Good participatory practice for coronavirus disease 2019 (COVID-19) research: the case of a COVID-19 prevention study [version 3; peer review: 2 approved, 1 approved with reservations]
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. Par...
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| Format: | Article |
| Language: | English |
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Wellcome
2022-12-01
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| Series: | Wellcome Open Research |
| Subjects: | |
| Online Access: | https://wellcomeopenresearch.org/articles/6-216/v3 |
| _version_ | 1811170574812053504 |
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| author | Borimas Hanboonkunupakarn Mayfong Mayxay Carlo Perrone Elizabeth A. Ashley Hannah Chase Nicholas J. White William Schilling Nipaphan Kanthawang Piyush Dahal Daranee Intralawan Supalert Nedsuwan Vimalay Souvong Abhilasha Karkey Summita Udas Shakya Phaik Yeong Cheah Hien Tran Minh Surendra Uranw James J. Callery Sanjib Kumar Sharma Charles Woodrow Souphaphone Vannachione Mary Chambers |
| author_facet | Borimas Hanboonkunupakarn Mayfong Mayxay Carlo Perrone Elizabeth A. Ashley Hannah Chase Nicholas J. White William Schilling Nipaphan Kanthawang Piyush Dahal Daranee Intralawan Supalert Nedsuwan Vimalay Souvong Abhilasha Karkey Summita Udas Shakya Phaik Yeong Cheah Hien Tran Minh Surendra Uranw James J. Callery Sanjib Kumar Sharma Charles Woodrow Souphaphone Vannachione Mary Chambers |
| author_sort | Borimas Hanboonkunupakarn |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-10T17:00:00Z |
| format | Article |
| id | doaj.art-c33fe5a3aefb44518987a81a48148b4d |
| institution | Directory Open Access Journal |
| issn | 2398-502X |
| language | English |
| last_indexed | 2024-04-10T17:00:00Z |
| publishDate | 2022-12-01 |
| publisher | Wellcome |
| record_format | Article |
| series | Wellcome Open Research |
| spelling | doaj.art-c33fe5a3aefb44518987a81a48148b4d2023-02-07T01:00:00ZengWellcomeWellcome Open Research2398-502X2022-12-01620526Good participatory practice for coronavirus disease 2019 (COVID-19) research: the case of a COVID-19 prevention study [version 3; peer review: 2 approved, 1 approved with reservations]Borimas Hanboonkunupakarn0Mayfong Mayxay1https://orcid.org/0000-0002-6056-4516Carlo Perrone2https://orcid.org/0000-0001-9499-0399Elizabeth A. Ashley3https://orcid.org/0000-0002-7620-4822Hannah Chase4https://orcid.org/0000-0002-9858-159XNicholas J. White5https://orcid.org/0000-0002-1897-1978William Schilling6https://orcid.org/0000-0002-6328-8748Nipaphan Kanthawang7Piyush Dahal8Daranee Intralawan9Supalert Nedsuwan10Vimalay Souvong11Abhilasha Karkey12https://orcid.org/0000-0002-5179-650XSummita Udas Shakya13https://orcid.org/0000-0001-7717-7881Phaik Yeong Cheah14https://orcid.org/0000-0001-6327-3266Hien Tran Minh15Surendra Uranw16https://orcid.org/0000-0002-1471-8318James J. Callery17https://orcid.org/0000-0002-3218-2166Sanjib Kumar Sharma18https://orcid.org/0000-0002-8392-8028Charles Woodrow19https://orcid.org/0000-0002-5134-7165Souphaphone Vannachione20Mary Chambers21https://orcid.org/0000-0003-0535-3895Mahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, ThailandCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UKMahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, ThailandCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UKMedical Sciences Divisional Office, University of Oxford, Oxford, UKMahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, ThailandKHDC Program, B.P. Koirala Institute of Health Sciences, Dharan, NepalPrimary Care Department, Chiangrai Prachanukroh Hospital, Chiang Rai, ThailandPrimary Care Department, Chiangrai Prachanukroh Hospital, Chiang Rai, ThailandLao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Vientiane, Lao People's Democratic RepublicOxford University Clinical Research Unit (OUCRU-Nepal), Patan Hospital,, Kathmandu, NepalOxford University Clinical Research Unit (OUCRU-Nepal), Patan Hospital,, Kathmandu, NepalMahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, ThailandOxford University Clinical Research Unit (OUCRU), Ho Chi Minh city, VietnamDepartment of Internal Medicine, B.P. Koirala Institute of Health Sciences, Dharan, NepalMahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, ThailandDepartment of Internal Medicine, B.P. Koirala Institute of Health Sciences, Dharan, NepalCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UKLao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Vientiane, Lao People's Democratic RepublicCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UKBackground: 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.https://wellcomeopenresearch.org/articles/6-216/v3Good participatory practice public engagement Coronavirus Disease 2019 (COVID-19) prevention clinical trials bioethicseng |
| spellingShingle | Borimas Hanboonkunupakarn Mayfong Mayxay Carlo Perrone Elizabeth A. Ashley Hannah Chase Nicholas J. White William Schilling Nipaphan Kanthawang Piyush Dahal Daranee Intralawan Supalert Nedsuwan Vimalay Souvong Abhilasha Karkey Summita Udas Shakya Phaik Yeong Cheah Hien Tran Minh Surendra Uranw James J. Callery Sanjib Kumar Sharma Charles Woodrow Souphaphone Vannachione Mary Chambers Good participatory practice for coronavirus disease 2019 (COVID-19) research: the case of a COVID-19 prevention study [version 3; peer review: 2 approved, 1 approved with reservations] Wellcome Open Research Good participatory practice public engagement Coronavirus Disease 2019 (COVID-19) prevention clinical trials bioethics eng |
| title | Good participatory practice for coronavirus disease 2019 (COVID-19) research: the case of a COVID-19 prevention study [version 3; peer review: 2 approved, 1 approved with reservations] |
| title_full | Good participatory practice for coronavirus disease 2019 (COVID-19) research: the case of a COVID-19 prevention study [version 3; peer review: 2 approved, 1 approved with reservations] |
| title_fullStr | Good participatory practice for coronavirus disease 2019 (COVID-19) research: the case of a COVID-19 prevention study [version 3; peer review: 2 approved, 1 approved with reservations] |
| title_full_unstemmed | Good participatory practice for coronavirus disease 2019 (COVID-19) research: the case of a COVID-19 prevention study [version 3; peer review: 2 approved, 1 approved with reservations] |
| title_short | Good participatory practice for coronavirus disease 2019 (COVID-19) research: the case of a COVID-19 prevention study [version 3; peer review: 2 approved, 1 approved with reservations] |
| title_sort | good participatory practice for coronavirus disease 2019 covid 19 research the case of a covid 19 prevention study version 3 peer review 2 approved 1 approved with reservations |
| topic | Good participatory practice public engagement Coronavirus Disease 2019 (COVID-19) prevention clinical trials bioethics eng |
| url | https://wellcomeopenresearch.org/articles/6-216/v3 |
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