Research needs and challenges in the development of HIV diagnostic and treatment monitoring tests for use in resource-limited settings

PURPOSE OF REVIEW: The aim of this article is to review research priorities for current and new technologies to diagnose HIV and to monitor treatment response, including technologies to enumerate CD4 cell counts and quantify plasma viral load, in resource-limited settings. RECENT FINDINGS: Numerous challenges remain before HIV diagnostic and treatment monitoring technologies can be broadly implemented, especially in rural areas. New technologies that are less costly and complex to use are in development and may be better suited than current technologies for use in resource-limited settings. Investment into research activities is needed for development, evaluation and validation of new technologies. The lack of clarity in the process for evaluation and validation for these technologies affects country and program-level decisions on the appropriateness of technologies for individual settings. Implementation research is needed to assess how best to use CD4 and viral load to guide initiation and management of antiretroviral treatment, as well as how best to scale up diagnosis of HIV serostatus in infants. Studies also need to be conducted to determine if the same CD4 cutoffs can be used in resource-limited settings for initiating antiretroviral therapy and prophylaxis against opportunistic infections due to potential regional differences and the impact of other common co-morbidities on CD4 cell counts. SUMMARY: Increased availability of antiretroviral therapy in resource-limited settings increases the need for reliable, less costly and simpler to use HIV diagnostic and treatment monitoring technologies. Global leadership is needed to coordinate the research and development necessary to ensure that HIV diagnostic and treatment monitoring technologies are properly evaluated in the setting where they will be used.