NCT05786547RecruitingPhase 3
V+PSF-M for Tobacco Cessation in HIV Care in India
Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India
Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 13 Mar 2023
- Start date
- 2 Jan 2024
- Primary completion date
- 22 Jul 2026
- Lead sponsor
- University of Colorado, Denver
- Diseases
- HIV
- NCT number
- NCT05786547
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 2 Jan 2024 to the primary completion date, 22 Jul 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Myocardial infarction in past 30 days or unstable angina
- History of liver or kidney failure
- History of suicide attempt
- Untreated or unstable major depressive disorder
- History of psychosis or on anti-psychotic medications
- Cognitive impairment limiting ability to consent
- Allergy to varenicline
Lab values
- Alanine aminotransferase and Aspartate aminotransferase \> 2 times upper limit of normal or creatinine clearance \<50 in past 6 months
Other
- Pregnant or planning to become pregnant in the next 6 months
- Breastfeeding
- Current suicidal ideation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VHS Infectious Disease Medical Centre, CART Clinical Research Site Coordinator of this site? Confirm its status | Chennai | India | Recruiting |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.