Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- 7-Day Point Prevalent Abstinence Rate
研究概览
简要总结
The goal of this research study is to test an intervention to help quit tobacco use in participants with Human Immunodeficiency Virus (HIV).
The study interventions used in this research study are:
- Positively Smoke Free - Mobile (PSF-M) (mobile behavioral program)
- Varenicline (or Chantix, apovarenicline, Champix or Nocrav)
详细描述
Open-label, practice-based randomized trial of varenicline + Positively Smoke Free-Mobile (PSF-M) for people living with Human Immunodeficiency Virus (PWH) who smoke or use both smoked and smokeless tobacco compared with a group that receives standard care including brief advice and quitline referral.
Positively Smoke Free (PSF) is a behavioral intervention which has been tested in multiple formats including a mobile version. Varenicline is the single most-effective pharmacotherapy agent for quitting tobacco with demonstrated efficacy for cessation of cigarettes, smokeless tobacco, and cessation among smokers with comorbidities
In this study, participants will be randomized to either Group 1: Varenicline + Positively Smoke Free-Mobile adapted for Chennai versus Group 2: Standard care with brief tobacco cessation advice and referral to the national quitline.
Research procedures include screening for eligibility, in-clinic visits, and completion of surveys and questionnaires.
Participation in this study is expected to last about 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years)
- •Confirmed HIV diagnosis
- •Self-reported current smoking or dual tobacco use verified either by exhaled carbon monoxide ≥7 ppm, or by positive qualitative cotinine point-of-care test
- •Able to read at 6th grade level or greater and speak Tamil, Telugu or English
- •Able to use varenicline safely based on evaluation by primary provider at VHS
- •Women of childbearing potential who consent to use a medically approved method of contraception or abstain from intercourse while taking study medication and for one month after.
- •Ready to quit or interested in quitting
排除标准
- •Pregnant or planning to become pregnant in the next 6 months
- •Breastfeeding
- •Myocardial infarction in past 30 days or unstable angina
- •History of liver or kidney failure
- •Alanine aminotransferase and Aspartate aminotransferase > 2 times upper limit of normal or creatinine clearance <50 in past 6 months
- •History of suicide attempt
- •Current suicidal ideation
- •Untreated or unstable major depressive disorder
- •History of psychosis or on anti-psychotic medications
- •Cognitive impairment limiting ability to consent
- •Allergy to varenicline
研究组 & 干预措施
Varenicline + Positively Smoke Free - Mobile
Offer of varenicline per package dosing with dose escalation over week 1: 0.5 mg once daily on days 1 - 3, 0.5 mg twice daily on days 4 -7, followed by 1.0 mg twice daily on days 8 to 84.
Offer of Positively Smoke Free Mobile delivered by mobile phone including 42 days of content, tailored to individual quit date.
干预措施: Varenicline (Drug)
Varenicline + Positively Smoke Free - Mobile
Offer of varenicline per package dosing with dose escalation over week 1: 0.5 mg once daily on days 1 - 3, 0.5 mg twice daily on days 4 -7, followed by 1.0 mg twice daily on days 8 to 84.
Offer of Positively Smoke Free Mobile delivered by mobile phone including 42 days of content, tailored to individual quit date.
干预措施: Positively Smoke Free Mobile (PSF-M) (Behavioral)
Standard Care
Brief advice to quit tobacco Offer of referral to the national tobacco quitline
干预措施: Standard Care (Behavioral)
结局指标
主要结局
7-Day Point Prevalent Abstinence Rate
时间窗: 24 weeks post-randomization
Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding 24-week follow-up supported by a negative urine cotinine test of \< 50 ng/ml
次要结局
- 7-day self-reported Point Prevalent Abstinence Rate(12 weeks post-randomization)