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

NCT04232540 | Completed Results FDA Device

• 3 other identifiers: 18-3360R01AI122319122319
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medication Adherence

Keywords

HIV infection; Medication Adherence; Hair; Dolutegravir; Emtricitabine; Antiretrovirals

Outcome Measures

Primary Outcomes (4)

• Percent of Patient Participants That Received a MedViewer Report as Planned

  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.

  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

  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.

  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

  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.

  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

  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.

  Visit 1 (Day 1) after patient participant clinic visit

Secondary Outcomes (7)

• 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

  Visit 1 (Day 1) after patient participant clinic visit

• Mean Hours From Patient Participant Hair Sample Processing Initiation to MedViewer Report Delivery to Designated Research Staff Member

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

• Percent of Participants Reporting a High Likelihood of Future MedViewer Report Use

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

• Percent of Patient Participants Reporting High Comprehension of the MedViewer Report

  Visit 1 (Day 1) after patient participant clinic visit

• Percent of Patient Participants Reported by Provider Participants as Having High Comprehension of the MedViewer Report

  Visit 1 (Day 1) after patient participant clinic visit

Study Arms (2)

Patient participants

EXPERIMENTAL

Patient and provider will view and discuss results of the MedViewer test.

Device: MedViewer report

Provider participants

EXPERIMENTAL

Patient and provider will view and discuss results of the MedViewer test.

Device: MedViewer report

Interventions

MedViewer report DEVICE

Results from the analysis of hair samples performed using the MedViewer

Patient participants; Provider participants

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

• Golin CE, Rosen EP, Ferguson EG, Perry NR, Poliseno AJ, Munson AJ, Davis A, Hill LM, Keys J, White NR, Farel CE, Kashuba A. Feasibility, Acceptability and Appropriateness of MedViewer: A Novel Hair-Based Antiretroviral Real-Time Clinical Monitoring Tool Providing Adherence Feedback to Patients and Their Providers. AIDS Behav. 2023 Dec;27(12):3886-3904. doi: 10.1007/s10461-023-04104-1. Epub 2023 Jul 26.

  PMID: 37493932 DERIVED

• Poliseno A, Ferguson E, Perry R, Munson A, Davis A, Hill L, Keys J, White N, Farel C, Gay C, Golin C, Rosen E, Kashuba A. Establishing Novel Antiretroviral Imaging for Hair to Elucidate Nonadherence: Protocol for a Single-Arm Cross-sectional Study. JMIR Res Protoc. 2023 Apr 21;12:e41188. doi: 10.2196/41188.

  PMID: 37083754 DERIVED

MeSH Terms

Conditions

Medication Adherence; HIV Infections

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Amanda Poliseno
• Organization: UNC Chapel Hill

amanda_poliseno@unc.edu

919-962-5344

Study Officials

• Angela Kashuba, PharmD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dual Group Assignment

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: January 14, 2020
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: October 12, 2022
• Results First Posted: October 12, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Upon acceptance of final manuscript for publication for an indefinite time period
• Access Criteria: Before data will be shared, a data use agreement will be put in place in accordance with local regulations. The requestor will need to obtain appropriate ethics approval.

Locations

US (1)