COVID-19 restrictions
deaths, patients•
RECRUITMENT
Conducted at the height of the pandemic, 687,511 COVID-19 cases and 14,696 deaths were recorded across Gauteng province over the study duration [In the context of COVID-19, “alert levels” refer to a system used by governments or health authorities to categorise the severity of the COVID-19 pandemic and guide public health responses. In South Africa, five alert levels were defined, though specific restrictions varied within each level based on experience and what was politically acceptable (Table Summary of COVID-19 alert levels in South Africa [Operational impact of COVID-19 on clinical trials conduct• Existing workspaces and shared office zones enlarged to accommodate social distancing• Physical barriers set up between colleagues and patients• Separate isolation areas with a new entrance built to accommodate patients under investigation• Additional staff required, or current staff took on an additional role, for screening procedures at entrance• PPE was procured urgently for all staff• Staff training amidst rapidly evolving guidelines was challenging, especially for non-clinical team members• Taxi companies contracted to ensure staff could safely get to site during lockdown• Hybrid work arrangements were implemented• Site initiation visits and meetings were held virtually• Regulatory authorities and ethical body approval process were expedited with electronic submissions• Use of e-consent procedures• Community healthcare worker engagement became intensive and indispensable to drive recruitment and ensure retention• New logistical consideration of providing transport for those reliant on public transport translated to hiring drivers and rental cars• Fully equipped mobile vans were deployed into communities to minimise the number of patients being seen on site• Introduction of telemedicine and trial-specific smart phone apps, which is unfamiliar for many South African healthcare workers who are accustomed to in-person consultations• Training and support for patients on completing and reporting study assessments from home• Remote monitoring became more prevalent• On-site monitoring visits were often postponed, leading to the possibility of delayed recognition of areas requiring improvement