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: 10737813
• 负责人: Nam Truong Nguyen
• 金额: $ 11.81万
• 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/10737813
• 关键词: Abstinence; Acquired Immunodeficiency Syndrome; Adoption; Ambulatory Care Facilities; Belief; Biochemical; Caring; Cessation of life; Cities; Climate; Clinic; Clinical; Collaborations; Counseling; Data; Effectiveness of Interventions; Focus Groups; Funding; General Population; Goals; HIV; HIV/AIDS; Health; Health Personnel; Hybrids; Infrastructure; Intervention; Interview; Medical; Modeling; Morbidity - disease rate; Neighborhood Health Center; Outcome Measure; Outpatients; Patients; Persons; Policy Maker; Prevalence; Primary 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; Vietnamese; Village Health Workers; Woman; Work; arm; comorbidity; comparative cost effectiveness; compare effectiveness; contextual factors; cost; cost effective; cost effectiveness; effectiveness testing; evidence base; forging; 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; public policy on tobacco; quitline; recruit; secondary outcome; smoking abstinence; smoking prevalence; social; social culture; standard care; three-arm study; tobacco abstinence; tobacco cessation intervention; 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 越南男性吸烟率是世界上最高的国家之一（45%），吸烟率甚至 HIV 感染者/艾滋病患者 (PLWH) 的比例更高 (59%)。吸烟的艾滋病患者吸烟过量的风险增加 与不吸烟者相比，发病率和过早死亡。然而，在越南，治疗并没有被纳入 HIV 门诊 (OPC) 的常规护理部分。我们的长期目标是开发一个可扩展的模型 在医疗机构中实施循证烟草使用治疗 (TUT)，治疗中低收入国家的艾滋病感染者 比如越南。本研究的目的是进行一项 3 组随机对照试验 (RCT)， 比较了 OPC 中嵌入的三种多成分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 越南国家戒烟热线； 2) SC+Counsel（Counsel=6 次戒烟咨询干预调整 为感染者提供服务，并由经过培训的现场诊所工作人员提供； 3) SC+Counsel+N（N=尼古丁替代品 疗法（NRT））。这种 1 类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测量， 可能会影响实施和可持续性。将从两个城市的 14 个 OPC 中招募患者 (n=672) 在越南，并随机分为 3 个研究组之一。该提案建立在团队 2 臂的调查结果的基础上 NCI 资助的集群 RCT (VQUI​​T) 比较了两种提高 TUT 采用率的实施策略 为越南普通民众提供初级保健的 26 个卫生中心的指导方针。在 VQUIT 中， 在戒烟热线开通之前实施，干预地点的临床医生转介烟草 用户向经过培训的乡村卫生工作者 (VHW) 寻求 3 次戒烟咨询。控制位点包括 3A 只有模型，没有推荐选项。接受 VHW 提供的咨询以及临床医生提供的咨询的患者 与戒烟建议和咨询 (3As+R) 相比，经生化验证的 6 个月戒烟率更高 仅接受 3A 的患者（25.7% vs.10.5%；p<.001）。该提案在逻辑上建立在先前工作的基础上。我们 将进行形成性研究，以进一步调整和定制 VQUIT 材料以适应社会文化背景 PLWH 和 HIV 临床背景。然后我们将比较 3As+R 模型（现在的标准护理 (SC) 与 戒烟热线转诊）到两种增强型 TUT 模式，它们提供：a）针对 PLWH 的更深入的咨询 并由 HIV 临床医生（SC+顾问）提供，以及 b) 分配 NRT（SC+顾问+N）。具体目标 的目标是：1) 根据 PLWH 和 HIV 护理环境调整和定制干预措施，2) 进行 3 组 RCT 比较 基于生化验证的 6 个月戒烟的三种护理模式的成本效益； 3) 评估促进或阻碍实施的多层次因素以及可持续发展的潜力 越南艾滋病毒治疗机构中的 TUT。