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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use; HIV; Alcohol Use Disorder
• Intervention / Treatment: Drug: Cystine; Behavioral: Positively Smoke Free; Other: Standard of Care; Other: Placebo

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: +254 20 699 4000 Email: esrc.kenya@amref.org

Address:

Langata Road PO Box 27691-00506 Nairobi, Kenya

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Walter Mchembere; Phone Number: +254 20 3908219; Email: wmchembere@cihebkenya.org
• Study Contact Backup: Name: Emily Koech, MD; Phone Number: +254 20 3908219; Email: ekoech@cihebkenya.org

Study Locations

• Kenya
  • Nairobi, Kenya
    • Riruta Health Centre
  • Nairobi, Kenya
    • Mathari National Teaching and Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Experimental: 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	Drug: Cystine; Used for smoking cessation and alcohol reduction; Other: Standard of Care; Standardized brief advice to quit smoking (standard of care)
Experimental: Experimental: Placebo + Positively Smoke Free; Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Placebo--matched to bupropion	Behavioral: Positively Smoke Free; An 8 session tailored behavioral treatment for smoking cessation and alcohol reduction; Other: Placebo; Matched to cystine
Placebo Comparator: Placebo Comparator: Placebo + Standard of Care.; Placebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format	Other: Standard of Care; Standardized brief advice to quit smoking (standard of care); Other: Placebo; Matched to cystine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day point prevalence abstinence (PPA)	Defined as self-reported no smoking in the past 7 days + Carbon Monoxide (CO)<7 ppm	36 months
Dried blood spot phosphatidylethanol (PEth)	PEth level of less than 50ng/dl for cessation from heavy drinking linked (P30D)	36 months
Timeline Follow-Back (TLFB)	denial of self-reported heavy drinking days (denying any prior 7-day period with >7 drinks or any single day with 4 drinks) for the past 30 days	36 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Cancer Institute (NCI); University of Maryland
• Investigators: Principal Investigator: Seth Himelhoch, University of Chicago

Publications and helpful links

General Publications

• Rigotti NA, Benowitz NL, Prochaska J, Leischow S, Nides M, Blumenstein B, Clarke A, Cain D, Jacobs C. Cytisinicline for Smoking Cessation: A Randomized Clinical Trial. JAMA. 2023 Jul 11;330(2):152-160. doi: 10.1001/jama.2023.10042.
• Himelhoch SS, Koech E, Omanya AA, Oduor P, Mchembere W, Masai TW, Bennett ME, Li L, Potts W, Ojoo S, Shuter J. Efficacy of Smoking Cessation Interventions among People with HIV in Kenya. NEJM Evid. 2024 Nov;3(11):EVIDoa2400090. doi: 10.1056/EVIDoa2400090. Epub 2024 Oct 22.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: HIV; Tobacco Cessation; Alcohol Reduction
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Behavior; Health Behavior; Alcoholism; Tobacco Use; Tobacco Use Cessation; Health Services Administration; Health Care Quality, Access, and Evaluation; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Quality of Health Care; Quality Indicators, Health Care; Inorganic Chemicals; Amino Acids; Amino Acids, Dicarboxylic; Sulfides; Anions; Ions; Electrolytes; Hydrogen Sulfide; Amino Acids, Diamino; Cysteine; Amino Acids, Sulfur; Disulfides; Standard of Care; Cystine
• Other Study ID Numbers: IRB24-1626; 1R01CA288235-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No