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

NCT06790342 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-12-11

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Maryland

    collaborator OTHER

  • University of Chicago

    lead OTHER

Principal Investigators

  • Seth Himelhoch · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-08-01
Completion
2030-02-01

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

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 NCT06790342 on ClinicalTrials.gov