Malaria accounts for over half a million child deaths annually. WHO recommends RTS,S/AS01 to prevent malaria in children living in moderate-to-high malaria transmission regions. We conducted a qualitative longitudinal study to investigate the contextual and dynamic factors shaping vaccine delivery and uptake during a pilot introduction in western Kenya. The study was conducted between Oct 3, 2019, and Mar 24, 2022. We conducted participant and non-participant observations and in-depth interviews with health-care providers, health managers, and national policymakers at three timepoints using an iterative approach and observations of practices and processes of malaria vaccine delivery. Transcripts were coded by content analysis using the consolidated framework for implementation research, to which emerging themes were added deductively and categorised into challenges and opportunities. We conducted 112 in-depth interviews with 60 participants (25 health-care providers, 27 managers, and eight policy makers). Health-care providers highlighted limitations in RTS,S/AS01 integration into routine immunisation services due to the concurrent pilot evaluation and temporary adaptations for health reporting. Initial challenges related to the complexity of the four-dose schedule (up to 24-months); however, self-efficacy increased over time as the health-care providers gained experience in vaccine delivery. Low uptake of the fourth dose remained a challenge. Health managers cited insufficient trained immunisation staff and inadequate funding for supervision. Confidence in the vaccine increased among all participant groups owing to reductions in malaria frequency and severity. Integration of RTS,S/AS01 into immunisation services in western Kenya presented substantial operational challenges most of which were overcome in the first 2 years, providing important lessons for other countries. Programme expansion is feasible with intensive staff training and retention, enhanced supervision, and defaulter-tracing to ensure uptake of all doses. PATH via World Health Organization; Gavi, the Vaccine Alliance; The Global Fund; and Unitaid.

中文翻译：

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将 RTS,S/AS01 疟疾疫苗纳入肯尼亚西部基本免疫规划：从卫生系统角度进行的定性纵向研究

疟疾每年导致超过 50 万儿童死亡。世卫组织建议使用 RTS,S/AS01 预防生活在中度至高度疟疾传播地区的儿童患疟疾。我们进行了一项定性纵向研究，以调查在肯尼亚西部试点引入过程中影响疫苗交付和吸收的背景和动态因素。该研究于2019年10月3日至2022年3月24日期间进行。我们使用迭代方法和观察在三个时间点进行了参与者和非参与者观察以及对医疗保健提供者、健康管理者和国家政策制定者的深入访谈疟疾疫苗接种的实践和流程。使用实施研究的综合框架通过内容分析对成绩单进行编码，其中演绎地添加了新兴主题，并将其分为挑战和机遇。我们对 60 名参与者（25 名医疗保健提供者、27 名管理人员和 8 名政策制定者）​​进行了 112 次深度访谈。卫生保健提供者强调了由于同时进行的试点评估和健康报告的临时调整，RTS、S/AS01 纳入常规免疫服务的局限性。最初的挑战与四剂方案的复杂性（长达 24 个月）有关；然而，随着卫生保健提供者获得疫苗接种经验，自我效能随着时间的推移而提高。第四剂的低吸收率仍然是一个挑战。卫生管理人员指出，训练有素的免疫人员不足，监督资金也不足。由于疟疾频率和严重程度的降低，所有参与者群体对疫苗的信心都增加了。将 RTS,S/AS01 纳入肯尼亚西部的免疫服务带来了巨大的运营挑战，其中大部分在头两年内得到了克服，为其他国家提供了重要的经验教训。通过强化员工培训和保留、加强监督和违约者追踪以确保所有剂量的吸收，计划的扩展是可行的。通过世界卫生组织的 PATH； Gavi，疫苗联盟；全球基金；和国际药品采购机制。