Actively Recruiting
V+PSF-M for Tobacco Cessation in HIV Care in India
Led by University of Colorado, Denver · Updated on 2025-06-15
400
Participants Needed
2
Research Sites
133 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
V+PSF-M for Tobacco Cessation in HIV Care in India
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 years or older)
- Confirmed diagnosis of HIV
- Current smoker or dual user of smoked and smokeless tobacco verified by tests
- Able to read at 6th grade level or higher and speak Tamil, Telugu, or English
- Medically able to use varenicline as determined by primary provider
- Women of childbearing potential agree to use approved contraception or abstain while on medication and for one month after
- Interested in quitting tobacco or ready to quit
You will not qualify if you...
- Pregnant or planning pregnancy within 6 months
- Breastfeeding
- Heart attack in past 30 days or unstable angina
- History of liver or kidney failure
- Elevated liver enzymes or low kidney function in past 6 months
- History of suicide attempt or current suicidal thoughts
- Untreated or unstable major depression
- History of psychosis or on anti-psychotic medication
- Cognitive impairment that limits ability to consent
- Allergy to varenicline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
VHS Infectious Disease Medical Centre, CART Clinical Research Site
Chennai, Tamil Nadu, India, 600113
Actively Recruiting
Research Team
G
Gina Kruse, MD
CONTACT
Y
Yamila L Sierra, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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