Good participatory practice for coronavirus disease 2019 (COVID-19) research: the case of a COVID-19 prevention study

<ns4:p><ns4:bold>Background: </ns4:bold>The COPCOV study (chloroquine/ hydroxychloroquine prevention of coronavirus disease), which started recruitment in April 2020, is a multi-country double-blind, randomised, placebo-controlled trial which is being conducted in healthcare facilities involved in COVID-19 case management. Participants are staff employed in facilities managing people with proven or suspected COVID-19. As part of the study, we conducted a series of engagement sessions. The aims were to assess the feasibility of the study, to identify context-specific ethical issues, to understand possible concerns, to fine tune research procedures and to refine the COPCOV information materials.</ns4:p><ns4:p> <ns4:bold>Methods:</ns4:bold> The COPCOV study was approved by relevant institutional review boards. The sessions described in this paper were part of the study. We conducted a series of engagement sessions, each involving a short presentation of the study, a section where attendees were asked to express their willingness to participate in such a study, which information they would need to change their view and an open Q&amp;A section. Answers were transcribed and coded into themes by two independent investigators. Themes were derived from the data. They complemented other site-specific engagement, communication, and public relation activities such as press releases and websites.</ns4:p><ns4:p> <ns4:bold>Results and conclusions:</ns4:bold> From 16 <ns4:sup>th</ns4:sup> March 2020 to 20 <ns4:sup>th</ns4:sup> January 2021, 13 engagement sessions were conducted in Thailand, Laos, Vietnam, Nepal and the UK involving 222 attendees in total. Issues raised revolved around the social value and study rationale; safety of trial medications and risk-benefit balance; study design and commitments. These sessions helped us identify concerns people had, which helped us refine information materials as well as complement site feasibility assessments. Our experience strongly supports the use of participatory practices prior to conducting clinical trials.</ns4:p>