RECRUITING

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

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Conditions

Human Immunodeficiency VirusSmoking CessationSmoking, Tobacco

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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

Quick Facts

Study Start:2024-01-02
Study Completion:2026-04-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05786547

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (≥18 years)
  2. * Confirmed HIV diagnosis with viral load \< 1000 copies/mL and CD4\>200 cells/mm3 within past 6 months
  3. * Self-reported current smoking or dual tobacco use verified by exhaled carbon monoxide ≥7 ppm
  4. * Able to read at 6th grade level or greater and speak Tamil, Telugu or English
  5. * Able to use varenicline safely based on evaluation by primary provider
  6. * 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.
  1. * Pregnant or planning to become pregnant in the next 6 months
  2. * Breastfeeding
  3. * Myocardial infarction in past 30 days or unstable angina
  4. * History of liver or kidney failure
  5. * Alanine aminotransferase and Aspartate aminotransferase \> 2 times upper limit of normal or creatinine clearance \<50 in past 6 months
  6. * History of suicide attempt
  7. * Current suicidal ideation
  8. * Untreated or unstable major depressive disorder
  9. * History of psychosis or on anti-psychotic medications
  10. * Cognitive impairment limiting ability to consent
  11. * Allergy to varenicline

Contacts and Locations

Study Contact

Gina Kruse, MD
CONTACT
303-724-4811
gina.kruse@cuanschutz.edu
Yamila L Sierra, MPH
CONTACT
(303) 724-4549
yamila.sierra@cuanschutz.edu

Principal Investigator

Gina Kruse, MD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

University of Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-02
Study Completion Date2026-04-26

Study Record Updates

Study Start Date2024-01-02
Study Completion Date2026-04-26

Terms related to this study

Keywords Provided by Researchers

  • Human Immunodeficiency Virus
  • Smoking Cessation
  • Smoking, Tobacco

Additional Relevant MeSH Terms

  • Human Immunodeficiency Virus
  • Smoking Cessation
  • Smoking, Tobacco