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Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India
Trial Status: active
This phase III clinical trial compares the effect of the combination of varenicline and a mobile application (app), positively smoke free (PSF), compared to standard of care for tobacco cessation in people with human immunodeficiency virus (HIV) in India. People living with HIV (PLHIV) who smoke are more likely to develop heart and lung diseases and cancer compared to smokers without HIV. However only 5% of people can quit using tobacco. Medicines to help quit smoking are available but only 4% of people using tobacco products use it. PLHIV are motivated to quit and the success at quitting depends on their social support and other illnesses. Hence, they need a combined treatment of pharmacotherapy (taking medicine to quit tobacco) and behavioral support. Varenicline is a drug used to help people stop smoking by acting the same way nicotine acts in the brain. It is a type of nicotine receptor partial agonist. PSF is a mobile web app and text message intervention to help people quit tobacco use. Combined treatment of varenicline and the PSF app may help PLHIV in India quit tobacco use.
Inclusion Criteria
Adults (>= 18 years)
Confirmed HIV diagnosis with viral load (VL) < 1000 copies/mL and CD4 > 200 cells/mm^3 within past 6 months
Self-reported current smoking or dual tobacco use verified by exhaled carbon monoxide >= 7 ppm
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 transaminase (ALT) and aspartate transaminase (AST) > 2 times upper limit of normal (ULN) 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 antipsychotic medications
Cognitive impairment limiting ability to consent
Allergy to varenicline
Additional locations may be listed on ClinicalTrials.gov for NCT05786547.
I. To demonstrate the effectiveness of an integrated intervention combining varenicline plus mobile behavioral treatment, compared to standard care, for achieving biochemically verified tobacco abstinence at 24 weeks among tobacco users in HIV care in India.
II. To examine the implementation processes of the integrated intervention in low- and middle- income country (LMIC) HIV practice.
III. To measure the costs and cost-effectiveness of an integrated intervention with varenicline and positively smoke free mobile (PSF-M).
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive standard of care (SOC) smoking cessation advice and referral to the national quitline.
GROUP II: Participants receive SOC smoking cessation advice and use the PSF-M app on study. Patients also receive varenicline orally (PO) daily (QD) on days 1-3 of week 1 and then twice daily (BID) starting on day 4 of week 1 for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
Upon completion of study intervention, participants are followed up to 24 weeks.
