V+PSF-M for Tobacco Cessation in HIV Care in India

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Varenicline
  • Positively Smoke Free Mobile (PSF-M)
  • Standard Care

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

National Cancer Institute (NCI)

Collaborator