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

Description

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)

Conditions

Human Immunodeficiency Virus, Smoking Cessation, Smoking, Tobacco

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Study Overview

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Study Details

Study overview

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)

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

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

Condition
Human Immunodeficiency Virus
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Gina Kruse, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

2026-04-26