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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-01

Study Completion Date

2030-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya

NCT05351606

Tobacco Use Cessation Tobacco Use

COMPLETED PHASE4

Cultural Adaptation and Piloting of a Smoking Cessation Intervention for Smokers With HIV

NCT03580460

Hiv Cigarette Smoking

COMPLETED NA

Development of a Tailored Smoking Cessation Program for Individuals With HIV Infection in Washington, D.C.

NCT04594109

Tobacco Smoking

COMPLETED NA

Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care

NCT03670316

HIV AIDS Smoking Cessation

COMPLETED PHASE4

Motivation and Patch Treatment for HIV-positive Smokers

NCT00551720

HIV Infections Smoking Cessation

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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: +254 20 699 4000 Email: [email protected]

Address:

Langata Road PO Box 27691-00506 Nairobi, Kenya

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Tobacco Use Alcohol Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental: Cystine (CYT) + Positively Smoke Free

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

Cystine--used for smoking cessation and alcohol reduction

Group Type EXPERIMENTAL

Cystine

Intervention Type DRUG

Used for smoking cessation and alcohol reduction

Positively Smoke Free

Intervention Type BEHAVIORAL

An 8 session tailored behavioral treatment for smoking cessation and alcohol reduction

Experimental: Cystine + Standard of Care

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 Type EXPERIMENTAL

Cystine

Intervention Type DRUG

Used for smoking cessation and alcohol reduction

Standard of Care

Intervention Type OTHER

Standardized brief advice to quit smoking (standard of care)

Experimental: Placebo + Positively Smoke Free

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

Placebo--matched to bupropion

Group Type EXPERIMENTAL

Positively Smoke Free

Intervention Type BEHAVIORAL

An 8 session tailored behavioral treatment for smoking cessation and alcohol reduction

Placebo

Intervention Type OTHER

Matched to cystine

Placebo Comparator: Placebo + Standard of Care.

Placebo--matched to bupropion

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matched to cystine

Standard of Care

Intervention Type OTHER

Standardized brief advice to quit smoking (standard of care)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cystine

Used for smoking cessation and alcohol reduction

Intervention Type DRUG

Positively Smoke Free

An 8 session tailored behavioral treatment for smoking cessation and alcohol reduction

Intervention Type BEHAVIORAL

Placebo

Matched to cystine

Intervention Type OTHER

Standard of Care

Standardized brief advice to quit smoking (standard of care)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Confirmed chart diagnosis of HIV
2. At least 18 years or age
3. 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.
4. Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)
5. Meets criteria for heavy drinking: National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines suggest gender-based criteria for heavy drinking but note that lower thresholds may be needed for people with a medical condition. PWH show increased physiologic injury and decreased survival at lower levels of alcohol consumption than those without HIV. Thus, we will use the lower limit for alcohol misuse/heavy drinking from the NIAAA guidelines for all study candidates, i.e. drinking 4+ drinks on a given day or \>7 drinks/week over the past 30 days
6. Able to speak English (in Nairobi spoken English is near universal as English is an official language of Kenya)
7. Willingness to accept behavioral and/or pharmacologic tobacco and alcohol treatment
8. Willingness and ability to provide informed consent to participate.

Exclusion Criteria

1. Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment
2. Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya)
3. History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations
4. Pregnant, nursing, or becoming pregnant during the study
5. Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician
6. Meets criteria for possible dementia by scoring below 10 on the Hopkins HIV Dementia Scale
7. Unstable psychiatric illness
8. Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period
9. Expected survival of less than 6 months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No