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Clinical Trials in India / NCT05786547
Recruiting Phase 3

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

NCT05786547 · tracked via the Priya Life Science India tracker
Sponsor
University of Colorado, Denver
Phase
Phase 3
Started
2024-01-02
Last updated
2025-06-15

Condition(s) studied

Human Immunodeficiency VirusSmoking CessationSmoking, Tobacco

Investigational drug(s) / intervention(s)

VareniclinePositively Smoke Free Mobile (PSF-M)Standard Care

Varenicline: Per package dosing, tablet taken orally

Positively Smoke Free Mobile (PSF-M): Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone

Standard Care: Brief cessation advice plus referral to local tobacco quitline

Study summary

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
University of Colorado Aurora Colorado Recruiting
VHS Infectious Disease Medical Centre, CART Clinical Research Site Chennai Tamil Nadu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05786547 on ClinicalTrials.gov ↗ ← All trials in India