Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya (NCT06790342) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya
Kenya300 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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