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

Carlo Perrone; William Schilling; James J Callery; Elizabeth A Ashley; Mary Chambers; Hannah Chase; Piyush Dahal; Nipaphan Kanthawang; Supalert Nedsuwan; Borimas Hanboonkunupakarn; Daranee Intralawan; Abhilasha Karkey; Mayfong Mayxay; Vimalay Souvong; Hien Tran Minh; Summita Udas Shakya; Sanjib Kumar Sharma; Surendra Uranw; Souphaphone Vannachione; Charles Woodrow; Nicholas J White; Phaik Yeong Cheah

doi:10.12688/wellcomeopenres.16880.3

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

Wellcome Open Res. 2022 Dec 1:6:216. doi: 10.12688/wellcomeopenres.16880.3. eCollection 2021.

Authors

Carlo Perrone^{1

2}, William Schilling^{1

2}, James J Callery^{1

2}, Elizabeth A Ashley^{2

3}, Mary Chambers^{2

4}, Hannah Chase⁵, Piyush Dahal⁶, Nipaphan Kanthawang¹, Supalert Nedsuwan⁷, Borimas Hanboonkunupakarn^{1

8}, Daranee Intralawan⁷, Abhilasha Karkey⁹, Mayfong Mayxay^{2

3

10}, Vimalay Souvong³, Hien Tran Minh⁴, Summita Udas Shakya⁹, Sanjib Kumar Sharma¹¹, Surendra Uranw¹¹, Souphaphone Vannachione³, Charles Woodrow^{2

12}, Nicholas J White^{1

2}, Phaik Yeong Cheah^{1

2

13}

Affiliations

¹ Mahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, Thailand.
² Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
³ Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Vientiane, Lao People's Democratic Republic.
⁴ Oxford University Clinical Research Unit (OUCRU), Ho Chi Minh city, Vietnam.
⁵ Medical Sciences Divisional Office, University of Oxford, Oxford, UK.
⁶ KHDC Program, B.P. Koirala Institute of Health Sciences, Dharan, Nepal.
⁷ Primary Care Department, Chiangrai Prachanukroh Hospital, Chiang Rai, Thailand.
⁸ Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
⁹ Oxford University Clinical Research Unit (OUCRU-Nepal), Patan Hospital,, Kathmandu, Nepal.
¹⁰ University of Health Sciences in Lao P.D.R., Vientiane, Lao People's Democratic Republic.
¹¹ Department of Internal Medicine, B.P. Koirala Institute of Health Sciences, Dharan, Nepal.
¹² John Radcliffe Hospital, Oxford, UK.
¹³ The Ethox Centre, University of Exford, Oxford, UK.

Abstract

Background: 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. Methods: 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&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. Results and conclusions: From 16 ^th March 2020 to 20 ^th January 2021, 12 engagement sessions were conducted in Thailand, Laos, Vietnam, Nepal and the UK involving 213 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.

Keywords: Coronavirus Disease 2019 (COVID-19); Good participatory practice; bioethics; clinical trials; prevention; public engagement.

Grants and funding

The COPCOV study and the related engagement activities are funded by the COVID-19 Therapeutics Accelerator. The Mahidol Oxford Tropical Medicine Research Unit is core funded by the Wellcome Trust [grant number 221307].