Establishing Novel Antiretroviral Imaging for Hair to Elucidate Non-Adherence (ENLIGHTEN)
Condition: Medication Adherence
Study type: Interventional

Summary: 
      This is a pilot study to assess the feasibility, acceptability and appropriateness of
      delivery of the investigational "MedViewer" intervention in adult patients living with HIV
      who have been prescribed antiretroviral (ARV) medications. The Medviewer uses Infra-red (IR)
      matrix-assisted laser desorption electrospray ionization (MALDESI) technology for mass
      spectrometry imaging (MSI) to analyze patient hair samples to provide information on ARV
      adherence in real-time.

      The study has two different groups of participants: the patients, and their clinician
      providers.
    

Detailed 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 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.
    

Intervention name(s): MedViewer report
Intervention type(s): Device
Intervention description(s): Results from the analysis of hair samples performed using the MedViewer
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Dual Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV infection; Medication Adherence; Hair; Dolutegravir; Emtricitabine; Antiretrovirals