NCT05786547 V+PSF-M for Tobacco Cessation in HIV Care in India
| NCT ID | NCT05786547 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Colorado, Denver |
| Condition | Human Immunodeficiency Virus |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2026-07-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2024-01-02 with a primary completion date of 2026-07-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, apovarenicline, Champix or Nocrav)
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 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
Contact & Investigator
Gina Kruse, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT05786547 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Human Immunodeficiency Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05786547 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT05786547 currently recruiting?
Yes, NCT05786547 is actively recruiting participants. Contact the research team at gina.kruse@cuanschutz.edu for enrollment information.
Where is the NCT05786547 trial being conducted?
This trial is being conducted at Aurora, United States, Chennai, India.
Who is sponsoring the NCT05786547 clinical trial?
NCT05786547 is sponsored by University of Colorado, Denver. The principal investigator is Gina Kruse, MD at University of Colorado, Denver. The trial plans to enroll 400 participants.