Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- 7-day point prevalence abstinence (PPA)
研究概览
简要总结
People with HIV (PWH) smoke tobacco cigarettes and drink alcohol at higher rates than the general population, both in the US and internationally, including low- and middle-income countries. Now that effective antiretroviral therapy is available throughout most of the world, PWH are surviving long enough to manifest the lethal consequences of both their smoking and drinking. In this project, the investigational team aims to advance the knowledge and understanding of treatment strategies (i.e. individual intensive counseling ± pharmacotherapy with cytisine) that target both tobacco and alcohol use among PWH in Kenya, a resource constrained environment, and to generate outcome data that may benefit co-users of tobacco and alcohol throughout the world.
详细描述
This study was reviewed and approved for data analysis by the University of Chicago.
The research portion of this study was also submitted to and is pending approval from:
Board Name: AMREF ETHICAL AND SCIENTIFIC REVIEW COMMITTEE (ESRC) Board Affiliation: The AMREF ESRC is affiliated with AMREF Health Africa and accredited by National Commission for Science, Technology and Innovation (NACOSTI) since 200 Phone: +254 20 699 4000 Email: esrc.kenya@amref.org
Address:
Langata Road PO Box 27691-00506 Nairobi, Kenya
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
- •Confirmed chart diagnosis of HIV
- •At least 18 years or age
- •Currently self-reports smoking (has smoked a cigarette within the past 7 days) and has expired air Carbon Monoxide (CO) 6ppm. Expired air CO provides an accurate indirect measure of carboxyhemoglobin (COHb) level and is a standard biochemical method for assessing a smoker's level of intake.
- •Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)
- •Meets criteria for heavy drinking: National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines suggest gender-based criteria for heavy drinking but note that lower thresholds may be needed for people with a medical condition. PWH show increased physiologic injury and decreased survival at lower levels of alcohol consumption than those without HIV. Thus, we will use the lower limit for alcohol misuse/heavy drinking from the NIAAA guidelines for all study candidates, i.e. drinking 4+ drinks on a given day or >7 drinks/week over the past 30 days
- •Able to speak English (in Nairobi spoken English is near universal as English is an official language of Kenya)
- •Willingness to accept behavioral and/or pharmacologic tobacco and alcohol treatment
- •Willingness and ability to provide informed consent to participate.
排除标准
- •Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment
- •Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya)
- •History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations
- •Pregnant, nursing, or becoming pregnant during the study
- •Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician
- •Meets criteria for possible dementia by scoring below 10 on the Hopkins HIV Dementia Scale
- •Unstable psychiatric illness
- •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.
研究组 & 干预措施
Experimental: Cystine (CYT) + Positively Smoke Free
Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction
Cystine--used for smoking cessation and alcohol reduction
干预措施: Positively Smoke Free (Behavioral)
Experimental: Cystine + Standard of Care
Cystine--used for smoking cessation and alcohol reduction
Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation
干预措施: Standard of Care (Other)
Experimental: Placebo + Positively Smoke Free
Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction
Placebo--matched to bupropion
干预措施: Positively Smoke Free (Behavioral)
Placebo Comparator: Placebo + Standard of Care.
Placebo--matched to bupropion
Standard of Care--brief advice to quit provided in a standardized format
干预措施: Placebo (Other)
Placebo Comparator: Placebo + Standard of Care.
Placebo--matched to bupropion
Standard of Care--brief advice to quit provided in a standardized format
干预措施: Standard of Care (Other)
Experimental: Cystine (CYT) + Positively Smoke Free
Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction
Cystine--used for smoking cessation and alcohol reduction
干预措施: Cystine (Drug)
Experimental: Cystine + Standard of Care
Cystine--used for smoking cessation and alcohol reduction
Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation
干预措施: Cystine (Drug)
Experimental: Placebo + Positively Smoke Free
Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction
Placebo--matched to bupropion
干预措施: Placebo (Other)
结局指标
主要结局
7-day point prevalence abstinence (PPA)
时间窗: 36 months
Defined as self-reported no smoking in the past 7 days + Carbon Monoxide (CO)\<7 ppm
Dried blood spot phosphatidylethanol (PEth)
时间窗: 36 months
PEth level of less than 50ng/dl for cessation from heavy drinking linked (P30D)
Timeline Follow-Back (TLFB)
时间窗: 36 months
denial of self-reported heavy drinking days (denying any prior 7-day period with \>7 drinks or any single day with 4 drinks) for the past 30 days
次要结局
未报告次要终点