Trial Outcomes & Findings for Establishing Novel Antiretroviral Imaging for Hair to Elucidate Non-Adherence (ENLIGHTEN) (NCT NCT04232540)

NCT ID: NCT04232540

Last Updated: 2022-10-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 57 participants
• Primary outcome timeframe: Visit 1 (Day 1) after patient participant clinic visit
• Results posted on: 2022-10-12

Participant Flow

Participant milestones

Measure	Patient Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
Overall Study STARTED	37	20
Overall Study Received MedViewer	34	16
Overall Study Completed In-Depth Interview	24	14
Overall Study COMPLETED	36	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Patient Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Patient Participants n=37 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants n=20 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Total n=57 Participants Total of all reporting groups
Age, Continuous	51 years n=5 Participants	44.5 years n=7 Participants	49 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	7 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	20 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	1 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	37 Participants n=5 Participants	20 Participants n=7 Participants	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 1 (Day 1) after patient participant clinic visit

Population: All patient participants were included in the analysis.

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.

Outcome measures

Measure	Patient Participants n=37 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
Percent of Patient Participants That Received a MedViewer Report as Planned	91.9 percentage of patient participants	—

PRIMARY outcome

Timeframe: Visit 1 (Day 1) before patient participant clinic visit

Population: All patients that were contacted and deemed eligible for study were included in the analysis.

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.

Outcome measures

Measure	Patient Participants n=75 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
Percent of Contacted Patients That Were Eligible for a Screening Visit and Agreed to Participate in the Study	49.3 percentage of contacted patients	—

PRIMARY outcome

Timeframe: Visit 1 (Day 1) after patient participant clinic visit

Population: Patient participants that received a MedViewer report and discussed the report with a provider participant as planned were included in the analysis.

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.

Outcome measures

Measure	Patient Participants n=34 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
Percent of Patient Participants That Were Satisfied With Their Discussion With a Provider Participant About Antiretroviral (ART) Adherence Using the MedViewer Report	100 percentage of patient participants	—

PRIMARY outcome

Timeframe: Visit 1 (Day 1) after patient participant clinic visit

Population: Patient participants that received a MedViewer report and discussed the report with a provider participant as planned were included in the analysis.

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.

Outcome measures

Measure	Patient Participants n=34 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
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 percentage of patient participants	—

SECONDARY outcome

Timeframe: Visit 1 (Day 1) after patient participant clinic visit

Population: Patient participants that did not receive and/or discuss a MedViewer report with a provider participant as planned were included in the analysis.

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.

Outcome measures

Measure	Patient Participants n=3 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
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 Technical Difficulties, Provider Did Not Think It Was Beneficial to Show Report to Patient	33.3 percentage of patient participants	—
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 No Time to Show Report, Did Not Receive Report Before Visit	33.3 percentage of patient participants	—
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 Patient Had More Pressing Medical Issues	0 percentage of patient participants	—
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 Other	33.3 percentage of patient participants	—

SECONDARY outcome

Timeframe: Time 1 to Time 2 prior to or on Visit 1 (Day 1)

Population: All patient participants were included in the analysis.

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.

Outcome measures

Measure	Patient Participants n=37 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
Mean Hours From Patient Participant Hair Sample Processing Initiation to MedViewer Report Delivery to Designated Research Staff Member	1.80 hours Standard Deviation 0.414	—

SECONDARY outcome

Timeframe: Visit 1 (Day 1) after patient participant clinic visit for patient participants, end line visit for provider participants

Population: All patient participants were included in the analysis. Only provider participants that saw patient participants were included in the analysis.

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.

Outcome measures

Measure	Patient Participants n=37 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants n=16 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
Percent of Participants Reporting a High Likelihood of Future MedViewer Report Use	97.2 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Visit 1 (Day 1) after patient participant clinic visit

Population: Patient participants that received a MedViewer report and discussed the report with a provider participant as planned were included in the analysis.

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.

Outcome measures

Measure	Patient Participants n=34 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
Percent of Patient Participants Reporting High Comprehension of the MedViewer Report	97.1 percentage of patient participants	—

SECONDARY outcome

Timeframe: Visit 1 (Day 1) after patient participant clinic visit

Population: Patient participants that received a MedViewer report and discussed the report with a provider participant as planned were included in the analysis.

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.

Outcome measures

Measure	Patient Participants n=34 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
Percent of Patient Participants Reported by Provider Participants as Having High Comprehension of the MedViewer Report	73.5 percentage of patient participants	—

SECONDARY outcome

Timeframe: Visit 1 (Day 1) after patient participant clinic visit for patient participants, end line visit for provider participants

Population: Patient participants that discussed the MedViewer as planned were included in the analysis. Provider participants that saw patient participants were included in the analysis.

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.

Outcome measures

Measure	Patient Participants n=34 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants n=16 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
Mean Usefulness Score for the MedViewer Report to Promote ART (Antiretroviral) Adherence	4.2 score on a scale Standard Deviation 0.999	4.00 score on a scale Standard Deviation 1.033

SECONDARY outcome

Timeframe: Visit 1 (Day 1) after patient participant clinic visit for patient participants, end line visit for provider participants

Population: Patient participants that discussed the MedViewer as planned were included in the analysis. Provider participants that saw patient participants were included in the analysis.

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 more satisfied than usual") was calculated.

Outcome measures

Measure	Patient Participants n=34 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer	Provider Participants n=16 Participants Patient and provider will view and discuss results of the MedViewer test. MedViewer report: Results from the analysis of hair samples performed using the MedViewer
Percent of Participants That Reported a Positive Change in the Patient-provider Relationship After Using the MedViewer Report	88.2 percentage of participants	50.0 percentage of participants

Adverse Events

Patient Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Provider Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amanda Poliseno

UNC Chapel Hill

Phone: 919-962-5344

Email: amanda_poliseno@unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place