N/A
Completed N=57
Establishing Novel Antiretroviral Imaging for Hair to Elucidate Non-Adherence (ENLIGHTEN)
Medication Adherence
Source: ClinicalTrials.gov NCT04232540 ↗
Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: Percent of Patient Participants That Received a MedViewer Report as Planned — 91.9 percentage of patient participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patient Participants That Received a MedViewer Report as Planned |
91.9 | — |
| PRIMARY Percent of Contacted Patients That Were Eligible for a Screening Visit and Agreed to Participate in the Study |
49.3 | — |
| PRIMARY Percent of Patient Participants That Were Satisfied With Their Discussion With a Provider Participant About Antiretroviral (ART) Adherence Using the MedViewer Report |
100 | — |
| PRIMARY Percent of Patient Participants for Whom Provider Participants Reported the MedViewer Report as Being Useful for Promoting a Productive Antiretroviral (ART) Adherence Discussion |
58.8 | — |
| SECONDARY Among Patient Participants That Did Dot Receive a MedViewer Report, Percent of Patient Participants That Did Not Receive the MedViewer for a Given Reason or Reasons |
33.3; 33.3; 0; 33.3 | — |
| SECONDARY Mean Hours From Patient Participant Hair Sample Processing Initiation to MedViewer Report Delivery to Designated Research Staff Member |
1.80 | — |
| SECONDARY Percent of Participants Reporting a High Likelihood of Future MedViewer Report Use |
97.2; 100 | — |
| SECONDARY Percent of Patient Participants Reporting High Comprehension of the MedViewer Report |
97.1 | — |
| SECONDARY Percent of Patient Participants Reported by Provider Participants as Having High Comprehension of the MedViewer Report |
73.5 | — |
| SECONDARY Mean Usefulness Score for the MedViewer Report to Promote ART (Antiretroviral) Adherence |
4.2; 4.00 | — |
| SECONDARY Percent of Participants That Reported a Positive Change in the Patient-provider Relationship After Using the MedViewer Report |
88.2; 50.0 | — |
Eligibility Criteria
Inclusion Criteria
Patient participants:
- Documentation of HIV-1 infection by means of any one of the following:
- Documentation of HIV diagnosis in the medical record by a licensed health care provider;
- OR HIV-1 RNA detection by a licensed HIV-1 RNA test demonstrating >1000 RNA copies/mL;
- OR any licensed HIV screening antibody and/or HIV antibody/antigen combination test confirmed by a second licensed HIV test such as a HIV-1 Western blot confirmation or HIV rapid Multispot antibody differentiation test.
- At least 18 years of age on the day of consent.
- Documentation of HIV viral loads over 2-year period prior to screening.
- Has been a patient at the UNC ID clinic for at least 90 consecutive days prior to the date of enrollment in the study (i.e. attended first appointment at the UNC ID Clinic at least 90 days prior to the date of enrollment in the study).
- Has attended at least one HIV appointment at the UNC ID clinic within the 365 days prior to the date of enrollment in the study.
- Has been prescribed one of the ARV medications eligible in this study (Dolutegravir, Emtricitabine) by a UNC provider for at least 90 days prior to the date of enrollment in the study.
- Has an HIV appointment scheduled at the UNC ID clinic during the enrollment period of the study with a medical provider enrolled in the study.
- Evidence of a personally signed and dated informed consent form indicating that the participant has been informed of all pertinent aspects of the study.
- Has stated willingness and availability to comply with all study procedures for the duration of the study.
- Literate in English.
- Has at least 1.0 cm of natural caput hair.
- As enrollment will occur in a stratified manner based on 2 viral load strata, (n = 25 for patients with undetectable viral loads, n = 25 for those with detectable viral loads), once a stratum quota is reached, patients whose viral loads fall within that stratum will not be eligible to participate in the study.
Provider participants:
- Medical provider (including, but not limited to: attending physician, ID fellow, nurse practitioner, physician assistant, or a designated HIV Care pharmacist) for UNC ID clinic patients living with HIV.
- Provides medical care for patients at the UNC ID clinic at least one half-day per week (i.e. 4 hours per week).
- Evidence of a personally signed and dated informed consent form indicating that the participant has been informed of all pertinent aspects of the study.
- Has stated willingness and availability to comply with all study procedures for the duration of the study.
Exclusion Criteria
Patient participants:
- Previous participation in the study UNC 11530- Formative Sub-Study for Novel Mass Spectrometry Imaging Methods to Quantify Antiretroviral Adherence.
- Deemed, by medical provider in UNC ID clinic, too ill, or other relevant reason, to participate in the study.
- Prior history of clinically significant alteration of the gastrointestinal system or drug absorption capability, including but not limited to: gastrectomy, total colectomy
- Any chemical hair treatment with dye, bleach, or relaxers within the past 4 weeks prior to sampling
Provider participants:
- Not willing or able to participate in any of the provider training sessions for this study or any form of make-up training session with research team.
Data sourced from ClinicalTrials.gov (NCT04232540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.