Département Biomédical et Santé Publique, Groupe de Recherche Action en Sante (GRAS), Ouagadougou, Burkina Faso
Access and Product Management, Medecine for Malaria Venture, Geneva, Switzerland.
BMJ Open. 2021 Feb 15;11(2):e040220. doi: 10.1136/bmjopen-2020-040220.
As demonstrated in mathematical models, the simultaneous deployment of multiple first-line therapies (MFT) for uncomplicated malaria, using artemisinin-based combination therapies (ACTs), may extend the useful therapeutic life of the current ACTs. This is possible by reducing drug pressure and slowing the spread of resistance without putting patients' life at risk. We hypothesised that a simultaneous deployment of three different ACTs is feasible, acceptable and can achieve high coverage rate if potential barriers are properly identified and addressed.
We plan to conduct a quasi-experimental study in the Kaya health district in Burkina Faso. We will investigate a simultaneous deployment of three ACTs, artemether-lumefantrine, pyronaridine-artesunate, dihydroartesinin-piperaquine, targeting three segments of the population: pregnant women, children under five and individuals aged five years and above. The study will include four overlapping phases: the formative phase, the MFT deployment phase, the monitoring and evaluation phase and the post-evaluation phase. The formative phase will help generate baseline information and develop MFT deployment tools. It will be followed by the MFT deployment phase in the study area. The monitoring and evaluation phase will be conducted as the deployment of MFT progresses. Cross-sectional surveys including desk reviews as well as qualitative and quantitative research methods will be used to assess the study outcomes. Quantitatives study outcomes will be measured using univariate, bivariate and multivariate analysis, including logistic regression and interrupted time series analysis approach. Content analysis will be performed on the qualitative data.
The Health Research Ethics Committee in Burkina Faso approved the study (Clearance no. 2018-8-113). Study findings will be disseminated through feedback meetings with local communities, national workshops, oral presentations at congresses, seminars and publications in peer-reviewed scientific journals.
NCT04265573.
数学模型表明，通过使用青蒿素类复方疗法（ACT），同时部署多种一线疗法（MFT）治疗无并发症疟疾，可以延长当前 ACT 的有效治疗寿命。这是通过降低药物压力和减缓耐药性传播来实现的，而不会使患者的生命处于危险之中。我们假设，如果能够正确识别和解决潜在的障碍，同时部署三种不同的 ACT 是可行的、可以接受的，并且可以实现高覆盖率。
我们计划在布基纳法索的卡亚卫生区进行一项准实验研究。我们将调查同时部署三种 ACT（青蒿琥酯-咯萘啶、氨酚喹啉-青蒿琥酯、二氢青蒿素-哌喹），针对三个人群段：孕妇、五岁以下儿童和五岁及以上个体。该研究将包括四个重叠阶段：形成阶段、MFT 部署阶段、监测和评估阶段以及后评估阶段。形成阶段将有助于生成基线信息并开发 MFT 部署工具。随后将在研究区域内进行 MFT 部署阶段。随着 MFT 的部署，监测和评估阶段将进行。将使用横断面调查，包括桌面审查以及定性和定量研究方法，来评估研究结果。定量研究结果将使用单变量、双变量和多变量分析进行测量，包括逻辑回归和中断时间序列分析方法。定性数据将进行内容分析。
布基纳法索的卫生研究伦理委员会批准了这项研究（批准号：2018-8-113）。研究结果将通过与当地社区的反馈会议、国家研讨会、大会口头报告、研讨会和在同行评议的科学期刊上发表来传播。
NCT04265573。
