Botswana Smoking and Abstinence Reinforcement Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 750
- 试验地点
- 15
- 主要终点
- Smoking Abstinence
研究概览
简要总结
Many people living with HIV in southern Africa, specifically Botswana use tobacco products. Using tobacco makes some of the effects of HIV worse and even causes excess deaths. The investigators plan to use an intervention called Screening, Brief Intervention and Referral to Treatment (SBIRT) to help people to quit smoking and also a drug called varenicline. Apart from helping people to stop smoking, the investigators will also test to see how task shifting can be used to help people stop smoking in a sustainable way. Finally, the investigators will estimate the cost of the intervention.
详细描述
The investigators will utilize a stepped wedge cluster randomized trial to implement BSMART. BSMART will be sequentially rolled out to 15 participating HIV treatment and care facilities assigned in three steps. Each step will provide data for a 12- month control/pre-implementation, a 12-month implementation, and a 12-month maintenance period. The investigators will stratify Botswana's HIV treatment and care facilities into three levels of facilities. The investigative team will randomly assign each of the three levels of facilities to one of three study steps. Each step will comprise (i.e. have representation) from 3 levels of facilities, giving each level of facilities the same probability of beginning the intervention at any step).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV infected
- •Self reported current daily smoker
- •Age 18 and older
- •Engaged in HIV care as defined by being on ART for at least 6 months
- •Willing/able to provide informed consent in English or Setswana
排除标准
- •Less than 18 years of age
- •Unable or cognitively impaired to provide consent
研究组 & 干预措施
SBIRT
Trained LHWs will oversee the screening and brief intervention procedures (i.e., the 5As). A culturally acceptable standardized form will be integrated into intake procedures within the HIV that will allow for the documentation and results of using the 5As. The first "A" will be the screening question where the LHW will "Ask" study participants about smoking. When a participant reports being a smoker, the LHW will proceed to the next 3 "A"s (Advise, Assess, Assist). These 3As will constitute the brief intervention. The LHW will utilize motivational enhancing discussion between the study participant with a focus on increasing insight and awareness regarding smoking and motivation toward behavioral change. For those participants who are motivated for treatment, a referral will be made to a clinic nurse practitioner for evaluation for treatment with varenicline.
干预措施: Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange) (Behavioral)
SBIRT
Trained LHWs will oversee the screening and brief intervention procedures (i.e., the 5As). A culturally acceptable standardized form will be integrated into intake procedures within the HIV that will allow for the documentation and results of using the 5As. The first "A" will be the screening question where the LHW will "Ask" study participants about smoking. When a participant reports being a smoker, the LHW will proceed to the next 3 "A"s (Advise, Assess, Assist). These 3As will constitute the brief intervention. The LHW will utilize motivational enhancing discussion between the study participant with a focus on increasing insight and awareness regarding smoking and motivation toward behavioral change. For those participants who are motivated for treatment, a referral will be made to a clinic nurse practitioner for evaluation for treatment with varenicline.
干预措施: Varenicline (Drug)
Standard of Care
Trained LHWs will provide a brief motivation counseling and a brochure about smoking cessation.
结局指标
主要结局
Smoking Abstinence
时间窗: Week 24
Abstinence will be based on self-reported 7-day point prevalence abstinence confirmed by expired CO\<6 ppm. Abstinence criteria must be met in study month 6 or at an earlier study week and maintained through study month 6 to be considered a responder. We will use CO Check+ (MD Spiro), a single-breath point-of-care tool designed specifically for use in smoking cessation programs and clinics
次要结局
- Adherence to medication(Weeks 0, 1, 2, 4, 8, and 12)
研究者
Man Charurat
Director, Division of Epidemiology and Prevention
University of Maryland, Baltimore