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

NCT05786547 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-06-15

No results posted yet for this study

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)

Conditions

  • Human Immunodeficiency Virus
  • Smoking Cessation
  • Smoking, Tobacco

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Gina Kruse, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2026-07-22
Completion
2026-07-22
FDA Drug
Yes

Countries

  • United States
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05786547 on ClinicalTrials.gov