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RECRUITINGPhase 3INTERVENTIONAL

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

Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Varenicline

Per package dosing, tablet taken orally

BEHAVIORAL

Positively Smoke Free Mobile (PSF-M)

Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone

BEHAVIORAL

Standard Care

Brief cessation advice plus referral to local tobacco quitline

Locations (2)

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