A study to provide Varenicline and mobile behavioral assistance for quitting tobacco in HIV positive individuals in India
Phase 3
- Conditions
- Health Condition 1: B998- Other infectious disease
- Registration Number
- CTRI/2023/03/050240
- Lead Sponsor
- ational Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
HIV positive
willing to participate in the study
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biochemically validated 7-day point prevalent abstinence (PPA) at 6-monthsTimepoint: 4 Weeks, 12 weeks and 24 weeks
- Secondary Outcome Measures
Name Time Method 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 sustainabilityTimepoint: 24 weeks