Optimizing Smoking Cessation Interventions for People Living With HIV in Nairobi, Kenya
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 7-day Abstinence
研究概览
简要总结
The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. The study will randomize 300 participants people living with HIV , who smoke and who are receiving care in HIV clinics affiliated with the Center for International Health, Education, and Biosecurity in Nairobi, Kenya to one of the following 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for people living with HIV smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care.
详细描述
The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. The will randomize 300 participants people living with HIV, who smoke and who are receiving care at HIV clinics affiliated with the Center for International Health, Education, and Biosecurity in Nairobi, Kenya to one of the following 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for people living with HIV smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care. The study will use a factorial design as it is a highly efficient method of assessing multiple treatments in a single trial with the possibility of saving both time and resources. All participants will be assessed at baseline,12 weeks and 36 weeks with the main outcome being 7-day abstinence (defined as self-reported no smoking in the past 7 days + CO<7 ppm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Has a history of seizure disorder or bulimia nervosa
- •Recent use of Bupropion (by participant report in the past 3 months)
- •Previous allergic reaction/hypersensitivity to Bupropion (by participant report ever in lifetime)
- •Pregnant, nursing, or becoming pregnant during the study (pregnancy test)
- •Current use of any medication that would interfere with the protocol in the opinion of a medically accountable Physician
- •Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period.
- •Expected survival of less than 6 months
- •Meets criteria for dementia by scoring below 10 on the Hopkins HIV Dementia Scale.
- •The study physician believes that the individual is not medially stable enough to participate in the study. This exclusion will be based on a review of the individual's past medical history and current medical status.
- •Based on screening, not meeting criteria for moderate or severe substance disorder as established by the MINI International Neuropsychiatric Interview.
研究组 & 干预措施
Bupropion + Positively Smoke Free
Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation bupropion--used for smoking cessation
干预措施: Bupropion (Drug)
Bupropion + Positively Smoke Free
Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation bupropion--used for smoking cessation
干预措施: Positively smoke free (Behavioral)
Bupropion + Standard of Care
Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation
干预措施: Bupropion (Drug)
Bupropion + Standard of Care
Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation
干预措施: Brief advice to quit smoking (Other)
Placebo + Positively Smoke Free
Placebo--matched to bupropion Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation
干预措施: Positively smoke free (Behavioral)
Placebo + Standard of Care.
Placebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format
干预措施: Brief advice to quit smoking (Other)
结局指标
主要结局
7-day Abstinence
时间窗: Up to 36 Weeks
defined as self-reported no smoking in the past 7 days + CO\<7 ppm
次要结局
未报告次要终点
研究者
Seth Himelhoch
Professor
University of Maryland, Baltimore