Establishing Novel Antiretroviral Imaging for Hair to Elucidate Non-Adherence (ENLIGHTEN)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Medication Adherence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Dual Group AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
Description
This study is part of a larger research program that is investigating a novel non-invasive approach to rapidly quantify ARV concentrations and provide evidence of drug ingestion. The ultimate goal is to provide clinicians and patients feedback on ARV adherence. Infra-red (IR) matrix-assisted laser d...
This study is part of a larger research program that is investigating a novel non-invasive approach to rapidly quantify ARV concentrations and provide evidence of drug ingestion. The ultimate goal is to provide clinicians and patients feedback on ARV adherence. Infra-red (IR) matrix-assisted laser desorption electrospray ionization (MALDESI) technology for mass spectrometry imaging (MSI) is used to visualize and quantify ARV concentrations in hair. The IR-MALDESI MSI has been labeled the "MedViewer". Patient participants will be scheduled for the sampling visit to correspond with their next appointment at the University of North Carolina (UNC) Infectious Disease (ID) clinic. Patient participants will be asked to arrive to their clinic appointment at least two hours prior to the scheduled time to be consented and enrolled. If eligible and enrolled in the study, patient participants will have a small hair sample (5 strands) plucked from a discrete location on the back of their head. Patient participants will also have a small blood sample collected. The results from the MedViewer test will be provided to both the patient and their provider, in order to facilitate a discussion around medication adherence. After receiving the results, all participants will complete a brief questionnaire about their experience with the MedViewer. As this is a feasibility study, results from the Medviewer test will not be used to make clinical decisions related to care.
Tracking Information
- NCT #
- NCT04232540
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Investigators
- Principal Investigator: Angela Kashuba, PharmD University of North Carolina, Chapel Hill