Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2024-01-02
2026-07-22
Brief Summary
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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)
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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 advice to quit tobacco Offer of referral to the national tobacco quitline
Standard Care
Brief cessation advice plus referral to local tobacco quitline
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Gina Kruse, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado
Aurora, Colorado, United States
VHS Infectious Disease Medical Centre, CART Clinical Research Site
Chennai, Tamil Nadu, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-1017
Identifier Type: -
Identifier Source: org_study_id
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