"Sign Me Up": a qualitative study of video observed therapy (VOT) for patients receiving expedited methadone take-homes during the COVID-19 pandemic.

BACKGROUND: Federal and state regulations require frequent direct observation of methadone ingestion at an Opioid Treatment Program (OTP)-a requirement that creates barriers to patient access. Video observed therapy (VOT) may help to address public health and safety concerns of providing take-home medications while simultaneously reducing barriers to treatment access and long-term retention. Evaluating user experiences with VOT is important for understanding the acceptability of this strategy. METHODS: We conducted a qualitative evaluation of a clinical pilot program of VOT via smartphone that was rapidly implemented between April and August 2020 during the COVID-19 pandemic within three opioid treatment programs. In the program, selected patients submitted video recordings of themselves ingesting methadone take-home doses, which were asynchronously reviewed by their counselor. We recruited participating patients and counselors for semi-structured, individual interviews to explore their VOT experiences after program completion. Interviews were audio recorded and transcribed. Transcripts were analyzed using thematic analysis to identify key factors influencing acceptability and the effect of VOT on the treatment experience. RESULTS: We interviewed 12 of the 60 patients who participated in the clinical pilot and 3 of the 5 counselors. Overall, patients were enthusiastic about VOT, noting multiple benefits over traditional treatment experiences, including avoiding frequent travel to the clinic. Some noted how this allowed them to better meet recovery goals by avoiding a potentially triggering environment. Most appreciated having increased time to devote to other life priorities, including maintaining consistent employment. Participants described how VOT increased their autonomy, allowed them to keep treatment private, and normalized treatment to align with other medications that do not require in-person dosing. Participants did not describe major usability issues or privacy concerns with submitting videos. Some participants reported feeling disconnected from counselors while others felt more connected. Counselors felt some discomfort in their new role confirming medication ingestion but saw VOT as a useful tool for select patients. CONCLUSIONS: VOT may be an acceptable tool to achieve equipoise between lowering barriers to treatment with methadone and protecting the health and safety of patients and their communities.

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

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.

Video-Observed Therapy With a Notification System for Improving the Monitoring of Tuberculosis Treatment in Thailand: Usability Study.

BACKGROUND: In Thailand, the health care system has struggled to cope with COVID-19, resulting in directly observed therapy for tuberculosis being de-emphasized. A video-observed therapy (VOT) system, or more specifically, the Thai VOT (TH VOT) system, was developed to replace directly observed therapy. According to the pilot study, the system needed notifications to improve usability and user compliance. The updated version of the TH VOT system thus enabled LINE (Line Corporation) notifications. OBJECTIVE: This study aimed to reassess users' compliance with and the usability of the updated TH VOT system. METHODS: This study was conducted in the Hat Yai and Mueang Songkhla districts in Songkhla Province, Southern Thailand, from September 18 to December 1, 2021. The system was used by not only patients with tuberculosis but also tuberculosis staff, who acted as observers in primary health care settings. Some of the observers used the simulated VOT system instead of the actual system due to the lack of participating patients in their jurisdiction. After 30 days of using the system, VOT session records were analyzed to determine the compliance of the patients and observers. The User Experience Questionnaire was administered to reassess the usability of the system and compare the ratings of the participants with the general benchmark scores of the User Experience Questionnaire. The results were summarized to reveal the degree of user compliance and usability in the following three groups: the patients, actual VOT observers, and simulated VOT observers. RESULTS: Of the 19 observers, 10 used the actual VOT system, and the remaining 9 used the simulated VOT system; there were also 10 patients with tuberculosis. The patients, actual VOT observers, and simulated VOT observers exhibited about 70%, 65%, and 50% compliance, respectively, in terms of following the standard operating procedures every day. The scores of all groups on all dimensions were well above the average scores. There was no significant difference in any of the dimensional scores among the three groups. CONCLUSIONS: The updated version of the TH VOT system was deemed usable by both the patients and the health care staff. Compliance with the use of the system was high among the patients but moderate among the observers.

Cost-effectiveness of video-observed therapy for ambulatory management of active tuberculosis during the COVID-19 pandemic in a high-income country.

OBJECTIVE: The coronavirus 2019 (COVID-19) pandemic caused suspension of directly observed therapy (DOT) for patients with active tuberculosis (TB). This study aimed to estimate the outcomes of pandemic-related DOT suspension and the cost-effectiveness of video-observed therapy (VOT) during the pandemic. METHODS: A decision-analytic model was constructed to project outcomes of adult patients with active TB from the perspective of a US healthcare provider. Two model-based analyses were conducted: (1) before (with DOT) and during [with self-administered therapy (SAT)] the pandemic; and (2) VOT vs SAT during the pandemic. The primary outcome measures were direct medical costs and disability-adjusted life years (DALYs). RESULTS: In the base-case analysis, care during the pandemic (with SAT) increased the cost (by US$285 per patient) and DALYs (by 0.2155 per patient) in comparison with DOT. Care with VOT reduced DALYs (by 0.4870) and costs (by US$1797) in comparison with SAT. On probabilistic sensitivity analysis, care during the pandemic (with SAT) increased DALYs in 100% of 10,000 simulations, and increased costs in 55.52% of instances. Care with VOT reduced DALYs and costs in 99.7% and 68.79% of instances, respectively. The probability of VOT being cost-effective was 99.4% at the willingness-to-pay threshold of 50,000 US$/DALY. CONCLUSION: Suspension of DOT during the COVID-19 pandemic worsened treatment outcomes. VOT was found to be a cost-effective option for active TB care in an outpatient setting.

Development of a Video-Observed Therapy System to Improve Monitoring of Tuberculosis Treatment in Thailand: Mixed-Methods Study.

BACKGROUND: Directly observed therapy programs for monitoring tuberculosis (TB) treatment in Thailand are unsustainable, especially during the COVID-19 pandemic. The current video-observed therapy (VOT) system, the Thai VOT (TH VOT), was developed to replace the directly observed therapy program. OBJECTIVE: This study aimed to describe the VOT system design and identify the potential for system improvements. METHODS: This pilot study was conducted in Na Yong district, a small district in Trang province, south of Thailand. The TH VOT system consists of a smartphone app for patients, a secured web-based platform for staff, items used, and standard operating procedures. There were three groups of users: observers who were TB staff, healthy volunteers as simulated patients, and patients with active TB. All participants were trained to follow the standard operating procedures. After 2-week usage, VOT session records were analyzed to measure the compliance of the patients and observers. The User Experience Questionnaire was used to lead the participant users to focus on 6 standard dimensions of usability, and was supplemented with an in-depth interview to identify potential system improvements from users' experience. RESULTS: Only 2 of 16 patients with currently active TB had a usable smartphone. Sixty of 70 drug-taking sessions among 2 patients and 3 simulated patients in 2 weeks were recorded and uploaded. Only 37 sessions were inspected by the observers within 24 hours. All participants needed a proper notification system. An audit system was also requested. CONCLUSIONS: Before upscaling, the cost of smartphone lending, audit management, and notification systems should be elucidated.