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

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 3

Conditions: Human Immunodeficiency Virus; Smoking, Tobacco; Smoking Cessation

Treatments: Behavioral: Positively Smoke Free Mobile (PSF-M); Drug: Varenicline; Behavioral: Standard Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05786547

1U01CA261614-01 (U.S. NIH Grant/Contract)

23-1017

Details and patient eligibility

About

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)

Full 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).

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Varenicline + Positively Smoke Free - Mobile

Experimental group

Description:

Offer 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.

Treatment:

Drug: Varenicline

Behavioral: Positively Smoke Free Mobile (PSF-M)

Standard Care

Active Comparator group

Description:

Brief advice to quit tobacco Offer of referral to the national tobacco quitline

Treatment:

Behavioral: Standard Care