Implementing tobacco use treatment in HIV clinics in Viet Nam

摘要 越南的男性吸烟率是世界上最高的国家之一(45%)，吸烟率持平 艾滋病毒/艾滋病携带者(PLWH)的比例较高(59%)。吸烟的PLWH有更高的过量风险 与非吸烟者相比，发病率和过早死亡的比例更高。然而，在越南，治疗没有被整合为一种 艾滋病毒门诊(OPC)常规护理的一部分。我们的长期目标是开发一种可扩展的模型 在卫生保健环境中实施循证烟草使用治疗(TUT)治疗LMICs中的PLWH 比如越南。本研究的目的是进行一项三臂随机对照试验， 比较OPC中嵌入的三种多组件干预措施的成本效益：1) 3AS+R(标准护理(SC))：询问烟草使用情况，建议戒烟，协助(简短咨询)，并参考 越南的国家Quitline；2)SC+律师(律师=6次会议--改编的戒烟咨询干预 由训练有素的现场诊所工作人员提供；以及3)SC+Counsel+N 治疗(NRT))。这一类型1混合实施试验的主要结果是 干预(6个月戒烟)和次要结果是对背景因素的衡量， 可能会影响执行和可持续性。患者(n=672)将从两个城市的14个门诊招募 在越南，并被随机分为3个研究小组之一。该提案建立在该团队的2-ARM发现的基础上 NCI资助的集群RCT(VQUIT)，比较了两种提高TUT采用率的实施战略 为越南普通民众提供初级保健的26个保健中心的指导方针。在VQUIT中， 在Quitline可用之前实施，干预地点的临床医生提到烟草 用户向训练有素的乡村卫生工作者(VHW)进行3次戒烟咨询。控制点包括一个3A 只有型号，没有推荐选项。接受vHW提供的咨询和临床医生提供的咨询的患者 戒烟建议和咨询(3AS+R)的生物化学验证的6个月戒烟率高于 仅接受3A治疗的患者(25.7%vs.10.5%；p&lt；.001)。这项建议在逻辑上建立在先前的工作基础上。我们 将进行形成性研究，以进一步调整和调整VQUIT材料以适应 PLWH和艾滋病毒临床背景。然后，我们将比较3AS+R模式(现在的标准护理(SC)和 Quitline推荐)两种增强的图坦卡蒙模型，这两种模型提供：a)适用于PLWH的更密集的咨询 并由艾滋病毒临床医生(SC+律师)提供，以及b)分配NRT(SC+律师+N)。具体目标 是：1)调整和定制干预措施以适应PLWH和HIV护理环境，2)进行三臂随机对照试验 基于生物化学验证的6个月戒烟的三种护理模式的成本效益； 以及3)评估促进或阻碍执行和可持续发展的多层次因素 越南艾滋病毒治疗环境中的图坦卡蒙。

ABSTRACT Male smoking prevalence in Viet Nam is one of the highest in the world (45%), and smoking rates are even higher among people living with HIV/AIDS (PLWH) (59%). PLWH who smoke are at increased risk of excess morbidity and premature death compared with nonsmokers. Yet, in Viet Nam treatment is not integrated as a routine part of care in outpatient HIV clinics (OPCs). Our long-term goal is to develop a scalable model for implementing evidence-based tobacco use treatment (TUT) in health care settings treating PLWH in LMICs like Viet Nam. The objective of this study is to conduct a 3-arm randomized controlled trial (RCT) that compares the cost-effectiveness of three multi-component interventions that are embedded in OPCs: 1) 3As+R (Standard Care (SC)): Ask about tobacco use, Advise to quit, Assist (brief counseling), and Refer to Viet Nam’s national Quitline; 2) SC+Counsel (Counsel=6-session cessation counseling intervention adapted for PLWH and delivered by a trained, onsite clinic staff; and 3) SC+Counsel+N (N=nicotine replacement therapy (NRT)). The primary outcome of this type 1 hybrid implementation trial is the effectiveness of the intervention (6-month tobacco abstinence) and secondary outcomes are measures of contextual factors that may influence implementation and sustainability. Patients (n=672) will be recruited from 14 OPCs in two cities in Viet Nam and randomized into one of 3 study arms. The proposal builds on findings from the team’s 2-arm NCI-funded cluster RCT (VQUIT) that compared two implementation strategies for increasing adoption of TUT guidelines in 26 health centers that provide primary care for a general population in Viet Nam. In VQUIT, which was implemented prior to the availability of the Quitline, clinicians in the intervention sites referred tobacco users to a trained village health worker (VHW) for 3-session cessation counseling. Control sites included a 3As only model and no referral option. Patients receiving VHW-delivered counseling plus clinician-delivered cessation advise and counseling (3As+R) had higher biochemically validated 6-month quit rates compared with those who received 3As only (25.7% vs.10.5%; p<.001). This proposal builds logically on this prior work. We will conduct formative research to further adapt and tailor the VQUIT materials to the sociocultural context of PLWH and to the HIV clinical context. We will then compare the 3As+R model (Standard care (SC) now with Quitline referral) to two enhanced models of TUT that offer: a) more intensive counseling adapted for PLWH and delivered by HIV clinicians (SC+Counsel), and b) dispensing of NRT (SC+Counsel+N). The specific aims are to: 1) Adapt and tailor the intervention to PLWH and HIV care settings, 2) Conduct a 3-arm RCT comparing the cost effectiveness of three models of care based on biochemically validated 6-month smoking abstinence; and 3) Evaluate multilevel factors that facilitate or impede implementation and potential for sustainability of TUT in HIV treatment settings in Viet Nam.