Varenicline and mobile behavioral assistance for tobacco cessation in HIV care in India
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Biochemically validated 7-day point prevalent abstinence (PPA) at 6-months
研究概览
简要总结
This project proposes an open label, randomized controlled trial of 400 persons living with HIV who smoke or use smoked and smokeless tobacco and are in care for HIV in Chennai. Participants will be followed over 24 weeks. Participants will be randomized 1:1, stratified by gender, language and tobacco use type to either:
§ Group 1: Varenicline + Positively Smoke Free-Mobile;
§ Group 2: Standard care with brief tobacco cessation advice and referral to the national quitline.
Participant data will be collected at baseline, 4-, 12- and 24-weeks post enrollment.This project proposes an open label, randomized controlled trial of 400 persons living with HIV who smoke or use smoked and smokeless tobacco and are in care for HIV in Chennai. Participants will be followed over 24 weeks. Participants will be randomized 1:1, stratified by gender, language and tobacco use type to either:
§ Group 1: Varenicline + Positively Smoke Free-Mobile;
§ Group 2: Standard care with brief tobacco cessation advice and referral to the national quitline.
Participant data will be collected at baseline, 4-, 12- and 24-weeks post enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •HIV positive willing to participate in the study.
排除标准
- •1.Past 30-day use of tobacco cessation pharmacotherapy or behavioral treatments 2.Pregnant or planning to become pregnant in the next 6 months 3.Breastfeeding 4.Myocardial infarction in past 30 days or unstable angina 5.History of liver or kidney failure 6.ALT and AST > 2 times ULN or creatinine clearance <50 in past 6 months 7.History of suicide attempt 8.Current suicidal ideation53 9.Untreated or unstable major depressive disorder 10.History of psychosis or on anti-psychotic medications 11.Cognitive impairment limiting ability to consent 12.Allergy to varenicline.
结局指标
主要结局
Biochemically validated 7-day point prevalent abstinence (PPA) at 6-months
时间窗: 4 Weeks, 12 weeks and 24 weeks
次要结局
- process outcomes and an adaptation of the framework for digital health interventions81,82 we will examine acceptability, adoption, appropriateness, feasibility, fidelity, cost, reach also called penetration, and sustainability(24 weeks)