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Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion moved earlier from Aug 1, 2029 to Jan 1, 2028
    • Start date: Jun 1, 2026 to Jul 31, 2026
    • Study completion moved earlier from Feb 1, 2030 to Jun 1, 2029
    v3
  2. Notable Start date: Aug 1, 2025 to Jun 1, 2026v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
People with HIV (PWH) smoke tobacco cigarettes and drink alcohol at higher rates than the general population, both in the US and internationally, including low- and middle-income countries. Now that effective antiretroviral therapy is available throughout most of the world, PWH are surviving long enough to manifest the lethal consequences of both their smoking and drinking. In this project, the investigational team aims to advance the knowledge and understanding of treatment strategies (i.e. individual intensive counseling ± pharmacotherapy with cytisine) that target both tobacco and alcohol use among PWH in Kenya, a resource constrained environment, and to generate outcome data that may benefit co-users of tobacco and alcohol throughout the world.
Trial Details
NCT Number NCT06790342
Lead Sponsor University of Chicago
Collaborators: National Cancer Institute (NCI), University of Maryland
Conditions
(from sponsor)
HIV, Tobacco Use, Alcohol Use Disorder
Related terms Alcoholism, Tobacco Use, Tobacco Use Cessation
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov