V+PSF-M for Tobacco Cessation in HIV Care in India
Recruiting now · Phase 3
Conditions studied: Human Immunodeficiency Virus, Smoking Cessation, Smoking, Tobacco
In brief
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)
Key facts
- Study ID
- NCT05786547
- Run by
- University of Colorado, Denver
- People needed
- 400
- Starts
- 2024-01-02
- Expected to finish
- 2026-07-22
- Last updated by the study team
- 2025-06-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Colorado — Aurora, Colorado, United States (enrolling)
- VHS Infectious Disease Medical Centre, CART Clinical Research Site — Chennai, Tamil Nadu, India (enrolling)
Full record on ClinicalTrials.gov
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