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NOT YET RECRUITING

NCT06790342

PHASE3

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

Sponsor: University of Chicago

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-06-01

Completion Date

2030-02-01

Last Updated

2025-12-11

Healthy Volunteers

Conditions

HIV Tobacco Use Alcohol Use Disorder

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)

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.

Locations (2)

Mathari National Teaching and Referral Hospital

Nairobi, Kenya

Riruta Health Centre