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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786547
• Other study ID #: 23-1017
• Secondary ID: 1U01CA261614-01
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2024
• Est. completion date: July 20, 2025

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: Gina Kruse, MD
• Phone: 303-724-4811
• Email: gina.kruse[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 20, 2025
• Est. primary completion date: July 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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.

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Smoking Cessation
• Smoking, Tobacco

Intervention

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
• Standard Care
Brief cessation advice plus referral to local tobacco quitline

Locations

Country	Name	City	State
India	VHS Infectious Disease Medical Centre, CART Clinical Research Site	Chennai	Tamil Nadu
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-Day Point Prevalent Abstinence Rate	Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding 24-week follow-up supported by a negative urine cotinine test of < 50 ng/ml	24 weeks post-randomization
Secondary	7-day self-reported Point Prevalent Abstinence Rate	Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding follow-up	4 weeks post-randomization
Secondary	7-day self-reported Point Prevalent Abstinence Rate	Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding 24-week follow-up supported by a negative urine cotinine test of < 50 ng/ml	12 weeks post-randomization