跟踪对实施策略的修改:SNaP 案例研究--在越南开展的一项混合 III 型随机对照试验,旨在扩大针对感染艾滋病毒的吸毒者的综合系统导航和心理咨询。

IF 3.9 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Minh X Nguyen, Sophia M Bartels, Christopher F Akiba, Teerada Sripaipan, Ha Tt Nong, Linh Th Dang, Ha V Tran, Van Th Hoang, Giang M Le, Vivian F Go, William C Miller, Byron J Powell
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引用次数: 0

摘要

导言:对实施策略进行评估是实施试验的核心,但实施策略往往会偏离原计划,以适应现实世界的条件。跟踪实施策略调整的最佳方法尚不明确,尤其是在资源匮乏的环境中。我们利用越南一项针对注射吸毒者(PWID)艾滋病病毒感染者的实施试验的数据,描述了对实施策略修改的跟踪,并介绍了这一过程的发现:SNaP(系统导航和社会心理咨询)是一项混合型-III 效应-实施随机对照试验,旨在推广循证干预措施--综合系统导航和社会心理咨询,用于越南的艾滋病感染者。42 个艾滋病检测点按 1:1 随机分配到标准组或定制组。标准组(SA)接受统一的一揽子策略,而定制组(TA)的实施策略则是根据每个检测点的具体需求量身定制的。中央研究小组还每月与 TA 会面,记录他们在一段时间内如何实施量身定制的策略。跟踪过程包括五个部分:描述计划战略;跟踪战略使用情况;监测障碍和解决方案;描述修改情况;以及识别和描述任何其他战略:我们的方法使我们能够每月密切跟踪定制臂中实施策略的修改情况。在实施前,技术援助站点最初确定了 27 项实施策略。在实施过程中,4 个项目点放弃了 5 项战略,12 个项目点增加了 2 项新战略。有 4 个项目点修改了 5 项战略,以适应其不断变化的需求和资源。与 COVID-19 大流行有关的困难、招募的参与者人数少、诊所工作量大、缺乏 HIV 检测资源以及人员流动率高,都是实施策略的障碍。我们还注意到在跟踪修改方面存在一些挑战,包括需要花费大量的时间和精力,以及现场工作人员缺乏跟踪和保留书面修改文件的动力:我们证明了在资源匮乏的环境中采用系统方法跟踪大规模实施试验的实施策略的可行性。这一过程可以在类似环境中进一步加强和推广,以平衡实施策略跟踪的严格性和可行性。我们的研究结果可作为未来研究人员计划报告和跟踪大型复杂试验中实施策略修改情况的补充指南。试验注册:clinicaltrials.gov ID:NCT03952520(首次发布时间:2019-05-16)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Tracking modifications to implementation strategies: a case study from SNaP - a hybrid type III randomized controlled trial to scale up integrated systems navigation and psychosocial counseling for PWID with HIV in Vietnam.

Introduction: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: clinicaltrials.gov ID: NCT03952520 (first posted 2019-05-16).

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来源期刊
BMC Medical Research Methodology
BMC Medical Research Methodology 医学-卫生保健
CiteScore
6.50
自引率
2.50%
发文量
298
审稿时长
3-8 weeks
期刊介绍: BMC Medical Research Methodology is an open access journal publishing original peer-reviewed research articles in methodological approaches to healthcare research. Articles on the methodology of epidemiological research, clinical trials and meta-analysis/systematic review are particularly encouraged, as are empirical studies of the associations between choice of methodology and study outcomes. BMC Medical Research Methodology does not aim to publish articles describing scientific methods or techniques: these should be directed to the BMC journal covering the relevant biomedical subject area.
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