Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya
Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya
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DOI：
10.1186/1745-6215-15-65
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发表时间：
2014-02-25
期刊：
影响因子：
2.5
通讯作者：
Molyneux, Sassy
中科院分区：
文献类型：
--
作者：
Angwenyi, Vibian;Kamuya, Dorcas;Molyneux, Sassy
背景：社区参与(CE)在资源匮乏的环境中进行的生物医学研究日益受到推动，既有内在的目的，也有工具的目的。考虑到CE的潜在重要性，但也考虑到复杂性和可能出现意想不到的负面结果，有必要在实践中更多地记录CE过程。我们分享了在肯尼亚Kilifi县的三个地点进行的儿科随机对照疟疾疫苗试验的正式CE的经验。方法：独立于试验的社会科学家对试验研究人员(n=5)、社区领袖(n=8)和父母(15名有登记的儿童和4名没有登记的儿童)进行了深入的个人访谈；与现场工作人员(n=6)和设施工作人员(n=2)进行了小组讨论。我们对参与调查的家庭(n=200)进行了调查，并观察了150多项CE活动。结果：三个研究站点的整体CE计划相似，尽管C站点的社区信息较少。大多数人认为CE活动是为了消除先前存在的担忧和误解；增加对试验人员的可见度、意识和信任。挑战包括：一些社区领袖试图向人们施加压力，要求人们登记；信息单和同意书中的当地措辞加剧了对审判的严重担忧；以及对行政长官随着时间的推移而减少的担忧。这些挑战的负面影响通过改变正在进行的CE活动，以及由训练有素的临床工作人员单独进行最终信息共享和同意来缓解。登记一年后，31%(n=62)的受试者父母将预防疟疾作为其子女参与活动的主要目标，93%的受试者希望他们的孩子继续参与。结论：试验组对CE的目标从一开始就比较明确。其他行为者的希望和期望(如更高的津贴和未来的就业)没有公开讨论，但在参与过程中出现了。鼓励从一开始就公开讨论所有行为者的意图和目标需要时间，有可能提高无法实现的期望，而且是复杂的。然而，在未来的类似试验中这样做可能会使这里的成功建立在基础上，并将一些挑战降至最低或避免。
Background: Community engagement (CE) is increasingly promoted for biomedical research conducted in resource poor settings for both intrinsic and instrumental purposes. Given the potential importance of CE, but also complexities and possibility of unexpected negative outcomes, there is need for more documentation of CE processes in practice. We share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County, Kenya.Methods: Social scientists independent of the trial held in-depth individual interviews with trial researchers (n = 5), community leaders (n = 8) and parents (15 with enrolled children and 4 without); and group discussions with fieldworkers (n = 6) and facility staff (n = 2). We conducted a survey of participating households (n = 200) and observed over 150 CE activities.Results: The overall CE plan was similar across the three study sites, although less community-based information in site C. Majority perceived CE activities to clear pre-existing concerns and misconceptions; increase visibility, awareness of and trust in trial staff. Challenges included: some community leaders attempting to exert pressure on people to enrol; local wording in information sheets and consent forms feeding into serious anxieties about the trial; and concerns about reduced CE over time. Negative effects of these challenges were mitigated through changes to on-going CE activities, and final information sharing and consent being conducted individually by trained clinical staff. One year after enrolment, 31% (n = 62) of participants' parents reported malaria prevention as the main aim of the activities their children were involved in, and 93% wanted their children to remain involved.Conclusion: The trial teams' goals for CE were relatively clear from the outset. Other actors' hopes and expectations (like higher allowances and future employment) were not openly discussed, but emerged over the course of engagements. Encouraging open discussion of all actors' intentions and goals from the outset takes time, risks raising expectations that cannot be met, and is complex. However, doing so in future similar trials may allow successes here to be built upon, and some challenges minimized or avoided.