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)
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 cessation among smokers with comorbidities In this study, participants will be randomized to either Group 1: Varenicline + Positively Smoke Free-Mobile adapted for Chennai versus Group 2: Standard care with brief tobacco cessation advice and referral to the national quitline. Research procedures include screening for eligibility, in-clinic visits, and completion of surveys and questionnaires. Participation in this study is expected to last about 24 weeks. It is expected about 400 people will take part in this research study. This study is funded by the National Cancer Institute of the National Institute of Health (NIH).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
400
Per package dosing, tablet taken orally
Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone
Brief cessation advice plus referral to local tobacco quitline
University of Colorado
Aurora, Colorado, United States
RECRUITINGVHS Infectious Disease Medical Centre, CART Clinical Research Site
Chennai, Tamil Nadu, India
RECRUITING7-Day Point Prevalent Abstinence Rate
Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding 24-week follow-up supported by a negative urine cotinine test of \< 50 ng/ml
Time frame: 24 weeks post-randomization
7-day self-reported Point Prevalent Abstinence Rate
Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding follow-up
Time frame: 4 weeks post-randomization
7-day self-reported Point Prevalent Abstinence Rate
Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding 24-week follow-up supported by a negative urine cotinine test of \< 50 ng/ml
Time frame: 12 weeks post-randomization
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