Point-of-Care and Pharmacy-based Antiretroviral Drug Adherence Assays

(Fast-Track and Direct-to-Phase II proposals will not be accepted) Number of anticipated awards: 1-3 Budget (total costs): Phase I: $ 306,872 for up to 1 year; Phase II: $ 2,045,816 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. The World Health Organization (WHO) reports that as of 2021, there were approximately 38 million people living with HIV worldwide, and around 1.5 million new infections were recorded that year. Over the last several decades, advancements in the efficacy of antiretroviral therapy (ART) have significantly prolonged survival in people with HIV(PWH). ART treatment suppresses viral replication, enhances immunological status, reduces HIV transmission to uninfected individuals, and increases life expectancy in people living with HIV. Newer ART medications have become safer and easier to take, with most now co-formulated into a single tablet taken once a day. Additionally, longacting medications which maintain prolonged therapeutic levels that allow, monthly or quarterly dosing, are currently in trials and early stages of implementation. Pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) share a common foundation in utilizing antiretroviral medications to combat HIV. While PrEP focuses on averting HIV acquisition among individuals without HIV, ART effectively providing better long term health outcomes in people living with HIV. Both rely on consistent adherence to medication regimens for optimal effectiveness. Adherence to ART and PrEP is influenced by various factors, including individual, service-related, and therapy-related elements such as substance abuse, psychiatric issues, inability to disclose HIV status, lack of psychosocial support, stigma, drug side effects, pill burden, poor quality service delivery, and unexplained treatment costs. Despite advancements in ART and PrEP formulations, adherence remains a significant predictor of success and variability in clinical outcomes. Currently, there is no gold standard method to accurately measure ART adherence.