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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05786547
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Varenicline — DRUG
    Per package dosing, tablet taken orally
  • Positively Smoke Free Mobile (PSF-M) — BEHAVIORAL
    Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone
  • Standard Care — BEHAVIORAL
    Brief cessation advice plus referral to local tobacco quitline

Study Details

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)

Key Dates

Start date
Jan 2, 2024
Status verified
Jun 2025
Primary completion
Jul 22, 2026
Completion
Jul 22, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045
Gina Kruse, MD
[email protected]
303-724-4811
Yamila L Sierra, MPH
[email protected]
303-724-4549
Gina Kruse, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
HIV
By specialty
Infectious disease
By research site
University of Colorado· Aurora, CO

Related Studies