Epicentre Niger, Niamey, Niger.
Research Department, Epicentre Paris, Paris, France.
Am J Trop Med Hyg. 2023 Aug 14;109(3):511-514. doi: 10.4269/ajtmh.22-0606. Print 2023 Sep 6.
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 vitro and in vivo 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' perspectives, and trial design had a major impact on participation.
2020 年，一种迅速出现的导致 2019 年冠状病毒病（COVID-19）大流行的新型冠状病毒严重急性呼吸综合征冠状病毒 2（SARS-CoV-2），当时尚无已知有效的预防措施，也没有广泛可用的经证实有效的抗病毒治疗方法。羟氯喹/氯喹被确定为一种早期有潜力的治疗候选药物，这一结论源自体外和体内试验报告的证据。一项多国家安慰剂对照随机试验旨在评估羟氯喹/氯喹在预防医护人员和参与 COVID-19 管理的医疗机构工作人员感染方面的作用。该试验的一个地点在尼日尔。在尼日尔，有 240 人被告知了有关该研究的信息并与他们讨论了参与的问题，但只有 5 名参与者表示同意。在本文中，我们从现场研究小组的角度描述了开展这项试验所遇到的主要困难。其中包括，我们认识到疫情背景、羟氯喹的争议、疫苗的推出、参与者的观点以及试验设计都对参与度产生了重大影响。
