Tuberculosis Treatment Compliance Under Smartphone-Based Video-Observed Therapy Versus Community-Based Directly Observed Therapy: Protocol for a Cluster Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND The healthcare system in Thailand has struggled to cope with the coronavirus disease 2019 (COVID-19), resulting in the de-emphasis of community-based directly observed therapy (DOT) for tuberculosis (TB). To replace the failed DOT, video-observed therapy (VOT) or, more specifically, the Thai VOT "TH VOT" system, was and used. This protocol was developed to test the superiority of VOT over DOT in ensuring treatment compliance. OBJECTIVE We will compare compliances of TB patients and their observers in the VOT group with those in the DOT group during the intensive phase of TB treatment. METHODS A cluster randomized controlled superiority trial will be conducted for two months among patients with pulmonary TB and their observers. This study will be conducted in Hat Yai and Meuang Songkhla districts in Songkhla Province, Southern Thailand. 38 observers working in 38 primary care units (PCUs) will be randomized into equal VOT and DOT groups. The TH VOT system will be implemented in 19 PCUs in the VOT group while the other 19 PCUs will continue the traditional DOT program. Approximately 1 to 5 TB patients will be assigned to be observed by an observer depending on the PCU jurisdiction where the patients live. The inclusion criteria for the TB patients are: newly active pulmonary TB; age more than 18 years old; and having a smartphone with the LINE application. The exclusion criteria are: having a condition that must be referred to a specialist; an antibiotic sensitivity test by a cartridge-based nucleic acid amplification (GeneXpert) shows rifampicin resistance; status is not compatible to continuing the treatment; and/or alcohol dependence. After the two-month observation period, all sessions and follow-up clinical outcomes recorded will be retrieved. Intention to treat analysis will be performed to assess the compliance of both the patients and observers on the observation of drug-taking. RESULTS The study was ethically approved in February 2021, and funded in May 2021. The recruitment will start in January 2022 and stop in July 2022. The observation is scheduled to end by September 2022. CONCLUSIONS If the VOT shows superiority in observational compliance among the patients and observers, it will then be justified to replace the existing sloppy DOT. CLINICALTRIAL thaiclinicaltrials.org TCTR20210624002; https://www.thaiclinicaltrials.org/show/TCTR20210624002

Tuberculosis Treatment Compliance Under Smartphone-Based Video-Observed Therapy Versus Community-Based Directly Observed Therapy: Cluster Randomized Controlled Trial

“…Therefore, the data could not be used to indirectly identify a person; however, they were sufficiently detailed to enable analysis and yield results consistent with the original data. The research data have been shared on GitHub [49].…”