NCT05786547 · University of Colorado, Denver
V+PSF-M for Tobacco Cessation in HIV Care in India
What this study 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).
View original scientific description
The goal of this research study is to test an intervention to help quit tobacco use in participants with Human Immunodeficiency Virus (HIV).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Aurora, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2025 · Source of record for eligibility and locations