Photo: © KNCV Tuberculosis Foundation. A nurse shows a tuberculosis patient how to use medication sleeves to track his treatment in a clinic in the Philippines.
Geneva, 11 August 2021 – As the Unitaid-funded ASCENT project launches the main research phase, investigating the effectiveness of digital adherence technologies and data-driven support interventions on TB treatment completion and success rates, we asked the researchers leading the study to tell us more about their work and its potential impact.
Three digital adherence technologies – smart pillboxes, video supported treatment and medication labels or sleeves – connect patients remotely to health centres, allowing patients flexibility in their treatment while ensuring clinics can track patients’ adherence and provide tailored care where needed.
“Practical, patient-centred solutions are essential in developing public health strategies that work. Digital adherence technologies are designed to support people in taking their medication while providing information that helps healthcare workers give more tailored care. These innovations, when coupled with advances in treatment and prevention, could modernize and accelerate global efforts against TB”, said Janet Ginnard, Director of Strategy at Unitaid.
The project is piloting the use of these three technologies in five countries – the Philippines, Ukraine, South Africa, Tanzania and Ethiopia – with the aim of improving treatment success through person-centred solutions.
We spoke with lead researchers on the project, Jens Levy of the KNCV Tuberculosis Foundation, as well as Katherine Fielding and Amare Tadesse of the London School of Hygiene and Tropical Medicine (LSHTM), as they begin their research across the five countries.
Levy: “We are trying to evaluate whether facilities that utilize DATs do better in terms of treatment outcomes than facilities that do not.”
Fielding: “We keep using the word pragmatic, because this is a very important aspect of the research. The intervention is delivered by healthcare workers, rather than by a separate team of researchers. If we find the project to be successful, we will be demonstrating the success of DATs in the real world.”
Tadesse: “Countries make all kinds of efforts to align their country TB protocols and guidelines. Directly observed treatment (DOT) is most common now. That means patients have to take their medication daily at a healthcare facility or a healthcare worker visits their home every day. This has done a lot for treatment outcomes of TB patients, but not to a level that will help us achieve the National Tuberculosis Programme (NTP) strategy goals (95% reduction in TB deaths and 90% reduction in TB incidence by 2035). DOT is burdensome to both patients and the health system and is limited as a public health tool to encourage adherence to TB treatment. That is where the DATs come into the picture. DATs may make it more feasible to achieve the goals by the end of 2035.”
Levy: “In each country, the study is being conducted in a large number of healthcare facilities. In all of these countries the studies align. It is very helpful – and almost essential – to have just about identical protocols to see how the DATs work in different countries.”
What do you hope the results will show?
Levy: “We hope to show that a relatively simple technology can enhance relationships between the health care worker and the patient and make it feasible for patients to get the right amount of follow-up to keep them adherent – in a way that is not burdensome socially or financially.”
While there is existing research on DATs, the ASCENT study is different in a couple of important ways. How is this research taking an innovative approach?
Levy: “The pragmatic aspect of it is really critical. We are trying to enhance the generalizability by looking across several countries in parallel. But specifically, we’re evaluating and showing what the tool can do in the hands of healthcare workers. The other thing is that we can better and more easily look at context – to look across countries to the particular circumstances.”
Fielding: “When you’re on the research side, you have the tendency to always move away from being pragmatic. Because you’re obsessed with other aspects. We’re very pleased we held on to this pragmatic approach.”
Tadesse: “The way the project is delivered is quite critical and important. I’d also like to add that the National Tuberculosis Programmes (NTP) of each country are being involved in the implementation as well as the research. This is to reflect capacity building and promoting country ownership.”
In four of the five countries where ASCENT research is taking place, NTP members are involved as co-investigators as well as in-country investigators.
Fielding: “What’s important about what we’re doing with our study, is that healthcare workers have the possibility to look at the data in real time, immediately.”
Levy: “This gives ASCENT solidity that impacts relationships between the patient and the healthcare worker in a more productive way. It’s a little intangible to describe, but I think that that relationship is really critical to what we are evaluating.”
Photo: © KNCV Tuberculosis Foundation. A healthcare worker in Tanzania explains how to use a medication sleeve – one of three digital adherence technologies used in the ASCENT project.
What are the main challenges?
Fielding: “Covid. Across all of the counties, the frequency with which patients attend clinics has decreased. They go less often because of Covid. But also, in terms of bumps in the road, just trying to set up the project within the context of the pandemic is really tricky! A lot of the trainings have to be done either online or face to face, but with certain measures to keep everyone safe. It’s hard to get to clinics, and sometimes clinics have had to close temporarily because of Covid infections amongst healthcare workers.”
Levy: “At the same time, some countries are so eager to implement DATs, they’re willing to skip over this very essential research. We’re kind of pressured to hurry up. And then of course, in terms of challenges, we have to take ethics into account. We have to be particularly careful to what extent this type of technology may give away a patient’s TB-status to others. If people connect the dots between the smart pillbox and TB, for example, their privacy is compromised. We have at least seven different ethics boards to negotiate matters like these. But it’s definitely a challenge to make meetings happen in a timely fashion where they’re aligned.”
Tadesse: “One of the technologies that we are hoping to use, requires the patients to have access to mobile phones. In both study arms we are hoping the patients have this, because we want to send them motivational messages. It also requires a good connection to send the real-time data through the platform. That’s something to be further explored in the research.”
ASCENT is supported by a number of advisory boards to help them navigate these challenges.
Photo: © KNCV Tuberculosis Foundation. Using digital adherence technologies, patients can communicate remotely with healthcare centers via SMS.
What can this research be used for?
Fielding: “If it’s shown to be a successful intervention, that could be very beneficial for worldwide TB programmes. On top of that, the economic evaluation of the intervention will also show whether the project is cost effective. Those two points might reveal to countries you don’t need to directly observe therapy any longer. In our experience, the majority of patients adhere very well, and don’t need additional support. But this intervention can help identify those patients that need extra help for whatever reason. This might change policy of TB treatment across the world.”
Tadesse: “In terms of healthcare providers, they would have access to more reliable timely data from patients, which could help them in managing a particular patient.”
Levy: “We really expect that the lessons we learn – what works, and for whom – are important lessons that we can convey to other countries, so they can more effectively scale-up or adopt this type of technology and avoid the usual pitfalls.”
The ASCENT project is funded by Unitaid and led by the KNCV Tuberculosis Foundation in partnership with The Aurum Institute, London School of Hygiene and Tropical Medicine, and PATH. It is implemented in Ethiopia, Tanzania, Ukraine, the Philippines and South Africa, in partnership with the National TB Programmes. The project aims to contribute to developing more flexible treatment solutions and support for people in TB treatment worldwide.
Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, cheaply, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV/AIDS, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities such as cervical cancer and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator. Unitaid is hosted by the World Health Organization.
Hervé Verhoosel, Director, External Relations and Communication a.i.
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