Who is eligible for clinical trial NCT05786547?

Participants must meet protocol criteria for Human Immunodeficiency Virus. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05786547 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-06-13

V+PSF-M for Tobacco Cessation in HIV Care in India (NCT05786547)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: University of Colorado, Denver

🩺 Plain-English Summary (8th-Grade Level)

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)

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (12 items).

Location: University of Colorado — Aurora, Colorado

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

University of Colorado — Aurora, Colorado
VHS Infectious Disease Medical Centre, CART Clinical Research Site — Chennai, Tamil Nadu

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗