Seeking Rapid Diagnostic Technologies for HIV Self-Testing

Funding News Edition: November 18, 2020
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In 2016, the World Health Organization began recommending that people with HIV conduct self-testing. Doing so, however, has posed a few challenges. For instance, the rapid HIV self-tests that are currently available depend on detecting host antibody responses, which are most reliably detectable several weeks after infection. Antibody tests do not directly detect HIV, will not detect acute or very early infection, and do not detect viral rebound following treatment interruption. 

Sensitive and accurate tests to directly measure HIV involve either expensive, sophisticated equipment in a lab or hospital setting, or point-of-care devices that require a trained professional to administer the test and read the result.

Given these obstacles, it’s clear that developing simple, inexpensive, rapid self-testing assays to directly detect HIV would make it easier for people to monitor themselves for acute or early HIV infection, and would allow people to monitor their viral suppression status during therapy. Such is the goal of the reissued funding opportunity announcement (FOA) for Detection of HIV for Self-Testing (R61/R33, Clinical Trial Now Allowed).

Research Objectives

The FOA will support high-risk, bi-phasic, milestone-driven research and early-stage development of innovative technologies designed to enable rapid self-testing assays to meet one or both of the following research objectives:

  • Detecting HIV (RNA, DNA, protein, or biomarker) at the earliest stage of initial infection, ideally less than two weeks post-infection
  • Detecting HIV rebound in treated individuals as early as possible following treatment interruption or loss of viral suppression by antiretroviral treatment

Your proposed research should establish feasibility for directly detecting HIV (RNA, DNA, protein, or biomarkers that reliably correlate with HIV positivity or rebound) in a qualitative or semi-quantitative diagnostic self-test assay. Be sure to design assays that 1) have a user-centered approach and 2) are as easy to use as a home pregnancy test or an in-home glucose monitoring device. See the FOA for additional studies to address assay feasibility.

The FOA encourages innovative technologies, e.g., microfluidics for electricity-free RNA/DNA amplification, synthetic biology approaches, paper- or plastic-based analytical platforms, and smartphone-enabled diagnostics. Developing such technology will likely require that you collaborate with experts in the fields of virology and biotechnology (e.g., bioengineering, nanotechnology, and manufacturing), as well as clinical, social and behavioral science.

You also need to demonstrate to reviewers that you are capable of developing the proposed technologies and assay, have access to appropriate virus and biospecimen resources, and have the means to obtain meaningful end-user input on assay performance and usability during early-stage assay development. 

About the Activity Code

Due to the high-risk, high-impact nature of the research, this FOA uses the bi-phasic R61/R33 activity code.

For the R61 phase, funded investigators will receive up to three years of support for hypothesis- and milestone-driven basic technology research, assay development, and end-user input.

Before the R61 phase ends, awardees will submit the R33 transition package, which NIH program staff will review. Up to two years of support may follow (R33 phase) for additional activities as appropriate, such as expanded assay development and usability testing. Proposed milestones will be reviewed and negotiated before award. For additional details, see the FOA, and to learn more about the R61/R33 activity code and others like it, go to our Phased Award SOP.

Award Information, Deadlines, and More

As you plan your application, keep in mind the following:

  • Award Budget
    • For R61 phase: limited to $300,000 in direct costs each year
    • For R33 phase: limited to $500,000 in direct costs each year
    • All facilities and administrative costs are excluded from this limit. Request a budget that reflects the actual needs of the proposed project.
  • Project Period—the scope of the proposed project should determine the project period, which for this FOA cannot exceed five years total—three years for the R61 phase and two years for the R33 phase.    
  • Due Dates—March 17, 2021; March 17, 2022; and March 17, 2023 (by 5 p.m. local time of applicant organization)

Have Questions?

Direct them to our scientific/research contacts Drs. Diane Lawrence and Joseph Fitzgibbon.

Contact Us

Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures.

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