Testing Treatments for Smoking and Heavy Drinking in Adults With HIV in Kenya
Tests cytisine and counseling to help adults with HIV quit smoking and drink less.
Plain-language title generated from the registry record
Registry title: Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya
Key facts
- Where
- Nairobi, KenyaSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with HIV in Nairobi, Kenya who smoke and drink heavily, want to quit smoking within 6 months and are willing to accept treatment for both.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- HIV confirmed in the medical chart. Currently smoking, with a carbon monoxide breath reading of 6ppm. Heavy drinking: 4+ drinks on a given day or more than 7 drinks a week over the past 30 days.
- Earlier treatment
- Cannot be getting any treatment for tobacco or alcohol use at the moment.
- Biomarker or test result
- Carbon monoxide in the exhaled breath of 6ppm (a test of smoking).
Main reasons for not taking part
- Currently getting any treatment for tobacco or alcohol use
- Allergic reaction to cytisine in the past
- Severe alcohol withdrawal in the past 12 months, such as seizure or hallucinations
- Pregnant, nursing or becoming pregnant during the study
- Possible dementia, unstable psychiatric illness, or expected survival of less than 6 months
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06790342, who can take part
Where in Kenya
- Mathari National Teaching and Referral HospitalNairobi, KenyaNo longer taking part
- Riruta Health CentreNairobi, KenyaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Chicago
- Trial code
- NCT06790342
- Record updated
- 30 July 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya); Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician; History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations; Meets criteria for possible dementia by scoring below 10 on the Hopkins HIV Dementia Scale; Unstable psychiatric illness; Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment; Pregnant, nursing, or becoming pregnant during the study; 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.