Addressing Smokeless Tobacco and building Research Capacity in South Asia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- 1.Intervention delivery (quantitative and qualitative)
研究概览
简要总结
Addressing smokeless tobacco (ST) research and capacity building in South Asia is an NIHR, UK funded project having four arms. This project is a collaborative effort of 5 UK Universities and few institutes in India, Bangladesh, and Pakistan. Two of the arms are being conducted in India.
The coordinating centers in India being ICMR-National Institute of Cancer Prevention and Research and Maulana Azad Medical College, New Delhi.
The study is conducted under two arms/heads in India 1. Cessation
- Sellers
The study would be done in both Urban and rural communities settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Self-reported daily users of ST products at least for the last 6 months or ST use on >25 days in the past month 2.Able to provide informed consent 3.Motivated and willing to quit ST use within the next 30 days.
排除标准
- •1.Self-reported users of any combustible tobacco product (cigarettes, bidis, hookah) or e-cigarettes in the past 30 days or those having Carbon monoxide (CO) levels >10ppm, identified by a breath test.
- •2.Pregnant or breastfeeding women.
- •3.Individuals with health conditions, which warrant caution in using NRT and have previously been excluded in trials of nicotine replacement in smoking.
- •These will be assessed by participant self-report at the pre-trial screening by asking participants whether they have suffered angina pectoris, myocardial infarction or stroke the past three weeks.
- •4.Individuals who are already on an existing treatment, either pharmacological or behavioral, for tobacco cessation.
- •5.ST using individuals with diagnosis or oral cancer.
- •Due to the nature of care required, any such individuals identified during the recruitment process will receive a direct referral to specialist care for treatment.
结局指标
主要结局
1.Intervention delivery (quantitative and qualitative)
时间窗: 6, 12, 26 weeks
3.Data collection and measurement methods
时间窗: 6, 12, 26 weeks
Feasibility assessments of:
时间窗: 6, 12, 26 weeks
2.Recruitment, randomisation and retention
时间窗: 6, 12, 26 weeks
次要结局
- Secondary:(1.Preliminary economic assessment: Change in quality of life and health resource use at 26 weeks)