Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India
University of Colorado, Denver
Summary
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)
Description
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 cessat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugVarenicline
Per package dosing, tablet taken orally
- BehavioralPositively Smoke Free Mobile (PSF-M)
Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone
- BehavioralStandard Care
Brief cessation advice plus referral to local tobacco quitline
Locations (2)
- University of ColoradoAurora, Colorado
- VHS Infectious Disease Medical Centre, CART Clinical Research SiteChennai, Tamil Nadu