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BACKGROUND: Direct-acting antiviral medications have the potential to eliminate the hepatitis C virus (HCV) epidemic among people who inject drugs; yet, suboptimal adherence remains a barrier. Directly observed treatment (DOT), an effective strategy for optimizing adherence, has been frequently implemented in opioid treatment programs but less commonly in community health settings due to the heavy burden of daily visits. An alternative is video-observed therapy (VOT), which uses mobile health technology to monitor adherence. VOT has not been widely studied among people who inject drugs with HCV. OBJECTIVE: This qualitative study, part of a larger implementation evaluation, investigates stakeholder perceptions and experiences with VOT in Project HERO (Hepatitis C Real Outcomes), a multisite pragmatic trial testing treatment delivery models for people who inject drugs with HCV. Our goal was to understand the potential barriers and facilitators to the implementation of the VOT technology. METHODS: Qualitative interviews were conducted with 27 Project HERO study staff and 7 patients. Interviews focused on perceptions and experiences with the VOT app and barriers and facilitators to implementation. Team meeting minutes over the first 2 years of the project were transcribed. A coding system was developed and applied to the data. We summarized thematic data and compared participant perceptions to generate a close understanding of the data. RESULTS: Frequent barriers to VOT included mechanical failure, stolen or lost phones, and a steep learning curve for participants and study staff. In sites with older and less technically skilled participants, staff found it difficult to implement the VOT app. Research staff found that the routine monitoring of app use led to closer engagement with participants. This was both a benefit and a potential threat to the validity of this pragmatic trial. Patient participants reported mixed experiences. CONCLUSIONS: VOT may be a useful alternative to DOT for some patients, but it may not be feasible for all. Significant staff involvement may be required.

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BACKGROUND: The success rate of tuberculosis (TB) treatment in Malaysia remains below the recommended World Health Organization target of 90% despite the implementation of directly observed therapy, short-course, a physical drug monitoring system, since 1994. With increasing numbers of patients with TB in Malaysia defaulting on treatment, exploring another method to improve TB treatment adherence is vital. The use of gamification and real-time elements via video-observed therapies in mobile apps is one such method expected to induce motivation toward TB treatment adherence. OBJECTIVE: This study aimed to document the process of designing, developing, and validating the gamification, motivation, and real-time elements in the Gamified Real-time Video Observed Therapies (GRVOTS) mobile app. METHODS: The modified nominal group technique via a panel of 11 experts was used to validate the presence of the gamification and motivation elements inside the app, which were assessed based on the percentage of agreement among the experts. RESULTS: The GRVOTS mobile app, which can be used by patients, supervisors, and administrators, was successfully developed. For validation purposes, the gamification and motivation features of the app were validated as they achieved a total mean percentage of agreement of 97.95% (SD 2.51%), which was significantly higher than the minimum agreement score of 70% (P<.001). Further, each component of gamification, motivation, and technology was also rated at 70% or more. Among the gamification elements, fun received the lowest scores, possibly because the nature of serious games does not prioritize the fun element and because the perception of fun varies by personality. The least popular element in motivation was relatedness, as stigma and discrimination hinder interaction features, such as leaderboards and chats, in the mobile app. CONCLUSIONS: It has been validated that the GRVOTS mobile app contains gamification and motivation elements, which are intended to encourage medication adherence to TB treatment.

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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.

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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.

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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.

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AIM: The aim of this review is to inform the reader on the latest developments in epidemiology, diagnostics and management. EPIDEMIOLOGY: Drug-resistant Tuberculosis (DR-TB) continues to be a current global health threat, and is defined by higher morbidity and mortality, sequelae, higher cost and complexity. The WHO classifies drug-resistant TB into 5 categories: isoniazid-resistant TB, rifampicin resistant (RR)-TB and MDR-TB, (TB resistant to isoniazid and rifampicin), pre-extensively drug-resistant TB (pre-XDR-TB) which is MDR-TB with resistance to a fluoroquinolone and finally XDR-TB that is TB resistant to rifampicin, plus any fluoroquinolone, plus at least one further priority A drug (bedaquiline or linezolid). Of 500,000 estimated new cases of RR-TB in 2020, only 157 903 cases are notified. Only about a third of cases are detected and treated annually. DIAGNOSTICS: Recently newer rapid diagnostic methods like the GeneXpert, whole genome sequencing and Myc-TB offer solutions for rapid detection of resistance. TREATMENT: The availability of new TB drugs and shorter treatment regimens have been recommended for the management of DR-TB. CONCLUSION: Despite advances in diagnostics and treatments we still have to find and treat two thirds of the drug resistant cases that go undetected and therefore go untreated each year. Control of TB and elimination will only occur if cases are detected, diagnosed and treated promptly.

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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.

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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.

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BACKGROUND: The World Health Organization's End TB Strategy envisions a world free of tuberculosis (TB)-free of deaths, disease, and suffering due to TB-by 2035. Nonadherence reduces cure rates, prolongs infectiousness, and contributes to the emergence of multidrug-resistant TB (MDR-TB). Moreover, MDR-TB is a growing, complex, and costly problem that presents a major obstacle to TB control. Directly observed therapy (DOT) for treatment adherence monitoring is the recommended standard; however, it is challenging to implement at scale because it is labor-intensive. Mobile health interventions can facilitate remote adherence monitoring and minimize the costs and inconveniences associated with standard DOT. OBJECTIVE: The study aims to evaluate the effectiveness of using video directly observed therapy (VDOT) plus incentives to improve medication adherence in TB treatment versus usual-care DOT in an African context. METHODS: The DOT Selfie study is an open-label, randomized controlled trial (RCT) with 2 parallel groups, in which 144 adult patients with TB aged 18-65 years will be randomly assigned to receive the usual-care DOT monitoring or VDOT as the intervention. The intervention will consist of a smartphone app, a weekly internet subscription, translated text message reminders, and incentives for those who adhere. The participant will use a smartphone to record and send time-stamped encrypted videos showing their daily medication ingestion. This video component will directly substitute the need for daily face-to-face meetings between the health provider and patients. We hypothesize that the VDOT intervention will be more effective because it allows patients to swallow their pills anywhere, anytime. Moreover, patients will receive mobile-phone-based "social bundle" incentives to motivate adherence to continued daily submission of videos to the health system. The health providers will log into a secured computer system to verify treatment adherence, document missed doses, investigate the reasons for missed doses, and follow prespecified protocol measures to re-establish medication adherence. The primary endpoint is the adherence level as measured by the fraction of expected doses observed over the treatment period. The main secondary outcome will be time-to-treatment completion in both groups. RESULTS: This study was funded in 2019. Enrollment began in July and is expected to be completed by November 2020. Data collection and follow-up are expected to be completed by June 2021. Results from the analyses based on the primary endpoint are expected to be submitted for publication by December 2021. CONCLUSIONS: This random control trial will be among the first to evaluate the effectiveness of VDOT within an African setting. The results will provide robust scientific evidence on the implementation and adoption of mobile health (mHealth) tools, coupled with incentives to motivate TB medication adherence. If successful, VDOT will apply to other low-income settings and a range of chronic diseases with lifelong treatment, such as HIV/AIDs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04134689; http://clinicaltrials.gov/ct2/show/NCT04134689. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18029.

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BACKGROUND: Treatment of pulmonary tuberculosis (TB) requires at least six months and is compromised by poor adherence. In the directly observed therapy (DOT) scheme recommended by the World Health Organization, the patient is directly observed taking their medications at a health post. An alternative to DOT is video-observed therapy (VOT), in which the patients take videos of themselves taking the medication and the video is uploaded into the app and reviewed by a health care worker. We developed a comprehensive TB management system by using VOT that is installed as an app on the smartphones of both patients and health care workers. It was implemented into the routine TB control program of the Nanshan District of Shenzhen, China. OBJECTIVE: The aim of this study was to compare the effectiveness of VOT with that of DOT in managing the treatment of patients with pulmonary TB and to evaluate the acceptance of VOT for TB management by patients and health care workers. METHODS: Patients beginning treatment between September 2017 and August 2018 were enrolled into the VOT group and their data were compared with the retrospective data of patients who began TB treatment and were managed with routine DOT between January 2016 and August 2017. Sociodemographic characteristics, clinical features, treatment adherence, positive findings of sputum smears, reporting of side effects, time and costs of transportation, and satisfaction were compared between the 2 treatment groups. The attitudes of the health care workers toward the VOT-based system were also analyzed. RESULTS: This study included 158 patients in the retrospective DOT group and 235 patients in the VOT group. The VOT group showed a significantly higher fraction of doses observed (P<.001), less missed observed doses (P<.001), and fewer treatment discontinuations (P<.05) than the DOT group. Over 79.1% (186/235) of the VOT patients had >85% of their doses observed, while only 16.4% (26/158) of the DOT patients had >85% of their doses observed. All patients were cured without recurrences. The VOT management required significantly (P<.001) less median patient time (300 minutes vs 1240 minutes, respectively) and transportation costs (¥53 [US $7.57] vs ¥276 [US $39.43], respectively; P<.001) than DOT. Significantly more patients (191/235, 81.3%) in the VOT group preferred their treatment method compared to those on DOT (37/131, 28.2%) (P<.001), and 92% (61/66) of the health care workers thought that the VOT method was more convenient than DOT for managing patients with TB. CONCLUSIONS: Implementation of the VOT-based system into the routine program of TB management was simple and it significantly increased patient adherence to their drug regimens. Our study shows that a comprehensive VOT-based TB management represents a viable and improved evolution of DOT.

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To attain the Global End Tuberculosis (TB) goals, the treatment of persons with TB requires advancements in coordinated approaches that are low-cost and highly accessible. Treating TB successfully requires prolonged medication regimens with good adherence, which in turn requires patients to be adequately supported. Furthermore, TB care-providers often wish to monitor treatment-taking by patients in order to track the success of their programs and ensure adequate completion of therapies by individuals. The standard-of-care for treatment monitoring in TB programs often includes directly observed therapy (DOT). Video observed therapy (VOT) has emerged as a method to mimic in-person visits or observations, especially in the smartphone era with internet data connections, but remains simply inaccessible to patients in areas where TB is most endemic. Both approaches may be considered more intensive than necessary for many patients, leaving an opportunity for more affordable and acceptable approaches. The rapid increase in mobile phone penetration provides an opportunity to reach patients between clinical visits. Short message services (SMS) are available on almost every mobile phone and are supported by first generation cellular communication networks, thus providing the farthest reach and penetration globally. Evidence from non-TB conditions suggests SMS, used in a variety of ways, may support outpatients for better medication adherence and quality of care but the evidence in TB remains limited. In this paper, we discuss how basic mobile phones and SMS-related services may be used in supporting global care of persons with TB, with a focus on patient-centered approaches.

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A recent innovation to help patients adhere to daily tuberculosis (TB) treatment over many months is video (or virtually) observed therapy (VOT). VOT is becoming increasingly feasible as mobile telephone applications and tablet computers become more widely available. Studies of the effectiveness of VOT in improving TB patient outcomes are being conducted.

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