Health Condition 1: B998- Other infectious disease
Conditions
Interventions
Intervention1: Varenicline and Positively smoke free Mobile App: Varenicline is a FDA approved drug for tobacco cessation
Positively smoke free is a mobile app tailored to assist tobacco cessation
Va
Sponsors
National Cancer Institute
Eligibility
Inclusion criteria
Inclusion criteria: HIV positive willing to participate in the study
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemically validated 7-day point prevalent abstinence (PPA) at 6-monthsTimepoint: 4 Weeks, 12 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactPoongulali Selvamuthu
VHS Infectious Diseases Medical Centre, CART Clinical Research Site
Outcome results
None listed