Health TrialsbyHealthPanel

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

ConditionsHuman Immunodeficiency VirusSmoking CessationSmoking, Tobacco
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Varenicline

    Drug

    Per package dosing, tablet taken orally

  • Positively Smoke Free Mobile (PSF-M)

    Behavioral

    Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone

  • Standard Care

    Behavioral

    Brief cessation advice plus referral to local tobacco quitline

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Varenicline + Positively Smoke Free - MobileExperimental treatment 2 interventions
Group B: Standard CareActive comparator 1 intervention

Trial outcomes

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

Time frame
24 weeks post-randomization

Secondary outcomes

1

7-day self-reported Point Prevalent Abstinence Rate

Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding follow-up

Time frame
4 weeks post-randomization
2

7-day self-reported 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

Time frame
12 weeks post-randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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