V+PSF-M for Tobacco Cessation in HIV Care in India
RecruitingPhase 3
Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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)
What is being tested
- Varenicline (drug)
- Positively Smoke Free Mobile (PSF-M) (behavioral)
- Standard Care (behavioral)
Sponsor: University of Colorado, Denver · Participants: 400 · Started: Jan 2, 2024
Contact the study team
- Gina Kruse, MD · Phone: 303-724-4811
- Yamila L Sierra, MPH · Phone: (303) 724-4549
Official record on ClinicalTrials.gov — NCT05786547
Locations in the U.S.
| Colorado | University of Colorado, Aurora |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.