NCT03266003

An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment

Completed NA Last updated 28 July 2021

What this trial tests

NA trial testing Electronic DOT in Tuberculosis in 216 participants. Completed in 31 December 2020.

Timeline

19 July 2017

Primary endpoint
10 January 2020

31 December 2020

Quick facts

Lead sponsor	Centers for Disease Control and Prevention
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	health services research
Enrollment	216
Start date	19 July 2017
Primary completion	10 January 2020
Estimated completion	31 December 2020
Sites	4 locations across United States

Drugs / interventions tested

• Electronic DOT
• In-person DOT

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →
• Drug-resistant Tuberculosis — all drugs for Drug-resistant Tuberculosis →
• Adherence, Medication — all drugs for Adherence, Medication →
• Adherence, Patient — all drugs for Adherence, Patient →

Sponsor

Centers for Disease Control and Prevention — full company profile →

Who can join

12 and older, any sex, with Tuberculosis or Drug-resistant Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic Resistance Solutions Initiative) that will be implemented to evaluate traditional directly observed therapy (DOT) and electronic forms of DOT (eDOT) for tuberculosis (TB) treatment. The trial will assess whether eDOT that employs electronic communication methods, such as video via computer or cellphone, is a non-inferior approach to monitor TB treatment adherence, compared to traditional in-person DOT (ipDOT), in which a trained person is in the physical presence of patients as anti-TB drugs are ingested. ipDOT is the single best intervention proven to be successful when it comes to TB patients' adherence to therapy (which reduces risk of acquired drug resistance). However, ipDOT is resource intensive and many times challenging to facilitate in-person. If eDOT is found to be non-inferior to ipDOT, health departments and other clinicians might be able to provide eDOT to certain populations of TB patients in a more flexible and potentially cost-saving manner.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. In-Person vs Electronic Directly Observed Therapy for Tuberculosis Treatment Adherence: A Randomized Noninferiority Trial.
   Burzynski J, Mangan JM, Lam CK, Macaraig M, et al · · 2022 · cited 37× · PMID 35050357 · DOI 10.1001/jamanetworkopen.2021.44210
2. Adverse events among persons with TB using in-person vs. electronic directly observed therapy.
   Salerno MM, Burzynski J, Mangan JM, Hill A, et al · · 2023 · cited 1× · PMID 37880884 · DOI 10.5588/ijtld.22.0594
3. Challenges associated with electronic and in-person directly observed therapy during a randomized trial.
   Mangan JM, Burzynski J, deCastro BR, Salerno MM, et al · · 2023 · cited 1× · PMID 37035970 · DOI 10.5588/ijtld.22.0583