Development of a novel, low-cost Point of Care HIV viral load diagnostic for resource-limited communities. Development of a novel, low-cost Point of Care HIV viral load diagnostic for resource-limited communities. HIV/AIDS is currently the second leading cause of death worldwide, behind only lower respiratory infections (3). HIV has already killed more people than any other viral epidemic in recent history. There are estimated to be 33 million people infected worldwide (3), and unless treated the vast majority of these infected people will die of AIDS. The highest HIV/AIDS prevalence rates in the world are found in developing nations and resource-limited settings and in particular, in Sub-Saharan Africa where national prevalence rates reach as high as 36%. Increased access to anti-HIV drugs (known as antiretrovirals or ARVs) has allowed for the implementation of large-scale public health programs for HIV and the scaling up of distribution for HIV combination therapy (known as Highly Active Antiretroviral Therapy, HAART) (16). The US Presidents Emergency Plan for AIDS Relief is alone providing ARVs for more than 1.4 million people living in sub-Saharan Africa today. The severe side-effects of the drugs, along with structural impediments to provision of the drugs, make compliance difficult in the developing world. And less than perfect compliance can lead to drug-resistant HIV, which threatens to make the current treatment available in the developing world, and eventually the developed world, obsolete. Simple, low-cost HIV biological tools for monitoring the increasing number of HIV-positive individuals included in these programs is now a crucial issue for sub-Saharan Africa (16). Highly Active Anti-retroviral Therapy has proven to be enormously effective in prolonging life for people infected with HIV (7). In the developed world there are at least 25 drugs in five classes that can routinely be used in HAART. Since combinations of three drugs are routinely used, there are a very large number of combinations available in the developed world. In the developing world there are fewer drugs available for public use. Thus, the loss of effectiveness of a few types of combination therapy could be a humanitarian and public health disaster. The effectiveness of HAART at the public health level can be compromised by the emergence of HAART-resistant HIV (2). The goal of HAART for individuals is to suppress HIV replication to the point that the HIV viral load in the blood is undetectable. Since mutations that can lead to HAART-resistant HIV occur during virus replication, the profound suppression of virus replication in people who are successfully using HAART minimizes the evolution of drug resistance. However, effective suppression of virus replication requires over a 90% compliance rate (11). In the developed world, viral load assays are done shortly after initiation of HAART, to ensure that viral load is suppressed to below an undetectable level, and quarterly thereafter, to rapidly deal with lapses in adherence that can lead to therapy failure (1). But viral load assays cost several hundred dollars in the US, and even in the developing world a viral load assay is more than $50 USD, well out of the range of people who earn on average $2 USD/day. Thus, throughout the developing world there is essentially no monitoring of the effectiveness of HAART, and thus no possibility of intervening to increase compliance and ART effectiveness (2).The goal of this proposal is to complete development of a novel, affordable assay product to identify patients who are non-adherent and to provide improved clinical data for largescale public health programs and more particularly, patients and care providers. We envision the product as a kit comprising two pieces of equipment (a blue-light box and a water bath) and a package of reagents that can be easily shipped anywhere in the world without concern for cold-chain or environmental stress. The kit can be installed in rural locations, is adaptable for power requirements (AC or battery), requires minimal installation (find a countertop and plug in or switch on the equipment), and does not require skilled technicians
|Effective start/end date||4/1/09 → 4/30/10|
- VentureWell: National Collegiate Inventors & Innovators Alliance: $20,000.00
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