Department of Epidemiology, Institute of Preventive Medicine and Public Health, Hanoi Medical University, No 1 Ton That Tung, Dong Da, Hanoi, Vietnam.
The University of North Carolina-Vietnam Office, Hanoi, Vietnam.
BMC Med Res Methodol. 2024 Oct 26;24(1):249. doi: 10.1186/s12874-024-02367-3.
Evaluation of implementation strategies is core to implementation trials, but implementation strategies often deviate from the original plan to adjust to the real-world conditions. The optimal approach to track modifications to implementation strategies is unclear, especially in low-resource settings. Using data from an implementation trial for people who inject drugs (PWID) with HIV in Vietnam, we describe the tracking of implementation strategy modifications and present findings of this process.
SNaP (Systems Navigation and Psychosocial Counseling) is a hybrid type-III effectiveness-implementation randomized controlled trial aiming to scale up the evidence-based intervention, integrated systems navigation and psychosocial counseling, for PWID with HIV in Vietnam. Forty-two HIV testing sites were randomized 1:1 to a standard or tailored arm. While the standard arm (SA) received a uniform package of strategies, implementation strategies for the tailored arm (TA) were tailored to address specific needs of each site. The central research team also met monthly with the TA to document how their tailored strategies were implemented over time. Five components were involved in the tracking process: describing the planned strategies; tracking strategy use; monitoring barriers and solutions; describing modifications; and identifying and describing any additional strategies.
Our approach allowed us to closely track the modifications to implementation strategies in the tailored arms every month. TA sites originally identified 27 implementation strategies prior to implementation. During implementation, five strategies were dropped by four sites and two new strategies were added to twelve sites. Modifications of five strategies occurred at four sites to accommodate their changing needs and resources. Difficulties related to the COVID-19 pandemic, low number of participants recruited, high workload at the clinic, lack of resources for HIV testing and high staff turnover were among barriers of implementing the strategies. A few challenges to tracking modifications were noted, including the considerable amount of time and efforts needed as well as the lack of motivation from site staff to track and keep written documentations of modifications.
We demonstrated the feasibility of a systematic approach to tracking implementation strategies for a large-scale implementation trial in a low-resource setting. This process could be further enhanced and replicated in similar settings to balance the rigor and feasibility of implementation strategy tracking. Our findings can serve as additional guidelines for future researchers planning to report and track modifications to implementation strategies in large, complex trials.
clinicaltrials.gov ID: NCT03952520 (first posted 2019-05-16).
实施策略的评估是实施试验的核心，但实施策略经常偏离原始计划，以适应现实情况。在资源有限的环境中，跟踪实施策略修改的最佳方法尚不清楚。本研究使用来自越南艾滋病毒感染者注射毒品者（PWID）实施试验的数据，描述了实施策略修改的跟踪情况，并介绍了该过程的发现。
SNaP（系统导航和心理社会咨询）是一种混合的 III 型有效性-实施随机对照试验，旨在扩大基于证据的干预措施，即整合系统导航和心理社会咨询，用于越南的 HIV 感染者注射毒品者。42 个 HIV 检测点以 1:1 的比例随机分为标准或定制臂。标准臂（SA）接受统一的策略包，而定制臂（TA）的实施策略则根据每个地点的具体需求进行定制。中央研究团队还每月与 TA 会面，记录他们的定制策略是如何随着时间的推移实施的。跟踪过程涉及五个组件：描述计划策略；跟踪策略使用情况；监测障碍和解决方案；描述修改；并确定和描述任何其他策略。
我们的方法允许我们每月密切跟踪定制臂实施策略的修改情况。TA 站点在实施前最初确定了 27 项实施策略。在实施过程中，四个站点放弃了五个策略，十二个站点增加了两个新策略。四个站点对五个策略进行了修改，以适应其不断变化的需求和资源。与 COVID-19 大流行相关的困难、参与者招募人数少、诊所工作量大、缺乏 HIV 检测资源和员工高流动率是实施策略的障碍。在跟踪修改时，我们注意到一些挑战，包括需要大量的时间和精力，以及站点工作人员缺乏跟踪和记录修改的动力。
我们展示了在资源有限的环境中对大规模实施试验实施策略进行系统跟踪的可行性。在类似的环境中，可以进一步加强和复制这一过程，以平衡实施策略跟踪的严谨性和可行性。我们的研究结果可为未来计划报告和跟踪大型复杂试验实施策略修改的研究人员提供额外的指导。
clinicaltrials.gov ID：NCT03952520（首次于 2019 年 5 月 16 日发布）。
