Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05786547

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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V+PSF-M for Tobacco Cessation in HIV Care in India | DecenTrialz