Real-Time Electronic Drug Monitoring: Experiences from a Multinational Phase 3 Clinical Trial to Prevent Multidrug-Resistant TB

Authors

• T. Jimah, Northeastern Universit
• J.E. Haberer, Massachusetts General Hospital
• K.R. Amico, University of Michigan - Ann Arbor
• J. Tinkamanyire, Aurum Institute PLC
• M.A. Kendall, Harvard T.H. Chan School of Public Health
• S. Moonsamy, University of the Witwatersrand, Johannesburg
• R.T. Khan, Y.R. Gaitonde Centre for AIDS Research and Education
• K.B.F. Fetalvero, TB HIV Innovations and Clinical Research Foundation Corp. Silang
• N. Suryavanshi, B.J. Government medical College-CRS
• A. Gupta, Johns Hopkins University School of Medicine
• A.C. Hesseling, Stellenbosch University
• Susan Swindells, University of Nebraska Medical CenterFollow
• G. Churchyard, Aurum Institute NPC

Document Type

Article

Journal Title

IJTLD Open

Publication Date

2026

Volume

3

Abstract

OBJECTIVE: We describe the experience of implementing real-time electronic drug monitoring (EDM) within a clinical trial to prevent multidrug-resistant TB (MDR-TB) among high-risk household contacts.

METHODS: The Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx) trial is a phase 3, open-label, cluster-randomised clinical trial conducted in 31 sites in Africa, Asia, and Latin America. Household contacts of adults with MDR-TB were enrolled from June 2019 to January 2025, each receiving an EDM device to monitor adherence to TB preventive therapy. Here, we review selection of the adherence monitoring approach and key procedures implemented to support EDM use and oversight throughout the trial.

RESULTS: Integrating EDM in the PHOENIx trial enabled objective monitoring and early non-adherence identification to ensure timely counselling. Dedicated effort was needed to develop, train, and implement standardised protocols, but overall coordination required relatively few staff. Technical issues were manageable, and monitoring costs were relatively low for a large trial.

CONCLUSION: Findings highlight the added value of objective adherence monitoring, which can inform future trials, particularly for prevention. Our experiences suggest that with the appropriate support, EDM can be used to monitor and characterise adherence, even in a complex multi-country phase 3 trial in settings with a high TB burden.

DOI Link

10.5588/ijtldopen.25.0702

ISSN

3005-7590

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Recommended Citation

Jimah, T.; Haberer, J.E.; Amico, K.R.; Tinkamanyire, J.; Kendall, M.A.; Moonsamy, S.; Khan, R.T.; Fetalvero, K.B.F.; Suryavanshi, N.; Gupta, A.; Hesseling, A.C.; Swindells, Susan; and Churchyard, G., "Real-Time Electronic Drug Monitoring: Experiences from a Multinational Phase 3 Clinical Trial to Prevent Multidrug-Resistant TB" (2026). Journal Articles: Infectious Diseases. 28.
https://digitalcommons.unmc.edu/com_infect_articles/28