In-Person vs Electronic Directly Observed Therapy for Tuberculosis Treatment Adherence

Dear Colleague Letters

January 20, 2022

Dear Colleagues,

The U.S. Centers for Disease Control and Prevention (CDC) Division of Tuberculosis Elimination (DTBE), together with collaborators from the New York City (NYC) Department of Health and Mental Hygiene and Columbia University, published "In-Person vs Electronic Directly Observed Therapy for Tuberculosis Treatment Adherence" in the Journal of the American Medical Association (JAMA) Network Open.

Directly observed therapy (DOT) is the most effective strategy for ensuring that tuberculosis (TB) patients adhere to treatment. Yet traditional in-person DOT can require a significant amount of TB programs' staff time and resources.

Digital adherence technologies (DAT) have the potential to lessen the time and resources required. Electronic DOT (eDOT), a DAT approach, employs personal electronic devices, particularly smart mobile telephones with video capabilities, to view patients ingesting their medications remotely.

In the published study, while undergoing in-person DOT, participants could choose to meet with health department staff at the TB clinic (clinic-based DOT) or at a mutually agreed-upon location in the community (community-based DOT). While undergoing eDOT, participants could choose to use live or recorded video formats.

The study was designed as a randomized two-period cross-over non-inferiority trial and was conducted through NYC tuberculosis clinics to evaluate whether eDOT could attain a level of treatment adherence comparable to traditional in-person DOT. The study observed patients from July 2017 through October 2019.

The study demonstrates that when implemented by a program with a history of successfully providing in-person DOT, eDOT is noninferior to in-person DOT across multiple modes of statistical analysis.

• The percentage of completed doses with in-person DOT was 87.2% vs 89.8% with eDOT.
• Issues affecting medication observations (such as operating software, schedule interferences, or unscheduled staff absences) occurred with both electronic and in-person DOT. Community-based in-person DOT observations had the greatest percentage of issues affecting the DOT session with 19% of observations having issues compared with 10% for live-video electronic DOT observations, 8% for recorded-video electronic DOT, and 6% for clinic-based in-person DOT.
• After experiencing both in-person and eDOT, 84% of the participants reported they preferred to continue treatment with eDOT.

Some TB programs have already adopted the use of alternative DOT methods, like eDOT, for treatment of both TB disease and latent TB infection. During public health emergencies like COVID-19 alternative DOT methods can help TB patients continue and complete their treatment regimen. For example, a combination of DOT and eDOT methods enabled the NYC Bureau of Tuberculosis Control to achieve high rates of direct observation throughout the COVID-19 pandemic.

CDC will use the results of this study to help inform future guidelines and recommendations. CDC previously published Implementing an Electronic Directly Observed Therapy (eDOT) Program: A Toolkit for Tuberculosis (TB) Programs to assist TB programs in developing and implementing a TB eDOT program. I would like to thank the researchers, clinical staff, and most of all, study participants, for their important and groundbreaking contributions that will bring us closer to our goal of TB elimination.

Sincerely,

Philip LoBue, MD, FACP, FCCP
Director
Division of Tuberculosis Elimination
National Center for HIV, Viral Hepatitis, STD, and TB Prevention