Helping people with HIV quit smoking in India
Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India
This study is testing if a combination of a smoking cessation medication and a mobile support program can help people with HIV in India quit smoking more effectively than standard care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT05786547 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of a combined intervention using varenicline and a mobile behavioral program called Positively Smoke Free-Mobile (PSF-M) to assist individuals living with HIV in quitting tobacco. Participants will be randomly assigned to receive either the intervention or standard care, which includes brief advice and referral to a quitline. The study will involve screening for eligibility, in-clinic visits, and completion of surveys over a 24-week period. Approximately 400 participants are expected to take part in this open-label, practice-based randomized trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed HIV diagnosis who currently smoke or use tobacco and are ready to quit.
Not a fit: Patients who are pregnant, breastfeeding, or have certain medical conditions such as recent myocardial infarction or severe liver or kidney failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve smoking cessation rates among individuals living with HIV.
How similar studies have performed: Previous studies have shown success with similar behavioral interventions for smoking cessation, particularly among populations with comorbidities.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- VHS Infectious Disease Medical Centre, CART Clinical Research Site — Chennai, Tamil Nadu, India (Recruiting)
Study contacts
- Principal investigator: Gina Kruse, MD — University of Colorado, Denver
- Study coordinator: Gina Kruse, MD
- Email: gina.kruse@cuanschutz.edu
- Phone: 303-724-4811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.