Angwenyi Vibian, Asante Kwaku-Poku, Traoré Abdoulaye, Febir Lawrence Gyabaa, Tawiah Charlotte, Kwarteng Anthony, Ouédraogo Alphonse, Sirima Sodiomon Bienvenue, Owusu-Agyei Seth, Imoukhuede Egeruan Babatunde, Webster Jayne, Chandramohan Daniel, Molyneux Sassy, Jones Caroline
Department of Public Health Research, KEMRI/Wellcome Trust Research Programme (KWTRP), P.O. Box, 230-80108, Kilifi, Kenya.
Kintampo Health Research Centre (KHRC), P.O. Box 200, Kintampo, Ghana.
PLoS One. 2015 May 1;10(5):e0124554. doi: 10.1371/journal.pone.0124554. eCollection 2015.
Clinical trials conducted in Africa often require substantial investments to support trial centres and public health facilities. Trial resources could potentially generate benefits for routine health service delivery but may have unintended consequences. Strengthening ethical practice requires understanding the potential effects of trial inputs on the perceptions and practices of routine health care providers. This study explores the influence of malaria vaccine trials on health service delivery in Ghana, Kenya and Burkina Faso.
We conducted: audits of trial inputs in 10 trial facilities and among 144 health workers; individual interviews with frontline providers (n=99) and health managers (n=14); and group discussions with fieldworkers (n=9 discussions). Descriptive summaries were generated from audit data. Qualitative data were analysed using a framework approach.
Facilities involved in trials benefited from infrastructure and equipment upgrades, support with essential drugs, access to trial vehicles, and placement of additional qualified trial staff. Qualified trial staff in facilities were often seen as role models by their colleagues; assisting with supportive supervision and reducing facility workload. Some facility staff in place before the trial also received formal training and salary top-ups from the trials. However, differential access to support caused dissatisfaction, and some interviewees expressed concerns about what would happen at the end of the trial once financial and supervisory support was removed.
Clinical trials function as short-term complex health service delivery interventions in the facilities in which they are based. They have the potential to both benefit facilities, staff and communities through providing the supportive environment required for improvements in routine care, but they can also generate dissatisfaction, relationship challenges and demoralisation among staff. Minimising trial related harm and maximising benefits requires careful planning and engagement of key actors at the outset of trials, throughout the trial and on its' completion.
在非洲开展的临床试验通常需要大量投资来支持试验中心和公共卫生设施。试验资源有可能为常规卫生服务带来益处，但也可能产生意想不到的后果。加强道德实践需要了解试验投入对常规医疗服务提供者观念和实践的潜在影响。本研究探讨了疟疾疫苗试验对加纳、肯尼亚和布基纳法索卫生服务提供的影响。
我们开展了以下工作：对10个试验设施和144名卫生工作者的试验投入进行审计；对一线提供者（n = 99）和卫生管理人员（n = 14）进行个人访谈；与现场工作人员进行小组讨论（n = 9次讨论）。从审计数据中生成描述性总结。采用框架法对定性数据进行分析。
参与试验的设施受益于基础设施和设备升级、基本药物支持、试验车辆的使用以及额外合格试验人员的配备。设施中的合格试验人员常被同事视为榜样，协助进行支持性监督并减轻设施工作量。一些在试验前就在位的设施工作人员也从试验中获得了正规培训和薪资补贴。然而，支持的差异获取导致了不满，一些受访者对试验结束后一旦财政和监督支持取消会发生什么表示担忧。
临床试验在其所在设施中作为短期复杂的卫生服务提供干预措施发挥作用。它们有可能通过提供改善常规护理所需的支持性环境，使设施、工作人员和社区受益，但也可能在工作人员中产生不满、关系挑战和士气低落的情况。将试验相关危害降至最低并使益处最大化需要在试验开始时、整个试验过程及其结束时，关键行为者进行仔细规划和参与。
