Trials in the time of COVID - lessons from Tanzania and Uganda
Dr Anu Garrib is Principal Research Associate at Liverpool School of Tropical Medicine (LSTM), and senior researcher at RESPOND Africa, the NIHR Global Health Group on the prevention and management of HIV and non-communicable diseases, a partnership based in the UK, Uganda and Tanzania
The past year has served as a stark reminder of the impact of the rising burden of non-communicable diseases, and has shown just how important scientific research is in a globalised world. People with underlying conditions such as diabetes, heart disease and hypertension have been disproportionately affected and at greater risk of serious illness and death than the general population if they contracted COVID. In low and middle income countries (LMICs), health systems are struggling to deliver an increasing volume and complexity of care to patients with chronic conditions.
The META Trial research team in Tanzania
As a partnership of institutions based in the UK, Uganda and Tanzania, our work is focused on developing and testing new ways of delivering care for patients with HIV and non-communicable diseases, and on preventing the onset of chronic conditions amongst high-risk groups.
We are currently conducting a number of clinical trials in sub-Saharan Africa. These include a large pragmatic trial on clinic-based integrated management for diabetes, hypertension and HIV. While a randomised placebo-controlled trial, the META Trial, is also assessing whether metformin, a common first-line drug used to treat type 2 diabetes, could prevent or delay progression to diabetes among people living with HIV at high-risk of developing diabetes.
The declaration of the COVID pandemic had an almost immediate impact on our trials, as we had to pause recruitment in both of these studies. The national lockdown in Uganda curbed movement of staff and people attending for care. In both countries we found that people were afraid to attend health facilities and many moved from urban to rural areas as they were perceived to be safer. HIV clinics moved patients to longer appointment intervals and increasing numbers of participants were missing study appointments. We struggled to source scarce PPE to keep our staff and study participants safe.
While these disruptions were frustrating for us as researchers, we knew that it was far worse for patients, who were struggling more than ever to access care and vital medication, as well as facing increased anxiety about the risk to themselves and their families from COVID.
In the META trial, the research team worked quickly to respond to changes in health facility operations, putting in place contingency plans to minimise the impact on patient safety by ensuring the risks were as low as possible during visits. For example, making increased use of outdoor space for waiting areas.
The team is well embedded in the health service and the relationships we have with policy makers, health facility managers and patients have been critical in keeping the studies going during this period - a testament to the skills and resilience of the research teams on the ground. Communication between the partners has also been key, with provision of as much support as is possible over video-conferencing!
We’ve learnt many lessons from conducting the META trial in the midst of a pandemic. Indeed we are still learning how best to empower our study participants and how to ensure the collection of high quality data in this challenging situation - learning that will hopefully continue to provide benefit long after this is over. Generating evidence through clinical trials in low and middle income countries settings is critical to addressing the challenges of non-communicable disease prevention, diagnosis and management. Without the involvement of patients, public and policy-makers in the research we would not have the learnings we have today. The greatest impact from our experience is the development of high-level skills for the conduct of clinical trials in these settings.
Find out more information about the RESPOND AFRICA group and our work.
Dr Anu Garrib is Principal Research Associate at Liverpool School of Tropical Medicine (LSTM), and senior researcher at RESPOND Africa, the NIHR Global Health Group on the prevention and management of HIV and non-communicable diseases, a partnership based in the UK, Uganda and Tanzania.
The views and opinions expressed in this blog are those of the authors and do not necessarily reflect those of the NIHR or the Department of Health and Social Care.