V+PSF-M for Tobacco Cessation in HIV Care in India
Recruiting
Phase 3
Interventional Study
Human Immunodeficiency Virus
Smoking Cessation
Smoking, Tobacco
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 400 (estimated)
- Sponsor
- University of Colorado, Denver · Other
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About This Trial
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)
Trial Locations
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Eligibility Criteria
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 En…
Contacts