RecruitingPhase 3NCT05786547

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

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


Sponsor

University of Colorado, Denver

Enrollment

400 participants

Start Date

Jan 2, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a program combining varenicline (a prescription quit-smoking pill), personalized support, and mHealth tools to help people living with HIV in India quit smoking or using tobacco. Tobacco use is especially harmful for people with HIV, and this program aims to offer an effective, accessible approach. **You may be eligible if...** - You are 18 or older and have a confirmed HIV diagnosis - You currently smoke cigarettes or use tobacco in combination with other products - You can read at a 6th grade level and speak Tamil, Telugu, or English - You are ready to quit or interested in quitting - Your doctor considers it safe for you to take varenicline **You may NOT be eligible if...** - You are pregnant or planning to become pregnant in the next 6 months - You are breastfeeding - You have had a heart attack in the past 30 days or have unstable chest pain - You have a history of liver or kidney failure - You have a history of suicide attempts or current suicidal thoughts - You have untreated or unstable major depression or a history of psychosis - You are allergic to varenicline Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVarenicline

Per package dosing, tablet taken orally

BEHAVIORALPositively Smoke Free Mobile (PSF-M)

Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone

BEHAVIORALStandard Care

Brief cessation advice plus referral to local tobacco quitline


Locations(2)

University of Colorado

Aurora, Colorado, United States

VHS Infectious Disease Medical Centre, CART Clinical Research Site

Chennai, Tamil Nadu, India

View Full Details on ClinicalTrials.gov

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NCT05786547


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