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Additional Information on Eligibility. The purpose of this Funding Opportunity Announcement FOA is to support bi-phasic developmental, discovery-driven, or hypothesis-driven research focused on innovative strategies to detect HIV moh within the first two weeks of infection or to monitor viral rebound after stopping or developing resistance to antiretroviral therapy.

Applications should propose simple diagnostic tools that would be feasible for a self-testing fomr to allow untrained individuals to detect HIV. Interdisciplinary collaborations that include biomedical, physical, and behavioral sciences are highly encouraged. December 6,December 6,and December 6,by 5: All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged omhh apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV.

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When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. There are several options available to submit your application through Grants. You must use one of these submission options to access the application forms for this opportunity.

Overview Information Part 2. Full Text of the Announcement. Eligibility Information Section IV. Application and Submission Information Section V. The purpose of this FOA is to support bi-phasic developmental, proof-of-concept research focused on innovative strategies for direct detection of HIV or associated biomarkers in infected individuals other than host antibody response or CD4 levels that would be feasible for a self-testing platform.

Note that proposing technologies for detecting the host antibody response to HIV will not be supported under this FOA. Applications are expected to propose design-directed, developmental, discovery-driven, or hypothesis-driven research that will address the need for simple, inexpensive devices that can be used by an untrained individual to detect HIV either within the first two weeks of infection, or as early as possible following viral rebound after stopping or developing resistance to antiretroviral therapy ART.

For most people living with HIV who have access to care, current ART regimens reduce HIV viral load in blood to undetectable levels, which in turn significantly reduces mortality and morbidity and reduces transmission of HIV.

However, worldwide a significant proportion of individuals are unaware of their infection. Acceptability of self-testing for HIV has increased in recent years, and strategies to expand self-testing have a high potential to reach untested high-risk populations in the U.

However, current self-testing technologies only detect the host antibody response to HIV infection, which arises weeks after initial infection. No self-testing technologies have yet been developed that are able to detect HIV during peak viremia and transmissibility in acute infection. Additional tools are needed to facilitate earlier diagnosis and initiation of antiretroviral treatment, particularly among hard-to-reach populations, individuals who have never tested, and individuals who do not have regular access to clinical care.

Wider access to self-testing platforms would greatly enhance testing and treatment uptake by bypassing the need for repeated access to care providers. For individuals aware of their infection and on treatment, viral rebound can occur through non-adherence or emergence of drug resistance mutations. As the timing of rebound can be unpredictable with a rapid increase in viral load, self-monitoring for HIV plasma RNA would help identify viral rebound early and allow intervention to prevent clinical progression.

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Such a technology could also be used for home monitoring of individuals enrolled in clinical trials involving a treatment interruption who need to have their viral load monitored very frequently. Recent advances in rapid point-of-care testing have demonstrated the capacity for portable and inexpensive diagnostics for viral infections.

The rapidly evolving fields of molecular diagnostics, biotechnology, synthetic biology and other related research areas could be useful in developing innovative approaches that ultimately would allow direct detection of HIV in a self-testing platform.

To move toward this goal, this FOA is focused on early-stage development of innovative diagnostic technologies designed ohm enable rapid self-testing capable of meeting one or both following research objectives: Such assays would complement existing self-testing tools that detect the host antibody response to HIV.

Research objectives may include either the initial development of a novel technology or adaptation of an emerging technology to detect HIV in a self-test platform. The self-test assays should be designed with a user-centered approach, and should be as easy to perform as a home pregnancy test or in-home glucose monitoring device for diabetics. The self-test should detect HIV from finger stick blood or other biospecimen at the earliest possible time either post-infection or after loss of viral suppression by ART.

The candidate technologies are expected to be at the discovery and feasibility stage. For the purposes for, this FOA, discovery corm feasibility studies are defined as preliminary studies designed to show potential efficacy in the detection of HIV-1 and feasibility as a self-test platform.

At the end of the project period, a successful project will have demonstrated proof of principle with the capability of the prototype technology to detect HIV in human clinical samples without the use of expensive equipment or trained individuals. For the purposes of this FOA, the following features are desirable general characteristics for the design of an ideal diagnostic.

Applicants should consider these features in defining parameters for the proposed milestones. Development of such technology is expected to require collaboration among experts in the fields of virology and biotechnology e.

Support will be provided for up to three years for the R61 phase, and up to two years of support may follow for the R33 phase. Preliminary data are not required for the Fork phase. However, appropriate theoretical justification and hypotheses should be provided as evidence that the proposed project is feasible and well-designed for the intended purpose. The use of milestones for the R61 phase will guide the potential transition to the R33 phase.

The R33 phase is for expanded discovery and development, such as optimization of performance specifications and validation testing, with comparison to FDA-approved HIV self-test and HIV viral load test methods, using human samples.

Applications should include research plans and budgets for both the R61 and R33 phases.

Before the end of the R61 phase, awardees will submit the R33 transition package, which includes the R61 progress report describing in detail the progress towards the initial R61 milestones, and an updated description of the om proposed for the R33 phase based on completion of the R61 milestones. These materials will be evaluated by NIH Program staff. Transition to the R33 phase is neither automatic nor guaranteed; funding decisions will be based on the successful completion of pre-defined milestones, Program priorities, and availability of funds.

Grants selected for continued funding will be transitioned to an R33 award without the need to submit a new application. Other Information for award authorities and regulations. A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

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Future year amounts will depend on annual appropriations. Requested budgets should reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period for an application submitted in response to this FOA cannot exceed five 5 years.

Applicants may request up to three years of support for the R61 phase, and up to two years of support for the R33 phase.

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Entities Foreign Institutions are eligible to apply. Organizations are eligible to apply. 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission. Obtaining an eRA Commons account can take up to 2 weeks. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:. See your administrative office for instructions if you plan to use an institutional system-to-system solution. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Informationprospective applicants are asked to submit a letter of intent that includes the following information:. Within the budget justification section, for each budget year provide a justification indicating whether costs are for the R61 or R33 phase. The specific aims for both the R61 phase and the R33 phase should be included in the application.

Include headers indicating the R61 specific aims and the R33 specific aims. Thus, clarity and completeness of the application with regards to specific goals and the feasibility of each phase and the Transition Milestones are critical.

Within the Research Strategy section, applicants should include:. Do not use the Appendix to circumvent page limits. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

When a submission date falls on a weekend or Federal holidaythe application deadline is automatically extended to the next business day.

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Organizations must submit applications to Grants. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. This initiative is not subject to intergovernmental review.

Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the gorm process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

See more tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review. Applications that are incomplete or non-compliant will not be reviewed. Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Only the review criteria described below will be considered in the review process. As part of the NIH missionall applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical kmh through the NIH peer review system.

Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.