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MyTPill: study protocol for a cross-over randomised controlled trial comparing novel strategies to monitor antiretroviral adherence among HIV+ prescription opioid users. | LitMetric

AI Article Synopsis

  • This study focuses on improving HIV treatment adherence through electronic adherence monitoring (EAM) technologies specifically for patients using antiretroviral therapy (ART).
  • It compares traditional EAM systems that monitor pillbox openings to a digital pill system (My/Treatment/Pill) that accurately measures medication ingestion in HIV-positive patients using a specific regimen.
  • The trial aims to assess the effectiveness of these EAM systems and identify factors contributing to ART non-adherence in a group of 80 patients while prioritizing ethical standards and dissemination of results in scientific forums.

Article Abstract

Introduction: Adherence to HIV antiretroviral therapy (ART) remains the cornerstone of HIV treatment. For individuals with suboptimal adherence, electronic adherence monitoring (EAM) technologies have become an important component of multimodal adherence support strategies. Most EAM technologies detect pillbox opening, and therefore, assume but cannot verify actual ingestion of oral medication. In contrast, a digital pill system (ID-capsule manufactured by etectRX, here named My/Treatment/Pill) measures directly ingestion of medications. Identifying the superior method to measure ART adherence would improve virological suppression by enabling the delivery of real-time interventions to support ART adherence, particularly in high-risk populations.

Methods And Analysis: Cross-over, randomised trial with 1:1 variable block size randomisation comparing two EAM systems in prescription opioid-using HIV+patient on once daily oral bictegravir, emtricitabine and tenofovir alafenamide regimens and detectable viral load >200 copies/mL within 30 days of screening (n=80). The primary outcome is once daily ART adherence measurement efficacy as assessed by comparing the accuracy of each EAM system as measured by concordance of the respective EAM systems to dried blood spot ART concentrations. Secondary outcomes are the identification of multilevel factors that are prevalent in the target population most closely linked to ART non-adherence and EAM non-adherence.

Ethics And Dissemination: This protocol was approved by the institutional review boards of participating sites (The Ohio State University, The Fenway Institute and the University of Miami). Data will be presented at scientific conferences and published in peer-reviewed journals.

Trial Registration Number: NCT03978793.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9835860PMC
http://dx.doi.org/10.1136/bmjopen-2022-062805DOI Listing

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