PDF(Pubmed)
Abstract：
BACKGROUND: With expanded and sustained availability of HIV treatment resulting in substantial improvements in life expectancy, the need to address modifiable risk factors associated with leading causes of death among people living with HIV/AIDS (PLWH), such as tobacco smoking, has increased. Tobacco use is highly prevalent among PLWH, especially in southern Africa, where HIV is heavily concentrated, and many people who smoke would like to quit but are unable to do so without assistance. SBIRT (Screening, Brief Intervention and Referral to Treatment) is a well-established evidence-based approach successful at supporting smoking cessation in a variety of settings. Varenicline is efficacious in supporting smoking cessation. We intend to assess the effectiveness of SBIRT and varenicline on smoking cessation among PLWH in Botswana and the effectiveness of our implementation.
METHODS: BSMART (Botswana Smoking Abstinence Reinforcement Trial) is a stepped-wedge, cluster randomized, hybrid Type 2 effectiveness-implementation study guided by the RE-AIM framework, to evaluate the effectiveness and implementation of an SBIRT intervention consisting of the 5As compared to an enhanced standard of care. SBIRT will be delivered by trained lay health workers (LHWs), followed by referral to treatment with varenicline prescribed and monitored by trained nurse prescribers in a network of outpatient HIV care facilities. Seven hundred and fifty people living with HIV who smoke daily and have been receiving HIV care and treatment at one of 15 health facilities will be recruited if they are up to 18 years of age and willing to provide informed consent to participate in the study.
CONCLUSIONS: BSMART tests a scalable approach to achieve and sustain smoking abstinence implemented in a sustainable way. Integrating an evidence-based approach such as SBIRT, into an HIV care system presents an important opportunity to establish and evaluate a modifiable cancer prevention strategy in a middle-income country (MIC) setting where both LHW and non-physician clinicians are widely used. The findings, including the preliminary cost-effectiveness, will provide evidence to guide the Botswanan government and similar countries as they strive to provide affordable smoking cessation support at scale.
BACKGROUND: NCT05694637 Registered on 7 December 2022 on clinicaltrials.gov, https://clinicaltrials.gov/search?locStr=Botswana&country=Botswana&cond=Smoking%20Cessation&intr=SBIRT.
METHODS: BSMART (Botswana Smoking Abstinence Reinforcement Trial) is a stepped-wedge, cluster randomized, hybrid Type 2 effectiveness-implementation study guided by the RE-AIM framework, to evaluate the effectiveness and implementation of an SBIRT intervention consisting of the 5As compared to an enhanced standard of care. SBIRT will be delivered by trained lay health workers (LHWs), followed by referral to treatment with varenicline prescribed and monitored by trained nurse prescribers in a network of outpatient HIV care facilities. Seven hundred and fifty people living with HIV who smoke daily and have been receiving HIV care and treatment at one of 15 health facilities will be recruited if they are up to 18 years of age and willing to provide informed consent to participate in the study.
CONCLUSIONS: BSMART tests a scalable approach to achieve and sustain smoking abstinence implemented in a sustainable way. Integrating an evidence-based approach such as SBIRT, into an HIV care system presents an important opportunity to establish and evaluate a modifiable cancer prevention strategy in a middle-income country (MIC) setting where both LHW and non-physician clinicians are widely used. The findings, including the preliminary cost-effectiveness, will provide evidence to guide the Botswanan government and similar countries as they strive to provide affordable smoking cessation support at scale.
BACKGROUND: NCT05694637 Registered on 7 December 2022 on clinicaltrials.gov, https://clinicaltrials.gov/search?locStr=Botswana&country=Botswana&cond=Smoking%20Cessation&intr=SBIRT.
摘要：
背景：随着艾滋病毒治疗的扩大和持续提供，预期寿命大幅改善，需要解决与艾滋病毒/艾滋病感染者（PLWH）的主要死亡原因相关的可改变的风险因素，比如吸烟，增加了。烟草使用在PLWH中非常普遍，尤其是在南部非洲，艾滋病毒高度集中的地方，许多吸烟的人想戒烟，但没有帮助就无法戒烟。SBIRT(筛查，简短干预和转诊治疗）是一种公认的循证方法，可在各种环境中成功支持戒烟。伐尼克林在支持戒烟方面是有效的。我们打算评估SBIRT和伐尼克兰对博茨瓦纳PLWH戒烟的有效性以及我们实施的有效性。
方法：BSMART（博茨瓦纳禁烟强化试验）是一种阶梯式楔形，集群随机化，以RE-AIM框架为指导的混合2型有效性实施研究，与增强的护理标准相比，评估由5A组成的SBIRT干预措施的有效性和实施情况。SBIRT将由训练有素的非专业卫生工作者(LHW)提供，随后在门诊HIV护理机构网络中,由训练有素的护士开处方者转诊并监测伐尼克兰治疗.每天吸烟并在15个医疗机构之一接受艾滋病毒护理和治疗的750名艾滋病毒感染者将被招募，如果他们年满18岁，并愿意提供知情同意参加研究。
结论：BSMART测试了以可持续方式实现和维持戒烟的可扩展方法。整合基于证据的方法，如SBIRT，在LHW和非医师临床医生都被广泛使用的中等收入国家（MIC）环境中，进入HIV护理系统为建立和评估可修改的癌症预防策略提供了重要的机会。调查结果,包括初步的成本效益，将提供证据，以指导博茨瓦纳政府和类似国家努力提供负担得起的大规模戒烟支持。
背景：NCT05694637于2022年12月7日在clinicaltrials.gov上注册，https://clinicaltrials.gov/search?locStr=博茨瓦纳&country=博茨瓦纳&cond=吸烟%20戒烟&intr=SBIRT.
方法：BSMART（博茨瓦纳禁烟强化试验）是一种阶梯式楔形，集群随机化，以RE-AIM框架为指导的混合2型有效性实施研究，与增强的护理标准相比，评估由5A组成的SBIRT干预措施的有效性和实施情况。SBIRT将由训练有素的非专业卫生工作者(LHW)提供，随后在门诊HIV护理机构网络中,由训练有素的护士开处方者转诊并监测伐尼克兰治疗.每天吸烟并在15个医疗机构之一接受艾滋病毒护理和治疗的750名艾滋病毒感染者将被招募，如果他们年满18岁，并愿意提供知情同意参加研究。
结论：BSMART测试了以可持续方式实现和维持戒烟的可扩展方法。整合基于证据的方法，如SBIRT，在LHW和非医师临床医生都被广泛使用的中等收入国家（MIC）环境中，进入HIV护理系统为建立和评估可修改的癌症预防策略提供了重要的机会。调查结果,包括初步的成本效益，将提供证据，以指导博茨瓦纳政府和类似国家努力提供负担得起的大规模戒烟支持。
背景：NCT05694637于2022年12月7日在clinicaltrials.gov上注册，https://clinicaltrials.gov/search?locStr=博茨瓦纳&country=博茨瓦纳&cond=吸烟%20戒烟&intr=SBIRT.
