The goal of this research study is to test an intervention to help quit tobacco use inparticipants 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).
Drug: Varenicline
Per package dosing, tablet taken orally
Other Name: Champix, apovarenicline, Nocrav
Behavioral: Positively Smoke Free Mobile (PSF-M)
Behavioral tobacco cessation intervention for people living with HIV, delivered via
mobile phone
Behavioral: Standard Care
Brief cessation advice plus referral to local tobacco quitline
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 quitting
Exclusion Criteria:
- Pregnant or planning to become pregnant in the next 6 months
- Breastfeeding
- Myocardial infarction in past 30 days or unstable angina
- History of liver or kidney failure
- Alanine aminotransferase and Aspartate aminotransferase > 2 times upper limit of
normal or creatinine clearance <50 in past 6 months
- History of suicide attempt
- Current suicidal ideation
- Untreated or unstable major depressive disorder
- History of psychosis or on anti-psychotic medications
- Cognitive impairment limiting ability to consent
- Allergy to varenicline
University of Colorado
Aurora, Colorado, United States
VHS Infectious Disease Medical Centre, CART Clinical Research Site
Chennai, Tamil Nadu, India
Gina Kruse, MD
303-724-4811
gina.kruse@cuanschutz.edu
Yamila L Sierra, MPH
(303) 724-4549
yamila.sierra@cuanschutz.edu
Gina Kruse, MD, Principal Investigator
University of Colorado, Denver