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.
Major changes after the start of enrollment:
1. Removed the term "real-time" throughout the document-Pertinent feasibility endpoints now use "delivery of the report to the designated research staff member within 2 hours of initiation of hair processing" rather than "…within 2 hours of hair sample collection"
2. Removed mitra sampling for the remaining 15 participants in cohort A. Now stated as "blood sample will be collected for 10 participants in Group A and a subset of participants in Group B." After Mitra is analyzed for the first 10 participants in Group B, we will reevaluate to determine if additional samples are needed to validate hair samples.
3. V1 and V2 study activities will be conducted virtually (except hair collection and in-person patient provider clinic visits) to minimize in-person contact. Consent and screening will be conducted virtually using videoconferencing via zoom on computer, tablet or phone. All questionnaires (patient baseline, patient post-visit, patient endline, provider baseline, provider post-visit, and provider endline) will be conducted virtually through REDCap (emailed to participant or verbally administered via phone or videoconferencing). Hair collection will be conducted by research staff at remote locations to limit time in clinic. Implementation of the intervention will now be allowed in the setting of telehealth clinical visits between patient and provider in addition to in-person clinical visits. MedViewer reports will be sent to providers via secure email. All remaining V2s will be conducted virtually. Hair and blood samples will not be collected.
4. Consenting will take place up to 3 days before scheduled clinic appointment with provider. Hair sample will be collected by research staff at a remote location in the 3 days between consent and the scheduled provider visit. MedViewer report will be discussed between patient and provider (or patient and pharmacist, if needed) within 4 weeks of hair sample collection.
5. Interviewer-administered portions of the baseline questionnaire have been modified. Health Literacy measure (Newest Vital Sign) removed. ART adherence Visual Analog Scale modified to allow for remote self-administration.
6. Maximum duration on study extended by 6 months for providers (increased from 10 to 16 months). Provider sample size range reduced (from 20-30 to 16-30)
These changes were implemented on November 5, 2020 in a Letter of Amendment (LOA) to ENLIGHTEN Protocol Version 2. The LOA detailed changes made to the protocol due to the COVID-19 Pandemic.
