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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Human Immunodeficiency Virus; Smoking, Tobacco
• Intervention / Treatment: Drug: Varenicline; Behavioral: Positively Smoke Free Mobile (PSF-M); Behavioral: Standard Care

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).

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Gina Kruse, MD; Phone Number: 303-724-4811; Email: Gina.Kruse@cuanschutz.edu
• Study Contact Backup: Name: Yamila L Sierra, MPH; Phone Number: (303) 724-4549; Email: yamila.sierra@cuanschutz.edu

Study Locations

• India
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600113
      • Recruiting
      • VHS Infectious Disease Medical Centre, CART Clinical Research Site
      • Contact: N Kumarasammy; Phone Number: 09176912007; Email: kumarasamy@cartcrs.org
      • Contact: Poongulali Selvamuthu; Phone Number: 09940560019; Email: poongulali@cartcrs.org
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Contact: Gina Kruse, MD; Phone Number: 303-724-4811; Email: Gina.Kruse@cuanschutz.edu
      • Contact: Yamila L Sierra, MPH; Phone Number: 303-724-4549; Email: yamila.sierra@cuanschutz.edu
      • Principal Investigator: Gina Kruse, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults (≥18 years)
• Confirmed HIV diagnosis
• Self-reported current smoking or dual tobacco use verified either by exhaled carbon monoxide ≥7 ppm, or by positive qualitative cotinine point-of-care test
• 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 at VHS
• 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.
• Ready to quit or interested in quitting

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varenicline + Positively Smoke Free - Mobile; Offer of varenicline per package dosing with dose escalation over week 1: 0.5 mg once daily on days 1 - 3, 0.5 mg twice daily on days 4 -7, followed by 1.0 mg twice daily on days 8 to 84. Offer of Positively Smoke Free Mobile delivered by mobile phone including 42 days of content, tailored to individual quit date.	Drug: Varenicline; Per package dosing, tablet taken orally; Other Names: Champix, apovarenicline, Nocrav; Behavioral: Positively Smoke Free Mobile (PSF-M); Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone
Active Comparator: Standard Care; Brief advice to quit tobacco Offer of referral to the national tobacco quitline	Behavioral: Standard Care; Brief cessation advice plus referral to local tobacco quitline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Gina Kruse, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Estimated): July 22, 2026
• Study Completion (Estimated): July 22, 2026

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Human Immunodeficiency Virus; Smoking Cessation; Smoking, Tobacco
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 23-1017; 1U01CA261614-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Principle Investigator. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No