PDF(Pubmed)
Abstract：
BACKGROUND: Smoking rates remain high in Vietnam, particularly among people living with HIV/AIDS (PLWH), but tobacco cessation services are not available in outpatient HIV clinics (OPCs). The research team is conducting a type II hybrid randomized controlled trial (RCT) comparing the cost-effectiveness of three tobacco cessation interventions among PLWH receiving care in HIV clinics in Vietnam. The study is simultaneously evaluating the implementation processes and outcomes of strategies aimed at increasing the implementation of tobacco dependence treatment (TDT) in the context of HIV care. This paper describes the systematic, theory-driven process of adapting intervention components and implementation strategies with demonstrated effectiveness in high-income countries, and more recently in Vietnam, to a new population (i.e., PLWH) and new clinical setting, prior to launching the trial.
METHODS: Data collection and analyses were guided by two implementation science frameworks and the socio-ecological model. Qualitative interviews were conducted with 13 health care providers and 24 patients in three OPCs. Workflow analyses were conducted in each OPC. Qualitative data were analyzed using rapid qualitative analysis procedures. Based on findings, components of the intervention and implementation strategies were adapted, followed by a 3-month pilot study in one OPC with 16 patients randomized to one of two intervention arms.
RESULTS: The primary adaptations included modifying the TDT intervention counseling content to address barriers to quitting among PLWH and Vietnamese sociocultural norms that support smoking cessation. Implementation strategies (i.e., training and system changes) were adapted to respond to provider- and clinic-level determinants of implementation effectiveness (e.g., knowledge gaps, OPC resource constraints, staffing structure, compatibility).
CONCLUSIONS: Adaptations were facilitated through a mixed method, stakeholder (patient and health care provider, district health leader)-engaged evaluation of context-specific influences on intervention and implementation effectiveness. This data-driven approach to refining and adapting components aimed to optimize intervention effectiveness and implementation in the context of HIV care. Balancing pragmatism with rigor through the use of rapid analysis procedures and multiple methods increased the feasibility of the adaptation process.
BACKGROUND: ClinicalTrials.gov NCT05162911 . Registered on December 16, 2021.
METHODS: Data collection and analyses were guided by two implementation science frameworks and the socio-ecological model. Qualitative interviews were conducted with 13 health care providers and 24 patients in three OPCs. Workflow analyses were conducted in each OPC. Qualitative data were analyzed using rapid qualitative analysis procedures. Based on findings, components of the intervention and implementation strategies were adapted, followed by a 3-month pilot study in one OPC with 16 patients randomized to one of two intervention arms.
RESULTS: The primary adaptations included modifying the TDT intervention counseling content to address barriers to quitting among PLWH and Vietnamese sociocultural norms that support smoking cessation. Implementation strategies (i.e., training and system changes) were adapted to respond to provider- and clinic-level determinants of implementation effectiveness (e.g., knowledge gaps, OPC resource constraints, staffing structure, compatibility).
CONCLUSIONS: Adaptations were facilitated through a mixed method, stakeholder (patient and health care provider, district health leader)-engaged evaluation of context-specific influences on intervention and implementation effectiveness. This data-driven approach to refining and adapting components aimed to optimize intervention effectiveness and implementation in the context of HIV care. Balancing pragmatism with rigor through the use of rapid analysis procedures and multiple methods increased the feasibility of the adaptation process.
BACKGROUND: ClinicalTrials.gov NCT05162911 . Registered on December 16, 2021.
摘要：
背景：越南的吸烟率仍然很高，特别是在艾滋病毒/艾滋病感染者(PLWH)中，但门诊艾滋病毒诊所(OPCs)不提供戒烟服务。研究小组正在进行II型混合随机对照试验（RCT），比较在越南接受HIV诊所护理的PLWH中三种戒烟干预措施的成本效益。该研究同时评估了旨在增加在艾滋病毒护理背景下实施烟草依赖治疗（TDT）的策略的实施过程和结果。本文系统的阐述了,理论驱动的过程，调整干预组成部分和实施战略，在高收入国家表现出有效性，最近在越南，到新的人口(即，PLWH)和新的临床环境，在开始审判之前。
方法：数据收集和分析以两个实施科学框架和社会生态模型为指导。在三个OPCs中，对13名医疗保健提供者和24名患者进行了定性访谈。在每个OPC中进行工作流分析。使用快速定性分析程序分析定性数据。根据调查结果,干预和实施战略的组成部分进行了调整，随后在一项OPC中进行了为期3个月的试点研究，研究对象为16名患者，随机分配到两个干预组之一。
结果：主要的适应包括修改TDT干预咨询内容，以解决支持戒烟的PLWH和越南社会文化规范中戒烟的障碍。实施战略(即，培训和系统变更)进行了调整，以应对实施有效性的提供者和临床水平决定因素(例如，知识差距，OPC资源限制，人员配置结构，兼容性)。
结论：通过混合方法促进适应，利益相关者(患者和医疗保健提供者，地区卫生负责人)参与评估特定环境对干预和实施有效性的影响。这种数据驱动的方法来完善和调整组成部分，旨在优化艾滋病毒护理背景下的干预效果和实施。通过使用快速分析程序和多种方法来平衡实用主义与严谨，增加了适应过程的可行性。
背景：ClinicalTrials.govNCT05162911。2021年12月16日注册。
方法：数据收集和分析以两个实施科学框架和社会生态模型为指导。在三个OPCs中，对13名医疗保健提供者和24名患者进行了定性访谈。在每个OPC中进行工作流分析。使用快速定性分析程序分析定性数据。根据调查结果,干预和实施战略的组成部分进行了调整，随后在一项OPC中进行了为期3个月的试点研究，研究对象为16名患者，随机分配到两个干预组之一。
结果：主要的适应包括修改TDT干预咨询内容，以解决支持戒烟的PLWH和越南社会文化规范中戒烟的障碍。实施战略(即，培训和系统变更)进行了调整，以应对实施有效性的提供者和临床水平决定因素(例如，知识差距，OPC资源限制，人员配置结构，兼容性)。
结论：通过混合方法促进适应，利益相关者(患者和医疗保健提供者，地区卫生负责人)参与评估特定环境对干预和实施有效性的影响。这种数据驱动的方法来完善和调整组成部分，旨在优化艾滋病毒护理背景下的干预效果和实施。通过使用快速分析程序和多种方法来平衡实用主义与严谨，增加了适应过程的可行性。
背景：ClinicalTrials.govNCT05162911。2021年12月16日注册。
