Implementing tobacco use treatment in HIV clinics in Viet Nam

在越南艾滋病毒诊所实施烟草使用治疗

• 批准号: 10398023
• 负责人: Nam Truong Nguyen
• 金额: $ 52.47万
• 依托单位: NEW YORK UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10398023
• 关键词: AIDS/HIV problem; Abstinence; Acquired Immunodeficiency Syndrome; Adoption; Ambulatory Care Facilities; Belief; Biochemical; Caring; Cessation of life; Cities; Climate; Clinic; Clinical; Collaborations; Counseling; Data; Data Analyses; Effectiveness of Interventions; Focus Groups; Funding; General Population; Goals; HIV; Health; Health Personnel; Hybrids; Infrastructure; Institutes; Intervention; Interview; Medical; Modeling; Morbidity - disease rate; Neighborhood Health Center; Outcome Measure; Outpatients; Patients; Persons; Prevalence; Primary Health Care; Process Assessment; Provider; Public Health; Randomized; Randomized Controlled Trials; Research; Research Personnel; Resources; Risk; Science; Site; Smoke; Smoking; Source; Structure; Surveys; System; Tobacco; Tobacco Use Cessation; Tobacco use; Training; United States National Institutes of Health; Universities; Vietnam; Village Health Workers; Woman; Work; arm; base; comorbidity; comparative cost effectiveness; compare effectiveness; contextual factors; cost; cost effective; cost effectiveness; effectiveness testing; evidence base; health care delivery; health care settings; hybrid type 1 trial; implementation evaluation; implementation framework; implementation process; implementation strategy; implementation study; implementation trial; low and middle-income countries; male; men; multi-component intervention; nicotine patch; nicotine replacement; non-smoker; post intervention; premature; primary outcome; provider adherence; quitline; recruit; secondary outcome; smoking abstinence; smoking prevalence; social; social culture; standard care; three-arm study; tobacco abstinence; tobacco cessation intervention; tobacco control; tobacco user; treatment guidelines; treatment services; trial design

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.

抽象的 越南的男性吸烟率是世界上最高的吸烟率（45％），甚至吸烟率是 患有艾滋病毒/艾滋病（PLWH）的人中（59％）。吸烟的PLWH有多余的风险 与非吸烟者相比，发病率和过早死亡。然而，在越南的治疗中并未将其整合为 门诊艾滋病毒诊所（OPC）的常规护理一部分。我们的长期目标是为 在医疗保健环境中实施基于证据的烟草使用治疗（TUT） 像越南一样。这项研究的目的是进行3臂随机对照试验（RCT） 比较OPC中嵌入的三种多组分干预措施的成本效益：1） 3AS+R（标准护理（SC））：询问烟草使用，建议退出，协助（简短咨询），并参考 越南国家戒烟； 2）SC+律师（律师= 6条戒烟咨询干预措施适应 用于PLWH，由训练有素的现场诊所工作人员交付；和3）SC+律师+N（n =尼古丁替代品 治疗（NRT））。此类型1混合实施试验的主要结果是 干预（6个月的烟草禁欲）和次要结果是情境因素的度量 可能会影响实施和可持续性。患者（n = 672）将从两个城市的14个OPC招募 在越南，随机分为三个研究组之一。该提案以团队2臂的发现为基础 NCI资助的集群RCT（VQUIT），它们比较了增加TUT采用的两种实施策略 26个卫生中心的指南为越南的普通人群提供初级保健。在VQUIT中，哪个 是在Quitline的可用性之前实施的 用户获得训练有素的乡村卫生工作者（VHW）进行三局戒烟咨询。控制站点包括3AS 唯一的模型，没有推荐选项。接受VHW交付咨询的患者加上临床服务 停止顾问和咨询（3AS+R）的生物化学验证率更高，与6个月的戒烟率相比 那些仅接受3AS的人（25.7％，10.5％； p <.001）。该建议在这项先前的工作上以逻辑为基础。我们 将进行形成性研究，以进一步适应和量身定制VQUIT材料 PLWH和HIV临床环境。然后，我们将与3AS+R模型（现在的标准护理（SC）进行比较 戒烟线转介）提出的两个增强模型的TUT：a）适合PLWH的更密集的咨询 并由艾滋病毒临床医生（SC+律师）和b）分配NRT（SC+Counsel+N）。具体目标 为：1）适应和量身定制干预措施，以适应PLWH和HIV护理设置，2）进行3臂RCT比较 基于生物化学验证的6个月戒酒的三种护理模型的成本效益； 3）评估促进或阻碍实施或潜在可持续性的多层次因素 越南艾滋病毒治疗环境中的TUT。