SAMRC/Wits Developmental Pathways for Health Research Unit, Department of Paediatrics, Faculty of Health Sciences, School of Clinical Medicine, University of the Witwatersrand, Private Bag 3, Wits, Johannesburg, 2050, South Africa.
Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Trials. 2022 Sep 6;23(1):758. doi: 10.1186/s13063-022-06696-w.
Despite the importance of intervention fidelity in interpreting the outcomes of complex public health interventions, there is a lack of both reporting fidelity trial protocols and uniformity. In evaluating complex, adaptable/pragmatic interventions in resource-strapped settings with systemic issues, unique challenges to intervention adherence and monitoring are introduced, increasing the importance of a fidelity protocol. We aim to describe the intervention fidelity and monitoring protocol for the Healthy Life Trajectories Initiative (HeLTI) South Africa, a complex four-phase intervention set in urban Soweto, starting preconceptionally and continuing through to pregnancy, infancy, and early childhood to improve the health of young women and reduce the intergenerational risk of obesity.
The HeLTI SA fidelity protocol was based on the NIH Behaviour Change Consortium (NIH BCC) Treatment Fidelity Framework, outlining the following components of intervention fidelity: study design, provider training, intervention delivery, intervention receipt, and intervention enactment. Context-specific fidelity challenges were identified. The intervention fidelity components and associated monitoring strategies were developed to align with HeLTI SA. Strategies for fidelity monitoring include, amongst others, qualitative process evaluation methods, reviewing observed and recorded intervention sessions, monitoring of activity logs, standardized training, and intervention session checklists. Possible challenges to fidelity and fidelity monitoring include high provider turnover, lack of qualification amongst providers, difficulty tracing participants for follow-up sessions, participant health literacy levels, and the need to prioritize participants' non-health-related challenges. Solutions proposed include adapting intervention delivery methods, recruitment methods, and provider training methods.
The NIH BCC Treatment Fidelity Framework provided a solid foundation for reporting intervention fidelity across settings to improve intervention validity, ability to assess intervention effectiveness, and transparency. However, context-specific challenges to fidelity (monitoring) were identified, and transparency around such challenges and possible solutions in low- and middle-income settings could help foster solutions to improve adherence, reporting, and monitoring of intervention fidelity in this setting.
Pan African Clinical Trials Registry PACTR201903750173871 . Registered on 27 March 2019.
尽管干预一致性对于解释复杂公共卫生干预措施的结果非常重要，但在报告一致性试验方案和统一标准方面都存在不足。在资源匮乏且存在系统性问题的环境中评估复杂、适应性/务实的干预措施时，会引入对干预措施依从性和监测的独特挑战，从而增加了一致性协议的重要性。我们旨在描述南非健康生活轨迹倡议（HeLTI）的干预一致性和监测方案，该方案是一项复杂的四阶段干预措施，从受孕前开始，一直持续到怀孕、婴儿期和幼儿期，以改善年轻女性的健康状况，并降低肥胖的代际风险。
HeLTI SA 一致性方案基于 NIH 行为改变联盟（NIH BCC）治疗一致性框架，概述了干预一致性的以下组成部分：研究设计、提供者培训、干预措施的提供、干预措施的接收和干预措施的实施。确定了与特定背景相关的一致性挑战。干预一致性组件和相关监测策略是根据 HeLTI SA 制定的。一致性监测策略包括定性过程评估方法、审查观察到的和记录的干预措施、监测活动日志、标准化培训和干预措施检查表等。一致性和一致性监测可能面临的挑战包括提供者高周转率、提供者缺乏资格、难以追踪参与者进行随访、参与者健康素养水平以及需要优先考虑参与者非健康相关的挑战。提出的解决方案包括调整干预措施的提供方法、招聘方法和提供者培训方法。
NIH BCC 治疗一致性框架为在不同环境下报告干预一致性提供了坚实的基础，以提高干预措施的有效性、评估干预措施有效性的能力和透明度。然而，在一致性（监测）方面确定了与特定背景相关的挑战，在低收入和中等收入环境中透明度可以帮助促进解决方案，以提高该环境下的干预一致性的依从性、报告和监测。
泛非临床试验注册处 PACTR201903750173871。于 2019 年 3 月 27 日注册。
