NCT04232540: ENLIGHTEN

Establishing Novel Antiretroviral Imaging for Hair to Elucidate Non-Adherence (ENLIGHTEN)

Completed NA Results posted Last updated 12 October 2022

What this trial tests

NA trial testing MedViewer report in Medication Adherence in 57 participants. Completed in 15 November 2021.

Timeline

14 January 2020

Primary endpoint
15 November 2021

15 November 2021

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	57
Start date	14 January 2020
Primary completion	15 November 2021
Estimated completion	15 November 2021
Sites	1 location across United States

Drugs / interventions tested

• MedViewer report

Conditions studied

• Medication Adherence — all drugs for Medication Adherence →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 18 to 99, any sex, with Medication Adherence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Patient Participants That Received a MedViewer Report as Planned Primary · Visit 1 (Day 1) after patient participant clinic visit

Patient participants received their MedViewer report as planned if: (1) they had results delivered to the research team member within 2 hours of initiation of hair sample processing; and (2) discussed results with a provider participant during their clinic visit. The percent of patient participants that received the MedViewer report as planned is reported.

Group	Value	95% CI
Patient Participants	91.9

Percent of Contacted Patients That Were Eligible for a Screening Visit and Agreed to Participate in the Study Primary · Visit 1 (Day 1) before patient participant clinic visit

Contacted patients were deemed eligible for a screening visit using a pre-screening questionnaire and provided documented informed consent to participate in the study. The percent of all contacted eligible patients that agreed to participate in study is reported. Per study protocol, this outcome is not measured in providers.

Group	Value	95% CI
Patient Participants	49.3

Percent of Patient Participants That Were Satisfied With Their Discussion With a Provider Participant About Antiretroviral (ART) Adherence Using the MedViewer Report Primary · Visit 1 (Day 1) after patient participant clinic visit

Patient participants were asked to rate their satisfaction with the MedViewer report for promoting a productive discussion of ART adherence with a provider participant. Satisfaction was rated on a rated on a 5-point scale (1="very unsatisfied" to 5="very satisfied"), with higher scores being more favorable. The percent of patient participants reporting 4 or greater (4="somewhat satisfied" or 5="very satisfied") on this scale as was calculated.

Group	Value	95% CI
Patient Participants	100

Percent of Patient Participants for Whom Provider Participants Reported the MedViewer Report as Being Useful for Promoting a Productive Antiretroviral (ART) Adherence Discussion Primary · Visit 1 (Day 1) after patient participant clinic visit

For each of patient participant, provider participants were asked to rate the usefulness of the MedViewer report in promoting a productive discussion with the patient participant about ART adherence using a 5-point scale (1="not at all useful" to 5="extremely useful"), with a higher score being more favorable. The percent of patient participants with provider participants reporting 4 or greater (4="very useful" or 5="extremely useful") on this scale as was calculated.

Group	Value	95% CI
Patient Participants	58.8

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 Secondary · Visit 1 (Day 1) after patient participant clinic visit

Reasons for patient participants' non-receipt of MedViewer report were only assessed for the subset of patient participants for whom non-receipt was reported. Reasons for non-receipt were assessed by provider participants for each patient participant after their scheduled visit using a single multiple-choice, multiple-answer question. The percent of patient participants for whom a reason or combination of reasons for non-receipt is reported.

Technical Difficulties, Provider Did Not Think It Was Beneficial to Show Report to Patient

Group	Value	95% CI
Patient Participants	33.3

No Time to Show Report, Did Not Receive Report Before Visit

Group	Value	95% CI
Patient Participants	33.3

Patient Had More Pressing Medical Issues

Group	Value	95% CI
Patient Participants	0

Other

Group	Value	95% CI
Patient Participants	33.3

Mean Hours From Patient Participant Hair Sample Processing Initiation to MedViewer Report Delivery to Designated Research Staff Member Secondary · Time 1 to Time 2 prior to or on Visit 1 (Day 1)

For each patient participant, the number of hours elapsed from the time of initiation of hair processing in the lab (Time 1) to the time of results delivery to designated research staff member (Time 2) was calculated, and a population mean was determined.

Group	Value	95% CI
Patient Participants	1.80	± 0.414

Percent of Participants Reporting a High Likelihood of Future MedViewer Report Use Secondary · Visit 1 (Day 1) after patient participant clinic visit for patient participants, end line visit for provider participants

The 4-point scale measuring the likelihood of future MedViewer report use ranged from 1="definitely would not" to 4="definitely would", with a higher score being more favorable. The percent of participants that scored 3 or greater on the likelihood of future MedViewer use scale (3="probably would" or "4="definitely would") was calculated.

Group	Value	95% CI
Patient Participants	97.2
Provider Participants	100

Percent of Patient Participants Reporting High Comprehension of the MedViewer Report Secondary · Visit 1 (Day 1) after patient participant clinic visit

Patient participants were asked to rate their comprehension of the information presented in the MedViewer report using a 4-point scale (1="very difficult to understand" to 4="very easy to understand"), with a higher score being more favorable. The percent of patient participants reporting 3 or greater on this scale (3="somewhat easy to understand" or 4="very easy to understand") was calculated.

Group	Value	95% CI
Patient Participants	97.1

Percent of Patient Participants Reported by Provider Participants as Having High Comprehension of the MedViewer Report Secondary · Visit 1 (Day 1) after patient participant clinic visit

Provider participants were asked to rate each of patient participant's comprehension of the information presented in the MedViewer report using a 5-point scale (1="understood not at all well" to 5="understood excellently"), with a higher score being more favorable. The percent of patient participants with provider participants reporting 4 or greater (4="understood very well" or 5="understood excellently") on this scale as was calculated.

Group	Value	95% CI
Patient Participants	73.5

Mean Usefulness Score for the MedViewer Report to Promote ART (Antiretroviral) Adherence Secondary · Visit 1 (Day 1) after patient participant clinic visit for patient participants, end line visit for provider participants

Participants were asked to rate their perceived usefulness of the MedViewer report for promoting ART adherence. Usefulness was rated on a rated on a 5-point scale (1="not at all useful" to 5="extremely useful"), with higher scores being more favorable. A mean usefulness score was calculated for each participant.

Group	Value	95% CI
Patient Participants	4.2	± 0.999
Provider Participants	4.00	± 1.033

Percent of Participants That Reported a Positive Change in the Patient-provider Relationship After Using the MedViewer Report Secondary · Visit 1 (Day 1) after patient participant clinic visit for patient participants, end line visit for provider participants

Participants were asked to rate the comparative satisfaction with patient participant-provider participant discussions during the MedViewer visits as compared to typical visits. Patient participants were asked this question after Visit 1, while provider participants were asked this question at their end line visit. Change in relationship was rated on 5-point scale (1="much less satisfied than usual" to 5="much more satisfied than usual"), with a higher score being more favorable. The percent of participants reporting 4 or greater on this scale (4="somewhat more satisfied than usual" or 5="much

Group	Value	95% CI
Patient Participants	88.2
Provider Participants	50.0

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mass Spectroscopy Imaging of Hair Strands Captures Short-Term and Long-Term Changes in Emtricitabine Adherence.
   Mwangi JN, Gilliland WM, White N, Sykes C, et al · · 2022 · cited 7× · PMID 35266824 · DOI 10.1128/aac.02176-21
2. Establishing Novel Antiretroviral Imaging for Hair to Elucidate Nonadherence: Protocol for a Single-Arm Cross-sectional Study.
   Poliseno A, Ferguson E, Perry R, Munson A, et al · · 2023 · cited 1× · PMID 37083754 · DOI 10.2196/41188
3. Feasibility, Acceptability and Appropriateness of MedViewer: A Novel Hair-Based Antiretroviral Real-Time Clinical Monitoring Tool Providing Adherence Feedback to Patients and Their Providers.
   Golin CE, Rosen EP, Ferguson EG, Perry NR, et al · · 2023 · PMID 37493932 · DOI 10.1007/s10461-023-04104-1