Recruiting
Phase 3

V+PSF-M

Sponsor:

University of Colorado, Denver

Code:

NCT05786547

Conditions

Human Immunodeficiency Virus

Smoking Cessation

Smoking, Tobacco

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Varenicline

Positively Smoke Free Mobile (PSF-M)

Standard Care

Study Details

Brief 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)

Conditions

Human Immunodeficiency Virus

Smoking Cessation

Smoking, Tobacco

Study ID

NCT05786547

Start date

Jan 2, 2024

Status verified date

Jun, 2025

Completion date

Jul 22, 2026

Anticipated

Primary completion date

Jul 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

active comparator: Standard Care

Brief advice to quit tobacco Offer of referral to the national tobacco quitline

Interventions

Varenicline

Per package dosing, tablet taken orally

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

Primary outcome measure

  • 7-Day Point Prevalent Abstinence Rate [ Time Frame: 24 weeks post-randomization ]

Central Contacts and Locations

Central contacts

Gina Kruse, MD

303-724-4811gina.kruse@cuanschutz.edu

Yamila L Sierra, MPH

(303) 724-4549yamila.sierra@cuanschutz.edu

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Gina Kruse, MD

303-724-4811Gina.Kruse@cuanschutz.edu

Yamila L Sierra, MPH

303-724-4549yamila.sierra@cuanschutz.edu

Principal Investigator:

Gina Kruse, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 15, 2025

Last verified

Jun, 2025

Keywords

  • Human Immunodeficiency Virus
  • Smoking Cessation
  • Smoking, Tobacco

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-06-15.