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

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).

Offer of varenicline per package dosing with dose escalation over week 1: 0.5 mg once daily on days 1 - 3, 0.5 mg twice daily on days 4 -7, followed by 1.0 mg twice daily on days 8 to 84. Offer of Positively Smoke Free Mobile delivered by mobile phone including 42 days of content, tailored to individual quit date.

Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding 24-week follow-up supported by a negative urine cotinine test of < 50 ng/ml

Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding follow-up

Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding 24-week follow-up supported by a negative urine cotinine test of < 50 ng/ml

Inclusion Criteria: Adults (≥18 years) Confirmed HIV diagnosis with viral load < 1000 copies/mL and CD4>200 cells/mm3 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 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. 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.