Recruiting soon

Smoking and Alcohol Use Treatment for People With HIV in Nairobi

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What is being tested

Cystine

+ Positively Smoke Free

+ Standard of Care

DrugBehavioralOther
Who is being recruted

Alcoholism+6

+ Behavior

+ Mental Disorders

From 18 to 80 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: June 2026
See protocol details

Summary

Principal SponsorUniversity of Chicago
Study ContactWalter MchembereMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on improving treatments for people living with HIV (PWH) in Nairobi, Kenya, who also struggle with smoking and unhealthy alcohol use. The aim is to find effective ways to manage these co-occurring issues, which can significantly impact the health and quality of life of individuals. Addressing both smoking and alcohol use in this population is crucial, as it can lead to better health outcomes and potentially improve the effectiveness of HIV treatments. Participants in the study will receive interventions designed to help reduce or quit smoking and unhealthy alcohol use. The study is in Phase 3, which means it is testing the effectiveness and safety of these interventions on a larger scale. The results will be measured to determine how well the treatments work in helping participants manage their smoking and alcohol use. The study's findings could lead to better strategies for improving the overall health and well-being of people living with HIV who face these additional challenges.

Official TitleOptimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya
NCT06790342
Principal SponsorUniversity of Chicago
Study ContactWalter MchembereMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlcoholismBehaviorMental DisordersHealth BehaviorSubstance-Related DisordersAlcohol-Related DisordersTobacco Use CessationChemically-Induced DisordersTobacco Use

Criteria

8 inclusion criteria required to participate
Confirmed chart diagnosis of HIV
At least 18 years or age
Currently self-reports smoking (has smoked a cigarette within the past 7 days) and has expired air Carbon Monoxide (CO) 6ppm. Expired air CO provides an accurate indirect measure of carboxyhemoglobin (COHb) level and is a standard biochemical method for assessing a smoker's level of intake.
Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)
Show More Criteria
9 exclusion criteria prevent from participating
Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment
Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya)
History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations
Pregnant, nursing, or becoming pregnant during the study
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Cystine--used for smoking cessation and alcohol reduction

Group II

Experimental
Cystine--used for smoking cessation and alcohol reduction Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation

Group III

Experimental
Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Placebo--matched to bupropion

Group IV

Placebo
Placebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Mathari National Teaching and Referral Hospital

Nairobi, KenyaOpen Mathari National Teaching and Referral Hospital in Google Maps
Suspended

Riruta Health Centre

Nairobi, Kenya
Recruiting soon2 Study Centers