V+PSF-M for Tobacco Cessation in HIV Care in India
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Aurora 5412347, Colorado 5417618 80045
More Details
- NCT ID
- NCT05786547
- Status
- Recruiting
- Sponsor
- University of Colorado, Denver
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).