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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 3
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
University of Colorado
RECRUITING
Aurora
Other Locations
India
VHS Infectious Disease Medical Centre, CART Clinical Research Site
RECRUITING
Chennai
Contact Information
Primary
Gina Kruse, MD
gina.kruse@cuanschutz.edu
303-724-4811
Backup
Yamila L Sierra, MPH
yamila.sierra@cuanschutz.edu
(303) 724-4549
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2026-07-22
Participants
Target number of participants: 400
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

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