| NB: Concepts represent early planning stages for PAs, RFAs, or RFPs for Council 's input. Council approval does not guarantee that a concept will become an initiative.
If NIAID publishes an initiative from one of these concepts, we link to it below. For a full list of initiatives, go to NIH Funding Opportunities Relevant to NIAID.
Table of Contents
Highly Innovative Tactics to Interrupt Transmission of HIV (HIT-IT)
For the published initiative, see the July 17, 2008, Guide announcement.
Request for Applications
Contact: Geetha Bansal
Phone: 301-496-5042
Internet: GBansal@niaid.nih.gov
Objective: To stimulate research on novel, unconventional, “outside--the-box”, high risk, potential high impact approaches that might provide long term, safe protection from HIV infection.
Description: This specialized R01 initiative will support novel areas of research that have not been explored in the past with the goal of discovering measures that might interrupt HIV transmission after single or limited number of applications. Cross-disciplinary collaborations will be encouraged.
Examples of responsive research include but will not be confined to:
- Research on the potential of host proteins as immunogens (alone or with HIV immunogens).
- Previously unexplored HIV encoded targets.
- Agents that may directly or indirectly inhibit a process required for HIV acquisition.
- Novel approaches that will produce or release agents that block HIV infection.
- Agents used alone or with HIV immunogens that modulate innate immune response and provide protection.
- Immunogens and adjuvants that stimulate potentially helpful but not harmful HIV-specific CD4 T cell responses.
- Novel approaches that positively modulate B cell responses to HIV immunogens for induction of broadly cross reactive neutralizing antibodies.
- Animal model evaluation of the proposed hypothesis (HIV or SIV challenge) will be strongly encouraged.
These unique R01s are expected to be:
- Innovative, high risk/high impact, original, unconventional
- Short – 10 page research plan, no appendices, short bio sketch
- Although no preliminary data are required or expected – review criteria will include:
- Novelty of underlying (mechanistic) hypothesis
- Biologic plausibility/rationale
- Potential for gain in fundamental knowledge
- <$500K direct cost in any year
- >$500K only with prior program approval
Examples of non-responsive research:
- Approaches covered by existing programs: single or combination microbicides, vaccines, or ART agents; incremental improvements of approaches already under development; combination strategies (e.g., microbicide + vaccine).
- Studies that are absent a truly novel intervention strategy to prevent acquisition, including:
- Development of new animal models
- Assay development and validation
- Vector development
- Use of lactobacillus or other microflora-derived delivery systems
- Product development
- Purely descriptive basic research or structural studies
- Human clinical trials
- Projects already supported in the applicant’s lab by NIH or others
Rapid Point-of-Care Virological Assays for Resource-Limited Settings
For the published initiative, see the August 1, 2008, solicitation, Rapid HIV Point-of-Care Diagnostic Device for Resource-Limited Settings.
Broad Agency Announcement
Contact: Cecil Butler
Phone: 301-496-0612
Internet: butlerce@mail.nih.gov
Objective: To develop an FDA-approvable and licensable point-of-care diagnostic device for identifying HIV-infected individuals in the presence of vaccine-induced HIV-1 specific antibody responses. Such tests could also be used to identify acutely infected HIV-1 individuals and to diagnose infant HIV-1 infections in resource-limited countries.
Description: Large scale vaccine test-of-concept clinical trials to assess the potential of an HIV vaccine to elicit T cell protective immunity against HIV-1 are being planned for the near future. In addition to T cell responses, the complex mixture of HIV-1 epitopes, peptides, or proteins present in the vaccine, can elicit persistent antibody responses in vaccinated volunteers that cause positive test results when using existing FDA-licensed HIV-1 detection kits in the absence of true HIV-1 infection. Molecular nanotechnology-based test to directly detect HIV-1 infection could distinguish between vaccinees that test positive due to immune responses to vaccine from those that test positive due to HIV-1 infection.
Simple, rapid, point-of-care HIV diagnostic tests are crucial in resource-limited locations. Many companies have developed technologies in response to bio-defense pathogen monitoring or diagnostics for identifying host molecular disease biomarkers, both of which can fill this gap. This initiative will support the assembly of a consortium of diverse expertise that includes scientific knowledge, management, diagnostics, product development, manufacture, testing, and marketing to develop a rapid test to detect HIV-1. Specifically, expertise would be required to: (a) develop a simple, rapid sample preparation method, (b) bridge the reagents to be specifically applicable for HIV, (c) place a greater emphasis on reagent stability over a wider temperature range, (d) conduct proof of concept studies in laboratory controlled environments and in field conditions, (e) evaluate positive and negative samples from target populations and participate in a clinical study, (f) file for intended use with the FDA, and (g) address technical, manufacturing, marketing, and distribution issues.
Methods for Prevention Packages Programs (MP-3)
For the published initiative, see the April 24, 2008, Guide announcement.
Request for Applications
Contact: David Burns
Phone: 301-435-8896
Internet: burnsda@niaid.nih.gov
Objective: The purpose of this cross-cutting initiative is to foster the development of new research strategies and methodologies that will facilitate the design of HIV prevention trials that test multiple simultaneous interventions (“prevention packages”). It will not only serve as a framework for assessing the expected benefits of specific prevention packages, but also provide a platform for identifying the most efficient mechanism for testing the impact of the package in the target population.
Description: Participating investigators will be expected to (1) devise optimal HIV prevention packages (combination interventions) for specific populations, (2) design clinical studies to rigorously examine the safety and efficacy of these “packages” in the target population, and (3) demonstrate that the proposed prevention package is acceptable to the target population and that the study design is appropriate and feasible.
The “prevention packages” should include biomedical and behavioral interventions that can be applied to a specific target population. Mathematical modeling is encouraged, but not required, to develop and justify the proposed prevention package. The impact of incomplete adherence, risk compensation, and other behavioral factors should also be considered. This research will require expertise in behavioral and biomedical methods of HIV prevention, epidemiology, and clinical trial design and implementation.
Multicenter AIDS Cohort Study (MACS)
For the published initiative, see the March 26, 2008, Guide announcement.
Request for Applications
Contact: Robin Huebner
Phone: 301-402-4239
Internet: rhuebner@niaid.nih.gov
Objective: The objective of this initiative is to support the continuation of the Multicenter AIDS Cohort Study (MACS), the largest cohort study of HIV/AIDS in men in the U.S. This initiative will support the four MACS clinical sites and one Statistical and Data Center.
Description: Despite advances in understanding transmission and in controlling infection through the use of therapies, the devastating impact of the HIV/AIDS epidemic among men who have sex with men (MSM) continues. The MACS cohort study has, since its inception in 1983, supported intensive epidemiologic research on the evolving epidemic in this population. The impact of HIV/AIDS has been particularly severe in minority populations in the US (77 percent of new HIV infections were among African Americans and Hispanics). Beginning in FY 2002, the MACS re-opened recruitment to ensure a study population that is representative of the epidemic among MSMs in the US. The expanded cohort is over 50 percent minority men and statistically powered to study outcomes in the era of effective anti-retroviral therapy. These outcomes include the long-term consequences of antiretroviral therapy, when to switch therapies, and when to initiate antiretroviral therapy. The MACS will complete its 25th year of funding in 2008 and has published over 1,000 peer-reviewed articles.
Because more intensive data can be collected during a MACs visit than under standard-of-care treatment, the MACS can study anticipated complications of treated HIV. This has fostered research in HIV and aging, genetics, cardiovascular disease, neuroimaging, and renal disease. Collection of high quality specimens and collaboration with outside investigators is a priority. Each participant has greater than 7,500 variables collected at each visit and there are more than one million specimens stored in the national repository. These data and specimens are widely available and have been used by a wide range of investigators.
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