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

Launched by UNIVERSITY OF COLORADO, DENVER · Mar 13, 2023

Keywords

ClinConnect Summary

This clinical trial, called V+PSF-M for Tobacco Cessation in HIV Care in India, is looking for ways to help people living with HIV quit smoking and using tobacco. The study will test two main tools: a mobile program called Positively Smoke Free - Mobile (PSF-M) that provides support and guidance through a phone app, and a medication called varenicline (also known as Chantix) that helps reduce cravings for nicotine. The goal is to find effective methods to help these individuals stop using tobacco, which is important for their overall health.

To participate in this study, you need to be an adult (18 years or older) with a confirmed HIV diagnosis, and your health needs to be stable. You should be currently smoking or using tobacco, and able to read and speak either Tamil, Telugu, or English. If you’re interested, it’s important to know that pregnant women, those planning to become pregnant, or individuals with certain health conditions may not be eligible. Participants will receive support through the mobile program and medication, and they’ll be monitored throughout the study to ensure their safety. This trial is currently recruiting participants, so this could be a great opportunity for those looking to quit smoking while managing their HIV.

Gender

ALL

Eligibility criteria

• 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