Study procedures
SEPARATION, RECRUITMENT
Strict lockdown regulations and the need to protect staff and patients required radical and innovative measures. Infrastructure had to be modified, for example, separate isolation areas with a new entrance were built to accommodate patients under investigation for COVID-19. Screening and enrolment procedures were transferred from the study site to fully equipped clinic vans that could travel into communities, minimising the number of symptomatic patients seen on site. Concurrent clinical trials including immunocompromised patients were being conducted at the participating health facilities, so ensuring separation of suspected COVID-19 cases was imperative. Study personnel wore PPE during all interactions, and patients and study personnel were instructed to adhere to COVID-19-related safety measures, and the need to quarantine as per the current guidance.Patients provided consent electronically, which was a new approach to use technology to address ethical obligations given the limits on in-person consultation. The process was compliant with regulatory requirements and provided seamless documentation through the enrolment process, allowing access to consent status while protecting patient’s personalised data.A key innovation was that patients were trained and supported to conduct follow-up assessments independently by providing them with a password-protected and secure data collection tool, installed on their phones. This allowed participants to log in with details unique to them and perform self-assessments, including vital signs, oxygen saturation, and health surveys, minimising the need for travel and clinic visits. Where necessary, COVID-compliant transport to the clinic was provided, and patients were loaned the tools to complete online assessments. However, there were some issues in collecting information as patients did not always have sufficient electronic data capacity to upload the results.Telemedicine is rarely available in African countries [The package of risk mitigation strategies was shown to be robust during civil unrest in July 2021. Although recruitment was paused, other study activities progressed fluidly while ensuring patients and research staff were safe. Although necessary in the context of the pandemic, such adaptations can be applied to any trial where reducing the need for clinic visits would be safe and more convenient for patients. Extensions of this approach include patients receiving automatic notifications for follow up visits, the use of apps for patients to collect data, and an online booking system for patients to book follow-up visits or transport, etc. Such measures would further reduce the burden on clinical trial staff and provide patients with additional flexibility, control, and agency.