Wurie, Fatmatta Bintu Rakie; (2023) Studies to inform the development and practical roll-out of a digital adherence intervention, Video-Observed Therapy (VOT). Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

BACKGROUND: Prior to the COVID-19 pandemic, globally, tuberculosis (TB) was the leading cause of death from a single infectious agent. It is an important example of a curable condition which has well-documented treatment adherence challenges. WHO recommends the use of video-observed therapy (VOT) as a flexible alternative to DOT (Directly Observed Treatment). There is limited evidence of VOT’s acceptability and how it may enable patients to engage with their treatment to elicit optimal adherence outcomes. This PhD thesis aims to improve understanding of patient groups who may benefit most from VOT. METHODS: Drawing upon a narrative literature review, this PhD thesis includes: a) a study to identify factors that predict non-completion of TB treatment through a retrospective cohort analysis of cases with TB notified to the Enhanced TB Surveillance System in England, Wales and Northern Ireland between 2010 and 2017; b) a study comparing VOT to in-person DOT to examine the factors which affect the levels of engagement with DOT and VOT and whether these affect the level of treatment observation achieved in DOT and VOT groups through a secondary analysis of the UK DOT/VOT trial dataset using descriptive analysis and logistic regression; c) a qualitative study exploring the lived experiences and perspectives of DOT and VOT users in two settings, the UK and Republic of Moldova using semi-structured interviews with 16 UK DOT/VOT trial participants and 22 Moldovan DOT/VOT trial participants. Themes were mapped onto the Capability Opportunity Motivation Behaviour (COM-B) model, Theoretical Domains Framework (TDF) and Behaviour Change Wheel (BCW) to identify how the VOT and DOT functions, strategies and its policy categories elicit treatment adherence outcomes to support decision-making on commissioning of DOT and VOT interventions. RESULTS: Recent migration to the UK (0 -1 years from entry to the UK to TB notification), multidrug resistance, increasing social complexity and a previous TB diagnosis were significantly associated with non-completion of TB treatment. Higher levels of initial engagement with VOT (90% initially engaged) rather than DOT (49% initially engaged) were observed amongst all patient groups. Amongst those who initially engaged with either DOT or VOT, patients with TB on VOT had improved TB treatment adherence compared those on DOT. Women were less likely to adhere and those with a history of being lost to follow-up were also less likely to adhere. The COM-B model and TDF provided explanatory frameworks highlighting how VOT acted on key behaviour change domains and utilised key strategies to facilitate adherence behaviour change. VOT facilitated patient-provider interactions served as a prompt/reminder to address forgetfulness through regular personalised messages from VOT observers, building rapport and habit-forming practices. VOT was a flexible, time- and cost-saving alternative to DOT and supported patients with split dosing or negotiated timing of dosing to manage side effects and pill burden. VOT also served as an incentive through the provision of a smartphone and data plan, free domestic calls, text messages and internet access linking patients to providers, banking and social support services. In turn these ‘capability and ‘opportunity’ components of the model enhanced ‘motivation’ by supporting patients to re-gain autonomy, self-responsibility and establish regular dosing. There were mixed views on privacy with participants expressing concerns on how video clips would be used, shared and may compromise confidentiality and increase stigma. The Behaviour Change Wheel identified seven key functions (‘active ingredients’) of VOT: Enablement (increasing means/reducing barriers to increase capability), Education (increasing knowledge or understanding), Persuasion (using communication to induce positive or negative feelings or stimulate action), Training (imparting skills), Incentivisation (creating expectation of reward), Restriction (using rules to reduce opportunity to engage in target behaviour) and Environmental restructuring (changing the physical or social context). While participants on DOT felt cared for, they had doubts about their personal necessity for treatment, found DOT invasive and stigmatising, time-consuming and costly. At a health system level, DOT was resource-intensive and batch collections of medicines made it difficult to prove fidelity. CONCLUSION: VOT promotes engagement and adherence to TB treatment in all groups at risk of non-adherence, which suggest it is a more acceptable approach to TB treatment observation compared to DOT. VOT can be universally applied to all patient groups in need of adherence support, including inclusion health groups (those with a current or history of homelessness, imprisonment, drug misuse and current alcohol misuse, vulnerable migrant groups (asylum seekers and refugees), in low TB incidence settings. DOT is an acceptable intervention to some groups with multiple needs (participants who were aged over 55, had a prison history, a history of homelessness (more than 5 years ago) and those with current alcohol problems). The evidence from this research could be used to develop a personalised decision support tool to support clinicians to offer VOT to groups based on risk of poor adherence and quantitative and qualitative assessment of acceptability and engagement. Use of the e-Health Implementation Toolkit (e-HIT) supports the national and practical roll-out of VOT to all patient groups in need of adherence support, including those with social complexity. In the era of COVID-19 and acceleration of the use of digital innovations, monitoring the roll-out of VOT should also involve engagement with patients on privacy and confidentiality issues. Engagement with the TB workforce is needed to examine staff attitudes to support learning on what adaptations could be made to VOT and to inform their needs and health system readiness, strengthen health protection and global health security. Further engagement with healthcare professionals to secure their buy-in, address their concerns and to minimise “technology fatigue” is needed. VOT has shown that it improves treatment adherence and while trials are yet to provide convincing evidence to data that it enhances final outcomes, the technology itself does have the potential to reduce treatment-related costs at a patient and health service level. In 2020 WHO proposed VOT as one of the options to support adherence in its target product profiles for TB preventative treatment. Further real-world programmatic evidence on how VOT works and health system cost-effectiveness should continue to be conducted under different conditions of care, including in different geographical settings, patient sub-groups and at different stages of treatment. FUNDING: UCL discretionary funds, Royal Society of Tropical Medicine and Hygiene and UCL Public Policy small grant awards

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