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.

摘要 越南的男性吸烟率是世界上最高的之一（45%），吸烟率与男性吸烟率持平。 艾滋病毒/艾滋病感染者（PLWH）的比例更高（59%）。吸烟的PLWH的风险增加 发病率和过早死亡率与非吸烟者相比。然而，在越南， 艾滋病毒门诊的常规护理。我们的长期目标是开发一个可扩展的模型， 在治疗中低收入国家艾滋病毒携带者和艾滋病患者的卫生保健机构实施循证烟草使用治疗（TUT） 比如越南。本研究的目的是进行一项3组随机对照试验（RCT）， 比较了嵌入OPC中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 由经过培训的现场诊所工作人员提供;以及3）SC+法律顾问+N（N =尼古丁替代品 治疗（NRT））。这种类型1混合实施试验的主要结果是 干预（6个月的戒烟）和次要结果是衡量环境因素的指标， 可能影响执行和可持续性。将从两个城市的14个OPC中招募患者（n = 672） 在越南，随机分为3个研究组。该提案建立在该团队的双臂研究结果的基础上 NCI资助的集群RCT（VQUIT），比较了增加TUT采用的两种实施策略 在越南，26个为普通民众提供初级保健的保健中心制定了指导方针。在VQUIT中， 在戒烟热线可用之前实施，干预地点的临床医生将烟草 使用者可向受过训练的乡村卫生工作者（VHW）咨询3次戒烟咨询。对照部位包括3As 只有模型，没有推荐选项。接受VHW提供的咨询和临床医生提供的 戒烟建议和咨询（3As + R）有更高的生化验证6个月戒烟率相比， 仅接受3A的患者（25.7% vs.10.5%; p <0.001）。这一建议在逻辑上建立在这一先前工作的基础上。我们 将进行形成性研究，以进一步适应和定制VQUIT材料的社会文化背景， 艾滋病毒感染者和艾滋病毒临床背景。然后，我们将比较3As + R模型（现在的标准护理（SC）与 戒烟热线转介），以两个加强模式的图坦卡门，提供：a）更密集的辅导，适合艾滋病毒携带者 并由HIV临床医生（SC + Counsel）提供，和B）分配NRT（SC + Counsel + N）。具体目标 是：1）调整和调整干预措施，以PLWH和艾滋病毒护理环境，2）进行三组RCT比较 基于经生化验证的6个月戒烟的三种护理模式的成本效益; （3）评价促进或阻碍执行的多层次因素以及可持续性的潜力 TUT在越南的艾滋病毒治疗环境中。