Overcoming COVID-19 disruptions: Innovations in product provision in a multi-national clinical trial among cisgender men, transgender men and transgender women in five countries

Abstract

Clinical trials often depend on participants receiving study product to meet objectives of the protocol. Vitally important are considerations for how sites receive and dispense study product during a study while ensuring appropriate handling, accountability and compliance. The process for provision of study product is detailed in Standard Operating Procedures (SOPs) which are adhered to by the research site throughout the trial. The COVID-19 pandemic unexpectedly affected the ability of study participants to receive study product. We report on the various methods implemented by trial sites to ensure timely provision of study product to participants during this unprecedented pandemic. In MTN-035, participants received 3 potential rectal microbicide formulations in randomized sequences to understand user preferences. Trial sites were permitted to revise dispensing methods to enable participants to continue to receive study product during COVID-19 restrictions. These actions mitigated disruption of study product administration and preserved the integrity of the trial. Out of the 78 participants expecting to receive study products on or after the onset of restrictions due to COVID-19, only four participants (5%) did not receive all three products. Adopting alternative methods to provide product to study participants in extraordinary circumstances was key to successful study completion and maintaining study integrity.