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

• Status: Not yet recruiting
• Trial end date: 2025-07-20
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Cancer Institute (NCI)
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• Adults (≥18 years)

• Confirmed HIV diagnosis with VL < 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 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.

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

• ALT and AST > 2 times 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 anti-psychotic medications

• Cognitive impairment limiting ability to consent

• Allergy to varenicline