Clinical trial NCT05786547: V+PSF-M for Tobacco Cessation in HIV Care in India
Official title: Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Human Immunodeficiency Virus
Smoking Cessation
Smoking, Tobacco
Keywords: Human Immunodeficiency Virus
Smoking Cessation
Smoking, Tobacco
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-03-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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).

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

Primary outcomes:
measure: 7-Day Point Prevalent Abstinence Rate
timeFrame: 24 weeks post-randomization
Secondary outcomes:
measure: 7-day self-reported Point Prevalent Abstinence Rate
timeFrame: 4 weeks post-randomization
measure: 7-day self-reported Point Prevalent Abstinence Rate
timeFrame: 12 weeks post-randomization
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Chennai
country: India
facility: VHS Infectious Disease Medical Centre, CART Clinical Research Site
state: Tamil Nadu
Study officials:
affiliation: University of Colorado, Denver
name: Gina Kruse, MD
role: PRINCIPAL_INVESTIGATOR
References: