Development and implementation of COVID-19 safety protocols for conducting a randomized trial in global mental...

The COVID-19 pandemic impacted ongoing clinical trials globally resulting in the suspension, cancellation or transition to entirely remote implementation of studies. In India, the first countrywide lockdown was imposed in phases starting from March 2020 to June 2020, followed by a continued restriction on in-person activities including study procedures, which halted the ESSENCE (Enabling translation of Science to Service to ENhance Depression CarE) trial activities such as recruitment, consenting, baseline assessment, digital training orientation, face to face training and end-line assessment evaluation. This situation made it imperative to amend procedures in order to mitigate the risk and address safety requirements for participants and the research team. This paper summarizes the need, development and implementation of the protocols focused on risk reduction and safety enhancement with an objective to resume and continue the research activities while ensuring the safety of study participants and research staff. These protocols are comprised of guidelines and recommendations based on existing literature tailored according to different components in each arm of the trial such as guidelines for supervisors, travellers, training/recruitment venue safety procedures, individual safety procedures; and procedures to implement the study activities. These protocols can be adapted by researchers in other settings to conduct research trials during pandemics such as COVID-19.