Point-of-Care HIV Viral Load and Drug Adherence Assays

(Fast-Track and Direct to Phase 2 proposals will not be accepted) Number of anticipated awards: 1-3 Budget (total costs): Phase I: $300,000 for up to 1 year; Phase II: $2,000,000 for up to 2 years. Background According to the Centers for Disease Control and Prevention (CDC), HIV remains a significant public health challenge both in the United States and globally. In the United States, an estimated 1.2 million people are currently living with HIV and globally over 38 million people are affected by HIV. Antiretroviral therapy (ART) has transformed the management of HIV infection, significantly improving patient outcomes and altering the trajectory of people living with HIV. ART involves the use of combinations of antiretroviral drugs that target different stages of the HIV life cycle, suppressing viral replication and restoring immune function. The goal of ART is to achieve and maintain viral suppression, defined as a decrease in HIV RNA levels to undetectable levels in the blood. Viral suppression not only benefits the individual by preserving immune function and reducing the risk of opportunistic infections but also has public health implications by reducing the risk of HIV transmission. However, the effectiveness of ART is highly dependent on consistent medication adherence and monitoring of viral load. One of the needs for people with HIV to maintain sustained viral suppression and reduce HIV incidence in the US are point-of-care assays that can measure viral load and adherence to ART.