O'Neill Sarah, Dierickx Susan, Okebe Joseph, Dabira Edgard, Gryseels Charlotte, d'Alessandro Umberto, Peeters Grietens Koen
Unit of Medical Anthropology, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
Amsterdam Institute of Social Science Research, University of Amsterdam, Amsterdam, The Netherlands.
PLoS One. 2016 Aug 15;11(8):e0160464. doi: 10.1371/journal.pone.0160464. eCollection 2016.
Clinical trials require high levels of participation and low drop-out rates to be successful. However, collecting blood samples from individuals recruited into clinical trials can be challenging when there is reticence about blood-taking. In addition to concerns regarding the feasibility of medical research, fears of 'blood-stealing' and 'blood-selling' have ethical implications related to cultural sensitivity and informed consent. This study explores anxieties around blood-taking during a malaria treatment trial in the Gambia.
This case study is based on ethnographic research in one theoretically selected village due to the high reticence to screening for the clinical trial 'Primaquine's gametocytocidal efficacy in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine' carried out in the Gambia between 2013 and 2014. Data collection tools included in-depth interviews, participant observation, informal conversations and group discussions.
In total only 176 of 411 habitants (42%) in the village accepted having a bloodspot taken to screen for malaria. Although trial recruitment was initially high in the village, some families refused screening when rumours started spreading that the trial team was taking too much blood. Concerns about 'loss of blood' were equated to loss of strength and lack of good food to replenish bodily forces. Families in the study village were concerned about the weakness of their body while they had to harvest their crops at the time of recruitment for the trial.
A common recommendation to prevent and avoid rumours against public health interventions and trials is the provision of full and consistent information during the consent procedure, which is assumed to lead to more accurate knowledge of the purpose of the intervention and increased trial participation. However, even when information provision is continuous, the emergence of rumours can be related to times of uncertainty and perceptions of vulnerability, which are often a reflection of structural inequalities and diverging value orientations between communities and public health institutions.
临床试验要取得成功，需要高水平的参与率和低退出率。然而，当招募到临床试验中的个体对采血有所顾虑时，采集血样可能具有挑战性。除了对医学研究可行性的担忧外，对“采血”和“卖血”的恐惧还涉及文化敏感性和知情同意方面的伦理问题。本研究探讨了在冈比亚进行的疟疾治疗试验中围绕采血的焦虑情绪。
本案例研究基于在一个理论上选定的村庄进行的人种志研究，原因是在2013年至2014年期间于冈比亚开展的“伯氨喹对接受双氢青蒿素 - 哌喹治疗的疟疾无症状携带者的配子体杀灭效果”临床试验的筛查工作遭到了很高的抵触。数据收集工具包括深度访谈、参与观察、非正式交谈和小组讨论。
该村庄411名居民中仅有176人（42%）同意采集血斑用于疟疾筛查。尽管该村庄最初参与试验招募的积极性很高，但当有谣言开始传播称试验团队采血过多时，一些家庭拒绝了筛查。对“失血”的担忧等同于力量的丧失以及缺乏补充体力的优质食物。研究村庄的家庭担心在试验招募期间他们必须收割庄稼时身体会变虚弱。
预防和避免针对公共卫生干预措施和试验的谣言的一个常见建议是在同意程序中提供全面且一致的信息，这被认为会使人们更准确地了解干预目的并提高试验参与度。然而，即便持续提供信息，谣言的出现仍可能与不确定时期以及对脆弱性的认知有关，而这往往反映了社区与公共卫生机构之间的结构性不平等和不同的价值取向。
