Establishing Novel Antiretroviral Imaging for Hair to Elucidate Non-Adherence (ENLIGHTEN): Study Design (Preprint)

BACKGROUND Adherence to antiretroviral (ARV) therapy is critical for achieving HIV RNA suppression in people living with HIV and for preventing HIV acquisition in uninfected individuals using pre-exposure prophylaxis (PrEP). Yet a high level of adherence can be challenging to achieve for people living with HIV on life-long ARVs and for HIV-negative individuals using daily PrEP who are not at daily risk for HIV acquisition. Current biological measures of adherence are invasive and utilize bioanalytical methods that don’t allow for real-time feedback during a clinic visit. This study is designed to test the feasibility and acceptability of using MedViewer (MV), a novel, minimally invasive, hair-based assay that measures longitudinal antiretroviral drug adherence in real-time and provides an output for provider-patient discussion. OBJECTIVE The primary objectives are to investigate the feasibility of delivering the MV results as planned, the acceptability of participation in a discussion of the MV results, and the appropriateness of using MV for adherence counseling. The secondary objectives are to investigate additional dimensions of feasibility, acceptability, and appropriateness of using the MV test during a routine clinic visit for people with HIV. METHODS The proposed study is a single-arm cross-sectional study among patients receiving HIV care and providers of HIV care in a southeastern Infectious Diseases Clinic. The study originally planned to implement the MV test with 50 eligible patients who were living with HIV across two viral load strata (undetectable or detectable plasma HIV RNA over the past 2 years), administer brief visit-specific questionnaires to all patient and provider participants, and to conduct qualitative in-depth interviews (IDIs) and quantitative endline questionnaires with a subsample of patient participants (n=30) and all provider participants. RESULTS The ENLIGHTEN study was funded by NIAID and was approved by the local IRB on November 04, 2019. Provider participant enrollment began on January 17, 2020 and patient participant enrollment began on January 22, 2020. Participant enrollment was halted on March 16, 2020 due to the COVID-19 pandemic (16 providers on study and 10 patients). Study activities resumed on February 02, 2021 with COVID-19 modifications approved by the local IRB. Participant enrollment closed on October 08, 2021 and data collection closed on November 15, 2021. In total, 36 unique patient participants were enrolled representing 37 samples, and 20 provider participants were enrolled. Data analysis and manuscript writing will take place through 2022. CONCLUSIONS We anticipate the data collected through this protocol will provide important insights regarding the feasibility, acceptability, and appropriateness of incorporating a new real-time longitudinal, minimally invasive adherence tests into routine clinical care and identify potential barriers to medication adherence among patients. CLINICALTRIAL NCT04232540