V+PSF-M for Tobacco Cessation in HIV Care in India
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Varenicline, Positively Smoke Free Mobile (PSF-M), Standard Care.
- Who it may be relevant to
- Registry conditions: Human Immunodeficiency Virus, Smoking Cessation, Smoking, Tobacco. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India
Overview
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)
Detailed description
Open-label, practice-based randomized trial of varenicline + Positively Smoke Free-Mobile (PSF-M) for people living with Human Immunodeficiency Virus (PWH) who smoke or use both smoked and smokeless tobacco compared with a group that receives standard care including brief advice and quitline referral.
Positively Smoke Free (PSF) is a behavioral intervention which has been tested in multiple formats including a mobile version. Varenicline is the single most-effective pharmacotherapy agent for quitting tobacco with demonstrated efficacy for cessation of cigarettes, smokeless tobacco, and cessation among smokers with comorbidities
In this study, participants will be randomized to either Group 1: Varenicline + Positively Smoke Free-Mobile adapted for Chennai versus Group 2: Standard care with brief tobacco cessation advice and referral to the national quitline.
Research procedures include screening for eligibility, in-clinic visits, and completion of surveys and questionnaires.
Participation in this study is expected to last about 24 weeks.
It is expected about 400 people will take part in this research study.
This study is funded by the National Cancer Institute of the National Institute of Health (NIH).
Interventions
- Drug Varenicline
Per package dosing, tablet taken orally - Behavioral Positively Smoke Free Mobile (PSF-M)
Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone - Behavioral Standard Care
Brief cessation advice plus referral to local tobacco quitline
Primary outcome measures
- 7-Day Point Prevalent Abstinence Rate [Time frame: 24 weeks post-randomization]
Secondary outcome measures (2)
- 7-day self-reported Point Prevalent Abstinence Rate [Time frame: 4 weeks post-randomization]
- 7-day self-reported Point Prevalent Abstinence Rate [Time frame: 12 weeks post-randomization]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Colorado — Aurora
India · 1 center
- VHS Infectious Disease Medical Centre, CART Clinical Research Site — Chennai
Publications
- Malpeddi T, Poongulali S, Shuter J, Rigotti NA, An LC, Kumarasamy N, Reddy KP, Shergina E, Colborn K, Faith B, Sierra YL, Kruse GR. Protocol for the Mobile behavioral support plus varenicline for tobacco cessation among people living with HIV in India (MoVIe): A hybrid implementation-effectiveness randomized trial. Contemp Clin Trials. 2026 Jan;160:108179. doi: 10.1016/j.cct.2025.108179. Epub 2025 PMID 41352530
Identifiers
NCT: NCT05786547 · 23-1017 · 1U01CA261614-01