V+PSF-M for Tobacco Cessation in HIV Care in India
Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India
2 other identifiers
interventional
400
2 countries
2
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2024
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 27, 2023
CompletedStudy Start
First participant enrolled
January 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 22, 2026
June 15, 2025
June 1, 2025
2.6 years
March 13, 2023
June 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
7-Day Point Prevalent Abstinence Rate
Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding 24-week follow-up supported by a negative urine cotinine test of \< 50 ng/ml
24 weeks post-randomization
Secondary Outcomes (2)
7-day self-reported Point Prevalent Abstinence Rate
4 weeks post-randomization
7-day self-reported Point Prevalent Abstinence Rate
12 weeks post-randomization
Study Arms (2)
Varenicline + Positively Smoke Free - Mobile
EXPERIMENTALOffer of varenicline per package dosing with dose escalation over week 1: 0.5 mg once daily on days 1 - 3, 0.5 mg twice daily on days 4 -7, followed by 1.0 mg twice daily on days 8 to 84. Offer of Positively Smoke Free Mobile delivered by mobile phone including 42 days of content, tailored to individual quit date.
Standard Care
ACTIVE COMPARATORBrief advice to quit tobacco Offer of referral to the national tobacco quitline
Interventions
Per package dosing, tablet taken orally
Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
University of Colorado
Aurora, Colorado, 80045, United States
VHS Infectious Disease Medical Centre, CART Clinical Research Site
Chennai, Tamil Nadu, 600113, India
Related Publications (1)
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 Dec 4.
PMID: 41352530DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gina Kruse, MD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2023
First Posted
March 27, 2023
Study Start
January 2, 2024
Primary Completion (Estimated)
July 22, 2026
Study Completion (Estimated)
July 22, 2026
Last Updated
June 15, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication.
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation.
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Principle Investigator. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.