Clinical research on COVID-19: perceptions and barriers to participation in The Gambia.
Clinical research on COVID-19: perceptions and barriers to participation in The Gambia.
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DOI：
10.1136/bmjgh-2021-007533
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发表时间：
2022-03
影响因子：
8.1
通讯作者：
Martinez-Alvarez M
中科院分区：
文献类型：
--
作者：
Diallo BA;Usuf E;Ceesay O;D'Alessandro U;Roca A;Martinez-Alvarez M
由于需要快速确定安全有效的COVID-19药物疗法，因此实施了多项临床试验，以研究潜在的治疗方案。这些都是在前所未有的研究环境中进行的，而且速度比以往任何时候都快。目前尚不清楚西非社区如何看待这些活动，以及这些看法如何影响参与COVID-19临床试验。这项定性研究旨在评估冈比亚预防和治疗COVID-19临床试验的可接受程度，并确定更好地吸引社区参与此类试验的策略。数据收集使用数字记录的半结构化访谈（SSI）和焦点小组讨论（FGD）在布里卡马和卡尼芬地方政府领域。这是冈比亚人口最稠密的两个行政分区，临床试验将由MRC冈比亚单位实施。26名男性和22名女性，年龄在19至70岁之间，具有不同的社会经济背景，参加了8个FGD（n = 36）和12个SSI（n = 12）。采用专题分析法对数据进行分析。对COVID-19患者污名化的恐惧是大多数FGD和SSI反复出现的主题，这对接受COVID-19检测和家访以随访COVID-19患者及其家庭接触者的意愿产生了不利影响。保护入组研究的个人隐私是潜在增加试验参与的关键。对实施机构的信任及其公认的专业知识是接受患者及其密切接触者接受研究药物给药的促进因素。COVID-19是一种耻辱性疾病。通过与社区成员的持续接触来发展研究参与者的合作对于成功招募COVID-19临床试验至关重要。执行机构的信任和公认的专门知识是促进这种合作的关键因素。
The need to rapidly identify safe and efficacious drug therapies for COVID-19 has resulted in the implementation of multiple clinical trials investigating potential treatment options. These are being undertaken in an unprecedented research environment and at a higher speed than ever before. It is unclear how West African communities perceive such activities and how such perceptions influence participation in COVID-19 clinical trials. This qualitative study was conducted to assess the level of acceptability of a clinical trial on the prevention and treatment of COVID-19 in The Gambia and identify strategies to better engage communities in participating in such a trial. Data were collected using digitally recorded semistructured interviews (SSIs) and focus group discussions (FGDs) in Brikama and Kanifing local government areas. These are two of the most densely populated administrative subdivisions in The Gambia, where the clinical trial was to be implemented by the MRC Unit The Gambia. 26 men and 22 women aged between 19 and 70 years, with diverse socioeconomic profiles, participated in 8 FGDs (n=36) and 12 SSIs (n=12). Thematic analysis was used to analyse the data. Fear of stigmatisation of patients with COVID-19 was a recurring theme in most FGDs and SSIs, with detrimental effects on willingness to accept COVID-19 testing and home visits to follow up patients with COVID-19 and their household contacts. Preserving the privacy of individuals enrolled in the study was key to potentially increase trial participation. Trust in the implementing institution and its acknowledged expertise were facilitators to accepting the administration of investigational products to sick individuals and their close contacts. COVID-19 is a stigmatising disease. Developing a research–participant collaboration through an ongoing engagement with community members is crucial to a successful enrolment in COVID-19 clinical trials. Trust and acknowledged expertise of the implementing institution are key facilitators to foster such collaboration.
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