Helping people with HIV quit smoking in India

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to evaluate the effectiveness of a combined intervention using varenicline and a mobile behavioral program called Positively Smoke Free-Mobile (PSF-M) to assist individuals living with HIV in quitting tobacco. Participants will be randomly assigned to receive either the intervention or standard care, which includes brief advice and referral to a quitline. The study will involve screening for eligibility, in-clinic visits, and completion of surveys over a 24-week period. Approximately 400 participants are expected to take part in this open-label, practice-based randomized trial.

Why it matters

Who can join: the full rules

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 it's running

• University of Colorado
  Aurora, Colorado, United States Recruiting
• VHS Infectious Disease Medical Centre, CART Clinical Research Site
  Chennai, Tamil Nadu, India Recruiting

Study contacts

• Principal investigator: Gina Kruse, MD — University of Colorado, Denver
• Study coordinator: Gina Kruse, MD
• Email: gina.kruse@cuanschutz.edu
• Phone: 303-724-4811

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.