CompletedNot Applicable

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

United States57 participantsStarted 2020-01-14

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Percent of Patient Participants That Received a MedViewer Report as Planned

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

Percent of Contacted Patients That Were Eligible for a Screening Visit and Agreed to Participate in the Study

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

Percent of Patient Participants That Were Satisfied With Their Discussion With a Provider Participant About Antiretroviral (ART) Adherence Using the MedViewer Report

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

Percent of Patient Participants for Whom Provider Participants Reported the MedViewer Report as Being Useful for Promoting a Productive Antiretroviral (ART) Adherence Discussion

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

Trial details

NCT IDNCT04232540

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-15

Results submitted2022-09-14

View on ClinicalTrials.gov More Medication Adherence trials

Plain-language summary

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.