A Breath-based Medication Adherence Monitoring System for HIV/AIDS Therapies

DESCRIPTION (provided by applicant): Principal Investigator/Program Director (Last, First, Middle): Abstract We propose to design and deploy a handheld breath-based "personal" medication adherence monitoring system (MAMS) which will meet the criteria of the solicitation from the National Institute of Mental Health (NIMH) for "Development of information, instruments or methodologies to improve and/or track adherence to complex HIV/AIDS drug therapies for Hispanic and African American populations". MAMS will consistent of a modified miniature battery powered gas chromatograph (mGC) capable of detecting the presence of a "taggant" or a metabolite of the taggant on the breath of an individual shortly after ingestion of a medication containing it. MAMS will include hardware and software capable of recording the detection of the "taggant", storing the information for later analysis, and notifying, in real-time by wireless or other communications, a healthcare provider if medication is not taken as prescribed. We will explore FDA approved "generally recognized as safe" (GRAS) compounds as taggants. The "taggants" can be applied as a coating to the medication, be added along with the medication to a special capsule or be added as an excipient. We have considerable expertise in the detection of drugs in exhaled breath and are knowledgeable about the properties of candidate "taggants" and their metabolites. Our Specific Aims are: Specific Aim 1: Identify 6-8 chemically diverse taggant candidates from GRAS compound databases that will likely generate appropriate EDIM(s) at doses currently permitted by the FDA in exhaled breath after oral ingestion. Either the taggant or taggant metabolite(s) could qualify as an EDIM. Specific Aim 2: Test whether the GRAS taggant candidates identified in Specific Aim 1 are suitable for MAMS in humans by sequentially analyzing the concentrations of taggant(s) and taggant metabolite(s) in breath after oral ingestion of the taggant using the "gold standard" analytical technique, GC-MS. Specific Aim 3: Design and build a mGC device to reliably measure in real-time the gas phase concentration of two suitable EDIMs identified in Specific Aim 2. Nonadherence to prescribed medication regimens is a major health issue in the US which costs our healthcare system over $100 billion annually. Nonadherence is a major cause of morbidity and mortality. It can result in a public health threat if, for instance, a patient fails to adhere to an antibiotic or antiviral medication. This can lead to the emergence of resistant organisms. We propose to develop a small portable device that a patient can blow into shortly after taking their medication which will detect and document that the appropriate medication was taken at the proper time. This technology should improve adherence rates, especially in high-risk populations.