A Randomized Controlled Smoking Cessation Trial and Prospective Cohort Study of TB Treatment Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Smoking cessation rate
研究概览
简要总结
The primary focus of this intervention trial is to understand the effect of quitting smoking on TB treatment outcomes. The investigators will compare a cessation strategy based on guidelines recommended by the World Health Organization (WHO) and the International Union against Tuberculosis and Lung Disease (IUTLD). This is currently not utilized in TB directly observed therapy (DOT) clinics in Pakistan. The investigators study will provide comprehensive data towards understanding the effectiveness of these strategies for TB patients who smoke in Pakistan, and most importantly, on the effect of quitting smoking on TB treatment outcomes. These findings will guide development of effective smoking cessation strategies in a region with high prevalence of TB and increasing tobacco use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males, ≥18 years of age
- •diagnosed with pulmonary TB
- •self-reported current smokers, or smoker within 6 months
- •anticipated to be attending the TB treatment clinic for at least 6 months
- •be willing to set a quit date within 2 weeks after baseline assessment
- •agree to participate
排除标准
- •less than 18 years of age
- •quit for more than 6 months
- •extra-pulmonary TB
- •unable/unwilling to provide written consent
研究组 & 干预措施
Counseling
Intensive anti-smoking counseling
干预措施: Intensive anti-smoking counseling (Other)
Standard Care
Control group will receive current standard of care.
结局指标
主要结局
Smoking cessation rate
时间窗: 6 months post-TB treatment
次要结局
- negative TB treatment outcome (death, treatment failure, relapse, required prolongation of TB therapy(6 months post-TB treatment)