About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cystine
- Positively Smoke Free
- Placebo
- Standard of Care
Treatment groups
Sponsors and collaborators
University of Chicago
Lead sponsor
National Cancer Institute (NCI)
Collaborator
University of Maryland
Collaborator