Tel-Me-Box: Validating and testing a novel, low-cost, real-time monitoring device with hair level analysis among adherence-challenged patients
Currently available methods to monitor antiretroviral (ARV) adherence to HIV treatment and prevention, such as self-report, pill counts, medication electronic monitoring system (MEMS), and devices which wirelessly monitor adherence in real-time, have multiple limitations, including over-reporting, inability to assess pill ingestion, and size/expense. Our multidisciplinary research team at UCSF and in India has designed a new adherence-monitoring device called 'Tel-Me-Box' which is small, low-cost, rechargeable, inconspicuous, and could be programmed to deliver tailored real-time adherence reminders following additional hardware modifications. In this application, we propose to modify and validate this discreet Tel-Me-Box adherence monitoring and reminder device against hair ARV concentrations as a pharmacologic measure of drug ingestion/adherence, a measure pioneered and validated by our team, with the expectation that this device and intermittent hair monitoring could have widespread utility for HIV and non-HIV adherence science, both in India and globally.
Aim 1 will further refine Tel-Me-Box by reducing its size and adding tailored reminder features. We will also demonstrate feasibility of hair analysis in RLS by training local staff to conduct the relevant hair assays.
Aim 2 will validate the Tel-Me-Box adherence measure, using ARV hair concentrations and HIV viral load, and examine the predictive utility of Tel-Me-Box monitoring and hair drug levels on virologic suppression in HIV- infected patients.
In Aim 3, we will conduct a pilot RCT to examine acceptability and feasibility and to estimate the effect size of automated tailored real-time adherence reminders on hair ARV concentrations, device- monitored adherence, and viral load suppression in adherence-challenged patients. At study completion, we expect to have validated Tel-Me-Box as an innovative tool to assess adherence and predict treatment outcomes and demonstrated the feasibility of hair analyses in RLS. If successful, we will also have collected pilot data on the efficacy of the Tel-Me-Box automated, tailored reminders for a future large scale RCT.