NCT06790342Not yet recruitingPhase 3
Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 17 Jan 2025
- Start date
- Jul 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- University of Chicago
- Diseases
- HIV
- NCT number
- NCT06790342
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From Jul 2026 to the primary completion date, Jan 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Riruta Health Centre Coordinator of this site? Confirm its status | Nairobi | Kenya | Unknown status |
| Mathari National Teaching and Referral Hospital Coordinator of this site? Confirm its status | Nairobi | Kenya | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.