Abstract：
OBJECTIVE: Smokeless tobacco (ST) use in South Asia is high, yet interventions to support its cessation are lacking. We tested the feasibility of delivering interventions for ST cessation in South Asia.
METHODS: We used a 2 × 2 factorial design, pilot randomized controlled trial with a duration of 26 weeks, including baseline and follow-up (6, 12 and 26 weeks) assessments.
METHODS: Two primary health-care facilities each in Dhaka (Bangladesh) and Karachi (Pakistan) and a walk-in cancer screening clinic in Noida (India) took part.
METHODS: Adult daily ST users willing to make a quit attempt within 30 days. Of 392 screened, 264 participants [mean age: 35 years, standard deviation = 12.5, 140 (53%) male] were recruited between December 2020 and December 2021; 132 from Bangladesh, 44 from India and 88 from Pakistan.
METHODS: Participants were randomized to one of three treatment options [8-week support through nicotine replacement therapy (NRT, n = 66), a behavioural intervention for smokeless tobacco cessation in adults (BISCA, n = 66) or their combination (n = 66)] or the control condition of very brief advice (VBA) to quit (n = 66).
METHODS: Recruitment and retention, data completeness and feasibility of intervention delivery were evaluated. Biochemically verified abstinence from tobacco, using salivary cotinine, was measured at 26 weeks.
RESULTS: Retention rates were 94.7% at 6 weeks, dropping to 89.4% at 26 weeks. Attendance in BISCA pre-quit (100%) and quit sessions (86.3%) was high, but lower in post-quit sessions (65.9%), with variability among countries. Adherence to NRT also varied (45.5% Bangladesh, 90% India). Data completion for key variables exceeded 93% among time-points, except at 26 weeks for questions on nicotine dependence (90%), urges (89%) and saliva samples (62.7%). Among follow-up time-points, self-reported abstinence was generally higher among participants receiving BISCA and/or NRT. At 26 weeks, biochemically verified abstinence was observed among 16 (12.1%) participants receiving BISCA and 13 (9.8%) participants receiving NRT.
CONCLUSIONS: This multi-country pilot randomized controlled trial of tobacco cessation among adult smokeless tobacco users in South Asia demonstrated the ability to recruit and retain participants and report abstinence, suggesting that a future definitive smokeless tobacco cessation trial is viable.
METHODS: We used a 2 × 2 factorial design, pilot randomized controlled trial with a duration of 26 weeks, including baseline and follow-up (6, 12 and 26 weeks) assessments.
METHODS: Two primary health-care facilities each in Dhaka (Bangladesh) and Karachi (Pakistan) and a walk-in cancer screening clinic in Noida (India) took part.
METHODS: Adult daily ST users willing to make a quit attempt within 30 days. Of 392 screened, 264 participants [mean age: 35 years, standard deviation = 12.5, 140 (53%) male] were recruited between December 2020 and December 2021; 132 from Bangladesh, 44 from India and 88 from Pakistan.
METHODS: Participants were randomized to one of three treatment options [8-week support through nicotine replacement therapy (NRT, n = 66), a behavioural intervention for smokeless tobacco cessation in adults (BISCA, n = 66) or their combination (n = 66)] or the control condition of very brief advice (VBA) to quit (n = 66).
METHODS: Recruitment and retention, data completeness and feasibility of intervention delivery were evaluated. Biochemically verified abstinence from tobacco, using salivary cotinine, was measured at 26 weeks.
RESULTS: Retention rates were 94.7% at 6 weeks, dropping to 89.4% at 26 weeks. Attendance in BISCA pre-quit (100%) and quit sessions (86.3%) was high, but lower in post-quit sessions (65.9%), with variability among countries. Adherence to NRT also varied (45.5% Bangladesh, 90% India). Data completion for key variables exceeded 93% among time-points, except at 26 weeks for questions on nicotine dependence (90%), urges (89%) and saliva samples (62.7%). Among follow-up time-points, self-reported abstinence was generally higher among participants receiving BISCA and/or NRT. At 26 weeks, biochemically verified abstinence was observed among 16 (12.1%) participants receiving BISCA and 13 (9.8%) participants receiving NRT.
CONCLUSIONS: This multi-country pilot randomized controlled trial of tobacco cessation among adult smokeless tobacco users in South Asia demonstrated the ability to recruit and retain participants and report abstinence, suggesting that a future definitive smokeless tobacco cessation trial is viable.
摘要：
目标：南亚无烟烟草（ST）使用率很高，然而，缺乏支持其停止的干预措施。我们测试了在南亚实施ST段停止干预措施的可行性。
方法：我们使用2×2阶乘设计，为期26周的试点随机对照试验，包括基线和随访（6、12和26周）评估。
方法：分别位于达卡（孟加拉国）和卡拉奇（巴基斯坦）的两个初级卫生保健机构和诺伊达（印度）的一个癌症筛查诊所参加了。
方法：成人每日ST用户愿意在30天内尝试戒烟。在392次筛选中，264名参与者[平均年龄：35岁，标准差=12.5，140（53%）男性]在2020年12月至2021年12月期间招募；132名来自孟加拉国，44来自印度，88来自巴基斯坦。
方法：参与者被随机分为三种治疗方案之一[通过尼古丁替代疗法提供8周支持（NRT，n=66),成人无烟戒烟的行为干预(BISCA，n=66）或其组合（n=66）]或非常简短的建议（VBA）退出（n=66）的控制条件。
方法：招聘和保留，评估了数据的完整性和干预交付的可行性.经生化验证的烟草禁欲，使用唾液可替宁，在26周测量。
结果：6周时保留率为94.7%，在26周时降至89.4%。BISCA预退出(100%)和退出会议(86.3%)的出勤率很高，但在离职后的会议中更低(65.9%)，各国之间存在差异。对NRT的坚持也各不相同(45.5%的孟加拉国，90%印度）。关键变量的数据完成时间点超过93%，除了在26周对尼古丁依赖的问题（90％），催促(89%)和唾液样本(62.7%)。在后续时间点，在接受BISCA和/或NRT的参与者中,自我报告的禁欲通常较高.26周时,在接受BISCA的16名(12.1%)参与者和接受NRT的13名(9.8%)参与者中观察到生化验证的禁欲。
结论：这项针对南亚成年无烟烟草使用者戒烟的多国试点随机对照试验证明了招募和留住参与者并报告禁欲的能力，这表明未来的最终无烟戒烟试验是可行的。
方法：我们使用2×2阶乘设计，为期26周的试点随机对照试验，包括基线和随访（6、12和26周）评估。
方法：分别位于达卡（孟加拉国）和卡拉奇（巴基斯坦）的两个初级卫生保健机构和诺伊达（印度）的一个癌症筛查诊所参加了。
方法：成人每日ST用户愿意在30天内尝试戒烟。在392次筛选中，264名参与者[平均年龄：35岁，标准差=12.5，140（53%）男性]在2020年12月至2021年12月期间招募；132名来自孟加拉国，44来自印度，88来自巴基斯坦。
方法：参与者被随机分为三种治疗方案之一[通过尼古丁替代疗法提供8周支持（NRT，n=66),成人无烟戒烟的行为干预(BISCA，n=66）或其组合（n=66）]或非常简短的建议（VBA）退出（n=66）的控制条件。
方法：招聘和保留，评估了数据的完整性和干预交付的可行性.经生化验证的烟草禁欲，使用唾液可替宁，在26周测量。
结果：6周时保留率为94.7%，在26周时降至89.4%。BISCA预退出(100%)和退出会议(86.3%)的出勤率很高，但在离职后的会议中更低(65.9%)，各国之间存在差异。对NRT的坚持也各不相同(45.5%的孟加拉国，90%印度）。关键变量的数据完成时间点超过93%，除了在26周对尼古丁依赖的问题（90％），催促(89%)和唾液样本(62.7%)。在后续时间点，在接受BISCA和/或NRT的参与者中,自我报告的禁欲通常较高.26周时,在接受BISCA的16名(12.1%)参与者和接受NRT的13名(9.8%)参与者中观察到生化验证的禁欲。
结论：这项针对南亚成年无烟烟草使用者戒烟的多国试点随机对照试验证明了招募和留住参与者并报告禁欲的能力，这表明未来的最终无烟戒烟试验是可行的。
