Description:
042 Qualitative HIV RNA Home Test
Direct to Phase II proposals will be accepted
Fast-Track proposals will not be accepted
Number of anticipated awards: 1-2
Budget (total costs):
Phase I: up to $300,000 for up to 1 year
Phase II: up to $3,000,000 for up to 3 years
Background:
Approximately 37 million people are living with HIV, with 15 million accessing antiretroviral therapy (ART). Recently revised WHO guidelines recommend that all people diagnosed with HIV be offered ART at any CD4 count, which will result in many more people on ART. Current ART regimens are very potent and reduce HIV viral load in blood to undetectable levels in most patients, which in turn significantly reduces mortality and morbidity and reduces transmission of HIV. However, viral rebound can occur through non-adherence or resistance. In either case, it is critical to identify viral rebound as early as possible in order to avoid drug resistance and clinical progression. The ability to easily monitor HIV plasma RNA in blood at home would help identify viral rebound early and allow intervention. Ideally, HIV RNA testing at home should be as easy as glucose monitoring for diabetics. If priced appropriately, this technology may be useful for home monitoring in resource limited settings where patients live far from the clinical care site. 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
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very frequently, in-home monitoring for individuals using pre-exposure prophylaxis (PrEP), where HIV infection must be detected very early to avoid resistance to the drugs in the PrEP regimen, and in-home monitoring for high risk individuals to allow early detection and early treatment, which may lead to smaller HIV reservoirs and reduced transmission.
Project goal:
The goal of this solicitation is to develop a method for HIV RNA home testing. The method need not be quantitative, but should detect HIV RNA with a sensitivity of at least 98% and specificity of at least 98% if the viral load is 1000 HIV RNA copies per ml of blood or higher. The proposed method must include a procedure for obtaining finger stick blood such that the blood can be easily manipulated and transferred to the test medium. Proposals can include the use of a small handheld unit to be used with individual test strips or cartridges, but device free, disposable units are preferred. Test units may require refrigeration, but stability at room temperature is preferable. All necessary materials should be supplied with the test and no additional materials should be required. The amount of handling required by the operator should be suitable for home testing by untrained individuals.
Phase I activities may include:
• Development of simple methods for: a) obtaining finger stick blood and easily transferring blood or plasma to the test medium, b) detecting HIV plasma RNA, but not cell associated HIV DNA and RNA, with a cutoff of 1000 RNA copies per ml of blood, c) providing an easily readable output. (see additional specifications above)
• Combining the methods into an inexpensive, easy to use, integrated assay platform (up to $100 for handheld unit, up to $10 per test unit/cartridge)
• Initial testing on laboratory isolates, including several HIV subtypes
Phase II activities may include:
• Validation testing to include sensitivity, specificity and lower limit of detection, with comparison to FDA-approved HIV viral load test methods
• Development of a well-defined test platform under good manufacturing practices (GMP)
• Development of a quality control program to ensure lot-to-lot consistency
• Scale-up and production for multi-site evaluations using clinical isolates
