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)

Open-label, practice-based randomized trial of varenicline + Positively Smoke Free-Mobile (PSF-M) for people living with Human Immunodeficiency Virus (PWH) who smoke or use both smoked and smokeless tobacco compared with a group that receives standard care including brief advice and quitline referral.

Positively Smoke Free (PSF) is a behavioral intervention which has been tested in multiple formats including a mobile version. Varenicline is the single most-effective pharmacotherapy agent for quitting tobacco with demonstrated efficacy for cessation of cigarettes, smokeless tobacco, and cessation among smokers with comorbidities

In this study, participants will be randomized to either Group 1: Varenicline + Positively Smoke Free-Mobile adapted for Chennai versus Group 2: Standard care with brief tobacco cessation advice and referral to the national quitline.

Research procedures include screening for eligibility, in-clinic visits, and completion of surveys and questionnaires.

Participation in this study is expected to last about 24 weeks.

It is expected about 400 people will take part in this research study.

This study is funded by the National Cancer Institute of the National Institute of Health (NIH).

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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Principle Investigator. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Data can be shared no earlier than 1 year following the date of publication.

Contact the Partners Innovations team at http://www.partners.org/innovation.