NCT06790342

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study was reviewed and approved for data analysis by the University of Chicago. The research portion of this study was also submitted to and is pending approval from: Board Name: AMREF ETHICAL AND SCIENTIFIC REVIEW COMMITTEE (ESRC) Board Affiliation: The AMREF ESRC is affiliated with AMREF Health Africa and accredited by National Commission for Science, Technology and Innovation (NACOSTI) since 200 Phone: [phone] Email: [e-mail] Address: Langata Road PO Box 27691-00506 Nairobi, Kenya

Conditions

• HIV
• Tobacco Use
• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Cystine	Used for smoking cessation and alcohol reduction
BEHAVIORAL	Positively Smoke Free	An 8 session tailored behavioral treatment for smoking cessation and alcohol reduction
OTHER	Placebo	Matched to cystine
OTHER	Standard of Care	Standardized brief advice to quit smoking (standard of care)

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-08-01
• Completion: 2030-02-01
• First posted: 2025-01-24
• Last updated: 2025-12-11

Locations

2 sites across 1 country: Kenya