Tests a quit-smoking medicine and mobile program for people with HIV in India
Tests varenicline and a mobile program to help adults with HIV quit tobacco.
Plain-language title generated from the registry record
Registry title: V+PSF-M for Tobacco Cessation in HIV Care in India
Key facts
- Where
- Chennai, IndiaSee the site
- Phase
- Phase 3
Where in India
- VHS Infectious Disease Medical Centre, CART Clinical Research SiteChennai, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Colorado, Denver
- Trial code
- NCT05786547
- Record updated
- 15 June 2025
- Original description
The goal of this research study is to test an intervention to help quit tobacco use in participants with Human Immunodeficiency Virus (HIV).Read full original descriptionShow less
Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India
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)
Inclusion: 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.
Exclusion: Myocardial infarction in past 30 days or unstable angina; History of liver or kidney failure; History of suicide attempt; Untreated or unstable major depressive disorder; History of psychosis or on anti-psychotic medications; Cognitive impairment limiting ability to consent; Allergy to varenicline; Alanine aminotransferase and Aspartate aminotransferase > 2 times upper limit of normal or creatinine clearance <50 in past 6 months; Pregnant or planning to become pregnant in the next 6 months; Breastfeeding; Current suicidal ideation.