{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T21:06:39Z","timestamp":1694120799043},"reference-count":18,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"3","license":[{"start":{"date-parts":[[2023,9,6]],"date-time":"2023-09-06T00:00:00Z","timestamp":1693958400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,9,6]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n<jats:p>In 2020, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a rapidly emerging virus causing the coronavirus disease 2019 (COVID-19) pandemic, had no known effective prophylaxis and no widely available proven effective antiviral treatment. Hydroxychloroquine\/Chloroquine was identified as an early potential therapeutic candidate drawing on evidence from reports of both in\u00a0vitro and in\u00a0vivo testing. A multicountry placebo-controlled randomized trial was set to evaluate the use of hydroxychloroquine\/chloroquine to prevent infection in healthcare workers and staff working in a health facility involved in COVID-19 management. One of the sites of this trial was in Niger. In Niger, of the 240 persons who were provided information about the study and with whom participation was discussed, only five participants provided their informed consent. In this article, we describe the key difficulties encountered in the conduct of this trial from the perspective of the site study team. Among the difficulties, we recognize that the epidemic context, controversy surrounding hydroxychloroquine, vaccine rollout, participants\u2019 perspectives, and trial design had a major impact on participation.<\/jats:p>","DOI":"10.4269\/ajtmh.22-0606","type":"journal-article","created":{"date-parts":[[2023,8,14]],"date-time":"2023-08-14T14:14:11Z","timestamp":1692022451000},"page":"511-514","source":"Crossref","is-referenced-by-count":0,"title":["Reflections on Participation in a Trial on Hydroxychloroquine as Prevention for COVID-19 among Health Workers in Niger"],"prefix":"10.4269","volume":"109","author":[{"given":"Youssouf","family":"Kabore","sequence":"first","affiliation":[{"name":"Epicentre Niger, Niamey, Niger;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Renaud","family":"Vatrinet","sequence":"additional","affiliation":[{"name":"Research Department, Epicentre Paris, Paris, France;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ousmane","family":"Guindo","sequence":"additional","affiliation":[{"name":"Epicentre Niger, Niamey, Niger;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Souleymane H.","family":"Moussa","sequence":"additional","affiliation":[{"name":"Service de Pneumologie, H\u00f4pital National Amirou Boubacar Diallo (Lamorde), Niamey, Niger;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William H. K.","family":"Schilling","sequence":"additional","affiliation":[{"name":"Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom;"},{"name":"Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rebecca F.","family":"Grais","sequence":"additional","affiliation":[{"name":"Research Department, Epicentre Paris, Paris, France;"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2795","reference":[{"key":"b1","series-title":"Cell Res","first-page":"269","article-title":"Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in\u00a0vitro","volume":"30","author":"Wang","year":"2020"},{"key":"b2","series-title":"N Engl J Med","first-page":"2030","article-title":"Effect of hydroxychloroquine in hospitalized patients with Covid-19","volume":"383","year":"2020"},{"key":"b3","series-title":"N Engl J Med","first-page":"497","article-title":"Repurposed antiviral drugs for Covid-19\u2014interim WHO Solidarity Trial results","volume":"384","year":"2021"},{"key":"b4","series-title":"Int J Rheum Dis","first-page":"613","article-title":"A systematic review of the prophylactic role of chloroquine and hydroxychloroquine in coronavirus disease-19 (COVID-19)","volume":"23","author":"Shah","year":"2020"},{"key":"b5","year":"2023"},{"key":"b6","author":"Faucon","year":"2021"},{"key":"b7","year":"2021"},{"key":"b8","year":"2021"},{"key":"b9","series-title":"Postgrad Med J","first-page":"550","article-title":"Hydroxychloroquine and COVID-19","volume":"96","author":"Sinha","year":"2020"},{"key":"b10","series-title":"Antiviral Res","first-page":"104762","article-title":"Of chloroquine and COVID-19","volume":"177","author":"Touret","year":"2020"},{"key":"b11","series-title":"Ann Pharmacother","first-page":"827","article-title":"Emergency authorization of chloroquine and hydroxychloroquine for treatment of COVID-19","volume":"54","author":"Piszczatoski","year":"2020"},{"key":"b12","series-title":"Am J Trop Med Hyg","first-page":"1184","article-title":"Chloroquine and hydroxychloroquine for the prevention or treatment of COVID-19 in Africa: caution for inappropriate off-label use in healthcare settings","volume":"102","author":"Abena","year":"2020"},{"key":"b13","series-title":"Nat Rev Genet","first-page":"496","article-title":"Benefit-sharing: a look at the history of an ethics concern","volume":"8","author":"Simm","year":"2007"},{"key":"b14","series-title":"EMBO Rep","first-page":"8","article-title":"Sharing benefits in international health research: research-capacity building as an example of an indirect collective benefit","volume":"8","author":"Schulz-Baldes","year":"2007"},{"key":"b15","series-title":"Bioethics","first-page":"476","article-title":"HIV international clinical research: exploitation and risk","volume":"19","author":"Ballantyne","year":"2005"},{"key":"b16","series-title":"Nat Rev Drug Discov","first-page":"797","article-title":"Adaptive platform trials: definition, design, conduct and reporting considerations","volume":"18","year":"2019"},{"key":"b17","series-title":"N Engl J Med","first-page":"1572","article-title":"Platform trials\u2014beware the noncomparable control group","volume":"384","author":"Dodd","year":"2021"},{"key":"b18","series-title":"F1000 Res","first-page":"1109","article-title":"Adaptive platform trials using multi-arm, multi-stage protocols: getting fast answers in pandemic settings","volume":"9","author":"Noor","year":"2020"}],"container-title":["The American Journal of Tropical Medicine and Hygiene"],"original-title":[],"link":[{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/109\/3\/article-p511.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/109\/3\/article-p511.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/109\/3\/article-p511.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,6]],"date-time":"2023-09-06T13:45:29Z","timestamp":1694007929000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/109\/3\/article-p511.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,6]]},"references-count":18,"journal-issue":{"issue":"3"},"URL":"https:\/\/doi.org\/10.4269\/ajtmh.22-0606","relation":{},"ISSN":["0002-9637","1476-1645"],"issn-type":[{"value":"0002-9637","type":"print"},{"value":"1476-1645","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,6]]}}}