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

NCT06790342 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: IRB24-16261R01CA288235-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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

HIV; Tobacco Use; Alcohol Use Disorder

Keywords

HIV; Tobacco Cessation; Alcohol Reduction

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Experimental: Cystine (CYT) + Positively Smoke Free

EXPERIMENTAL

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; Behavioral: Positively Smoke Free

Experimental: Cystine + Standard of Care

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

Drug: Cystine; Other: Standard of Care

Experimental: Placebo + Positively Smoke Free

EXPERIMENTAL

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

Behavioral: Positively Smoke Free; Other: Placebo

Placebo Comparator: Placebo + Standard of Care.

PLACEBO COMPARATOR

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

Other: Placebo; Other: Standard of Care

Interventions

Cystine DRUG

Used for smoking cessation and alcohol reduction

Experimental: Cystine (CYT) + Positively Smoke Free; Experimental: Cystine + Standard of Care

Positively Smoke Free BEHAVIORAL

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

Experimental: Cystine (CYT) + Positively Smoke Free; Experimental: Placebo + Positively Smoke Free

Placebo OTHER

Matched to cystine

Experimental: Placebo + Positively Smoke Free; Placebo Comparator: Placebo + Standard of Care.

Standard of Care OTHER

Standardized brief advice to quit smoking (standard of care)

Experimental: Cystine + Standard of Care; Placebo Comparator: Placebo + Standard of Care.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• Able to speak English (in Nairobi spoken English is near universal as English is an official language of Kenya)
• Willingness to accept behavioral and/or pharmacologic tobacco and alcohol treatment
• Willingness and ability to provide informed consent to participate.

You may not qualify if:

• 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
• Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician
• Meets criteria for possible dementia by scoring below 10 on the Hopkins HIV Dementia Scale
• Unstable psychiatric illness
• Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period
• Expected survival of less than 6 months.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Chicago: lead
• University of Maryland: collaborator

Study Sites (2)

Mathari National Teaching and Referral Hospital

Nairobi, Kenya

Location

Riruta Health Centre

Nairobi, Kenya

Location

Related Publications (2)

• 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.

  PMID: 37432430 BACKGROUND

• 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.

  PMID: 39437141 BACKGROUND

MeSH Terms

Conditions

Tobacco Use; Alcoholism; Tobacco Use Cessation

Interventions

Cystine; Standard of Care

Condition Hierarchy (Ancestors)

Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior

Intervention Hierarchy (Ancestors)

Disulfides; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Cysteine; Amino Acids, Sulfur; Organic Chemicals; Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Seth Himelhoch

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter Mchembere

CONTACT

+254 20 3908219; wmchembere@cihebkenya.org

Emily Koech, MD

CONTACT

+254 20 3908219; ekoech@cihebkenya.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 24, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KE (2)