Science to Advance HIV Prevention, Treatment, and Care
• Centers for AIDS Research (CFAR)
• Centers for Structural Biology of HIV and Other Infectious Diseases
• Patient Safety Monitoring in International Laboratories (pSMILE)
• Regional Prospective Observational Research in Tuberculosis (RePORT)
• Clinical Research Products Management Center (CRPMC)

Implementation Science to Advance HIV Prevention, Treatment, and Care

Request for Applications—proposed FY 2027 initiative

Contact:
Rebecca Mandt
rebecca.mandt@nih.gov

Objective: The objective of this FY 2027 initiative is to solicit implementation science to advance the goal of ending the HIV epidemic. Achieving this goal will require novel, locally tailored solutions, as well as the systematic development of generalized knowledge and scale-up of effective interventions. Projects will leverage multidisciplinary expertise and research-community partnerships to bring evidence-based advances in HIV diagnosis, treatment, prevention, and cluster and outbreak response to communities disproportionately impacted by HIV. Priority areas include:

• Develop, test, and evaluate novel multi-level strategies that engage a breadth of relevant stakeholders within a community.
• Assess implementation of interventions for HIV across multiple geographic locations or settings, using shared frameworks and measures to better understand what works where and why.

To inform strategies and/or evaluate the impact of interventions, researchers are strongly encouraged to engage with people with lived experience, and to leverage multidisciplinary innovations across fields such as data science, modeling, epidemiology, public health, nursing, medicine, and implementation science.

Description: This initiative will support proposals that seek to improve the delivery of health care and services for HIV in geographic areas disproportionately affected by the epidemic. Research should incorporate implementation science principles, theories, models, or frameworks. Studies should take a multidisciplinary approach to understanding the context of implementation setting(s), and develop and evaluate implementation strategies. Investigators would be particularly encouraged to include cost-related outcomes (e.g., resources expended, program costs, cost-effectiveness). Studies should be designed in close collaboration with implementing partners such as local governmental departments, community-based organizations, clinics, and social service agencies. We anticipate these proposals to be large-scale studies that build on the existing base of work in implementation science, epidemiology, and related fields. Clinical research studies are allowed, and clinical trials are optional; however, drug or device safety trials with registrational requirements to the FDA will not be supported. Clinical trials investigating the optimal implementation of FDA-approved drugs at the clinic and/or system level would be appropriate.

Centers for AIDS Research (CFAR)

Program Announcement with Special Receipt, Referral, and/or Review Considerations—proposed FY 2027 initiative

Contact:
Eric Refsland
eric.refsland@nih.gov

Objective: The objective of the CFAR program is to foster high-quality HIV/AIDS research by establishing shared resources and services to increase collaborations and multidisciplinary research within an institution and between institutions, and by facilitating translation of basic research findings into vaccine, therapeutic, prevention, and HIV cure strategies in a synergistic and cost-effective manner. Another goal of the CFARs is to mentor and support the next generation of HIV researchers.

Description: The CFAR program enables the establishment of shared core facilities to support HIV/AIDS research at institutions with at least $10 million in annual NIH-funded HIV research. All CFARs must include an Administrative Core and a Developmental Core and at least one Clinical Core, one Advanced Technology Core, and one Implementation Science Core. At least one Scientific Working Group (SWG) is also required. An SWG is defined as a group of investigators (HIV or non-HIV) who share a common interest in a specific area of scientific focus that is critical to addressing the HIV epidemic but is a gap or underdeveloped at the CFAR institution(s). The goal of an SWG is to promote multidisciplinary collaborations. The Developmental Core provides research support to early-career investigators and investigators new to HIV/AIDS research. This includes pilot studies, evolving research opportunities, and high-risk/high-impact collaborative studies. CFARs will also have the option to include a Special Programs component, designed to foster the development of innovative programs to end the HIV epidemic, as well as larger mentoring and training programs to meet the needs of broader populations. Support for animal and clinical research is allowed. Clinical trials are not allowed.

Centers for Structural Biology of HIV and Other Infectious Diseases

Request for Applications—proposed FY 2027 initiative

Contact:
Karl Salzwedel
salzwedelkd@niaid.nih.gov

Objective: The Centers for Structural Biology of Infectious Diseases will be engaged in cutting-edge structural biology research that informs key aspects of pathogen biology and host responses relevant to NIAID priorities of prevention, diagnosis, treatment, and cure of infectious diseases. The overall objective of the initiative is to attract the best scientists in diverse disciplines to develop and improve technologies that address questions related to the structural biology of HIV and other pathogen/host cell interactions across a broad range of spatial and temporal scales. The Centers are expected to facilitate new collaborations, offer services and resources to the research community, leverage resources across the entire program, and train the next generation of scientists engaged in structural and computational biology of infectious diseases.

Description: The initiative will support dynamic, multidisciplinary consortia of microbiologists, virologists, immunologists, structural biologists and computational scientists to drive the pace of discovery, leverage common resources, offer services and resources to the scientific research community, facilitate new collaborations, and engage and train researchers in structural biology of infectious diseases.

• Centers will support research on all aspects of structural biology related to HIV and other human pathogens ranging from viruses to bacteria, to fungi, to other eukaryotic pathogens, including the structural, dynamic and functional interplay of macromolecular complexes formed between components of the pathogen(s), host cell, immune system, and medical interventions.
• Centers should be built around four diverse scientific projects that apply innovative approaches to solve distinct scientific questions that address knowledge gaps of significance to one or more NIAID research priorities in diagnosis, prevention, treatment, or cure of infectious diseases.
  • Three projects should support HIV and/or priority HIV co-pathogen research; one project must address non-HIV-related pathogens.
  • Up to three scientific Cores should provide services and drive technological development in support of two or more of the projects.
  • A Developmental Core will support the training and mentoring of next-generation structural biologists. The Core will manage a Cooperative Development Awards program that invites proposals from across the infectious diseases research community to recruit new talent into the Center and/or address emerging research needs. The Core may also support small pilot projects and travel awards to support career development of junior members.
  • An Administrative Core will support daily operations, manage resources, facilitate communication and ensure timely progress toward Center goals.
• Centers should determine higher-order structures across a broad range of resolution scales, including subcellular, cellular, and tissue organization, that add context to molecular structures and their function.
• Centers should push the limits of technological advances and leverage state-of-the-art approaches including artificial intelligence, molecular dynamics, and protein design technologies.
• Each Center must include the identification and validation of new molecular targets for discovery of therapeutics, immunologic or vaccine components, and/or curative strategies for infectious diseases.
• Collaborations with established NIAID programs, such as Centers for AIDS Research (CFAR), the Consortia for HIV/AIDS Vaccine Development and Immunology (CHAVDI), Martin Delaney Collaboratories for HIV Cure Research (MDC), CEIRR, CREID, CIVICs, ReVAMPP, CARBIRU, TBRU, and/or ICEMR, are encouraged to facilitate translational research.
• Centers may also collaborate with researchers at U.S. government sites, for example the NIAID Vaccine Research Center, U.S. military infectious diseases programs, DOE National Labs, the NCI HIV Dynamics and Replication Program, or any other investigator with the skills and interest to contribute to the goals of the Center.
• Demonstration of substantial institutional support for appropriate equipment and other physical resources available to the investigators is highly encouraged. The Center will participate in an annual, NIAID-sponsored scientific meeting for programmatic evaluation of the Centers program. NIAID will evaluate the Centers’ continued impact on the field in technology development and high value research to help determine whether to reissue the notice of funding opportunity.
• Clinical trials are not allowed but clinical research using human blood and tissues is encouraged. Animal research using appropriate models is allowed.

Patient Safety Monitoring in International Laboratories (pSMILE)

Request for Proposals—proposed FY 2027 initiative

Contact:
Patrick Finn
patrick.finn@nih.gov

Objective: This initiative is expected to provide a contractual resource that will continue to work with more than 150 mostly non-U.S. laboratories (Labs) in approximately 20 countries to provide a comprehensive and uniform approach to evaluate initial and on-going capability and readiness to carry out NIAID-funded and collaborative clinical trial protocols by 1) supporting and monitoring Good Clinical Laboratory Practices (GCLP); 2) supporting and monitoring the quality and reliability of protocol-specified laboratory test results; 3) providing Labs with various means of assistance, guidance, and training to improve the quality of laboratory operations; and 4) hosting and maintaining the existing electronic data management system. Options to increase level of effort, to support unanticipated increases in demand related to oversight of additional Labs, are also within the scope of the contract. This activity will continue to help achieve:

• Safety of trial subjects.
• Safety of those performing the testing.
• Quality of trial laboratory data and accountability to regulatory authorities (FDA, EMA) for investigational new drug/registrational studies.
• Increased recognition and appreciation of the fact that good laboratory practices lead to better general local laboratory operations and service.
• Cross-network/non-network harmonization in laboratory operations and oversight.

Description: This initiative will:

• Help Labs achieve and maintain GCLP for organization and personnel, verification of reagent and instrument performance specifications, quality management, equipment maintenance and facilities, and personnel safety. These ensure quality and integrity of study data and accurate reconstruction of studies. This aim will be accomplished through guidance for the resolution of laboratory audit findings/GCLP deficiencies, review of a Lab's standard operating procedures (SOPs), implementation of corrective actions to avoid future deficiencies, and review of method verification and validations performed by participating Labs.
• Determine the ability of Labs to accurately and reliably perform all tests indicated in trial protocols (e.g., chemistry, hematology, pregnancy, HIV and TB diagnosis). This will be accomplished by:
  • Purchasing and arranging shipment of appropriate Proficiency Testing (PT) panels which include unknown (blinded) samples provided by an external source.
  • Monitoring and grading PT results.
  • Guiding Labs in the investigation of root causes to prevent future failures.
  • Assisting Labs to correct identified deficiencies.
• Provide guidance and training to Labs to achieve GCLP and test proficiency through email and phone communications, interactive web conferences, presentations at investigator meetings and regional training events, and visits of various durations to Labs as needed.
• Maintain a 508 and FISMA-compliant web-based information repository that includes password-protected Lab-specific documents such as records of resolution of each Lab's audit findings and performance in PT panels, as well as an open-access resource library that includes guidance documents and SOPs for various laboratory procedures. Examples of resource documents include a checklist and guidance for moving a Lab to a new location, and instructions for validating instruments. The contractor will provide each participating Lab with controlled access to its own documents and provide NIAID and Network lab managers with controlled access to all documents.
• Post GCLP audit reports (conducted by another resource) and Action Plans that capture audit observations and guidance for resolution; Lab-specific reports indicating the degree of performance for each round of PT; summary reports indicating to DAIDS and the Networks the proficiency status of all Labs; and trimester Progress Reports provided to DAIDS.

Regional Prospective Observational Research in Tuberculosis (RePORT)

Request for Applications—proposed FY 2027 initiative

Contact:
Nicole Espy
nicole.espy@nih.gov

Objective: The overarching objective of this initiative is to enable a network of U.S. and international scientists to advance tuberculosis (TB) science, particularly relevant to people living with HIV (PLWH). Specific objectives include 1) advance the current understanding of community, host, and microbial factors that impact outcomes of TB infection and disease, including subclinical TB and drug-resistant TB (DR-TB); 2) facilitate the development of tools to improve treatment outcomes at the individual and population level; and 3) inform strategies to curtail the TB epidemic at the public health level. To achieve this, this initiative will support Regional Prospective Observational Research in Tuberculosis (RePORT) networks that will leverage U.S. and international scientific collaborations and existing clinical research infrastructure to capacitate a wide range of research.

Description: This initiative will support the establishment of independent observational research networks in the United States and globally to address TB and TB/HIV research priorities and promote evidence-based strategies towards ending the TB/HIV epidemic. The outcomes of the projects conducted through these networks are expected to address domestic and global TB and TB/HIV biomedical and clinical research questions and inform the national TB control strategy in the United States and each respective country. Research projects supported through this initiative may include, but are not limited to, the following areas:

• Characterization of host and microbial factors and mechanisms that affect the risk, dynamics, pathophysiology, and transmission of TB and DR-TB in children and adults.
• Discovery, development, and/or validation of new biomarkers and diagnostics for active and subclinical TB, including those that predict progression to active TB, and treatment outcomes.
• Evaluation of the impact, pathogenesis, and clinical outcomes of associated TB comorbidities, including HIV and diabetes.
• Evaluation of interventions, such as TB vaccines, that impact the transmission, incidence, and prevalence of TB (including subclinical TB) and elucidation of mechanisms and markers of protection to support continued development and/or evaluation of these interventions.
• Conduct of pragmatic clinical trials of efficacious interventional strategies to collect real-world evidence or conduct of observational and implementation studies that bridge the knowledge-practice gap in TB diagnosis, treatment, and prevention.

The following areas will not be supported under this notice of funding opportunity:

• Collection of only epidemiological data.
• Establishment of de novo clinical cohorts (i.e., clinical research that does not build upon existing cohorts of active TB patients and their close contacts).
• Clinical trials that propose to evaluate the efficacy of an intervention (e.g., first-inhuman studies or drug/device safety trials).

Research supported through these networks is expected to leverage clinical data and specimens collected through existing cohorts of active TB participants and/or their close contacts. The successful applicant must leverage existing prospective observational cohorts and have access to clinical specimens and concomitant data collected at pre-defined time points for individuals being treated for active TB and TB/HIV, and/or close contacts of individuals with TB disease.

Applicants are strongly encouraged to include a multidisciplinary research team of investigators with access to existing resources (e.g., clinical research sites and laboratories, data management center, and specimen biorepository). Additional samples and clinical data may be collected if needed for the research proposed. The applicant is expected to implement the research protocol in accordance with established RePORT International standards, and in coordination with the RePORT International Coordination Center (RICC).

Clinical Research Products Management Center (CRPMC)

Request for Proposals—proposed FY 2027 initiative

Contact:
Ashley Kinderdine
ashley.kinderdine@nih.gov

Objective: This initiative is to provide continued operations of a Clinical Research Products Management Center (CRPMC) that adheres to current Good Manufacturing Practice (cGMP) and Good Clinical Practice (GCP) in support of the clinical trials networks of NIAID. In addition, this initiative will support the clinical site pharmacy oversight responsibilities. This initiative will have flexible options to provide clinical study products management in clinical trials of emerging or pandemic infectious diseases as the need may arise and Institute priority.

Description: This initiative will support the management of study products in support of NIAID-sponsored clinical trials. These activities will include but are not limited to the following:

• Receive shipments of study products (e.g., therapeutics, vaccines, biologics).
• Store and maintain study products under appropriate and secure conditions.
• Distribute study products to authorized clinical research sites both domestically and internationally.
• Recall and process study product returns, which may include:
  • Return of study product to the manufacturer.
  • Coordinating the destruction of unused study products as directed.
    • Verifying unused quantities and witnessing product destruction at international sites.
  • Maintain readily available, computerized electronic records of study product management activities.
  • Maintain all applicable Trial Master File (TMF) documents related to study product management.
  • In limited circumstances, provide for a mechanism for the procurement of commercially available products not available through donation.
  • Provide support for site pharmacy oversight activities.
  • Establish and maintain a quality program for all activities.
  • Ensure that all activities are conducted in accordance with federal, local, and international regulations governing study product including but not limited to the CFR, ICH GCP, cGMP, Good Distribution Practices (GDP), Good Documentation Practices, and all applicable regulations or guidance.