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

Abstract

Background The health care system in Thailand has struggled to cope with the COVID-19 pandemic, resulting in decreased administration of community-based directly observed therapy (DOT) for tuberculosis (TB). As an alternative to failed DOT, video-observed therapy (VOT) or the Thai asynchronous VOT system, “TH VOT,” was devised. We developed a protocol for a study to test the superiority of VOT over DOT in ensuring treatment compliance. Objective We aim to compare the mean cumulative compliance days of TB patients and their observers under the VOT program with that of individuals under the DOT program during the intensive phase of TB treatment. Methods A cluster randomized controlled trial of pulmonary TB patients and their observers will be conducted over a 2-month period. This study will be conducted in the Hat Yai and Meuang Songkhla districts of Songkhla Province, Southern Thailand. A total of 38 observers working at 38 primary care units (PCUs) will be randomized equally into 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 with the traditional DOT program. Approximately 1-5 TB patients will be under observation, depending on the PCU jurisdiction in which the patients reside. The inclusion criteria for TB patients will be as follows: patients diagnosed with newly active pulmonary TB with a positive acid-fast bacilli sputum smear, aged >18 years, own a smartphone, and are able to use the LINE (Line Corporation) app. The exclusion criteria will be patients with a condition that requires the intervention of a specialist, rifampicin resistance according to a cartridge-based nucleic acid amplification test (GeneXpert MTB/RIF), unable to continue the treatment, and/or alcohol dependence. After the 2-month observation period, all sessions and follow-up clinical outcomes recorded will be retrieved. An intention-to-treat analysis will be performed to assess the compliance of both patients undergoing drug administration and their observers. Results The Human Research Ethics Committee, Faculty of Medicine, Prince of Songkla University approved the trial on February 19, 2021 (approval number 64-03618-9). The trial was funded in May 2021. The recruitment period will be from January 2022 to July 2022. The observation is scheduled to end by September 2022. Conclusions If the VOT shows superiority in observational compliance among patients and observers, the existing DOT policy will be replaced with VOT. Trial Registration Thai Clinical Trials Registry TCTR20210624002; https://www.thaiclinicaltrials.org/show/TCTR20210624002 International Registered Report Identifier (IRRID) DERR1-10.2196/38796

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

“…The trial was registered in the Thai Clinical Trials Registry (TCTR20210624002). The trial protocol followed the CONSORT (Consolidated Standards of Reporting Trials) 2010 statement [ 23 ] and is available online [ 20 ].…”

“…It was particularly beneficial for patients taking medication late at night, allowing observers to review videos the following morning [ 13 ]. More details on system functions and usability are available on the internet in our previous studies [ 12 , 13 , 20 ].…”

“…Each patient and observer received a session booklet (more details in the protocol by Kumwichar et al [ 20 ]). After being notified by the automatic system, the observer conducted a home-visit DOT as a routine service.…”

“…However, daily compliance was judged as “achieved within the cut-off time” if the patients took their medication and submitted their videos before 6 AM on the following day. The auditor assessed the daily video sessions for both the patients and the observers based on the protocol [ 20 ].…”

“…The primary objective of this trial was to compare the average number of days that patients with pulmonary tuberculosis and their observers were compliant under VOT and DOT. This was conducted during the intensive phase of treatment, which lasted 60 days, and followed the published protocol [ 20 ]. We assumed that medication adherence depended on the compliance of both patients and observers in both the VOT and DOT programs.…”