Human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) present a significant global health problem, particularly for women and children in the developing world. There are approximately 2 million HIV-infected children in Africa alone, and while antiretroviral therapies are increasingly available and effective, 35% of infected children still die before the age of 1 and 52% before the age of 2. Additionally, there are nearly half a billion new cases of curable STIs each year, namely syphilis, gonorrhea, chlamydia, and trichomoniasis, resulting in blindness, stillbirths, neonatal deaths, and other morbidities.
The HIV/STI Diagnostics portfolio leverages PATH’s technical, programmatic, and global health expertise to improve access to HIV and STI diagnostics among the world’s most vulnerable populations. These resources are guided by several principles to maintain a long-term focus that extends beyond product development.
Impact: The Diagnostics Program focuses on diagnostic solutions that are not merely an incremental improvement but rather a clear driver of measurable impact on HIV/STI outcomes in low-resource settings. Specifically, the group aims to support efforts to reduce disease incidence through increased availability of appropriate diagnostic technologies.
Value: HIV diagnostic tools must demonstrate a clear value to the health systems of developing countries to offset the initial investment and risk of introducing a new product.
Sustainability: Affordability, availability, and accessibility of diagnostic solutions are key considerations to the sustainability of these solutions with perspective to long-term impact.
Areas of focus
HIV case detection
Large portions of the at-risk population are unaware of their HIV status. A portfolio of diagnostic testing platforms and algorithms are required to more effectively and comprehensively identify HIV cases, including detection of HIV in infants and recently infected patients. Another important factor in case detection centers on access to diagnostics. Solutions focused on bringing advanced molecular diagnosis to the point of care, as well as home testing, are in development.
HIV care and monitoring
Diagnostics play an important role in HIV case management. Given the chronic nature of HIV, it is critical that cost-efficient diagnostic solutions are incorporated appropriately, taking into consideration the supporting laboratory and health systems. Significant operational research is required to ensure diagnostics are used effectively and sustainably. The Diagnostics Program has made investments in advancing the development and deployment of HIV viral load testing in support of case management. Beyond individual care, a critical component of the sustainability of HIV programs is accurate drug-resistance testing. Understanding the technical and operational barriers to more effective drug-resistance testing is a key priority to the portfolio.
HIV influences a patient’s risk profile to other diseases. Conversely, infections such as STIs significantly increase the risk for a patient to contract HIV. The Diagnostics Program is currently focused on the development of highly sensitive diagnostic tests for STIs (see below). In addition, the Diagnostics Program regularly assesses diagnostic platforms and disease markers for the possibility of developing common platforms for diagnosis of multiple diseases under specific use cases.
HIV diagnostics auxiliary needs
Beyond the analytical performance of a diagnostic test and its compatibility with ideal target product profiles, there are a series of stakeholders, processes, and technologies that ensure that the operational performance of a test is maximized. The Diagnostics Program uses operational research to inform additional technology requirements that support the diagnostic tests, such as technologies that support specimen preservation and health applications that ensure timely transfer of information.
STIs are particularly detrimental during pregnancy and have life-threatening consequences for the newborn child. HIV transmission is part of this, but other common STIs such as syphilis, gonorrhea, and chlamydia are very dangerous in the ante- and post-natal setting. The HIV/STI portfolio is investigating dual and multiplex diagnostics focused on maternal health needs in low-resource settings.