V+PSF-M for Tobacco Cessation in HIV Care in India
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Varenicline
Per package dosing, tablet taken orally
Other Names:
Behavioral: Positively Smoke Free Mobile (PSF-M)
Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone
|
| Active Comparator: Standard Care Brief advice to quit tobacco Offer of referral to the national tobacco quitline |
Behavioral: Standard Care
Brief cessation advice plus referral to local tobacco quitline
|
Outcome Measures
Primary Outcome Measures
- 7-Day Point Prevalent Abstinence (PPA) Rate [24 weeks post-randomization]
Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding 24-week follow-up and supported by a negative urine cotinine test of < 50 ng/ml
Secondary Outcome Measures
- 7-day self-reported (PPA) Rate [4 weeks post-randomization]
Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding follow-up
- 7-day self-reported (PPA) Rate [12 weeks post-randomization]
Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding follow-up
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults (≥18 years)
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Confirmed HIV diagnosis with VL < 1000 copies/mL and CD4>200 cells/mm3 within past 6 months
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Self-reported current smoking or dual tobacco use verified by exhaled carbon monoxide ≥7 ppm
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Able to read at 6th grade level or greater and speak Tamil, Telugu or English
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Able to use varenicline safely based on evaluation by primary provider at VHS
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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.
Exclusion Criteria:
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Pregnant or planning to become pregnant in the next 6 months
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Breastfeeding
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Myocardial infarction in past 30 days or unstable angina
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History of liver or kidney failure
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ALT and AST > 2 times ULN or creatinine clearance <50 in past 6 months
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History of suicide attempt
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Current suicidal ideation
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Untreated or unstable major depressive disorder
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History of psychosis or on anti-psychotic medications
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Cognitive impairment limiting ability to consent
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Allergy to varenicline
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02215 |
| 2 | VHS Infectious Disease Medical Centre, CART Clinical Research Site | Chennai | Tamil Nadu | India | 600113 |
Sponsors and Collaborators
- Massachusetts General Hospital
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Gina Kruse, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-356
- 1U01CA261614-01