NCT05786547

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

Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, apovarenicline, Champix or Nocrav)

Detailed description

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).

Conditions

• Human Immunodeficiency Virus
• Smoking Cessation
• Smoking, Tobacco

Interventions

Type	Name	Description
DRUG	Varenicline	Per package dosing, tablet taken orally
BEHAVIORAL	Positively Smoke Free Mobile (PSF-M)	Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone
BEHAVIORAL	Standard Care	Brief cessation advice plus referral to local tobacco quitline

Timeline

• Start date: 2024-01-02
• Primary completion: 2026-07-22
• Completion: 2026-07-22
• First posted: 2023-03-27
• Last updated: 2025-06-15

Locations

2 sites across 2 countries: United States, India

Regulatory

• FDA-regulated drug study